Top Drug StoriesManufacturers Make Mistakes in Counterfeit Fight, Experts SayDrugmakers trying to keep counterfeit
versions of their products out of the supply chain are making mistakes, such as not targeting counterfeit internet sites and letting illegal diversion
of legitimate products slide.Read More
NIH, FDA Partnership Designed to Improve Clinical TrialsAn initiative between the NIH and FDA to advance
regulatory science could help drugmakers cut clinical trial costs and boost trial success.Read More
FDA Final Guidance Outlines Procedures for Viral Vaccine MakersManufacturers of viral vaccines can more easily use new cell substrates and other materials
to make vaccines now that the FDA has issued a final guidance on
developing and testing the cells, viral seeds and other biological materials.Read More
CHMP Biosimilar Epoetin Decision May Give Hospira BiosimilarHospira’s Retacrit may become the first biosimilar epoetin in the EU for subcutaneous use in dialysis patients, because the European Committee
for Medicinal Products for Human Use (CHMP) has recommended approval.Read More
Tyvaso Application Withdrawn, Company Cites Clinical LapsesUnited Therapeutics has withdrawn its Tyvaso
marketing authorization application following European regulators’ objections to company failures
to comply with good clinical practices.Read More
Drugmakers Ask FDA to Reconsider Social Media Policy for Drug RisksIndustry is asking the FDA to reconsider
its apparent rejection of a “one-click” policy for presenting drug safety information in some online
advertisements, which prompted 14 untitled letters a year ago.Read More
FDA: Aricept Television Ads Include Misleading ClaimsEisai has received an untitled letter for
two television advertisements for its Alzheimer’s
drug Aricept showing dramatic behavior changes that are not representative of clinical trial results.Read More
Piecemeal Legislation in Congress May Affect Generic IndustryAlthough comprehensive healthcare legislation
is now unlikely, bits and pieces that could affect generic-drug makers may be considered as stand-alone legislation, according to a roundtable of company
CEOs.Read More
Industry Awaits Congressional Sunshine Provision to Preempt State LawsDrugmakers are hoping Congress
will pass a “sunshine” provision, included in healthcare reform legislation, to preempt onerous state requirements
for companies to report ties to physicians.Read More
Court Hands Drugmakers Victory Against FTC in Pay-for-DelayA district court’s decision to dismiss an antitrust lawsuit against several drugmakers might encourage the FTC to increase its lobbying efforts
for legislation to prevent “pay-for-delay” settlements. Read More
Congress May Consider Fees for Reinspections by FDAFederal budget pressures, coupled with a need to
increase the FDA’s international presence, may give Congress the impetus to pass a new drugmaker
user fee to cover the costs of reinspections.Read More
FDA Issues First Draft Guidance on Noninferiority TrialsThe FDA has proposed the first draft guidance on noninferiority (NI) clinical
trials, which may help increase the availability of comparative information on drugs.Read More
European Directorate Updates Process for Amending, Renewing CEPsDrugmakers seeking to amend or renew
a Certification of suitability of European Pharmacopoeia monographs (CEPs) soon will be able to group amendments to multiple CEPs into a single application.Read More
GSK Disputes Senate Report on Avandia, Claiming It Ignores Data, Meta-AnalysisGlaxoSmithKline (GSK)
is challenging a recent Senate Finance Committee report associating
cardiovascular risks with GSK’s diabetes drug Avandia, saying the report contains factual errors and omissions.Read More
FDA Outlines Process to Demonstrate Product Sterilization ControlDrugmakers can meet sterility requirements
for their products — and avoid conducting a formal sterility test — if they can demonstrate control
of the sterilization process through parametric release.Read More
Expert: Study May Trigger FDA Request for More Statin TrialsStatins taken to lower cholesterol may
increase patients’ risk of developing diabetes by 9 percent, according to an analysis that may lead the
FDA to informally request manufacturers of such products to undertake additional studies on the potential diabetes risk, Gregory Conko, senior fellow at
the Competitive Enterprise Institute, said.Read More
FDA Clears Lupin’s Mandideep Manufacturing FacilityThe FDA has sent Lupin Pharmaceuticals an
official communication acknowledging that the company has resolved an earlier warning letter to its Mandideep, India, facility.Read More
Lilly Faces Expanded SEC, Justice Probe, Separate Mexico FineThe SEC and the Justice Department are
expanding an investigation into Eli Lilly’s compliance with the U.S. Foreign Corrupt Practices Act,
while the Mexican government has fined the company in a separate anti-competition probe.Read More
Teva Settles Drug-Pricing Lawsuits With Several StatesTeva has resolved certain claims brought under
federal and state false claims laws, and the company is setting aside $315 million to cover that settlement and other drug-pricing lawsuits.Read More
FDA Wants Sponsors to Report Falsified Data Within 45 DaysSponsors that learn their clinical trial data or its analysis may have been falsified must report the information to the FDA within 45 days under a new
proposed rule.Read More
TGA Seeks to Expand Requirements for Child-Resistant PackagingAustralia’s Therapeutic Goods Administration (TGA) is proposing to add angiotensin II antagonists to the classes of medicines requiring child-resistant
packaging (CRP).Read More
EMEA Outlines Washout Period, Endpoints for Diabetes TrialsSponsors conducting dose-ranging studies
of diabetes mellitus treatments should include a washout period for previously treated subjects and show at least neutral effects on cardiovascular risk
factors, the European Medicines Agency (EMEA) advises in a new draft guideline.Read More
Supreme Court Seeks Government Opinion in Procrit False Claims CaseThe U.S. Supreme Court has asked
Solicitor General Elena Kagan to file an opinion on whether a whistle-blower can sue drugmaker Centocor Ortho Biotech, alleging violations of the False
Claims Act without notifying the government first. Read More
Roche Delays Taspoglutide Filing, Though Drug Passes TrialsRoche has pushed its taspoglutide filing
date into 2011, back from a previously projected fourth quarter 2010 filing date in the U.S., most likely due to recently updated FDA requirements that
diabetes drugs in trials assess cardiovascular risk.Read More
PhRMA’s Deal May Evaporate, Annual Fees Remain in Obama Health ProposalDrugmakers would pay
$1 billion more a year in fees to help fund healthcare reform legislation under a new proposal from President Barack Obama.Read More
Osteoarthritis Drug Development Is Focus of EMEA GuidanceDrugmakers developing products to treat osteoarthritis
should use pain attributable to the target joint as the primary endpoint in clinical trials, the European Medicines Agency (EMEA) says.Read More
FDA Touts Approvals of Cancer Indications, Others Look at RejectionsRather than focusing on the number
of cancer drugs the FDA’s Office of Oncology Drug Products (OODP) has approved in the 32 months since it began
reviewing marketing applications, industry should be looking at why some drugs were not approved.Read More
NICE Denies Cancer Drugs, Citing Lack of EvidenceThe UK’s National Institute for Health and Clinical
Excellence (NICE) Appraisal Committee has recommended not paying for three cancer drugs, citing insufficient clinical evidence of benefits to support the
high costs of the products.Read More
Snow Delays FDA’s Decisions on Some Drug ApplicationsDrugmakers may have to wait longer than
usual for FDA decisions on their products as the agency catches up after being shut down for several days by heavy snow.Read More
FDA Urges Approval of Generic User Fees to Shrink ANDA BacklogThe FDA hopes to see generic user fees
enacted this year to reduce an unacceptable backlog of about 2,000 applications, FDA Commissioner Margaret Hamburg said.Read More
FDA Approves Generic Zyrtec for OTC Drug MarketThe FDA has approved Aurobindo’s generic Zyrtec for U.S. OTC sales. The generic Zyrtec (cetirizine HCl) 1mg/mL product is equivalent to Zyrtec
oral solution to treat seasonal allergic rhinitis and hives in children.Read More
Repros Revises Indication for AndroxalAt the FDA’s request, Repros Therapeutics has submitted a revised indication to investigate Androxal oral tablets as a low-testosterone treatment
for hypogonadal men.Read More
Novartis to Change Maalox Product Name After Medication ErrorsNovartis Consumer Health is changing the name of its Maalox Total Relief product for upset stomach and diarrhea after the FDA received five reports of serious medication errors involving consumers who confused the drug with one of the Maalox liquid antacid products.Read More
UK Appeals Court: Gene Sequence Needs Specific Application to Be PatentableIn a decision with major implications for the patentability of biotech inventions, a UK appeals court has knocked down a Human Genome Sciences (HGS) patent for a gene because it was not accompanied by an industrial application.Read More
Sponsor-Investigator Warned for Eyelash Growth TrialThe FDA warned Cayman Chemical for sponsoring and investigating a clinical trial of an eyelash-growth enhancement drug without filing an investigational new drug (IND) application or getting institutional review board approval.Read More
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