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A federal court decision this fall granting orphan drug marketing exclusivity to Depomed’s post-shingles pain drug Gralise will stand, after the FDA withdrew an appeal filed earlier this month. Read More
Mylan said earlier this month that it has launched a generic version of Warner Chilcott’s oral contraceptive Loestrin 24 Fe in the U.S., following final FDA approval. Read More
The Republican landslide in the midterm election will put GOP lawmakers in the driver’s seat on the generics labeling rule, user-fee negotiations and agency funding, but experts say the political shift’s impact remains uncertain. Read More
Biosimilars are expected to account for roughly 4 percent of all biologics sales over the next 10 years, saving the U.S. healthcare system an estimated $44.2 billion, according to new research that forecasts significantly lower savings from the products than another widely cited study. Read More
Citing quality problems at two of Ranbaxy’s Indian manufacturing facilities, the FDA has revoked its tentative approvals for two of the company’s ANDAs, one for a generic of AstraZeneca blockbuster Nexium and the other for Hoffman-LaRoche AIDS drug Valycte. Read More
The number of patent lawsuits filed over generic drug challenges has spiked this year, a development that coincides with the widely anticipated “patent cliff” of many brand drugs losing protection. Read More
AstraZeneca has filed a patent infringement lawsuit against Actavis subsidiary Watson over a proposed generic version of AZ’s diabetes drug Kombiglyze XR. Read More
The FDA said two generic versions of Janssen’s attention deficit hyperactivity disorder drug Concerta may not be therapeutically equivalent to the brand, a decision that could result in the products being withdrawn. Read More
India’s final guideline on drug patent applications drops a proposed clause that would have required manufacturers to list names of similar generic products in their filings. Read More
A federal judge has dismissed claims brought by a group of pharmacies that Pfizer and Ranbaxy forged an illegal deal to delay generic competition to Pfizer’s cholesterol drug Lipitor, marking another victory for the manufacturers in the class action filing. Read More
An HHS watchdog will audit how the FDA inspects generics manufacturing facilities, oversees postmarketing studies and ensures compliance with clinical trial reporting requirements, as well as how the drug industry is implementing the track-and-trace law. Read More
Amgen is asking the FDA to require that all biosimilar filers send a full copy of their application to the innovator company, a position that parallels the company’s lawsuit opposing Sandoz’s bid to make a version of its chemotherapy product Neupogen. Read More