Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where we have clear blue skies and pleasant breezes greeting us today. Who could ask for anything more? Actually, we could — it is time to reheat the kettle for another cuppa. Our choice today is super shroom. Please feel free to join us. Remember, no prescription is required and no rebates are involved. Just an old-fashioned, out-of-pocket cost. And now, here are your tidbits. Hope you have a productive and meaningful day, and, as always, please do keep in touch. We have adjusted our settings to accept postcards and telegrams.…
The co-founders of the Covid-19 vaccine developer BioNTech plan to leave the biotech to start a new mRNA-focused company, STAT notes. Ugur Sahin and Özlem Türeci, who are married, will transition to the as-of-yet unnamed company by the end of the year, with a focus on researching and developing next-generation mRNA medicines. BioNTech will be giving certain rights to its mRNA technology to the new company, while picking up a minority stake in it. BioNTech, meanwhile, will prioritize its late-stage cancer-focused pipeline that includes antibody-drug conjugates, immunotherapies, and some mRNA candidates. It will continue to sell its Covid-19 vaccine, which was developed with Pfizer. The company said the split — with the new firm dedicated to discovery and BioNTech gearing up to commercialize its medicines — could add more value for shareholders.
A key U.S. Republican senator said he launched an investigation into the U.S. Food and Drug Administration’s recent denials of treatments for rare diseases, adding political pressure on an agency that’s already in turmoil, Bloomberg News tells us. Wisconsin Sen. Ron Johnson said he is seeking the FDA’s written denials to drugmakers, known as complete response letters, and plans to write letters to the agency asking why it denied certain drugs. He said he is also considering having top FDA officials, including Commissioner Marty Makary, testify before the Senate’s Permanent Subcommittee on Investigations that he chairs. His comments came after the FDA has refused to approve treatments for several rare diseases, and demanded additional studies before it would consider approving others, sparking an outcry from patient advocates and investors.Continue to STAT+ to read the full story…