Topic:

Regulatory

Latest Headlines

Latest Headlines

EU suggests new warning for same sleeping pill that landed a Kennedy before a jury

Sleep drugs have been the root of plenty of safety worries over the years, especially when it comes to driving while under their influence. Now, just a week after the wrap of one of the highest-profile cases to revolve around Ambien generic zolpidem--Kerry Kennedy's--the European Medicines Agency's Pharmacovigilance Risk Assessment Committee is recommending updates to its product information to underscore the drug's associated risks.

AngioDynamics plans late FY14 rollout for latest dialysis catheter

AngioDynamics is gearing up for commercialization in the coming year for its latest chronic dialysis cathether, a product that will help protect and grow an already impressive U.S. market presence.

GlaxoSmithKline's FDA batting average tops the industry; Lilly, not so much

Reaping the benefits of deep-seated R&D reorganization, GlaxoSmithKline had the industry's best 6-year run of FDA nods for new drugs, according to EvaluatePharma, leading its competitors by a wide margin and leaving approval-starved outfits like Eli Lilly and Merck in the dust.

Novartis sees start of $2B dermatology opportunity with new EU Xolair approval

On Thursday, Novartis won European approval for its injectable Xolair to treat chronic hives--the first such product cleared there for patients who don't respond to antihistamines alone.

Pfizer recalls 104,000 bottles of antidepressant Effexor XR

The largest drugstore chains have been in a legal battle with Pfizer, accusing it of conspiring to keep generics of its antidepressant Effexor XR out of their stores for years. Now they will have to deal with losing some of the real thing. Pfizer is recalling three lots of the drug after a pharmacist discovered a capsule of one of Pfizer's heart pills in an Effexor XR bottle, a potentially fatal combo.

Baxter scrambles to retrieve glucose bags after reports of patient reactions

When Baxter International issued product recalls in December and January, it said there had been no reports of adverse events. But Baxter couldn't make that claim Wednesday when the company recalled a single lot of a dialysis product in which mold was found.

Endo clears the FDA with thrice-spurned drug as 'low-T' controversy boils

In its fourth trip to the FDA, Endo's testosterone-boosting Aveed finally won over regulators, but as the clamor over risks tied to "low-T" treatments reaches deafening volume, the in-transition drugmaker may be late to a profitable party.

Novartis nabs a new anti-hives use for Xolair in the EU

As the company points out, it's the only product cleared for patients whose chronic spontaneous urticaria haven't responded to antihistamines.

Bloomberg: Worker safety also an issue with Ranbaxy plant

The FDA placed an import ban on products from Ranbaxy Laboratories' active pharmaceutical plant in Toansa, India, in January, calling into question its drug analysis and sanitation. But there are other problems at the plant, like worker safety, that the FDA does not address and which get little attention from Indian authorities.

Obama administration looks to chop back market exclusivity for biologics

One of the signal achievements for the biotech industry in the Affordable Care Act was a provision granting 12 years of market exclusivity to biologics. The decade-plus period of protection against generic competition ensured that biologics would remain center stage in the R&D world, especially as Big Pharma tumbled over the patent cliff as it tried to rethink its megablockbuster-sized budgets for drug development.