Osmotica Stock Surges On $170M Divestiture Deal With Alora Pharmaceuticals
Osmotica Pharmaceuticals plc (NASDAQ:OSMT) has agreed to sell its portfolio of legacy products and Georgia manufacturing facility, for up to…
FDA AdCom In Favor Of Delaying Incyte’s Retifanlimab Approval In Anal Cancer
Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte Corporation’s (NASDAQ:INCY) retifanlimab…
FDA Denies Adial Pharma’s Fast Track Request For AD04 in Alcohol Use Disorder
Adial Pharmaceuticals Inc (NASDAQ:ADIL) has received notice from the FDA that its request for Fast Track Designation for AD04…
Tonix Pharma Stock Moving Higher On Plans For Vaccine Manufacturing Facility In Bitterroot Valley
Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) said in a regulatory filing that plans are underway to construct a commercial-scale manufacturing site to…
Sanofi – Regeneron’s Immunotherapy Scores European Approval For Skin And Lung Cancer Settings
The European Commission (EC) has approved Sanofi SA (NASDAQ:SNY) and Regeneron Pharmaceuticals Inc’s (NASDAQ:REGN) Libtayo (cemiplimab) for two additional indications – basal…
Vir Biotechnology To Present Clinical Data From Ongoing Trials Of VIR-2218 Qnd VIR-3434 in Patients With Chronic Hepatitis B Virus Infection At The International Liver Congress 2021
– Results demonstrate positive safety profiles and a reduction in HBsAg for two novel HBV therapies administrated as monotherapy or in combination with other agents –
– Management to host
FDA Gives Emergency Use Nod For Roche’s Arthritis Drug Against Severe COVID-19
The FDA has approved Roche Holding AG’s (OTC:RHHBY) arthritis drug Actemra (tocilizumab) for emergency use to treat adults and pediatric patients…
Pfizer Stops Global Smoking Cessation Pill Distribution After Flagging Impurities: Report
After finding unacceptable levels of potential carcinogens called nitrosamines in certain Chantix (varenicline) lots, Pfizer Inc (NYSE: PFE) has halted the worldwide distribution of the popular smoking cessation medicine.
Jazz Pharmaceuticals Announces FDA Orphan Drug Exclusivity For Xywav Oral Solution
Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has recognized seven years of Orphan Drug Exclusivity for Xywav™ (calcium, magnesium, potassium, and sodium
The Daily Biotech Pulse: Roche Gets Authorization For COVID-19 Treatment, Nods For Sanofi-Regeneron In Europe, Osmotica Divestment, 2 IPOs
Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs June 24)