Here are the latest stories being discussed in biopharma today:
Bayer’s Restructuring Impacting Executive Team
Bayer is halving its leadership team as part of a restructuring plan that aims to increase efficiency. Six places on the pharmaceutical division’s leadership team will be eliminated, shrinking the team from 14 to eight. Anne-Grethe Mortensen, Head of Global Marketing, will be leaving the company as part of this restructuring.
Opdivo-Yervoy Combo for First-Line Liver Cancer
Bristol Myers’ hopes to secure approval for its Opdivo-Yervoy combination as a first-line treatment for advanced liver cancer. The compound recently met its primary endpoint for a Phase 3 study, thereby demonstrating significant clinical improvements against rival kinase inhibitors Nexavar and Lenvima.
Idorsia’s Blood Pressure Drug Approved by FDA
The FDA has granted approval to Idorsia’s high blood pressure treatment, Aprocitentan. Branded as Tryvio, it is meant for patients who have not responded adequately to existing medications.
AstraZeneca Launches Campaign and Telehealth Option for Airsupra
AstraZeneca has launched its first direct-to-consumer campaign for its dual-medication asthma inhaler, Airsupra. The campaign features a CGI dinosaur representing old-style inhalers and emphasizes Airsupra as a modern asthma treatment.
FDA Draft Guidance on Observational Studies
The FDA has released draft guidance clarifying how drug sponsors can use observational studies to demonstrate a drug’s efficacy. The focus lies in ensuring the data collected in observational studies is reliable and relevant. The document includes detailed guidelines on study design and analytical approach.
Capstan Therapeutics Raises $175M for in Vivo CAR-T Testing
Capstan Therapeutics has raised $175 million in a Series B funding round to test its in vivo CAR-T. The company predicts that the use of cell therapies might be replaced within a decade by in vivo approaches, should the technology prove successful.
Orchard Prices Gen Therapy Lenmeldy at $4.25M
Orchard Therapeutics has set a US price tag for its new rare disease gene therapy Lenmeldy at $4.25 million, making it the most expensive treatment thus far. Other recent gene therapies also command high prices, such as CSL Behring’s Hemgenix at $3.5 million and bluebird bio’s Zynteglo at $2.8 million and Skysona at $3 million.
