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Sanofi’s LixiLan met the primary endpoint in a pivotal Phase 3 trial showing a greater drop in average blood glucose in diabetes patients when combined with Lantus (insulin glargine). Read More
A joint FDA advisory panel voted unanimously Friday to recommend Collegium Pharmaceutical’s Xtampza ER NDA, deciding that the possible risks related to food effects on the opioid’s efficacy were forgiving and not likely to pose serious safety challenges. Read More
European drugmakers are pressing regulators to streamline the conditional marketing authorization pathway for drugs that fulfill unmet needs, saying the current system is slower than the standard authorization process. Read More
Aridis Pharmaceuticals has received FDA fast track designation for its AR-301, a monoclonal antibody that is under development to treat acute pneumonia caused by certain bacteria, including multidrug-resistant MRSA strains. Read More
Drugmakers submitting an NDA or BLA with a tropical disease priority review voucher will pay a $2.7 million fee in fiscal year 2016 — a $165,000 increase over this year, which ends Sept. 30. Read More
Amgen is seeking approval for its 420 mg monthly dosage form of Repatha just over two weeks after the FDA signed off on the PCSK9 inhibitor to control low-density lipoprotein cholesterol. Read More
Janssen and Bayer are facing yet another lawsuit over alleged gastrointestinal bleeding with their blood thinner Xarelto, this time from 25 plaintiffs in six states. Read More
Two FDA advisory committees voted 23 to 1 on Thursday not to recommend approval of Purdue Pharma’s NDA for Avridi, saying the public health benefits of the abuse-deterrent opioid don’t outweigh the risks to patients posed by the effect of food intake. Read More
A pair of U.S. senators are renewing efforts to crack down on pay-for-delay pharmaceutical deals, reintroducing the Preserve Access to Affordable Generics Act Wednesday. Read More