Pharma News - Chemdiv

Biogen sends CEO to the exit, abandons Aduhelm sales team in $1B overhaul

Biogen’s yearlong struggle with the controversial FDA approval and launch of Aduhelm has culminated in a deep overhaul reaching all the way to the CEO.

Anticipating FDA Rejection, Spero Cuts 75% Of Workforce

Spero Therapeutics is laying off approximately 75% of its workforce as part of a restructuring operation in light of the U.S. Food and Drug Administration's expected rejection of its New Drug Appl...

Washington State Settles With Three Drug Distributors for $518 Million

Drug distributors McKesson, Cardinal Health and Amerisource Bergen have agreed to pay the state of Washington a total of $518 million to settle litigation over their alleged roles in fueling the op...

FDA Accepts Bayer's Application to Expand Nubeqa into New Prostate Cancer Indication

Bayer announced Tuesday that The U.S. Food and Drug Administration accepted its supplemental New Drug Application (sNDA) for Nubeqa as a potential treatment for metastatic hormone-sensitive prosta...

Phathom Wins Approvals Against Antibiotic Resistance in H. pylori

Phathom Pharmaceuticals is having a good week as the U.S. Food and Drug Administration approved two of its products for bacterial illnesses in adults. ...

European Commission Greenlights Idorsia’s Insomnia Drug Quviviq

The European Commission has granted marketing authorization for Idorsia’s Quviviq (daridorexant) for the treatment of adult patients with chronic insomnia disorder. ...

Teva Settles With Lupin Over Austedo Patent

Teva Pharmaceuticals and Lupin have settled their patent dispute over Lupin’s generic version of Teva’s Huntington’s disease drug, Austedo (deutetrabenazine). ...

AbbVie Touts Another FDA Approval for Rinvoq, Posts Strong First Quarter

AbbVie is off to a strong start for 2022, driven by success from Skyrizi and Rinvoq, as well as the company’s neuroscience platform that includes its depression treatments and its three-pronged a...

It's CRL Day at the FDA as Axsome, Junshi and Coherus Get Bad News

The U.S. Food and Drug Administration is quickly catching up after COVID-19 disrupted typical review timelines and planned inspections and it's bad news for three companies.

Pfizer’s COVID-19 Drug Paxlovid Fails in Postexposure Clinical Trial

Pfizer’s oral COVID-19 treatment Paxlovid (nirmatrelvir and ritonavir) failed to show meaningful improvements in people who took it after exposure to COVID-19.

Orphalan pushes first drug for Wilson's disease in 5 decades over FDA finish line

It has taken French rare disease specialist Orphalan 11 years to earn its first approval in the U.S.

Supernus Announces FDA Approval of Qelbree® for the Treatment of ADHD in Adults

Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced ...