Top Drug Stories

While the global generics market is set to surge over the next five years as patents for blockbuster drugs expire, generic-drug makers would be wise to pad their portfolios with specialty products that are more difficult to produce, a new consultancy report states.Read More

The FDA is updating bioequivalence (BE) guidelines on more than five-dozen drugs as it develops online product-specific BE recommendations for generic-drug sponsors.Read More

The FDA’s alleged monitoring of the personal emails of employees who voiced product safety concerns to Congress could dissuade other staffers from airing grievances, industry experts tell DID.Read More

The Medicare Payment Advisory Commission (MedPAC) has voted to recommend changing copays for low-income Medicare enrollees to encourage generic-drug substitution.Read More

The FDA is suing drug- and dietary supplement-maker Syntec and ordered U.S. marshals to seize its products, citing manufacturing violations and false and misleading health claims.Read More

The FDA has approved Amylin’s and Alkermes’ Type 2 diabetes drug Bydureon, marking the end of a long and rocky review path for the drug.Read More

A federal judge has dismissed a failure-to-warn lawsuit against Mylan, saying the generic-drug maker was preempted from making safety label changes even though its generic was the reference listed drug (RLD). Read More

Patent reform in the U.S. and EU, pricing pressures in numerous countries, increasing competition from emerging markets in Asia and Latin America and the global offensive against fake drugs, IPRM followed these issues and more to ensure that readers have the information they need to make smart business decisions in the U.S. and abroad.Read More

Par Pharmaceutical’s First Amendment suit against the FDA is based on false assumptions and misinterpretation of marketing regulations, the agency says, firing back at Par with a motion to dismiss the complaint. Read More

The Medicare Payment Advisory Commission (MedPAC) has voted to recommend changing copays for low-income Medicare enrollees to encourage generic-drug substitution. Read More

Drug importers must certify that foreign manufacturers adhere to good manufacturing practices (GMP) before a product can be registered in the Philippines, according to a draft guideline. Read More

The FDA will contract with an independent firm to study workload volume and full costs associated with reviewing biosimilars applications under proposed statutory language for a user fee program. Read More

The FDA formally closed out a Jan. 14, 2010, warning letter citing Sunrise Pharmaceuticals for manufacturing some of its products with excess active pharmaceutical ingredient (API) without justification in the batch records.Read More

The FDA’s consent decree for Ranbaxy requires third-party audits of four facilities and it can be expanded to other plants if future inspections reveal compliance or data integrity issues, making it “unprecedented in scope,” the Department of Justice says.Read More

While pharma compliance on off-label promotion is improving, drugmakers are falling short on stopping unsupported statements about approved uses by their sales staff and contractors, state attorneys general say. Read More

Dr. Reddy’s Laboratories’ failure to prominently display a boxed warning on its website for injectable anticoagulant fondaparinux sodium has landed the company an untitled letter. Read More

The FDA has handed Bristol-Myers Squibb (BMS) and AstraZeneca a complete response letter (CRL) for diabetes drug dapagliflozin that will probably necessitate new clinical trials, analysts say.Read More

Hearing CEO Paul Bisaro talk about the future of Watson Pharmaceuticals, you might not realize his company is the third largest generic-drug maker in the U.S. That’s because Watson is looking to spread its reach beyond generics, aiming for $1 billion in brand revenue by 2015.Read More

Sen. Kay Hagan (D-N.C.) will soon introduce legislation to expand the FDA’s use of an accelerated approval pathway, Biotechnology Industry Organization (BIO) officials say.Read More

The FDA in the coming weeks plans to issue two new guidance documents on positron emission tomography (PET) drugs: one on IND applications and a Q&A guidance with answers to more than 100 questions of continuing concern to PET drug manufacturers, FDA officials say.Read More

An FDA advisory committee voted 13–4 against recommending approval for Columbia Laboratories’ Prochieve progesterone gel, citing efficacy concerns and a lack of confidence in the company’s sole late-stage trial.Read More

Hospira has begun enrolling patients in a Phase III trial for a U.S. biosimilar of Amgen’s Epogen with results expected next year.Read More

The FDA formally closed out a Jan. 14, 2010, warning letter citing Sunrise Pharmaceuticals for manufacturing some of its products with excess active pharmaceutical ingredient (API) without justification in the batch records. Read More

The FDA has handed Bristol-Myers Squibb (BMS) and AstraZeneca a complete response letter (CRL) for diabetes drug dapagliflozin that will probably necessitate new clinical trials, analysts say.Read More

After months of searching for leadership, GPhA is revamping its upper management with several key hires.Read More

The U.S. Court of Appeals for the District of Columbia has reaffirmed a lower court decision that FDA warning letters are not final agency actions, so companies cannot seek judicial review of them under the Administrative Procedures Act.Read More

Columbia Laboratories’ Prochieve progesterone gel is no better than placebo at preventing preterm deliveries in women with a short cervical length, a finding particularly evident in the U.S. population, FDA reviewers say in advance of an advisory committee meeting. Read More

An FDA task force is “marching through” development of a project management plan to execute the logistics to support a generic drug user fee program, CDER Director Janet Woodcock told Generic Line in an exclusive interview.Read More

Janssen Pharmaceuticals recently received an untitled letter after a company representative was overheard making unsupported statements about pain drug Nucynta.Read More

The FDA and Commissioner Margaret Hamburg were too slow to address manufacturing mishaps at Novartis Consumer Health’s Lincoln, Neb., plant and should have pushed for an earlier recall of some of the OTC products made there, a lawmaker says. Read More

Generic-drug makers won’t have long to wait after Congress passes a user fee bill to learn the various fee levels in the Generic Drug User Fee Act (GDUFA). Read More

The FDA is encouraging generic-drug makers to use quality by design (QbD) for modified-release products by publishing an example of the development, design and manufacturing of a fictitious modified-release drug using QbD principles.Read More

Generic drugmakers won’t have long to wait after Congress passes a user fee bill to learn the various fee levels in the Generic Drug User Fee Act (GDUFA).Read More

Generic versions of blockbuster cholesterol drug Lipitor raked in roughly 60 percent of sales during their first two weeks on the market, with Watson’s authorized generic beating Ranbaxy’s competitor.Read More

The U.S. government confiscated more than $16.8 million in counterfeit pharmaceuticals in 2011, nearly three times the value of fake drugs seized a year earlier.Read More