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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
In the latest action stemming from the high-profile pay-for-delay case FTC v. Actavis, Par Pharmaceuticals is looking to dismiss the commission’s case by arguing a federal court sanctioned the deal the FTC is now challenging, giving it immunity. Read More
Brand drugmakers are denying accusations that they are behind a covert campaign to block proposed patent law changes that would improve access to generics in South Africa. Read More
A group of 28 Republican lawmakers is adding to the avalanche of opposition to the FDA’s proposed generic drug safety labeling rule, saying it will sow confusion and increase drug costs. Read More
Valeant Pharmaceuticals is objecting to the FDA’s planned eye-tracking study to assess how viewers see risk information in ads because it would exclude individuals wearing bifocals and hard contact lenses. Read More
UK regulators plan to reimburse drugmaker Astellas for its prostate cancer drug Xtandi (enzalutamide), but not in patients who have already been treated with Janssen’s Zytiga (abiraterone). Read More