FDA Pharmaceutical and Medical Device Headline NewsGE’s Surgery Division Gets Green Light to Resume ProductionThe FDA cleared GE Healthcare to resume full-scale manufacturing at its OEC Medical System division early this month, marking an end to the company’s yearlong effort to bring its X-ray surgical imaging systems operations into compliance.
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Companies to Develop Computer-Assisted Diagnostic Test for Cervical CancerHealth Discovery Corp. and DCL Medical Laboratories signed a letter of intent to jointly develop a computer-assisted diagnostic test for cervical cancer.
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Dilon Receives CE Marking for Medical Imaging System Gamma CameraDilon Technologies has received CE Marking for its Dilon 6800 gamma camera.
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Arthrocare Buys Denmark Medical Device DistributorArthroCare Corp. has acquired Aarhus, Denmark-based OrtoConcept Scandinavia for an undisclosed amount.
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Oxygen-Supply Firms Turn to Customers for Help on the HillThe air we breathe may be free. Oxygen is not. Just how much it should cost is pitting the multibillion-dollar industry that supplies oxygen to medical patients against a large number of lawmakers and Medicare, which said it was being charged many times more for oxygen equipment rentals than the actual cost.
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B. Braun Announces Upgraded Ambulatory and Pain Management PumpB. Braun Medical Inc… announces the launch of the Curlin 6000 CMS, made possible through its distribution agreement with Curlin Medical Inc.
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Oncovista Seeks FDA Approval to Market Breast-Cancer Detection DeviceOncoVista Innovative Therapies Inc. has asked the Food and Drug Administration for a pre-Investigational Device Exemption meeting to discuss the prospect of having its AdnaTest Breast Cancer device eventually approved to sell in the United States.
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Fluidigm Inks Nordic Distribution Pact With AME BioscienceFluidigm said it has signed up AME Bioscience to distribute its integrated fluidic circuits in the Nordic region.
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Grass Valley Company Gets FDA OK for Prostate Cancer Imaging DeviceA Grass Valley company has received U.S. Food and Drug Administration clearance to sell a new prostate cancer imaging machine.
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Advisory Committees Vote No to Expand Fentora UseTwo FDA advisory committees said concerns over Fentora’s potential for addiction were too strong to let Cephalon expand the use of its cancer pain drug to treat opioid-tolerant, noncancer, chronic pain patients with breakthrough pain.
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USPTO Confirms Validity of Lipitor PatentThe U.S. Patent & Trademark Office (USPTO) has notified Pfizer that it will confirm the viability of the company’s ’893 basic patent for cholesterol drug Lipitor.
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Teva Sees Significant Copaxone Sales in First QuarterSales of Teva’s multiple sclerosis drug Copaxone grew by 35 percent to $542 million during the first quarter of the year compared with the first quarter of 2007.
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Par Acquires Spectrum's Interest in Sumatriptan InjectionPar Pharmaceutical Companies, Inc. announced that it amended its agreement with Spectrum Pharmaceuticals, Inc. for $20 million in cash to increase its share of profits from the generic versions of GlaxoSmithKline's Imitrex Injection, which will be immediately accretive to 2008 earnings and provide a strong return on the Company's investment.
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Baxter Says Legal Costs Related to Heparin Recall Not SignificantBaxter International Inc. has yet to experience significant legal costs in dealing with potential liability surrounding problems with the recalled blood thinner heparin, company chairman Robert Parkinson told Baxter shareholders.
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Merck Cost-Cutting Could Be Boon for Biotech FirmsMerck & Co.'s ongoing cost-cutting plan could be good news for biotechnology companies looking to partner with the pharmaceutical giant, analysts told BioWorld.
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Orexigen Completes Enrollment in Phase III Clinical ProgramOrexigen Therapeutics, Inc. … announced completion of enrollment in NB-303 and NB-304, the final two Phase III clinical trials for Contrave, its lead obesity product candidate.
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Palace Dismisses Concerns Over Unsigned Cheaper Drugs BillMalacañang has dismissed concerns over its alleged inaction on the cheaper medicines bill that [the Philippines] Congress has passed, saying the Palace has yet to receive from the legislature the final version of the measure before President Gloria Macapagal-Arroyo would sign it.
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Clinical Research Firms Battle Talent CrunchIt's a Herculean task finding skilled people to steer businesses.
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FDA Requesting Firms Update User Fee Product Lists by Mid-JuneWith the FDA anticipating publishing fiscal year (FY) 2009 drug user fees this August, the agency is asking manufacturers to provide a list of products and finished-dose manufacturing facilities subject to such fees by June 16.
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Incomplete Press Release Draws Untitled LetterZymoGenetics omitted certain information regarding a claim it made for topical hemostat Recothrom in a press release announcing FDA approval of the product, earning it an untitled letter.
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Generic Firms Get FDA Nod for RequipGlaxoSmithKline (GSK) is certain to see a decline in its $518 million U.S. sales of Requip now that the FDA has approved four generic versions of the restless leg treatment.
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Clinical Trials Transformation Initiative Names Executive BoardA partnership aimed at modernizing the clinical trial process in the U.S. is gaining momentum.
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Astellas’ Advagraf Receives Another Approvable LetterJapanese drugmaker Astellas says it has received a fourth approvable letter from the FDA for its immunosuppressant drug Advagraf, delaying again the drug’s outright approval.
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Levaquin Approved for Pediatric Anthrax ExposureThe FDA has approved Ortho-McNeil’s antibiotic Levaquin to treat pediatric patients exposed to inhaled anthrax.
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AbstractIn February, the FDA issued a draft guidance allowing the distribution of journal articles on off-label uses to replace a now-expired provision of the FDA Modernization Act. The guidance outlines the agency’s criteria for acceptable use of such articles. Industry and consumer advocacy groups have submitted comments to the FDA on the draft. The industry-organized Medical Information Working Group supports the draft’s intent, saying patients benefit from “increased distribution of off-label use information.” The Patient and Consumer Coalition says the protections offered by the draft are “poorly defined, subjective and difficult to monitor.” The draft guidance, “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Devices,” could significantly change the way academic detailing is produced and accomplished. At the same time, state legislatures are introducing bills that would inhibit or prohibit practices traditionally employed by drugmakers to inform physicians and, in some cases, consumers, of their products’ uses and benefits. This issue of The Food & Drug Letter looks at the regulations, enforcement and penalties surrounding promotion of off-label uses.
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Regulatory Basis of Labeling Includes Verbal StatementsThe Federal Food, Drug, and Cosmetic Act (FDCA) defines “label” and “labeling” in Sections 201(k) and 201(m) as “a display of written, printed, or graphic matter upon the immediate container of any article….”
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Scientific Exchange of Information Versus PromotionAlthough the FDA does not define scientific exchange versus promotion in its regulations, distinguishing between the two is relevant because whether something is product promotion determines the level of government regulation and oversight.
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Off-label Dissemination Originally Detailed in Final RuleThe FDA issued a final rule on “Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices” (21 CFR Part 99) in the Nov. 20, 1998, Federal Register.
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Prohibited Acts and FDA EnforcementFederal regulations outline statutory violations regarding off-label promotions.
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FDA Draft Guidance Permits Use of Off-Label InformationIgnoring pleas from Congress to hold off, the FDA is pushing ahead with a controversial set of recommendations that would permit companies to distribute journal articles discussing off-label uses of drugs and medical devices.
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Enforcement Options Are Based on RiskThe FDA’s enforcement strategy is risk based, aiming to deter violations.
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Fraud and Abuse Issues Can Increase PenaltiesPromotional activity is affected by laws other than the Food, Drug and Cosmetic Act.
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OIG Guidance for Manufacturers Includes Seven RecommendationsThe Office of Inspector General (OIG) in HHS, which oversees the FDA and the Centers for Medicare & Medicaid Services, enforces requirements regarding false claims and anti-kickback law violations.
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South African Bill Would Regulate Devices Under Expanded Drug AgencyA bill approved by the South African Cabinet would abolish the Medicines Control Council, replacing it with a new South African Health Products Regulatory Authority that would oversee the certification and registration of medical devices, cosmetics and food.
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Thailand: New Law Strengthening Device Regulation Takes EffectThailand’s amended medical device law is in effect, imposing new controls aimed at improving the quality and performance of devices manufactured in or imported into the country.
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ASEAN Crafting Regional Medical Devices DirectiveThe Association of Southeast Asian Nations (ASEAN) plans to complete the final draft of a harmonized medical device regulatory framework this summer and release the document for consultation by Jan. 31, 2009.
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Malta First to Transpose MDD, AIMDD Regulations for EC ReviewMalta is the first European Union country to transpose the revised Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) under a prescreening initiative launched by the European Commission (EC).
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India to Develop New Regulatory Scheme for Medical DevicesIndia’s Ministry of Health and Family Welfare (MHFW) is developing a set of regulations for medical devices as part of its effort to increase access to quality healthcare, the Confederation of Indian Industry says.
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France Outlines Conditions for Compatibility Claims Between DevicesThe French health products safety agency (Afssaps) provides guidance to manufacturers marketing medical devices they claim to be compatible in a statement posted recently on its website.
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Report Calls for U.S. to Remove Trade BarriersA number of U.S. policies disadvantage European companies and threaten to disrupt the flow of exports from the European Union (EU) to the U.S., a new report by the European Commission (EC) finds.
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GHTF Framework, Procedures Outlined in Final DocumentsThe Global Harmonization Task Force (GHTF) Steering Committee recently published final documents describing the organization’s membership, operational structure and rules of procedure.
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Global Task Force Issues Guidance on Use of Standards in Device EvaluationA final guidance, recently released by the Global Harmonization Task Force (GHTF), describes the role of technical standards in demonstrating that a medical device conforms to essential safety and performance principles.
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Second Draft of Device Network Standard Slated for Late 2008After receiving hundreds of comments on IEC 80001, a U.S. Food and Drug Administration (FDA) draft standard covering risk management for medical devices incorporated into IT networks, the technical committee working on the proposal expects to issue another draft late this year.
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Singapore Issues Draft Guidance on Device DistributionSingapore’s Health Sciences Authority (HSA) has released a draft guidance on the development, implementation and management of quality management systems that support good distribution practice for medical devices in Singapore.
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U.S. Lawmakers Push for Increased Device Inspections, Import DocumentationA draft bill circulated by key legislators in the U.S. House of Representatives would require the U.S. Food and Drug Administration (FDA) to inspect all device-manufacturing facilities — both foreign and domestic — every two years.
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Progress May Remain Slow at Combination Products OfficeOrganizational changes at the U.S. Food and Drug Administration’s (FDA) Office of Combination Products (OCP) are expected to slow the issuance of guidance documents and regulations for combination products, according to an industry consultant.
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FDA Official Sees Push for Clinical Trial RulesThe FDA and the HHS Office for Human Research Protections are working on a final rule for registering institutional review boards (IRBs), the first of the FDA’s efforts to issue regulations instead of guidances for clinical trials.
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Boston Scientific Granted European Approval for Advanced PacemakersBoston Scientific was given European CE Marking for its new ALTRUA family of pacemakers.
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Vascular Insights Receives FDA Clearance for Infusion CatheterVascular Insights has achieved 510(k) clearance from the FDA to market its ClariVein infusion catheter.
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Mediaid Receives USFDA Approval for Vital Sign MonitorsBangalore based Opto Circuits … announced that Mediaid, a wholly-owned subsidiary, has received approval from the United States Food and Drug Administration (FDA) for key vital sign monitoring products.
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St. Jude Medical Gets FDA, European Approval for Guiding SheathMedical device maker St. Jude Medical Inc. announced U.S. Food and Drug Administration and European CE Mark approval of the Strada Carotid Guiding Sheath.
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Cohera Medical Closes on $7.6 Million Financing RoundMedical device firm Cohera Medical Inc. said Wednesday that it closed on a financing round that brought in $7.6 million.
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Atrium Medical Receives FDA Approval for its Novel PatchesAtrium Medical Corporation is pleased to announce it has obtained US FDA 510(K) approval for two new Omega 3 surgical mesh products; C-QUR Edge V-Patch and C-QUR Lite V-Patch.
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CLX Medical Gets Increased Interest, Sales of Zonda's Test for ChlamydiaCLX Medical, Inc. … announced that the company's European distributors have reported an increased interest in diagnostic testing products for chlamydia, which has resulted in increased sales of Zonda Incorporated's rapid point of care test for chlamydia by those distributors.
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Medical Device Group ExpandsIn phase one, he worked on his own in the basement, doing engineering consulting.
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FDA Requesting Firms Update User Fee Product Lists by Mid-JuneWith the FDA anticipating publishing fiscal year (FY) 2009 drug user fees this August, the agency is asking manufacturers to provide a list of products and finished-dose manufacturing facilities subject to such fees by June 16.
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No Clinical Trials Required for Sandoz’ Generic LovenoxThe FDA will not require human clinical trials to support the ANDA for Sandoz and Momenta’s generic version of the anticoagulant Lovenox, which previously received a not-approvable letter.
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Pharmaxis Moving Forward With Design of Phase III Bronchitol TrialFollowing advice from the FDA on the design of its pivotal Phase III trial for its mucus-clearing agent Bronchitol, Pharmaxis will begin the trial during the third quarter of this year.
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Drug Company Payoffs to Stall Generics Under U.S. Government ScrutinyThe Federal Trade Commission and some lawmakers are attempting to prevent major pharmaceutical companies from paying generic drug makers to delay putting less expensive medicines on the market, saying the practice violates antitrust law.
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Amneal Receives FDA Approval for Three Generic Prescription DrugsAmneal Pharmaceuticals … received U.S. FDA approval to manufacture Primidone Tablets (50/250mg), Cyclobenzaprine Tablets (10mg) and Demeclocycline Tablets (150/300mg) within the last several weeks.
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DOR BioPharma Acquires Option for Harvard Anthrax VaccineDOR BioPharma, Inc., … announced that it has entered into a one-year exclusive option with the President and Fellows of Harvard College to license analogues of anthrax toxin for prospective use in vaccines against anthrax, a potentially fatal disease caused by the spore-forming, gram-positive bacterium Bacillus anthracis.
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Forest Labs Study Demonstrates Lexapro Improves Depression SymptomsForest Laboratories, Inc. announced that study results show Lexapro (escitalopram oxalate) significantly improved symptoms of depression as compared to placebo treatment and was well tolerated in adolescents, aged 12-17, with major depressive disorder (MDD), according to phase III data presented at the 2008 Annual Meeting of the American Psychiatric Association.
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Statin Era Over?The era of statins, drugs like Zocor and Lipitor which lower cholesterol levels, may be ending.
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The Case for (and Against) Big PharmaBig pharma needs a miracle drug. The major drug makers are so beaten down that in some instances dividend yields, rather than the next blockbuster drug in the pipeline, are what are propping up the stocks.
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Stupak Says the FDA’s DTC Oversight Is ToothlessThe FDA’s regulation of direct-to-consumer advertising (DTC) is weak and Congress needs to consider if such advertisements should be banned, according to a senior Democratic lawmaker.
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Johnson & Johnson Faces Pricing InvestigationThe Michigan attorney general is investigating Johnson & Johnson over nominal price transactions, the company disclosed in its quarterly financial statement.
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AstraZeneca Seeks Generalized Anxiety Indication for SeroquelAstraZeneca has submitted an sNDA for Seroquel XR tablets to treat generalized anxiety disorder (GAD), including maintenance of the anti-anxiety effect.
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Strattera Approved for ADHD Maintenance TreatmentThe FDA has approved Eli Lilly’s Strattera for maintenance treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in children and adolescents.
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FTC Sues Companies for Nonworking Anti-Smoking PatchesThe FTC is suing two companies for offering free trials of smoking cessation patches on the internet, alleging the trials were not free, the patches did not work and the operation illegally debited consumers’ bank accounts.
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Medtronic Issues Precautionary Recall of Heparin-Coated ProductsMedtronic is recalling certain heparin-coated disposable products used during cardiopulmonary bypass for heart surgeries.
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IVD Makers Can Speed CLIA Categorization With New GuidanceIn vitro diagnostic (IVD) manufacturers can help expedite FDA categorization of their tests under the Clinical Laboratory Improvement Amendments (CLIA) by following a new guidance.
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Groups Sound Off to Congress on DME Bidding ConcernsThe Centers for Medicare & Medicaid Services’ (CMS) competitive bidding program for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) could drive thousands of manufacturers and providers out of business and artificially lower prices for these products, an industry group says.
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Canada Court Dismisses J&J Lawsuit Against Boston ScientificThe Canadian Federal Court has dismissed a lawsuit by Johnson & Johnson (J&J) accusing Boston Scientific’s NIR stent of infringing on two patents.
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Expert: Increase Quality Staff When OutsourcingAlthough manufacturers often look at outsourcing as a reason to shrink their quality assurance (QA) staff, they should do exactly the opposite, an expert recommends.
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Global Task Force Issues Guidance on Standards in Device EvaluationA new Global Harmonization Task Force (GHTF) guidance tells device manufacturers how to use international standards to show their product conforms to essential safety and performance principles.
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Stryker’s Biotech Division Gets Warning LetterStryker’s Biotech division received an FDA warning letter this month for quality system and compliance problems at its Hopkinton, Mass., facility.
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Report Calls for U.S. to Remove Trade BarriersThe U.S. 2006 SAFE Port Act is a unilateral measure that would hinder trade and hurt legitimate businesses, including devicemakers, without providing any tangible security benefits, a new report from the European Commission (EC) claims.
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WIPO Panel: Boston Scientific Stents Do Not Infringe on Medinol PatentsA World Intellectual Property Organization (WIPO) arbitration panel has ruled that Boston Scientific’s Liberte and Taxus Liberte stents do not infringe on Medinol patents.
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Medtronic to Cut 1,100 Jobs in Low-Growth AreasMedtronic will cut approximately 1,100 jobs this fiscal year in businesses “no longer growing at previous rates,” the company says.
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Insulin Pumps Risky for Teens, FDA Study ShowsInsulin pumps have been linked to adverse events and deaths in teens, so special attention must be given to the risk-benefit ratio of these devices when they are prescribed for adolescents, an FDA study says.
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Bill Boosting Overseas Device Inspections Advances With Debate on DetailsThe FDA, industry and Congress all support draft legislation to increase funding for more inspections of foreign manufacturing facilities, but agency officials and lawmakers differ on whether such inspections should be required every two years or prompted by risk-based analyses.
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Merck Slapped With GMP Warning Letter for Vaccine OperationsMerck’s bulk drug substances used to manufacture many of its vaccines are adulterated, and the FDA is requesting a meeting with senior management to expedite the firm’s corrective actions, according to a recent warning letter.
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Former Cardinal Health Subsidiary Cited for GMP ViolationsCatalent Pharma Solutions failed to follow appropriate procedures to ensure its drug products are sterile, according to an FDA warning letter.
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Millipore to Pare its Greenhouse Gases by 20 PercentJumping on the environmental bandwagon, Millipore Corp. plans to unveil a promise to cut its greenhouse gas emissions by 20 percent over the next five years.
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Swedish Giant Buys EurocutSwedish materials and engineering giant Sandvik has acquired Sheffield-based orthopaedic instruments and implants business Eurocut.
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Jubilant Acquires Speciality MoleculesJubilant Organosys Limited, an integrated pharmaceutical industry player and [a] custom research and manufacturing services company in India, announced that it had acquired 100 per cent stake in Speciality Molecules Limited, a niche manufacturer of Speciality Intermediates with manufacturing facilities located at Ambarnath. …
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Three Workers Die at Ankleshwar Pharmaceutical CompanyThree labourers died in the Wockhardt Pharmaceuticals Company premises after being hit by a stopper of a storage vessel on Monday afternoon in Ankleshwar GIDC (Gujarat Industrial Development Corporation) estate.
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PPF Pursues Zentiva SharesThe PPF Group has launched a takeover attempt on the Czech Republic’s largest generic-drug manufacturer, Zentiva.
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Canada Poised to Deliver Affordable Medicines to Developing Countries?The Canadian HIV/AIDS Legal Network welcomed announcement that Rwanda’s government, after a competitive tendering process, has chosen to purchase a low-cost AIDS drug from Ontario-based generic pharmaceutical manufacturer Apotex, Inc. - meaning that Canada’s Access to Medicines Regime should soon deliver for the first time on its promise of affordable medicines for developing countries.
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Stupak Says the FDA’s DTC Oversight Is ToothlessThe FDA’s regulation of direct-to-consumer advertising (DTC) is weak and Congress needs to consider if such advertisements should be banned, according to a senior Democratic lawmaker.
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Drug Quality Takes Center Stage at Woodcock’s CDERCDER Director Janet Woodcock plans to focus on the FDA’s Good Manufacturing Practices (GMP) for the 21st Century initiative now that she has taken the helm of the drugs center.
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PDUFA IV Fees Will Go to Improve Postmarket Drug SafetyThe FDA says it will significantly expand its postmarketing safety activities, adopting new scientific approaches to drug safety to meet its commitments under the Prescription Drug User Fee Act (PDUFA IV).
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Astellas’ Advagraf Receives Another Approvable LetterJapanese drugmaker Astellas says it has received a fourth approvable letter from the FDA for its immunosuppressant drug Advagraf, delaying again the drug’s outright approval.
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New OxyContin Formulation Faces Advisory Committee SkepticismPurdue Pharma met with tough questions from two FDA advisory committees Monday regarding its claims that a new formulation of its painkiller OxyContin is more tamper-resistant, reducing the potential for abuse.
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FDA Lifts Warning Letter for Watson Facility, Key Approvals to FollowWatson Pharmaceuticals is expecting to launch generic versions of Toprol-XL and Prilosec this year now that the FDA has lifted a warning letter, which had blocked approval of the drugs, for the firm’s manufacturing facility in Davie, Fla.
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Clinical Investigator Faces DisqualificationA clinical investigator faces disqualification by the FDA for conducting a trial without an approved IND application, institutional review board (IRB) approval or informed consent.
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China Blasts Baxter, Disputes Heparin Contaminate Caused Adverse EventsBaxter is refuting charges made Tuesday by China’s State Food and Drug Administration (SFDA) that the company did not cooperate with Chinese inspectors during an audit of its heparin finished-dose plant in New Jersey.
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Generic Firms Get FDA Nod for RequipGlaxoSmithKline (GSK) is certain to see a decline in its $518 million U.S. sales of Requip now that the FDA has approved four generic versions of the restless leg treatment.
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Incomplete Press Release Draws Untitled LetterZymoGenetics omitted certain information regarding a claim it made for topical hemostat Recothrom in a press release announcing FDA approval of the product, earning it an untitled letter.
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FDA Requesting Firms Update User Fee Product Lists by Mid-JuneWith the FDA anticipating publishing fiscal year (FY) 2009 drug user fees this August, the agency is asking manufacturers to provide a list of products and finished-dose manufacturing facilities subject to such fees by June 16.
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AstraZeneca Seeks Generalized Anxiety Indication for SeroquelAstraZeneca has submitted an sNDA for Seroquel XR tablets to treat generalized anxiety disorder (GAD), including maintenance of the anti-anxiety effect.
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Clinical Trials Transformation Initiative Names Executive BoardA partnership aimed at modernizing the clinical trial process in the U.S. is gaining momentum.
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Sernova Moving Forward With Diabetes TherapySernova has concluded a pre-IND meeting with the FDA, establishing definitive clinical trial requirements for its diabetes treatment Sertolin.
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FDA to Study Site Changes Without Postapproval SupplementsThe FDA plans to initiate a study to show that firms do not need to submit postapproval supplements when changing manufacturing sites of sterile drug products, according to agency procurement documents.
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Final Guidance on Adverse Events in Clinical Trials Due SoonThe FDA will soon issue a final guidance distinguishing between adverse events and unanticipated problems in clinical trials, clarifying when the former have to be reported to an institutional review board (IRB).
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Pathway Diagnostics Launches HIV Tropism AssayPathway Diagnostics has released its patented, second-generation SensiTrop II assay for HIV-infected patients.
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Volcano Corp. Performs First Human Use With Imaging CatheterVolcano Corp. has performed its first-in-human procedure using the Volcano Optimal Coherence Tomography (OCT) imaging catheter.
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St. Jude Medical to Launch New Brand IdentitySt. Jude Medical announced it will unveil its new corporate identity to physician customers at the 88th Annual Meeting of the American Association of Thoracic Surgery (AATS) on May 10, at EuroPCR on May 13 and at the Heart Rhythm Society’s (HRS) Annual Scientific Sessions on May 14.
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NuVasive Buying Osiris Unit for at Least $35 MillionMedical device company NuVasive Inc. said it will buy Osiris Therapeutics Inc.’s Osteocol unit, which includes a developing bone graft stem cell treatment.
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BDSI’s Pain Patch Does Well in Human TrialThe pain patch on which BioDelivery Sciences International has bet its future came up a winner in its latest round of human testing, the Raleigh drug company said.
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Doctors’ Secret Link to Device SupplierDoctors at one of Australia’s leading spinal clinics have secret financial links to the company selling the surgical devices they implant into patients.
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Ultrasonix Medical Restructures North American OperationsUltrasonix Medical, a developer and manufacturer of high quality diagnostic ultrasound imaging systems, has restructured its North American operations to focus on its target markets.
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Millstone Medical Outsourcing Achieves Quality Advantages in MemphisMillstone Medical Outsourcing announced that the company successfully expanded its ISO 13485 certified quality system to the Memphis, TN, facility.
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Stupak Says the FDA’s DTC Oversight Is ToothlessThe FDA’s regulation of direct-to-consumer advertising (DTC) is weak, and Congress needs to consider if such advertisements should be banned, according to a senior Democratic lawmaker.
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Discovery Faces Another Surfaxin SetbackThe FDA has sent Discovery Laboratories a third approvable letter for Surfaxin, a treatment for the prevention of respiratory distress syndrome in premature infants.
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GSK to Buy SirtrisGlaxoSmithKline (GSK) has offered to buy all outstanding shares of Sirtris Pharmaceuticals for $22.50 a share.
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Adolor Says FDA Delays Decision on Bowel Drug EnteregAdolor Corp. said that the Food and Drug Administration won’t be making a decision on approval of the company’s Entereg drug for post-surgery bowel blockage by … the scheduled action date.
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Price of Blood Thinner Has Doubled Since RecallMajor U.S. dialysis centers say the price of blood-thinner heparin has doubled since mid-April because of global recalls and tight supplies since the discovery of contaminated raw product from China.
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Novartis Ties With Vectura on Generic Asthma DrugsNovartis is working with British inhaled drug specialist Vectura Group on generic versions of today’s blockbuster asthma drugs, the head of the Swiss company’s generics business has disclosed.
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Schering-Plough Presents Data of Asenapine Clinical TrialsKenilworth, New Jersey-based drug maker Schering-Plough Corp. revealed that an overview of asenapine clinical trials from the Olympia program was presented at the 161st Annual Meeting of the American Psychiatric Association in Washington, D.C., May 3-8.
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Vaccine for Girls Oversold?Victoria author and massage therapist Julie Paul’s daughter will soon be eligible for the human papilloma virus vaccine. But with questions remaining unanswered about safety and whether the vaccine really will prevent cervical cancer as the provincial government claims, Paul’s daughter won’t be getting the shots.
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FDC Secures FDA Nod for Timolol MaleateFDC … received approval from the U.S. FDA for its abbreviated new drug application (ANDA), timolol maleate ophthalmic solution.
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GAO Criticizes FDA Regulatory Letters on Violative DTC AdsThe FDA continues to be slow in sending warning or untitled letters to pharmaceutical companies that it suspects of violating direct-to-consumer (DTC) advertising rules, according to a report by the Government Accountability Office (GAO).
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Novartis Gets Regulatory Letter as Congress Probes DTC AdsThe FDA sent two marketing-related regulatory letters, one to Novartis and the other to Shire, on the same day a House Oversight and Investigations Subcommittee heard testimony that the agency was issuing fewer letters citing firms for violative direct-to-consumer (DTC) advertising.
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Plavix Faces Generic Competition in EuropeA generic version of the antiplatelet drug Plavix will go on sale throughout the European Union (EU) by the end of June, the Swiss pharmaceutical company Schweizerhall said.
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FDA to Shire: It’s Not Reminder LabelingSome marketing materials intended as reminder labeling for Shire’s phosphate binder Fosrenol misbrand the product because the FDA does not consider them reminder promotions, according to the agency’s May 1 untitled letter.
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Public Citizen Tells FDA to Pull Ortho-EvraPublic Citizen has asked the FDA to require Johnson & Johnson (J&J) to remove its birth control patch Ortho-Evra from the market in six months due to increased blood clot risks.
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Medtronic Issues Precautionary Recall of Heparin-Coated ProductsMedtronic is recalling certain heparin-coated disposable products used during cardiopulmonary bypass for heart surgeries.
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Arbios Gets FDA Approval for Pivotal Trial for Liver-Assist DeviceArbios Systems has received approval from the FDA for an investigational device exemption to begin the pivotal clinical trial for SEPET, the company’s liver-assist device for purifying blood in acutely ill patients with chronic liver disease.
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Emergency Department Trial Produces Positive ResultsA study using Vicor Technologies’ PD2i Cardiac Analyzer to assess cardiac patients in six hospital emergency departments has produced successful results, the company says.
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Medtronic Study to Compare Stent vs. Abbott'sMedical device maker Medtronic Inc. said it has commenced a global study comparing the company's Endeavor drug-eluting stent against Abbott Laboratory's competing Xience V drug-eluting stent.
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Bioartificial Liver Exceeds Expectations in TestsHepaLife Technologies, Inc. announced that new tests of its bioartificial liver device demonstrate the company’s bioreactor system and patented PICM-19 cells inside the device remain functional over prolonged periods of time, far exceeding the number of treatment hours referenced in published research studies of human liver failure patients undergoing conventional liver support therapies.
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FAU Portable Robot Mimics Motions of Physical TherapistsFlorida Atlantic University researchers have developed a portable robot they believe can supplement face-to-face contact with a physical therapist, reducing medical costs and making it easier for patients to do exercises at home.
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That Must Be Bob. I Hear His New Hip Squeaking.The first time John L. Johnson’s artificial hip squeaked, he was bending down to pick up a pine cone in his yard in Thomasville, Ga. Mr. Johnson looked up, expecting to find an animal nearby.
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Should Spine Doctors Fuse Surgery and Investing?It is supposed to be a new business model in the medical device industry: A doctor-owned company that competes with big medical manufacturers, using its owners' expertise to make better products at lower costs.
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Fledgling South Florida Companies Face Hurdle of Lengthy Clinical TrialsAs Florida's economy reels under its worst recession in decades, business development groups are looking to the bioscience industry as a bright spot.
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GAO Criticizes FDA Regulatory Letters on Violative DTC AdsThe FDA continues to be slow in sending warning or untitled letters to pharmaceutical companies that it suspects of violating direct-to-consumer (DTC) advertising rules, according to a report by the Government Accountability Office (GAO).
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Sanofi-Aventis, Debiopharm Sue Heraeus for Patent InfringementSanofi-aventis and Debiopharm have filed a lawsuit against W.C. Heraeus in which they accuse the German firm of helping genericmakers infringe on a patent covering the active ingredient in Eloxatin.
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Wal-Mart Expands Prescription Program for GenericsWal-Mart says it will sell discounted 90-day supplies of up to 350 generic products as the third phase of its $4 prescription program.
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Barr Announces Approval of Generic YasminBarr Pharmaceuticals Inc. announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market a generic version of Yasmin (drospirenone and ethinyl estradiol), an oral contraceptive product manufactured and marketed by Bayer Schering Pharma, AG.
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Forest Labs and Daiichi Sankyo Terminate Azor Co-Promotion AgreementForest Laboratories, Inc., a U.S.-based pharmaceutical company, and Daiichi Sankyo, Inc.announced that they have terminated their co-promotion agreement for AZOR (amlodipine and olmesartan medoxomil), Daiichi Sankyo's fixed-dose combination of two antihypertensives, the calcium channel blocker amlodipine besylate and the angiotensin receptor blocker olmesartan medoxomil.
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Dental Anesthesia Reversal Drug OK'dA drug that reverses the numbing effects of local anesthesia used by dentists was approved by the Food and Drug Administration for patients as young as 6 years old. OraVerse, which was developed by private San Diego company Novalar, is the first dental anesthesia reversal agent on the market.
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Aurobindo Pharma Receives Approval From MCCThe pharmaceutical major Aurobindo Pharma Ltd has received approvals from the Medicines Control Council (MCC) to manufacture and market 9 products in South Africa.
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FDC's Timolol Maleate Receives Nod From FDAFDC Ltd has announced that the company has received approval from the U.S. FDA for its Abbreviated New Drug Application, Timolol Maleate Ophthalmic Solution.
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In-Licensing Deals Will Help Sustain Growth: EPLElder Pharmaceutical Ltd (EPL), with an array of acknowledged brands such as Shelcal, Fairone and others, has established itself as a fast growing pharmaceutical company.
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FDA: We’re Not Withholding Information From CongressContrary to recent press reports, the FDA is not withholding from Congress the names of 12 China-based companies implicated in distributing contaminated batches of heparin, the agency told DID.
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Ranbaxy, Merck to Collaborate on Anti-InfectivesIndia’s Ranbaxy has signed an agreement with Merck to partner on the clinical development of antibacterial and antifungal candidates.
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Sepracor Says Anxiety-Sleep Drugs Combo Improves Both TreatmentsSepracor said patients in a clinical trial who had both insomnia and generalized anxiety disorder (GAD) benefited from taking its sleep aid Lunesta with Forest Pharmaceuticals’ depression and anxiety drug Lexapro.
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Acting ODE II Director Now PermanentCurtis Rosebraugh has been appointed permanent director of the Office of Drug Evaluation II (ODE II) after serving as its acting director for nine months.
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Pipex Gets Orphan Designation for Idiopathic Pulmonary Fibrosis TreatmentPipex Pharmaceuticals received orphan drug designation from the FDA for its oral treatment for idiopathic pulmonary fibrosis (IPF), a deadly pulmonary disease.
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FDA Approves Psoriasis OintmentThe FDA approved Leo Pharma’s Taclonex Scalp for the treatment of moderate-to-severe plaque psoriasis of the scalp.
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EMEA Provides Guidance on Chronic Hepatitis C TrialsThe primary endpoint for confirmatory efficacy studies of treatments for chronic hepatitis C (CHC) should be sustained virological response (SVR), according to a draft guideline from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
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Barr Urges FDA Globalization Bill Not Delay Generic ApprovalsBarr’s CEO urged lawmakers at a recent congressional hearing on a draft bill to enhance the FDA’s authority to use risk-based criteria to schedule increased inspections of domestic or overseas drugmaking facilities.
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CGPA: Proposed Patent Rule Changes Could Cost CanadiansProposed amendments to Canada’s drug patent rules would force consumers and taxpayers to pay monopoly prices on prescriptions for longer than they should, the Canadian Generic Pharmaceutical Association (CGPA) says.
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Sanofi-Aventis, Debiopharm Sue Heraeus for Patent InfringementSanofi-aventis and Debiopharm have filed a suit against W.C. Heraeus in which they accuse the German firm of helping generic makers infringe on a patent covering the active ingredient in Eloxatin.
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Barr Sees Increased Earnings, Decreased Generics SalesDespite lagging generic sales, Barr’s net earnings of $23 million during the first quarter of 2008 nearly doubled its earnings compared with the same period last year, the company reported.
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Retailer Expands Prescription Program for GenericsWal-Mart says it will sell discounted 90-day supplies of up to 350 generic products as the third phase of its $4 prescription program.
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Sepracor Settles Xopenex Case, Inks AgreementsSepracor has settled a patent infringement suit with Breath Limited, an Arrow Group subsidiary, over generic Xopenex, a treatment for asthma and chronic obstructive pulmonary disease.
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FDA Green Lights Barr’s Generic YasminBarr Laboratories has received final FDA approval for its ANDA to manufacture and market a generic version of Bayer Schering Pharma’s oral contraceptive Yasmin.
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No Clinical Trials Required for Sandoz’ Generic LovenoxThe FDA will not require human clinical trials to support the ANDA for Sandoz and Momenta’s generic version of the anticoagulant Lovenox, which previously received a not-approvable letter.
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Generic Firms Get FDA Nod for RequipGlaxoSmithKline (GSK) is certain to see a decline in its $518 million U.S. sales of Requip now that the FDA has approved four generic versions of the restless leg treatment.
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Plavix Faces Generic Competition in EuropeA generic version of the antiplatelet drug Plavix will go on sale throughout the European Union (EU) by the end of June, the Swiss pharmaceutical company Schweizerhall said.
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FDA Approves Teva Heart Drug for Two StrengthsTeva Pharmaceutical has received FDA approval for its ANDA to market epoprostenol, the first generic version of GlaxoSmithKline’s Flolan for injection.
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Study Demonstrates Lexapro Improves Adolescent Depression SymptomsForest Laboratories has completed a study that shows Lexapro improved symptoms of adolescent depression as compared with placebo.
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Novartis Vaccine Successful Against Meningitis in Phase III TrialNovartis’ meningitis vaccine Menveo may offer greater protection for adolescents than sanofi pasteur’s Menactra based on results of a pivotal Phase III clinical trial, the company says.
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Trubion Starts Phase IIb Study for Rheumatoid Arthritis TreatmentTrubion Pharmaceuticals and its partner, Wyeth Pharmaceuticals, have begun patient dosing in the next Phase IIb clinical trial of TRU-015 in patients with rheumatoid arthritis (RA).
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Cleveland BioLabs Completes Recruitment for Prostate Cancer TrialCleveland BioLabs has enrolled all the patients in its Phase II clinical trial of Curaxin CBLC102 in advanced, hormone-refractory prostate cancer.
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Argos Initiates Phase II Trial for HIV ImmunotherapyArgos Therapeutics will begin a Phase IIa proof-of-concept clinical trial to test the efficacy of its AGS-004 therapy to improve immune control of viral replication in HIV-infected adults.
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Amylin Initiates Phase IIb Obesity StudyAmylin Pharmaceuticals has begun a Phase IIb study evaluating various dosing combinations of pramlintide, an analog of the natural hormone amylin, and recombinant human leptin for the treatment of obesity.
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Nventa Announces Positive Data From Phase I Cervical Dysplasia TrialNventa Biopharmaceuticals says it achieved positive immunological data in its ongoing Phase I clinical trial of its therapeutic product candidate HspE7 for patients with cervical intraepithelial neoplasia, a precursor to cervical cancer.
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Velcura Therapeutics Reports Successful Phase I Trial of Bone Disease TherapyVelcura Therapeutics has successfully completed a first-in-human clinical trial for its lead compound VEL-0230, which the company is investigating as a treatment for rheumatoid arthritis (RA) and other bone diseases, it says.
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VGX Signs Agreement With UK Cystic Fibrosis Gene Therapy ConsortiumVGX Pharmaceuticals has signed a multiyear agreement to provide plasmid DNA to support the ongoing toxicology and clinical trials of the UK Cystic Fibrosis Gene Therapy Consortium.
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Pipex Gets Orphan Designation for Idiopathic Pulmonary Fibrosis TreatmentPipex Pharmaceuticals received orphan drug designation from the FDA for its oral treatment for idiopathic pulmonary fibrosis (IPF), a deadly pulmonary disease.
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AstraZeneca Seeks Generalized Anxiety Indication for SeroquelAstraZeneca has submitted an sNDA for Seroquel XR tablets to treat generalized anxiety disorder (GAD), including maintenance of the anti-anxiety effect.
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Amneal Receives FDA Approval for Three Generic Prescription DrugsAmneal Pharmaceuticals has received FDA approval to manufacture Primidone tablets (50/250mg), Cyclobenzaprine tablets (10mg) and Demeclocycline tablets (150/300mg).
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Levaquin Approved for Pediatric Anthrax ExposureThe FDA has approved Ortho-McNeil’s antibiotic Levaquin to treat pediatric patients exposed to inhaled anthrax.
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Strattera Approved for ADHD Maintenance TreatmentThe FDA has approved Eli Lilly’s Strattera for maintenance treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents.
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Generic Firms Get FDA Nod for RequipThe FDA has approved four generic versions of Requip, GlaxoSmithKline’s (GSK) restless leg treatment.
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IVD Makers Can Speed CLIA Categorization With New GuidanceIn vitro diagnostic (IVD) manufacturers can help expedite FDA categorization of their tests under the Clinical Laboratory Improvement Amendments (CLIA) by following a new guidance.
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Medtronic Receives FDA Approval of Wireless, Implantable Cardiac DevicesMedtronic earned FDA approval of its first wave of cardiac rhythm disease management therapies under its Vision 3D portfolio, which will comprise a full line of implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy-defibrillators (CRT-Ds), pacemakers and cardiac resynchronization therapy-pacemakers.
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SunTech Medical Opens Chinese Manufacturing PlantSunTech Medical has opened a new manufacturing facility in Shenzhen, China.
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FDA Clears GE’s High-Definition CT ScannerGeneral Electric Co.'s (GE) GE Healthcare unit received Food and Drug Administration approval of its LightSpeed CT750 HD, which the company called the first high-definition computed tomography scanner.
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New Findings Show Xience Stents Are as Safe and Effective as OthersA drug-coated stent made by Abbott Laboratories that is awaiting U.S. regulatory approval is as safe as, and potentially more effective than, the market-leading version of the heart device made by Boston Scientific, according to findings presented at the EuroPCR conference in Barcelona.
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VantageCath Medical Device Gets FDA ApprovalThe U.S Food and Drug Administration has approved the marketing plans of a new safety engineered short-term peripheral Intra-Venous (IV) Catheter from ‘Advantage Medical Devices’ named VantageCath.
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Prism Glasses Expand View for Patients with HemianopiaInnovative prism glasses can significantly improve the vision and the daily lives of patients with hemianopia, a condition that blinds half the visual field in both eyes.
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Stanford Medical Center Tests Anti-Scar BandagesKeloid scars are angry red lesions that sometimes form after surgery or injury when the skin "overheals" creating an extra tough region of new skin. … So Geoff Gurtner and colleagues at the Stanford University Medical Center in California have developed bandages that can prevent this kind of stretching.
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New Facilities to Assist New Cancer Diagnosis Tool Roll OutContinued increasing sales of RedPath Integrated Pathology, Inc.'s PathFinderTG have fueled the company's expansion and relocation into new, state-of-the-art headquarters in Pittsburgh and the growth of the company's work force which now totals 50, up from 20 a year ago.
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Firm Settles With Justice for Manipulating Manufacturing DataLeiner Health Products agreed to forfeit $10 million and plead guilty to one count of wire fraud under a proposed settlement with the Justice Department concerning charges that the firm manipulated stability data at its OTC production facility.
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Study: Beta-Blockers Can Pose Risk for Patients After SurgeryPatients taking beta-blockers after noncardiac surgery have a higher risk of death or stroke than those given placebo, according to the authors of an article published in an upcoming edition of The Lancet.
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Indian Clinical Trials Industry Booming, Experts SayThe clinical trials industry in India has taken off since 2005 as trials have become standardized, predictable and quickly approvable, experts said at an RxTrials Institute audioconference Tuesday.
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Cipher Files Revised NDA for Opioid Pain DrugCipher Pharmaceuticals has submitted a revised NDA for CIP-Tramadol ER, an opioid pain reliever, after receiving an approvable letter for the drug a year ago.
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Supreme Court Rebuffs ApotexThe U.S. Supreme Court will not hear Canadian drugmaker Apotex’s appeal over the launch of its generic version of Abbott’s antiseizure drug Depakote.
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FDA: We’re Not Withholding Information From CongressContrary to recent press reports, the FDA is not withholding from Congress the names of 12 China-based companies implicated in distributing contaminated batches of heparin, the agency said.
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Novartis Vaccine Successful Against Meningitis in Phase III TrialNovartis’ meningitis vaccine Menveo may offer greater protection for adolescents than sanofi pasteur’s Menactra based on results of a pivotal Phase III clinical trial, the company says.
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Sernova Moving Forward With Diabetes TherapySernova has concluded a pre-IND meeting with the FDA, establishing definitive clinical trial requirements for its diabetes treatment Sertolin.
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Novo Nordisk Gets FDA Approval for Hemophilia DrugDrug developer Novo Nordisk said the Food and Drug Administration approved its new hemophilia treatment NovoSeven RT.
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Eli Lilly Dedicates $1B Biotech HubThe new building is massive — equivalent to eight football fields, with 33 laboratories spread over four floors.
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Indonesian Pharmaceutical Company to Produce Bird Flu Vaccine by 2011State pharmaceutical company PT Bio Farma is set to produce bird flu (avian influenza) vaccines for humans starting in 2011 with an initial production of 20 million doses.
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Piramal Starts Testing of Diabetes Drug in EuropePiramal Life Sciences Ltd, part of the Piramal Group of companies, has commenced the clinical study of its P1736, a drug meant for the treatment of diabetes (type II), in the Netherlands.
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India Pharma Marriages: Will They Work?Imagine a hypothetical situation of a Cipla merging with a Ranbaxy. This may seem quite difficult but not impossible.
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Vietnamese Government Gains More Control on Pharmaceutical MarketAfter years of poor regulation and IP protection, the Vietnamese government has started to gain more control in the administration of drugs in the market, particularly in the area of price control.
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China, India to Overhaul Clinical Trial RegulationsInternational pharmaceutical, biotech and device companies doing clinical trials in China and India may soon face new regulations.
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Clinical Investigator Faces Disqualification for Conducting Unapproved TrialA clinical investigator faces disqualification by the FDA for conducting a trial without an approved IND application, IRB approval or informed consent.
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Controversial Clinical Trial Results Databases Gather MomentumRequirements for databases of clinical trial results remain divisive, but U.S. sponsors must comply with them later this year, and the World Health Organization (WHO) started a survey earlier this month to determine which elements to include in a global standard.
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Clinical Investigator Warned for Altering Study RecordsA clinical investigator who performed diabetes, rheumatoid arthritis and other clinical trials altered study records and enrolled patients who had taken prohibited medications too close to the start of the trial, according to an FDA warning letter.
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Open-Label Studies Discouraged in Pneumonia TrialsOpen-label studies are not a good idea in clinical trials of community-acquired pneumonia (CAP) because favorable results are liable to be “used for marketing purposes,” a member of the FDA’s Anti-Infective Drugs Advisory Committee says.
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True Informed Consent Hard to Obtain in IndiaClinical investigators must tread cautiously when getting informed consent in India, where paternalistic traditions may keep patients from questioning anything a physician tells them, an expert says.
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Clinical Trials in India and China Offer Opportunity, DrawbacksInternational drug, biotech and device companies are being attracted to India and China for their clinical trials because of cost and patient recruitment advantages, but there are drawbacks they need to be aware of, experts say.
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Researcher Cited for Not Getting Psychiatric Patients’ ConsentA clinical investigator in two psychiatric drug clinical trials improperly obtained informed consent and gave patients too much of the investigational drug or other psychiatric medications, according to an FDA warning letter.
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EU Clinical Trials DirectiveThe legal provisions governing clinical trials in Slovakia are set forth in Law No. 140/1998 on drugs and medical devices.
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