Top Drug Stories

Drugmakers 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

An initiative between the NIH and FDA to advance regulatory science could help drugmakers cut clinical trial costs and boost trial success.Read More

Manufacturers 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

Hospira’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

United Therapeutics has withdrawn its Tyvaso marketing authorization application following European regulators’ objections to company failures to comply with good clinical practices.Read More

Industry 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

Eisai 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

Although 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

Drugmakers 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

A 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

Federal 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

The FDA has proposed the first draft guidance on noninferiority (NI) clinical trials, which may help increase the availability of comparative information on drugs.Read More

Drugmakers 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

GlaxoSmithKline (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

Drugmakers 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

Statins 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

The 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

The 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 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

Sponsors 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

Australia’s Therapeutic Goods Administration (TGA) is proposing to add angiotensin II antagonists to the classes of medicines requiring child-resistant packaging (CRP).Read More

Sponsors 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

The 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 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

Drugmakers 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

Drugmakers 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

Rather 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

The 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

Drugmakers 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

The 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

The 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

At 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 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

In 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

The 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