Despite pleas for approval during a public comment period, the FDA’s Psychopharmacologic Drugs Advisory Committee failed yesterday to recommend Levo Therapeutics’ intrasanal carbetocin — an oxytocin analogue delivered via a…

Novartis has agreed to sell its approximately one-third voting stake in its competitor Roche back to Roche for $20.7 billion. Source: Drug Industry Daily

Spartan Chemical didn’t conduct validation studies for the water system used to manufacture drug products, among other quality lapses observed during a recent FDA inspection of the company’s Maumee, Ohio…

Novartis has teamed up with Cambridge, UK-based Dunad Therapeutics to develop protein degradation therapies in a deal potentially worth more than $1.3 billion. Source: Drug Industry Daily

Pfizer has quietly launched what it’s calling the Pfizer Pledge, a pilot program that attaches an insurance-backed warranty to the performance of the company’s 10-year-old lung cancer drug Xalkori, promising…

Bayer is investing in GRO Biosciences, a Boston-based company that is developing protein therapeutics for patients with autoimmune and metabolic diseases. Source: Drug Industry Daily

COVID-19 vaccine makers didn’t undergo pre-approval facility inspections before receiving Emergency Use Authorizations (EUAs) from the FDA for their jabs, the Government Accountability Office (GAO) says. Source: Drug Industry Daily

In a 14-0 vote yesterday, a Centers for Disease Control and Prevention (CDC) expert panel recommended the Pfizer/BioNTech COVID-19 vaccine for children age five to 11 years. Source: Drug Industry…

A federal judge in California has handed four drugmakers their first win in the ongoing opioid crisis liability wars, rejecting claims by three counties that the companies created a public…

Congressional Democrats have struck a compromise allowing drug pricing reform to be included in the $1.75 trillion Build Back Better Act — almost a week after the White House disappointed…