| | | |   | Hello, everyone. Damian here with a reminder that Saturday is the deadline to apply for the Sharon Begley Science Reporting Fellowship, a one-year program will prepare early-career U.S. journalists from underrepresented racial and ethnic groups for a career in science journalism. Apply here. | | | Burning questions for Lilly, Gilead, and BioMarin Is Eli Lilly sticking to its guns on Alzheimer’s disease? Can BioMarin finally turn a consistent profit? And what does Gilead Sciences have to say for itself? We’ll get answers from (or at least hear questions for) all three in a crowded week for quarterly earnings in the drug industry. -
BioMarin made a promise last year: In 2022, the company will become sustainably profitable for the first time in its 25-year history. Its quarterly earnings call, slated for Wednesday at 4:30 p.m. ET, will present a window into how well that process is playing out. -
Last we heard from Eli Lilly, the company was still seeking accelerated approval for donanemab, its most advanced treatment for Alzheimer’s, despite Medicare taking a dim view of Biogen’s Aduhelm, approved through the same pathway. That’s likely to come up on company’s earnings call, starting at 9 a.m. ET on Thursday. -
Gilead Sciences has spent the past year on the losing end of clinical failures and deals gone sour. On Thursday at 4:30 p.m. ET, executives will again make the case for patience and field delicately worded questions about just what they’ve done to deserve it. | Novartis hired Wall Street’s most trusted pharma critic Ronny Gal has spent the last two decades striking a delicate balance: openly chastising major drug companies while holding down a job as a sell-side analyst whose clients rely on access to those same institutions. Starting this summer, he’ll get the chance to put his ideas into action at one of the world’s largest pharmaceutical companies.
Novartis said yesterday that it had hired Gal to the newly created position of chief strategy and growth officer, starting no later than Aug. 1. According to the company, he’ll have influence over its corporate direction, research pipeline, and business development.
As Jacob Plieth writes in Evaluate Vantage, the news calls to mind some of Gal’s more pointed observations from his years on the other side of the table. He has urged drug companies to break with tradition and compete on price, arguing that the reputational benefits would compensate for any lost revenue. He has advocated for novel approaches to biosimilars. And he has pressed for cash-rich companies like Novartis to take advantage of biotech’s downturn and start spending. | How a biotech startup is using AI tools to redefine how they approach clinical development Artificial Intelligence is transforming the way small biotechs are scaling their businesses. In our latest case study of Feldan Therapeutics, we show how STAT Trials Pulse has become a game-changer for them, helping accelerate data-gathering, better analyze their competitors, and streamline their operations. Read the case. | Like the pandemic never happened  Biotech’s 2022 bear run hit a new milestone yesterday: The industry’s most closely watched index hit its lowest point since April 2020, meaning the sector has erased all of the dramatic, volatile gains brought about by the Covid-19 pandemic.
The XBI fell 6% yesterday, and it’s now down 34% for the year. The last time it traded at these levels, the phrase “Covid-19” was only about a month old, and the notion that we’d have vaccines for the novel virus within a year was widely dismissed as irresponsibly optimistic.
Now the sector is trading as though the scientific exuberance and record-setting revenues of the ensuing two years didn’t happen. | What does it take to get Covid treatments past the FDA? Midway through Novartis’ 90-minute-long earnings call yesterday, CEO Vas Narasimhan casually made some news: The company’s treatment for Covid-19, currently awaiting FDA authorization, might need more data to convince regulators.
That sent shares of Molecular Partners, the company that invented Novartis’ treatment, down nearly 20%. Within hours, the company issued a statement of its own, confirming Narasimhan’s account and adding that Novartis is working with the FDA on the design of a Phase 3 study that might address the agency’s outstanding questions.
The news could signal a shift in the FDA’s standards when it comes to new Covid-19 treatments. Novartis and Molecular Partners were widely expected to win an emergency authorization based on Phase 2 data showing that their treatment significantly reduced patients’ viral load and the rate of hospitalization. If the FDA is now demanding data for larger trials to justify authorization, it could scramble the timelines of a host of companies moving toward the market with therapies of their own. | More reads - The doctor who is trying to bring back surprise billing. STAT
- Europe’s push to rival U.S. biotech hubs faces hit from market slump. Financial Times
- Pfizer asks FDA to authorize Covid-19 booster for 5- to 11-year-olds. Wall Street Journal
- U.S. to widen Covid antiviral pill distribution. Reuters
| Thanks for reading! Until tomorrow,  | | | |
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