Morning! As we speak, we’ve loads of attention-grabbing content material from yesterday’s STAT Breakthrough Summit East in New York. Additionally, Alnylam wins an necessary approval for ATTR-CM.
Alnylam’s Amvuttra enters ATTR-CM drug race
The FDA has authorised Alynylam’s RNAi remedy Amvuttra for treating transthyretin amyloid cardiomyopathy (ATTR-CM), positioning it to compete with Pfizer’s Vyndamax and BridgeBio’s Attruby. Priced at $476,000 yearly, Amvuttra is considerably costlier than BridgeBio’s tablet and will face entry hurdles, notably with Medicare Benefit.
Not like its rivals, Amvuttra silences the gene producing unstable proteins reasonably than stabilizing them. Regardless of trial information exhibiting efficacy, cross-trial comparisos stay inconclusive. Alnylam sees the launch as a turning level towards profitability, aiming to show Amvuttra into its flagship product.
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Is the gene remedy area in an overcorrection?
Gene remedy pioneer Jim Wilson argues that the sector is affected by “irrational pessimism,” he stated throughout STAT’s Breakthrough Summit East. Corporations are abandoning ship and authorised therapies are going unprescribed, however that’s an overrcorrection for the irrational exuberance for gene therapies a number of years again, he stated.
“I by no means would have thought that we might have been in a scenario the place there have been FDA-approved merchandise that have been priced a number of million per dose, and nobody’s prescribing them. Nobody,” Wilson stated, referring to hemophilia therapies.
He has transitioned from academia to guide GemmaBio, specializing in price discount and partnerships with middle-income international locations. And the largest similarity between college labs and the biotech startup hustle? Chasing funding, he stated.
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Value and entry hinder GLP-1 adoption
Though GLP-1 medicine provide great potential for weight problems and different well being situations, there’s subtantial concern from employers over price and affected person adherence — and that’s limiting broader use. Producers like Novo Nordisk and Eli Lilly are decreasing costs, however systemic points in U.S. well being care like inequity and protection restrictions are main roadblocks, STAT’s Ed Silverman writes.
“Individuals don’t keep on these drugs and, partially, it’s as a result of they don’t know keep on them,” Included Well being CEO Owen Tripp stated, talking at STAT’s Breakthrough Summit East. “…That’s why you hear me speak about an built-in strategy [to health care]as a result of it’s solely by means of an built-in strategy that we will obtain the kinds of outcomes that we speak about that make these medicine actually fantastic.”
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How weight problems biotechs compete in opposition to Novo and Lilly
Why isn’t Immunovant advancing the drug it simply reported constructive information on? And what did Jim Wilson should say about that gene remedy pessimism?
We focus on all that and extra on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast. We chat about constructive information from Immunovant’s autoimmune drug candidate, a affected person dying linked to Sarepta’s gene remedy, and dispatches from our STAT Breakthrough Summit East in New York.
We additionally carry on Zealand Pharma CEO Adam Steensberg to speak about his firm’s amylin-targeting weight problems therapy, the partnership deal it just lately signed with Roche, and his ideas on the trade’s intense give attention to weight reduction.
Pay attention right here.
Expedition Therapeutics seeks to carry Chinese language medicine to U.S.
Expedition Therapeutics, a brand new startup backed by Venrock and BVF Companions, goals to license promising Chinese language drug candidates for immune and inflammatory illnesses and produce them to the U.S. Led by biotech veteran Yi Larson, the corporate plans to create unbiased subsidiaries round completely different batches of medication, mirroring Roivant Sciences’ technique.
“China’s actually large. It’s actually onerous to be actually complete… I believe one of many greatest challenges is ensuring you discover an asset that’s actually differentiated, as a result of typically, there are lots of them,” Yi advised STAT’s Allison DeAngelis.
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Extra reads
Blood take a look at for ovarian most cancers misses some Black and Native American sufferers, examine finds, STAT
Eli Lilly launches weight-loss drug Mounjaro in India, beats Novo Nordisk to main market, Reuters
Elevation drops sole clinical-stage ADC over poor section 1 information, lays off 70% of employees, FierceBiotech
Former CDC director Tom Frieden shares warning for RFK Jr. on measles outbreak, STAT
