| | | |   | Good morning, everyone. Damian here with the latest on Biogen's CEO search, another test of the FDA's fast track, and a persistent dream for Covid-19 vaccine makers. | | | Did lecanemab upend Biogen’s CEO search? Mathai Mammen, the well-regarded head of research at Johnson & Johnson, is no longer in the running to be Biogen’s next CEO, STAT has learned.
A major sticking point, according to a person familiar with the situation, was Mammen’s desire for influence over future changes to Biogen’s board, something longtime chairman Stelios Papadopoulos wasn’t willing to accept.
But the surprising success of lecanemab, Biogen’s Eisai-partnered treatment for Alzheimer’s disease, might have played a role, too. The drug, expected to win FDA approval early next year, presents an opportunity to succeed where Aduhelm failed, becoming a multibillion-dollar product that changes Biogen’s business outlook for years to come. It could also change Biogen’s approach to picking its next CEO, leading the company to revert to form and find a commercially minded leader rather than a career scientist.
Read more. | More accelerated drug approval drama This time, courtesy of British pharma giant GSK, which said yesterday that its blood cancer drug Blenrep failed to delay disease progression compared to a standard treatment in a clinical trial involving patients with advanced multiple myeloma.
The study was meant to confirm the benefit of Blenrep, which won accelerated FDA approval in 2020 based on its ability to shrink tumors. The negative outcome of the confirmatory study, however, opens the door for the FDA to withdraw Blenrep from the U.S. market.
In a statement, GSK said data from the study are being shared with regulators and discussions are ongoing. The company does have a lifeline of sorts: Two additional studies of Blenrep in multiple myeloma are expected to have results in the first half of next year. | Patient support checklist: 5 steps to improved medication adherence Medication adherence is a primary factor in determining patient outcomes. An estimated 50% to 60% of patients with chronic illness skip their medications, alter doses, or stop their treatment altogether in the first year. Overcoming the myriad factors that can contribute to non-adherence is a daunting task. For companies who have moved the needle, success means a multi-faceted approach. Download the checklist from AmerisourceBergen and get considerations as you address clinical and non-clinical hurdles and incorporate technology into the workflow. | For Covid vaccine makers, the dream of Chinese approval remains alive BioNTech’s share price is up more than 10% on renewed hopes that the company might finally find a way to sell its blockbuster Covid-19 vaccine in China. But after years without progress, it’s unclear whether the latest discussions mark a real way forward or just wishful thinking on the part of investors.
It started on Friday, when German Chancellor Olaf Scholz said he had convinced Chinese authorities to let expatriates get BioNTech’s vaccine, which is partnered with Shanghai Fosun Pharmaceutical in China. Yesterday, on BioNTech’s quarterly earnings call, the company’s chief strategy officer said there had been “some positive re-engagement” with Chinese officials but cautioned the company could not predict whether or when the government might approve its vaccine for foreigners working in China.
Analysts and investors have become increasingly fixated on the possibility of selling mRNA vaccines in China, as BioNTech and its rival Moderna face steep revenue cliffs due to declining demand for their products. But Chinese regulators have approved only domestically developed vaccines, and there’s no guarantee an approval for expats, if it comes to pass, will lay the groundwork for broader use of Western vaccines. | Verve hits a roadblock in CRISPR trial The FDA placed a hold on Verve Therapeutics’ experimental gene-editing treatment for a common form of heart disease, the company said yesterday, possibly delaying a pioneering study already recruiting patients overseas.
As STAT’s Adam Feuerstein reports, Verve asked the FDA in October for permission to start treating patients in the U.S. with its CRISPR-based treatment, called VERVE-101. The agency responded by placing the study on clinical hold, meaning Verve can’t recruit trial volunteers in the U.S. until the FDA changes its mind. Verve didn’t provide further details, saying in a statement that the company “intends to work closely with the FDA to resolve the hold as promptly as possible.”
Verve has already treated three patients in its early-stage study, which is recruiting in New Zealand and the U.K. There have been no serious side effects related to VERVE-101 reported to date in the trial, the company said.
Read more. | More reads - Health and science are on the ballot this election. Here’s what we’re watching, STAT
- FDA staff flags uncertainties on Veru's Covid drug; EUA hopes lift shares, Reuters
- After years of lax oversight, the NIH is starting to contact institutions about unreported clinical trial results, STAT
- High court rejects Bristol Myers' $1.2 billion patent case, Bloomberg
| Thanks for reading! Until tomorrow,  | | | |
No comments