| | | |   | Want to be on biology’s cutting edge? Join gene editing pioneer David Liu, Vertex CEO Reshma Kewalramani, and Altos’s Hal Barron and Juan Carlos Izpisua Belmonte at the STAT Summit in Boston. Buy a virtual pass – and apply to attend in person – here. | | | Pfizer’s RSV vaccine reduces illness in newborns Pfizer’s maternal vaccine for respiratory syncytial virus met its goals in a pivotal study, reducing the rate of severe illness in newborns by about 82%.
As STAT’s Matthew Herper reports, Pfizer expects to submit those results to regulators by the end of the year, which could lead to approval in 2023. The vaccine, administered during pregnancy, reduced the number of RSV-related medical visits by about 57%, but the difference did not meet the threshold of statistical significance.
Pfizer’s success could create a commercial advantage over a rival RSV vaccine from GSK. Both treatments have proved to significantly reduce symptomatic infections in adults, but GSK stopped three maternal trials for undisclosed safety reasons.
Read more. | Times are good for biotech’s payday lenders Biotech stocks are deep in the red, and the cost of developing new medicines remains formidable, which makes 2022 a banner year for companies that trade present-day cash for points on the back end of products that sometimes don’t yet exist.
As the Financial Times reports, royalty deals are on the rise, and the likes of Royalty Pharma, Healthcare Royalty Partners, and Blackstone Life Sciences have seen a marked increase in interest from drug developers willing to mortgage their futures for much-needed capital. Royalty Pharma, which has been doing such deals since 1996, has seen a 50% rise in inbound calls since 2019 and expects to spend about $10 billion on royalty stakes over the next five years.
While that money will help plug financial holes for drugmakers in need, there’s also a systemic risk. Most royalty deals cover drugs that are on or near the market, but a growing number apply to investigational medicines that are years away from approval and could fail in clinical trials. If royalty financiers, who often rely on debt to fund their transactions, buy into a bunch of drugs that don’t turn out to work, the whole ecosystem could collapse. | Biotech investors and CEOs see two paths to growth, but are they equally viable? The biotech market is changing and the interplay of investors, private and public markets will be important going forward. Is optimism for the biotech market’s rebound warranted? Dr. Chen Yu, Founder and Managing Partner of TCG Crossover, discusses with RBC’s Noël Brown, Head of US Biotechnology Investment Banking. Get their perspectives on the biotech market’s road ahead and the two paths for company scale-up strategies. | How big is the market for novel weight-loss medicines? Wall Street expects the next generation of treatments for Type 2 diabetes and obesity to become blockbuster products, but just how many zeros belong in those revenue estimates remains the subject of debate. This week could bring some clarity.
Later this morning, Eli Lilly will report its third-quarter earnings, including the sales of Mounjaro, which won approval for diabetes in March and could be available for obesity next year. Analysts expect Lilly to book about $80 million in sales on the quarter, but a substantial outperformance would raise optimism for what is already expected to become a massively lucrative drug.
Then, on Thursday, Amgen will present its quarterly results, giving analysts a chance to ask about the future of AMG133, an early-stage medicine that promises to one day compete with Mounjaro in both diabetes and obesity. In October, Amgen’s stock price rose by the most all year after Morgan Stanley upgraded the stock on AMG133’s potential. | Personalized medicine isn’t living up to its promise And the problem isn’t scientific.
That’s according to a new study, which looked at data from nearly 40,000 patients and concluded that personalized cancer treatments ended up benefiting only about one-third of the people whose tumors may have contained genes that could be targeted by available therapies.
The barriers, two study authors write in STAT, came from gaps in the practice of medicine, not the mysteries of human biology. That means failures to order the right tests, errors in processing samples, delays that made treatment impossible, and misdiagnoses that saddled patients with the wrong medicines.
Read more. | More reads - Pulse oximeters and their inaccuracies will get FDA scrutiny today. What took so long? STAT
- Thermo Fisher to buy U.K.’s Binding Site in $2.6 billion deal, Bloomberg
- Biopharma innovation needs to harness lessons learned from Covid-19, STAT
- China bars GSK from bulk-buy drug program for 18 months, Reuters
| Thanks for reading! Until tomorrow,  | | | |
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