| | | |   | Hello, all. Damian here with a look ahead at Biogen's future, a test for GSK, and the implications of Pfizer's vaccine price hike. | | | Now a word from Biogen Biogen, a company about six months into the search for its new CEO, has been happy to defer to its partner Eisai on the subject of lecanemab, the companies’ seemingly successful treatment for Alzheimer’s disease. That’ll change this week as Biogen faces Wall Street for the first time since last month’s surprising Phase 3 victory.
On its third-quarter earnings call, scheduled for Tuesday morning, Biogen will hear the practical questions of how lecanemab can succeed in a market that decisively rejected its predecessor, Aduhelm. And the company’s interim management will face — and, probably, parry — more philosophical questions about just what type of leader will eventually succeed outgoing CEO Michel Vounatsos.
Earlier this month, STAT reported that Mathai Mammen, most recently the head scientist at Johnson & Johnson, had emerged as a leading candidate for the job. He would bring a "much-needed close look at [Biogen’s] R&D portfolio," RBC Capital Markets analyst Brian Abrahams wrote in a note to clients, and with his credentials as a trained scientist, he would be a departure from the company’s recent history of appointing salesmen and corporate operators as CEO. | A test for ‘New GSK’ GSK’s rocky transformation into a pharma-focused business is headed for an early test as daprodustat, an investigational treatment for anemia, goes to the FDA.
On Wednesday, a panel of agency advisers will consider GSK’s case for what would be its first drug approval since separating from its consumer health division earlier this year. In clinical trials, daprodustat met its primary endpoint but failed on secondary goals. Analysts expect daprodustat to win approval but have outstanding questions about the breadth of its eventual label. At issue for the FDA panel will be whether to approve GSK’s drug for patients both on and off dialysis or to restrict it to only the former.
A successful launch of daprodustat would be a valuable win for GSK’s management, which has faced doubts about its scientific execution in recent years and needs to meet ambitious revenue targets to appease skeptical investors.
| Next Generation Endocrine Therapy for ER+/HER2- Breast Cancer: Not All SERDs are Created Equal Our understanding of the estrogen receptor (ER) signaling pathway and the resistance mechanisms that develop in metastatic breast cancer is evolving, and the search for a better ER antagonist has shown us the characteristics that would make up an ideal next generation complete ER antagonist (CERAN). Learn more about progress in developing new therapies for ER+ breast cancer. | Will Pfizer come to regret its vaccine price hike? Pfizer’s decision to roughly quadruple the list price of its Covid-19 vaccine starting next year was warmly received on Wall Street, but there’s a risk it could seed a backlash that would cut into the company’s business.
Last week, Pfizer said it’s planning to charge between $110 and $130 per dose in the so-called commercial phase of the vaccine market, which will begin in 2023. That’s up from the $20 to $30 price Pfizer charged in the pandemic market, and it’s considerably higher than what analysts expected, sending the company’s share price up about 5% on Friday. Moderna rose 8% and Novavax jumped about 12% on the news, reflecting investors assumption that Pfizer’s pioneering price hike will lead them to charge more than expected, too.
While Pfizer’s decision helps address lingering questions about the long-term profitability of its Covid-19 vaccine, it could also come back to bite the company. As Evercore ISI analyst Umer Raffat pointed out in a note to clients, the vaccine accounts for only about 25% of Pfizer’s Covid-19 business, with the rest tied to Paxlovid, the company’s oral treatment for the disease. If Pfizer’s move goes over poorly, the decision to extend vaccine revenue could sour demand for Paxlovid, meaning the company will have taken a short-term measure that damages its long-term health. | FDA vaccines chief sees possibility of more Covid boosters While the uptake of the latest Covid-19 booster shots is lagging behind last year, the FDA’s head of vaccines is concerned a new variant might emerge and require yet another booster in a matter of months.
As STAT’s Helen Branswell reports, Peter Marks is losing sleep over the rapid rate at which SARS-CoV-2 mutates and the fact that current vaccines, while great at preventing severe disease, have only limited protection against contracting the virus.
“I would love to see us have a very ecumenical look over all of the available vaccines and all of the vaccines in development to try to see what’s best moving forward,” Marks said. “Not to diss the current mRNA vaccines, but because we owe it to the population to see what might provide the greatest breadth, depth, and duration of immunity against Covid-19.”
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| Thanks for reading! Until tomorrow,  | | | |
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