Top Drug Stories

Asada Milling, a Japanese maker of active pharmaceutical ingredients (API), has been warned by the FDA for a general lack of quality control — and cleanliness — at its facility located in Gunma, Japan. Read More

A federal judge handed Shire a victory May 9, ruling that Actavis’ generic version of Lialda, indicated for ulcerative colitis, infringed the company’s ‘720 patent.Read More

FDA and U.S. Pharmacopeial Convention (USP) officials say proactive industry participation — mainly by offering up drug samples and technical information — is vital to improving the quality of OTC finished drugs, the subject of recent high-profile recalls.Read More

Just two months after its first commercial sale, Biotest Pharmaceuticals has voluntarily recalled one lot of its immunodeficiency drug Bivigam due to visible particles.Read More

Generic drugmaker Ranbaxy announced May 13 it has agreed to a $500 million settlement with the Department of Justice following allegations of poor data integrity and manufacturing practices at three of its Indian facilities and a facility in Upstate New York.Read More

Blocking imports of every shipment of active pharmaceutical ingredient intended for compounding is an impossible feat requiring resources beyond the FDA’s means, the agency told an appeals court last week, calling KV Pharmaceuticals’ claims it should have done so “absurd.” Read More

Ranbaxy subsidiary Ohm Laboratories received a Form 483 for quality control lapses surrounding blue glass in the active pharmaceutical ingredient for atrovastatin calcium tablets.Read More

The FDA on May 8 issued two draft question-and-answer guidances intended to clear up industry confusion about how it charges patients for INDs during clinical trials and how it expands access to such drugs outside of the clinical arena. Read More

A House committee on Wednesday advanced legislation establishing a national track-and-trace system for pharmaceuticals despite vociferous Democratic objections over the bill’s immediate preemption of state laws and lack of a clear unit-level pedigree roadmap.Read More

The European Medicines Agency (EMA) on May 2 published draft guidelines aimed at facilitating global development of biosimilars and avoiding unnecessary repeats of clinical trials.Read More

The FDA’s 2011 about-face on Forest Laboratories’ antidepressant Celexa, in which the agency warned against taking the drug at doses higher than previously approved, is being challenged by a group of researchers who say the warning may do more harm than good.Read More

French drugmaker Sanofi-Aventis was fined $52.6 million by the French competition authority Tuesday for marketing practices that discouraged sales of generic versions of the company’s blood thinner Plavix.Read More

Acting on fresh health-risk assessments, the European Medicines Agency’s pharmacovigilance panel is calling for an EU-wide suspension of tetrazepam-containing drugs and recommending new restrictions on the use of a pair of French-made osteoporosis drugs.Read More

Industry stakeholders will have an opportunity to shape the FDA’s fiscal 2014 regulatory science roadmap for generic drugs during a June 21 public meeting at the agency’s headquarters.Read More

The White House Monday sought to block a lower court judge’s order requiring the FDA to remove all age restrictions from the emergency contraceptive known as Plan B One-Step.Read More

Alexion is reviewing its analytical methodologies and procedures to ensure its risk assessments meet the FDA’s expectations, the drugmaker said. Read More

The European Medicines Agency released a first revision of good pharmacovigilance practice guideline, adding practical instructions for the application, description and maintenance of the EU reference date list in — and amendments to — marketing authorizations.Read More

A federal judge Friday declined the Obama administration’s request to issue a stay pending appeal of his decision that would lift age and identification restrictions on Teva’s OTC emergency contraceptive Plan B One-Step.Read More

A growing number of pivotal clinical trials — typically Phase III studies — submitted in support of drug applications in Europe are being conducted outside the region, a European Medicines Agency report finds.Read More

To improve engagement between the European Medicines Agency, drugmakers and scientific committees, the agency is putting in motion planned changes discussed late last year.Read More

CDER Director Janet Woodcock, appearing before a Senate panel Thursday, reiterated the FDA’s call for enhanced authority to seize compounding pharmacy records.Read More

Improved transparency and better access to biosimilars and orphan drugs are key goals in an emerging blueprint for industry being developed by a panel of European pharma stakeholders.Read More

In an effort to reduce filing errors, the FDA has launched a pilot program for the electronic submission of field alert reports (FARs) using the XML data format.Read More

Jazz Pharmaceuticals told investors Monday it expects the FDA to require modifications to the current risk evaluation and mitigation strategy (REMS) for its highly controlled narcolepsy drug Xyrem, a move some analysts say could expand market opportunities for generic competitors.Read More

The General Court of the European Union has issued a temporary injunction barring the European Medicines Agency (EMA) from releasing information on clinical data.Read More

Over the past two weeks, the FDA has issued a flurry of safety alerts to warn the public of problems with different drugs, including adverse events tied to the anti-seizure drug Potiga, fake Botox and fleck-infused containers of injectable drugs produced by Hospira.Read More

A House discussion draft establishing a national drug track-and-trace system has inched closer to mandating unit-level traceability, but House GOP leaders want the FDA to draft the needed regulations.Read More

An FDA official praised a new excipient supplier certification program for drug manufacturers as a way to safeguard supply chain quality and ease the pain of shortages. Read More

Gilead’s efforts to win approval of two HIV medications — already marketed as part of its quad combo Stribild — came to a halt April 29.Read More

In a move that drew disgruntled comments from FDA advisors, the agency on Friday approved Merck’s Liptruzet, a combination of Merck’s Zetia and Pfizer’s Lipitor, to treat hyperlipidemia.Read More

The California State Board of Pharmacy has reported a possible attempt to introduce counterfeit versions of EMD Serono’s Serostim, an HIV treatment, into the U.S. supply chain.Read More

After continuous stalling of Impax Pharmaceuticals’ Parkinson’s drug Rytary, GlaxoSmithKline (GSK) is pulling out of its development and marketing partnership with the smaller company.Read More

Sweeping legal reforms in China signal the country’s commitment to improving trade with the U.S., including pressing pharmaceutical industry concerns such as protecting intellectual property rights and enhanced enforcement of counterfeiting, a new government report states.Read More

A class action suit brought by a Pennsylvania-based union claims Warner Chilcott schemed a pay-for-delay deal with generic competitors to maintain a market for its contraceptive drug Loestrin 24 FE while it fights to cement a 16-year patent hold on a weaker, follow-on version.Read More

An FDA advisory committee rejected two proposed cancer therapies Thursday — a tyrosine kinase inhibitor targeting advanced renal carcinoma and a drug-device combination product for treating a deadly form of liver cancer — citing concerns with safety and lack of supporting data.Read More