Pharma News - Chemdiv

Boehringer Ingelheim's Spevigo Bags First FDA Approval for Rare Skin Disease

The FDA has approved Boehringer Ingelheim's Spevigo (spesolimab) for generalized pustular psoriasis (GPP) flares in adults, making it the first drug approved for this indication. ...

Targeting $500M opportunity, Amneal files for FDA approval of extended-release Parkinson's prospect

Amneal Pharmaceuticals has filed for FDA approval of an extended-release Parkinson’s disease prospect that is tipped to deliver peak U.S. sales of up to $500 million. ...

Hepatitis of Unknown Origin Affecting Hundreds of Young Children

Research indicates that there is a growing amount of unusual hepatitis cases in children throughout Europe.

Merck Gains Fast Track Designation for Its Investigational Anticoagulant

Merck’s investigational anticoagulant therapy MK-2060 has received Fast Track designation from the FDA for reducing the risk of major thrombotic cardiovascular events in patients with end-stage r...

FDA Opioid Review Slow to Produce Actionable Results

The long-awaited review of problematic opioid prescribing is taking longer than observers had hoped. Studies of this extended use of the pain medications have lagged for years beyond their expected...

EC Authorizes Ranivisio, a Lucentis Biosimilar

The European Commission (EC) has granted marketing authorization to Ranivisio (ranibizumab), a biosimilar of Genentech and Novartis’ Lucentis, for treatment of several retinal diseases. ...

FDA Approves First Treatment for Acid Sphingomyelinase Deficiency, a Rare Genetic Disease

Today, the U.S. Food and Drug Administration approved Xenpozyme (Olipudase alfa) for intravenous infusion in pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a rare geneti...

Sanofi’s Tolebrutinib Phase 3 Clinical Trial Paused Globally After FDA Clinical Hold

Sanofi said that its phase 3 studies investigating tolebrutinib have been paused globally at the recommendation of the independent data monitoring committee.

Biogen Expected to Cut Costs by $1B as Industry Braves Economic Instability

While the economy expands and contracts, the biopharma industry follows, and many life science companies are announcing both layoffs and expansions.

GSK, Sanofi and Haleon ‘facing billions of dollars in Zantac liability’

GSK, its consumer health spin-off Haleon, and Sanofi could be on the hook for billions of dollars in potential damages over Zantac, a gastrointestinal drug pulled from the market in 2020 after it w...

Aura Biosciences Receives Fast Track Designation for Bladder Cancer Candidate

Aura Biosciences’s investigational drug belzupacap sarotalocan (AU-011) has received a Fast Track designation from the FDA as a potential treatment for patients with non-muscle invasive bladder c...

Merck’s Type 2 Diabetes Drugs Potentially Contaminated With Nitrosamines

The FDA has issued a notice about elevated levels of potentially carcinogenic nitrosamines found in Merck’s diabetes drugs Januvia and Janumet.

Pharma News, 2022