A little more than two years after signing up GlaxoSmithKline as its Big Pharma partner on an extended-release version of a carbidopa-levodopa combo for Parkinson's disease, Impax Laboratories is headed back to the bargaining table. The FDA rejected the drug based on manufacturing issues a few months ago, and a frustrated Glaxo has now decided to drop out of the game.
A team of researchers at the Stanford University School of Medicine has developed a data mining method that could divulge important information about possible drug side effects using records of interactions between doctors and patients.
The refusals for elvitegravir and cobicistat on a standalone basis were triggered after inspectors were left shaking their heads following a checkup on Gilead's "documentation and validation of certain quality testing procedures and methods."
Because of InsuPatch's mechanism of delivery, the company must submit an IND on top of its previous 510(k) de novo application.
Pfizer has big expectations for its oral rheumatoid arthritis treatment Xeljanz--about $3 billion worth. But those expectations were struck a serious blow when European Medicines Agency regulators Thursday turned it down for approval.
The FDA has tapped Corning to refine a device its own researchers developed that can help detect counterfeit drugs, and it will now share it in a program to reduce problems from counterfeit malaria drugs.
One of the key players in an investigation of counterfeit Avastin that appeared to have been imported into the U.S. by a Canadian Internet pharmacy has pleaded guilty to playing a part in the operation.
Last month, Becton Dickinson got FDA approval for its antihistamine diphenhydramine hydrochloride injection, the first sterile injectable drug to come out of its new $100 million plant in North Carolina. The second drug to come out of the new plant will be metoclopramide injection, USP, an injectable antiemetic.
Merck ($MRK) has a shot at a speedy development path for lambrolizumab. The FDA has pinned a "Breakthrough Therapy" tag on the experimental antibody drug for advanced melanoma, based on Phase Ib data that showed significant early signs of anti-tumor activity in some patients with aggressive cases of the deadly skin cancer.
The drug manufacturing supply chain is complex and global, making it harder for the FDA to keep an eye out for bad players and dangerous products. The vast amount of active pharmaceutical ingredients come from low-cost countries like India and China.