Roche wins FDA OK for targeted drug in early lung cancer and more...

The Food and Drug Administration has made a medicine from Roche the first specifically available for early treatment of lung tumors driven by a well-known cancer gene.

On Thursday, the agency cleared use of the drug, Alecensa, after surgical removal of a tumor in patients whose non-small cell lung cancer is positive for mutations in a gene called ALK.

     

For the first time since 2016, Abbott raised its organic sales guidance for the year during the first quarter. The company now expects to achieve organic sales growth between 8.5% and 10% over last year, excluding COVID testing.

“And medical devices, I mean, what can I tell you? It’s just been a real strong performer. The team's done an incredible job there,” CEO Robert Ford said during Abbott’s earnings call Wednesday. “Last year, we were the fastest-growing medtech company, at least from what I have seen from our guidance and from the other guidance’s in the market. That's what it seems to be again this year.”

     

Vir Biotechnology conducted a world-wide search to find the perfect CEO. In the end, the board picked Bayer’s Marianne De Backer, Ph.D., because of her three decades of experience in the pharmaceutical industry and her “deep and thorough understanding of the evolving healthcare landscape.”

     

Histogen Inc. (HSTO, the “Company” or “Histogen”), a drug development company for treatment of bacterial skin infections, today announced that it has filed voluntary petitions for relief under subchapter V of Chapter 11 of the U.S. Bankruptcy Code (“Chapter 11”) in the United States Bankruptcy Court for the Southern District of California to confirm a plan of liquidation that will distribute all value to stakeholders, including shareholders.

     

Alvotech and Teva Pharmaceuticals on Friday announced that they have signed a new long-term agreement with an undisclosed strategic partner in order to make its Humira biosimilar Simlandi (adalimumab-ryvk) more accessible to U.S. patients.