FDA Pharmaceutical and Medical Device Headline News

The 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.  Read More

Health Discovery Corp. and DCL Medical Laboratories signed a letter of intent to jointly develop a computer-assisted diagnostic test for cervical cancer.  Read More

Dilon Technologies has received CE Marking for its Dilon 6800 gamma camera.  Read More

ArthroCare Corp. has acquired Aarhus, Denmark-based OrtoConcept Scandinavia for an undisclosed amount.  Read More

The 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.  Read More

B. Braun Medical Inc… announces the launch of the Curlin 6000 CMS, made possible through its distribution agreement with Curlin Medical Inc.  Read More

OncoVista 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.  Read More

Fluidigm said it has signed up AME Bioscience to distribute its integrated fluidic circuits in the Nordic region.  Read More

A Grass Valley company has received U.S. Food and Drug Administration clearance to sell a new prostate cancer imaging machine.  Read More

Two 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.  Read More

The 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.  Read More

Sales 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.  Read More

Par 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.  Read More

Baxter 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.  Read More

Merck & Co.'s ongoing cost-cutting plan could be good news for biotechnology companies looking to partner with the pharmaceutical giant, analysts told BioWorld.  Read More

Orexigen 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.  Read More

Malacañang 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.  Read More

It's a Herculean task finding skilled people to steer businesses.  Read More

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With 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.  Read More

ZymoGenetics 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.  Read More

GlaxoSmithKline (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.  Read More

A partnership aimed at modernizing the clinical trial process in the U.S. is gaining momentum.  Read More

Japanese 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.  Read More

The FDA has approved Ortho-McNeil’s antibiotic Levaquin to treat pediatric patients exposed to inhaled anthrax.  Read More

In 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.   Read More

The 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….”  Read More

Although 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.  Read More

The 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.  Read More

Federal regulations outline statutory violations regarding off-label promotions.  Read More

Ignoring 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.  Read More

The FDA’s enforcement strategy is risk based, aiming to deter violations.  Read More

Promotional activity is affected by laws other than the Food, Drug and Cosmetic Act.  Read More

The 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.  Read More

A 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.  Read More

Thailand’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.  Read More

The 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.  Read More

Malta 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).  Read More

India’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.  Read More

The 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.  Read More

A 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.  Read More

The Global Harmonization Task Force (GHTF) Steering Committee recently published final documents describing the organization’s membership, operational structure and rules of procedure.  Read More

A 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.  Read More

After 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.  Read More

Singapore’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.  Read More

A 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.  Read More

Organizational 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.  Read More

The 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.  Read More

Boston Scientific was given European CE Marking for its new ALTRUA family of pacemakers.  Read More

Vascular Insights has achieved 510(k) clearance from the FDA to market its ClariVein infusion catheter.  Read More

Bangalore 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.  Read More

Medical device maker St. Jude Medical Inc. announced U.S. Food and Drug Administration and European CE Mark approval of the Strada Carotid Guiding Sheath.  Read More

Medical device firm Cohera Medical Inc. said Wednesday that it closed on a financing round that brought in $7.6 million.  Read More

Atrium 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.  Read More

CLX 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.  Read More

In phase one, he worked on his own in the basement, doing engineering consulting.  Read More

With 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.  Read More

The 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.  Read More

Following 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.  Read More

The 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.  Read More

Amneal 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.  Read More

DOR 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.  Read More

Forest 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.  Read More

The era of statins, drugs like Zocor and Lipitor which lower cholesterol levels, may be ending.  Read More

Big 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.  Read More

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The 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.  Read More

The Michigan attorney general is investigating Johnson & Johnson over nominal price transactions, the company disclosed in its quarterly financial statement.  Read More

AstraZeneca has submitted an sNDA for Seroquel XR tablets to treat generalized anxiety disorder (GAD), including maintenance of the anti-anxiety effect.  Read More

The FDA has approved Eli Lilly’s Strattera for maintenance treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in children and adolescents.  Read More

The 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.  Read More

Medtronic is recalling certain heparin-coated disposable products used during cardiopulmonary bypass for heart surgeries.  Read More

In vitro diagnostic (IVD) manufacturers can help expedite FDA categorization of their tests under the Clinical Laboratory Improvement Amendments (CLIA) by following a new guidance.   Read More

The 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.  Read More

The Canadian Federal Court has dismissed a lawsuit by Johnson & Johnson (J&J) accusing Boston Scientific’s NIR stent of infringing on two patents.  Read More

Although manufacturers often look at outsourcing as a reason to shrink their quality assurance (QA) staff, they should do exactly the opposite, an expert recommends.  Read More

A 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.  Read More

Stryker’s Biotech division received an FDA warning letter this month for quality system and compliance problems at its Hopkinton, Mass., facility.  Read More

The 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.  Read More

A World Intellectual Property Organization (WIPO) arbitration panel has ruled that Boston Scientific’s Liberte and Taxus Liberte stents do not infringe on Medinol patents.   Read More

Medtronic will cut approximately 1,100 jobs this fiscal year in businesses “no longer growing at previous rates,” the company says.  Read More

Insulin 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.  Read More

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The 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.  Read More

Merck’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.  Read More

Catalent Pharma Solutions failed to follow appropriate procedures to ensure its drug products are sterile, according to an FDA warning letter.  Read More

Jumping 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.  Read More

Swedish materials and engineering giant Sandvik has acquired Sheffield-based orthopaedic instruments and implants business Eurocut.  Read More

Jubilant 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. …  Read More

Three 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.  Read More

The PPF Group has launched a takeover attempt on the Czech Republic’s largest generic-drug manufacturer, Zentiva.  Read More

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.  Read More

The 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.   Read More

CDER 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.  Read More

The 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).  Read More

Japanese 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.  Read More

Purdue 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.   Read More

Watson 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.   Read More

A clinical investigator faces disqualification by the FDA for conducting a trial without an approved IND application, institutional review board (IRB) approval or informed consent.   Read More

Baxter 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.   Read More

GlaxoSmithKline (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.  Read More

ZymoGenetics 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.   Read More

With 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.  Read More

AstraZeneca has submitted an sNDA for Seroquel XR tablets to treat generalized anxiety disorder (GAD), including maintenance of the anti-anxiety effect.   Read More

A partnership aimed at modernizing the clinical trial process in the U.S. is gaining momentum.   Read More

Sernova has concluded a pre-IND meeting with the FDA, establishing definitive clinical trial requirements for its diabetes treatment Sertolin.  Read More

The 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.   Read More

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The 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).  Read More

Pathway Diagnostics has released its patented, second-generation SensiTrop II assay for HIV-infected patients.  Read More

Volcano Corp. has performed its first-in-human procedure using the Volcano Optimal Coherence Tomography (OCT) imaging catheter.  Read More

St. 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.  Read More

Medical device company NuVasive Inc. said it will buy Osiris Therapeutics Inc.’s Osteocol unit, which includes a developing bone graft stem cell treatment.  Read More

The 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.  Read More

Doctors at one of Australia’s leading spinal clinics have secret financial links to the company selling the surgical devices they implant into patients.  Read More

Ultrasonix Medical, a developer and manufacturer of high quality diagnostic ultrasound imaging systems, has restructured its North American operations to focus on its target markets.  Read More

Millstone Medical Outsourcing announced that the company successfully expanded its ISO 13485 certified quality system to the Memphis, TN, facility.  Read More

The 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.  Read More

The FDA has sent Discovery Laboratories a third approvable letter for Surfaxin, a treatment for the prevention of respiratory distress syndrome in premature infants.  Read More

GlaxoSmithKline (GSK) has offered to buy all outstanding shares of Sirtris Pharmaceuticals for $22.50 a share.  Read More

Adolor 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.  Read More

Major 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.  Read More

Novartis 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.  Read More

Kenilworth, 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.  Read More

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.  Read More

FDC … received approval from the U.S. FDA for its abbreviated new drug application (ANDA), timolol maleate ophthalmic solution.  Read More

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The 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).  Read More

The 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.  Read More

A 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.  Read More

Some 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.  Read More

Public 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.  Read More

Medtronic is recalling certain heparin-coated disposable products used during cardiopulmonary bypass for heart surgeries.  Read More

Arbios 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.  Read More

A study using Vicor Technologies’ PD2i Cardiac Analyzer to assess cardiac patients in six hospital emergency departments has produced successful results, the company says.  Read More

Medical 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.  Read More

HepaLife 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.  Read More

Florida 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.  Read More

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.  Read More

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.  Read More

As Florida's economy reels under its worst recession in decades, business development groups are looking to the bioscience industry as a bright spot.  Read More

The 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).  Read More

Sanofi-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.  Read More

Wal-Mart says it will sell discounted 90-day supplies of up to 350 generic products as the third phase of its $4 prescription program.  Read More

Barr 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.  Read More

Forest 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.  Read More

A 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.  Read More

The pharmaceutical major Aurobindo Pharma Ltd has received approvals from the Medicines Control Council (MCC) to manufacture and market 9 products in South Africa.  Read More

FDC Ltd has announced that the company has received approval from the U.S. FDA for its Abbreviated New Drug Application, Timolol Maleate Ophthalmic Solution.  Read More

Elder Pharmaceutical Ltd (EPL), with an array of acknowledged brands such as Shelcal, Fairone and others, has established itself as a fast growing pharmaceutical company.  Read More

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Contrary 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.  Read More

India’s Ranbaxy has signed an agreement with Merck to partner on the clinical development of antibacterial and antifungal candidates.  Read More

Sepracor 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.  Read More

Curtis Rosebraugh has been appointed permanent director of the Office of Drug Evaluation II (ODE II) after serving as its acting director for nine months.  Read More

Pipex Pharmaceuticals received orphan drug designation from the FDA for its oral treatment for idiopathic pulmonary fibrosis (IPF), a deadly pulmonary disease.  Read More

The FDA approved Leo Pharma’s Taclonex Scalp for the treatment of moderate-to-severe plaque psoriasis of the scalp.  Read More

The 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).  Read More

Barr’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.  Read More

Proposed 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.  Read More

Sanofi-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.  Read More

Despite 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.  Read More

Wal-Mart says it will sell discounted 90-day supplies of up to 350 generic products as the third phase of its $4 prescription program.  Read More

Sepracor 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.  Read More

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Barr Laboratories has received final FDA approval for its ANDA to manufacture and market a generic version of Bayer Schering Pharma’s oral contraceptive Yasmin.  Read More

The 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.  Read More

GlaxoSmithKline (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.  Read More

A 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.  Read More

Teva Pharmaceutical has received FDA approval for its ANDA to market epoprostenol, the first generic version of GlaxoSmithKline’s Flolan for injection.  Read More

Forest Laboratories has completed a study that shows Lexapro improved symptoms of adolescent depression as compared with placebo.  Read More

Novartis’ 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.  Read More

Trubion 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).  Read More

Cleveland BioLabs has enrolled all the patients in its Phase II clinical trial of Curaxin CBLC102 in advanced, hormone-refractory prostate cancer.  Read More

Argos 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.  Read More

Amylin 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.  Read More

Nventa 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.  Read More

Velcura 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.  Read More

VGX 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.  Read More

Pipex Pharmaceuticals received orphan drug designation from the FDA for its oral treatment for idiopathic pulmonary fibrosis (IPF), a deadly pulmonary disease.  Read More

AstraZeneca has submitted an sNDA for Seroquel XR tablets to treat generalized anxiety disorder (GAD), including maintenance of the anti-anxiety effect.  Read More

Amneal Pharmaceuticals has received FDA approval to manufacture Primidone tablets (50/250mg), Cyclobenzaprine tablets (10mg) and Demeclocycline tablets (150/300mg).  Read More

The FDA has approved Ortho-McNeil’s antibiotic Levaquin to treat pediatric patients exposed to inhaled anthrax.  Read More

The FDA has approved Eli Lilly’s Strattera for maintenance treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents.  Read More

The FDA has approved four generic versions of Requip, GlaxoSmithKline’s (GSK) restless leg treatment.  Read More

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In vitro diagnostic (IVD) manufacturers can help expedite FDA categorization of their tests under the Clinical Laboratory Improvement Amendments (CLIA) by following a new guidance.  Read More

Medtronic 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.  Read More

SunTech Medical has opened a new manufacturing facility in Shenzhen, China.  Read More

General 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.  Read More

A 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.  Read More

The 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.  Read More

Innovative 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.  Read More

Keloid 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.  Read More

Continued 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.  Read More

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Leiner 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.  Read More

Patients 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.  Read More

The 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.  Read More

Cipher 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.  Read More

The 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.   Read More

Contrary 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.  Read More

Novartis’ 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.  Read More

Sernova has concluded a pre-IND meeting with the FDA, establishing definitive clinical trial requirements for its diabetes treatment Sertolin.  Read More

Drug developer Novo Nordisk said the Food and Drug Administration approved its new hemophilia treatment NovoSeven RT.  Read More

The new building is massive — equivalent to eight football fields, with 33 laboratories spread over four floors.  Read More

State 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.  Read More

Piramal 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.  Read More

Imagine a hypothetical situation of a Cipla merging with a Ranbaxy. This may seem quite difficult but not impossible.  Read More

After 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.  Read More

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International pharmaceutical, biotech and device companies doing clinical trials in China and India may soon face new regulations.  Read More

A clinical investigator faces disqualification by the FDA for conducting a trial without an approved IND application, IRB approval or informed consent.  Read More

Requirements 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.  Read More

A 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.  Read More

Open-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.  Read More

Clinical 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.  Read More

International 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.  Read More

A 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.  Read More

The legal provisions governing clinical trials in Slovakia are set forth in Law No. 140/1998 on drugs and medical devices.  Read More