Pharma News - Chemdiv

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.

BMS Bets up to $1.9 Billion on GentiBio’s Treg Platform for Inflammatory bowel disease

Within the next eight years, more than 3.5 million people in the United States are expected to be diagnosed with inflammatory bowel disease.

Merck returns to Alzheimer’s disease with $1.1B Cerevance pact

With an investment valued at up to $1.1 billion, Merck is diving back into Alzheimer’s research through a collaboration with Cerevance.

FDA grants Fast-Track status for Relmada’s major depressive disorder therapy

The US Food and Drug Administration (FDA) has granted Fast-Track designation to Relmada Therapeutics’ REL-1017 as a single agent to treat major depressive disorder (MDD). ...

FDA Pushed Back PDUFA Date on Omaveloxolone

The FDA has pushed back its decision date on Reata Pharmaceuticals’ New Drug Application (NDA) for omaveloxolone, an investigational drug for treatment of the rare inherited neurodegenerative di...