|
|
Welcome back to Endpoints Weekly! It was another busy news week, so let’s dive in. Our reporters tracked a number of updates from DC, including the removal of all 17 members of the CDC’s vaccine advisory committee and the announcement of eight new members. The Endpoints team also covered a handful of noteworthy deals, including another cardiometabolic pact for Novo Nordisk and BioNTech’s plans to acquire CureVac. And ahead of an anticipated FDA decision for Gilead’s pre-exposure prophylactic (PrEP) injection for HIV, Kyle LaHucik examined some of
the challenges the company could face if it wins approval.
Set aside some extra time this weekend to read Ryan Cross’ feature story about a startup rebooting dead human brains in an effort to overcome the limitations of animal studies in neurological and psychiatric disorders.
We also opened nominations this week for our annual Women in Biopharma R&D report. Click here to learn more, or use this form to submit a nomination. — Nicole DeFeudis |
|
Nicole DeFeudis |
Editor, Endpoints News |
|
|
|
|
|
RFK removes all ACIP members |
HHS removed all 17 members of the CDC’s Advisory Committee on Immunization Practices and announced eight new members. HHS Secretary Robert F. Kennedy Jr. wrote in a Wall Street Journal editorial that “a clean sweep is needed to re-establish public confidence in vaccine science.”
You can read more about the new members here. Two of the new members previously served as paid expert witnesses for plaintiffs suing Merck over its HPV and MMR shots, Endpoints News’ Max Bayer, Alexis Kramer and Drew Armstrong reported this week.
The committee still plans to meet at the end of the month, HHS said in a release. According to a Federal Register notice on Monday, the committee is expected to discuss recommendations for the Covid-19 vaccines and other products.
|
|
|
Can dead brains be rebooted to test drugs? |
🧠That’s the big question being posed by Bexorg, a company spun out of Nenad Sestan’s lab at Yale University. No, it’s not trying to bring dead humans back to life like in Mary Shelley’s Frankenstein. Rather, a team led by Zvonimir Vrselja is attempting to overcome some of the limitations of animal studies in neurological and psychiatric disorders, senior science correspondent Ryan Cross reported this week. There are countless examples of experimental drugs for such conditions that looked promising in the
preclinical setting before flaming out when tested in humans.
In 2019, Vrselja’s team published research showing it could restore cellular activity in the brains of decapitated pigs. Now, Bexorg has a machine that can keep dead brains ticking on a cellular and molecular level by feeding them artificial blood to sustain the cells. The brains lack the electrical signals associated with consciousness — and are heavily sedated to keep them that way, Cross reported. Since 2022, Bexorg has put 100 human brains on the machine and hopes to get through 500 “brain runs” this year. It’s hoping to get to 1,000 per year in the near future.
So why now? Bexorg’s emergence from stealth comes months after the FDA laid out a plan to move away from animal testing in certain circumstances, with an emphasis on alternative preclinical models like organoids. Bexorg has also partnered with Biohaven, a longtime player in the neuroscience space. |
|
|
National Resilience to close six sites |
The drug manufacturing company founded by Bob Nelsen said it will shut down the underutilized sites through a separate legal entity, which filed for Chapter 11 bankruptcy this week. New CEO William Marth said the company will focus on manufacturing “high-growth segments to advance cell-based medicines, primarily biologics, and aseptic drug product operations.” Three of the affected sites are in Massachusetts, while two others are in California. The sixth site is in Florida.
Resilience had hoped to grow into a major player in biopharmaceutical contracting. This week’s move marks a significant reset, Andrew Dunn reported. Along with the site shutdowns, Resilience also raised a $250 million bridge financing, a type of short-term loan, from existing shareholders. The company has raised nearly $2.5 billion in total and is estimated to be worth more than $9.4 billion, according to PitchBook data. |
|
|
Deals and financing recap of the week |
🤝A handful of notable deals occurred this week, with the first coming from Novo Nordisk and Deep Apple Therapeutics. Novo agreed to pay Deep Apple up to $812 million in what represents at least the seventh cardiometabolic pact for Novo so far this year. Also this week, BioNTech disclosed plans to acquire CureVac in an all-stock deal valued at $1.25
billion, putting the one-time Covid vaccine rivals under the same roof.
Also this week, a Scorpion spinout unveiled its $177 million Series A round. The company, called Antares Therapeutics, is essentially getting the rest of Scorpion’s pipeline with the exception of the PI3Kα inhibitor that Eli Lilly bought for up to $2.5 billion earlier this year. |
|
|
Obesity market projections |
🚀GLP-1 sales forecasts have gone stratospheric. Last month, Morgan Stanley Research upped its 2035 peak estimate for the obesity drug market to $150 billion. In September, analysts from Morningstar appraised the total GLP-1 market at $217 billion in 2031. Are those figures realistic? And if so, how will those forecasts be met? Endpoints’ Elizabeth Cairns and Kyle LaHucik break down those questions here. |
|
|
|
|