BioSpace News Archive

The biopharma’s Adzynma, a human recombinant ADAMST13 therapeutic, is the first approved therapy for the ultra-rare clotting disorder congenital thrombotic thrombocytopenic purpura.

The two mid-stage flops—one in major depressive disorder and another in focal onset seizures—involve drug candidates from partnerships with Xenon Pharmaceuticals and Takeda, respectively.

To protect the central nervous system, the blood-brain barrier bars entry to around 98% of molecules—but approaches like Roche’s trontinemab could spell new hope in Alzheimer’s and beyond.

Following a more than two-month delay to its PDUFA action date, Valneva’s chikungunya vaccine Ixchiq has won the regulatory race beating biotech Bavarian Nordic.

In response to skyrocketing demand for its weight-loss drug Wegovy, Novo Nordisk announced Friday it is investing more than $6 billion to expand production capacity in its home country of Denmark.

The company’s immunotherapy, in combination with chemotherapy Avastin, showed favorable progression-free survival in a late-stage hepatocellular carcinoma study.

The FDA’s approval of Eli Lilly’s obesity drug Zepbound intensifies an already heated battle with Novo Nordisk’s Wegovy in the lucrative weight-loss drug market, as other drugmakers hope to get a piece of the action.

Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced new data from the Phase 3 MAESTRO-NASH trial demonstrating broad treatment effects of resmetirom on noninvasive tests that may be used to monitor NASH with liver fibrosis.

UNITY Biotechnology, Inc. announced the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 2,143,000 shares of common stock, having an exercise price of $8.50 per share, issued by UNITY on August 22, 2022, at a reduced exercise price of $2.045 per share.

IO Biotech (Nasdaq: IOBT) announced today that it has completed enrollment in the pivotal Phase 3 clinical trial for IO102-IO103, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced melanoma.