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The HHS Office of Inspector General (OIG) this year plans to analyze the findings from FDA inspections of generic drugmakers’ facilities to determine the effectiveness of inspections on ensuring the quality of generic medicines. Read More
Quebec drugmaker Valeant Pharmaceuticals is acquiring Rhode Island’s PreCision Dermatology in a transaction expected to close in the first half of this year. Read More
Proposed international guidelines on metal impurities in finished drugs may be impossible to meet because they lack specificity and are impractical for suppliers, drugmakers say. Read More
Ranbaxy’s regulatory woes deepened last month as the FDA prohibited the drugmaker’s Toansa, India, plant from manufacturing and distributing active pharmaceutical ingredients (APIs) for U.S. products after a poor inspection. Read More
The drug industry wants the FDA to drop plans to require drugmakers to report manufacturing stoppages that will result in shortages within five days of the stoppage occurring. Read More
Merck and Ablynx have signed an agreement that will further their collaboration in the area of nanobodies, this time to target tumors’ immune-coopting mechanisms. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MRHA) is reminding drugmakers they must report all defects in medicinal products that could lead to a recall immediately upon discovery and provide regular updates on internal investigations into the defects. Read More
Novartis is recalling more than 200 lots of OTC cold and flu drugs distributed in seven countries — a massive market correction by the company beset with quality problems at its OTC plants since 2012. Read More
GlaxoSmithKline has halted global shipments of two chickenpox vaccines after a manufacturing problem in late November caused some batches to fail to meet release criteria and standards, the British drugmaker said Tuesday. Read More
The Department of Justice (DOJ) wants to see that when it settles a fraud case with a drugmaker the company does not slip back to its old, bad habits once the prosecutors leave, and it’s increasingly using corporate integrity agreements to make that happen. Read More
After a tough 2013, Teva received some good news Tuesday in the form of a newly approved formulation of its blockbuster drug Copaxone, helping the product gain new market share as Teva fights off generic competition. Read More