| |   | Hello, everyone. Damian here with a look at a rash of FDA curveballs, a clever idea for antibiotics, and the latest in the Aduhelm saga. | | | The FDA is suddenly serving up surprises Just one month before an expected FDA approval date, partners Myovant and Pfizer got word from the agency that there were “deficiencies” in the application for their endometriosis treatment, virtually guaranteeing a rejection.
The news, disclosed yesterday, came as a surprise to Myovant’s management and sent the stock price down about 25%. And, according to Evercore ISI analyst Josh Schimmer, it’s part of a growing trend of FDA curveballs arriving on the eve of expected approvals. In a note to investors, Schimmer reported finding 14 similar cases of 11th-hour deficiencies, and more than half of them were disclosed in the past 12 months, suggesting the FDA is raising the regulatory bar.
Most important to Pfizer and Myovant is that 11 of those 14 cases resulted in rejections, with the remaining three still awaiting decisions. | Novartis is saving the money Wall Street wants it to spend Novartis, recently furnished with $21 billion in unexpected cash, came into 2022 as the odds-on favorite to make the kind of major acquisition investors invariably predict. Instead, the company is cutting into its own business in an effort to save $1 billion a year, a process that will reportedly cost thousands of jobs.
According to the Swiss newspaper Tages-Anzeiger, Novartis will lay off thousands of people worldwide, including more than 100 in its home nation. In a statement, Novartis said its planned cost cuts “will come through leaner structures and will inevitably lead to roles being impacted,” adding that “it is too early to indicate any specific numbers.”
Meanwhile, Novartis has said time and again that its cash windfall will be used not for “larger M&A,” as CEO Vas Narasimhan put it in the company’s last earnings call, but rather for “bolt-on deals.” That has left Wall Street to ponder what constitutes a “bolt-on” for Novartis, a multinational pharmaceutical giant worth more than $200 billion, and the answer remains unclear. | A conversation with the STAT Madness crowd favorite Each year, universities and research institutions across the country compete in STAT Madness, a bracket-style tournament, in order to be recognized as having produced the top biomedical innovation or discovery of the year. Register for a virtual event on April 20 to hear researchers from the winning team discuss their work. | The Aduhelm decision won’t set a new standard, CMS says Medicare’s decision to restrict payments for Aduhelm is not a sign of things to come for fast-tracked new medicines, a government official said yesterday, but rather a one-time reaction to the unprecedented case of Biogen and its Alzheimer’s drug.
Lee Fleisher, chief medical officer for the Centers for Medicare and Medicaid Services, said the organization’s ruling on Aduhelm “should not be viewed as setting a new direction on therapies that receive FDA accelerated approval,” Bloomberg reported. The bar for reimbursement hasn’t changed, Fleisher said, and CMS is not applying a new standard in other disease areas.
Meanwhile, the extraordinary nature of Medicare’s Aduhelm decision could be its undoing. Experts say CMS’s authority to tightly limit reimbursement for the drug is on shaky legal ground, and a lawsuit could lead to the next twist in the Aduhelm saga. | Can a Netflix model fix the antibiotic problem? The U.K. is one major step closer to a pioneering approach to paying for antibiotics, one that would pay companies upfront fees based on the drugs’ estimated societal benefits rather than paying for the actual volumes used.
As STAT’s Ed Silverman reports, the so-called Netflix model for antibiotics has long been discussed as a possible way to incentivize the development of badly needed new medicines. The idea, also known as a pull incentive, is to allow drugmakers to recover costs and make an appropriate profit without having to sell large volumes of antibiotics.
The U.K. has now wrapped up a cost-effectiveness review of two novel antibiotics, clearing the way for its pilot program to move forward. The next step is negotiating subscription contracts with the manufacturers.
Read more. | More reads - Covid vaccines didn’t work for many cancer patients — but researchers are designing a new shot for them. STAT
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- Incentives to spur repurposing of existing generics for novel uses would open a new paradigm in drug R&D. STAT+
- Trying not one, but a three-drug combination to help engineered T cells fight cancer. STAT+
| Thanks for reading! Until tomorrow,  | | | |
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