April 10, 2023

An open letter supporting the FDA

On Friday, a federal judge sided with anti-abortion groups, saying that the FDA was wrong in approving the abortion pill mifepristone in 2000. Now more than 200 biotech leaders have signed a strongly worded joint statement about this nationwide ban on abortion pills, supporting the FDA's authority to regulate medicines.

"The decision ignores decades of scientific evidence and legal precedent," they write, saying that the federal judge has "no scientific training," yet "fundamentally undermined" the FDA's bipartisan authority to approve and regulate medicines. The judge's interference "has set a precedence for diminishing FDA's authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry."

The statement calls "for the reversal of this decision to disregard science." Organizers are seeking more signatories here.

Reproductive medicine

Biotech using 'ovarioids' to help support IVF

The newest spinout from George Church's Harvard lab has a bold vision: building human eggs from scratch. Christian Kramme, working with the New York-based startup Gameto, spent the bulk of his doctoral studies under Church working on developing ovaries in miniature. In February, a paper published in eLife showed how his team turned the eggs from a 66-year-old woman into granuloma cells that could secrete reproductive hormones and form ovarian follicles.

Kramme's "ovarioids" aren't yet advanced enough to develop their own lab-grown human eggs. But Gameto has already licensed its technology to help boost the odds of success for people undergoing in vitro fertilization. The company has raised $40 million from private investors, including from 23andMe CEO Anne Wojicki.

business
Bankrupt Clovis selling Rubraca to highest bidder

Cancer drugmaker Clovis Oncology has been dismantling itself since declaring bankruptcy four months ago. It's now found a buyer for its ovarian cancer drug, Rubraca. Switzerland-based Pharma & Schweiz GmbH won a bidding war for the drug with a $70 million offer, along with an additional $65 million in potential milestone payments. Dr. Reddy's Laboratories of India has been named the "back-up bidder," FiercePharma writes.

Rubraca, which was approved in 2016, has been largely responsible for the company's insolvency. Sales of the PARP inhibitor drug peaked in 2014 at $164 million, but the pandemic reduced the number of women diagnosed with ovarian cancer. And last year, the FDA said that a Phase 3 study suggested that Rubraca might cause harm to some patients with ovarian cancer. Clovis said in its bankruptcy filing that it said it had $319 million in assets, and $754 in debt.

vaccines
Lofty claims from Moderna's chief medical officer

Fueled by momentum from the company's Covid vaccines, Moderna's chief medical officer is making some lofty statements about its pipeline. Paul Burton told the Guardian that vaccines for cancer, cardiovascular, and autoimmune diseases will be ready by 2030. Burton said the company's cancer vaccine "will be highly effective, and it will save many hundreds of thousands, if not millions of lives. I think we will be able to offer personalized cancer vaccines against multiple different tumor types to people around the world."

There's no doubt that such vaccines have been developing at rapid clip; Moderna said last month it was considering seeking accelerated approval for its personalized cancer vaccine, which it's testing in tandem with Merck's Keytruda. But we're a touch wary of bold claims after seeing one or two moonshots come and go. Whether a technology holds up, only time will tell.

More around STAT