| | | |   | Hello, it's Meghana. It looks like we're finally making some headway against RSV — just in time to meet a roiling season of the virulent disease. A leaked trade agreement causes concern for the global generic drug supply, and more. | | | RSV treatment approved by European Commission The European Commission today approved Sanofi and AstroZeneca’s preventative antibody treatment for RSV in infants. The single-dose passive immunization, called nirsevimab, has been sanctioned for use in the general infant population — encompassing all healthy, ill, and preterm babies. It will be a while yet before the FDA considers following suit, but the approval is significant nonetheless, especially given how severe this season has been for respiratory syncytial virus. Scientists have tried since the 1960s to develop a vaccine for RSV, but it’s been exceptionally challenging. But there’s suddenly been a lot of advancement: Just last week, Pfizer’s RSV vaccine was shown to be 82% effective in preventing hospitalization for infants. Also last month, GSK said its RSV vaccine had 83% efficacy against serious illness in older adults. “Today is a landmark day for RSV prevention, as decades of research and development come together in the world’s first approval of a broadly protective option against RSV disease,” one of Sanofi’s top vaccine execs said in a statement. | What’s the atom bomb of biology? Why don’t we run better clinical trials? And how is CRISPR like a Ferrari? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Matthew Herper joins us to discuss his thoughtful, personal story on how the biotech revolution that brought us genome editing, Covid-19 vaccines, and lifesaving medicines could run aground if humanity can’t get out of its own way. Listen here. | Watch these stunning videos of T cells killing cancer Today, advanced microscopy techniques are revealing how immune cells kill tumor cells and how cancer evades our normal defenses. Scientists at Genentech are unraveling these complex relationships to develop more effective cancer immunotherapy treatments. Watch these killer T cells in action and see what the scientists see as they carefully observe these dynamic interactions under the microscope. | Leaked India-U.K. trade agreement sparks concern A draft trade agreement between the U.K. and India has leaked, showing proposed changes to patent and regulatory laws that, according to patient advocacy groups, could limit the global supply of affordable generic medications. Indian pharmaceutical companies produce a huge proportion of the world’s generic drugs. The language in the free trade pact goes against a World Trade Agreement governing how governments can sidestep patents to widen accessibility to medicine. The changes could potential change how poor countries are able to access medicines. “The U.K.’s demands are seeking to gut India’s patent and drug regulatory laws of the safeguards that make it a manufacturing powerhouse,” one advocate said in a statement. “Introducing more and more intellectual property hoops for generic manufacturers in India to jump through will have a chilling effect on the country’s ability to supply millions of people around the world.” Read more. | Apellis pushes back FDA review The FDA’s review of Apellis Pharmaceuticals’ experimental eye treatment is being delayed, as the company plans on providing additional clinical data. Initially, the agency planned on announcing an approval decision on Nov. 26. Now, that’s been pushed back until February 2023. “This was our decision,” CEO Cedric Francois told STAT, when asked whether any communications with the FDA had suggested the original application wasn’t strong enough to warrant approval. The Apellis drug, called pegcetacoplan, has already faced controversy because its FDA submission was based on two identically designed clinical trials that produced confounding results last year. The drug targets geographic atrophy — a chronic eye disease that often leads to blindness in older people. Read more. | More reads - Amgen cancer drug Lumakras price rises 53% in five years, Reuters
- Moderna shares fall after Covid vaccine maker lowers 2022 sales outlook, CNBC
- Teva to pay over $500 million in New York drug case settlement, New York Times
| Thanks for reading! Until next week,  | | | |
No comments