FDA Takes Aim at Delaying Tactics for Shared REMS
The FDA is working to prevent manufacturers of branded high-risk drugs from stalling an application for approval of a generic competitor via manipulation of a requirement to share safety programs,…
The FDA is working to prevent manufacturers of branded high-risk drugs from stalling an application for approval of a generic competitor via manipulation of a requirement to share safety programs,…
A workers’ benefits fund filed a lawsuit claiming Johnson & Johnson maintained an illegal monopoly for its blockbuster drug Remicade, employing anticompetitive schemes involving insurer contracts, rebate protocols and bundling.…
The UK’s competition watchdog agency claimed the drugmaker Concordia overcharged the NHS by millions for its hypothyroid medication liothyronine, also known as Cytomel, following price increases of almost 6,000 percent…
Chiome Bioscience says it announces termination of candidate antibody related joint research contract, which was signed between the co and Chugai Pharma, as the contract has expired on Dec. 31…
The possibility of a tax bill being passed has many investors and analysts forecasting 2018 to be a big year for mergers and acquisitions. Source: BioSpace
Intellia has named John Leonard, M.D., President and CEO, effective January 1, 2018. Source: BioSpace
Under terms of the deal, Boehringer has the option to acquire Autifony's Kv3.1/3.2 positive modulator platform, which includes the company's lead compound AUT00206. Source: BioSpace
Now that we've got the bad news out of the way, we’re here to spread some Christmas cheer with the biggest clinical successes in biotech over the past 12 months.…
Dr. Ryan becomes a Director of the Company effective immediately and will assume his responsibilities as CEO effective February 15, 2018. Source: BioSpace
The round was led by Bain Capital Life Sciences. Source: BioSpace