FDA Approvals - Emergent BioSolutions to Acquire Protein Sciences' Phase III Recombinant Flu
Emergent BioSolutions to Acquire Protein Sciences' Phase III Recombinant Flu Vaccine Candidate, FluBlok(R), and ... (Finanzen.net)
Emergent BioSolutions Inc. (NYSE:EBS) and Protein Sciences Corporation (PSC), based in Meriden, Connecticut, announced today that the two companies have entered into an asset purchase agreement under which Emergent will acquire PSC s ...
FDA Will Monitor Medical Records Of Medicare Beneficiaries To Identify Potential Prescription Drug, Medical Device ... (Medical News Today)
HHS on Thursday announced the creation of a new program that will allow FDA, state agencies and academic researchers to use medical record data to ensure drugs and medical devices are safe for consumers after they enter the market, the Washington Post reports (Stein, Washington Post, 5/23). The so-called "Sentinel Initiative" has been discussed for years, according to the New York Times.
Osmotica Pharmaceutical Receives FDA Approval To Market Novel Forms Of Extended Release Venlafaxine HCl (Medical News Today)
Osmotica Pharmaceutical Corp. received notice of final approval for its Venlafaxine Hydrochloride Extended-release 37.5 mg, 75 mg, 150 mg and 225 mg tablets NDA from FDA for major depressive disorder and social anxiety disorder. The Osmotica product provides a controlled release tablet form of venlafaxine HCl including a previously unavailable 225 mg dosage strength.