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Hello everyone. Here’s Damian with main points about the approval of a potentially primary drug, a concept to make CAR-T fairer, and the slow release of a gene therapy.
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The FDA has approved Merck’s new remedy for rare cardiovascular disease, authorizing a drug that could reach about $5 billion a year at its peak.
The approval of Merck’s injectable drug for pulmonary arterial hypertension was widely expected, but the drug’s final label has merit for Merck. The FDA did not include a boxed warning about its side effects, which included an increased number of occasions of bleeding. Compared to placebo. Merck’s drug will be called Winrevair and worth about $245,000 per year (each vial costs $14,000 and is injected every three weeks).
Analysts have described Winrevair as a promising expansion driver for Merck. Keytruda, the company’s successful cancer treatment, will lose patent coverage in 2028, and the potential loss of biosimilars could especially affect Merck’s revenue.
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More than three months after Bluebird Bio’s genetic treatment for sickle cell anemia won FDA approval, no patients got the treatment, the company said yesterday.
Bluebird said there were “multiple patients” in line to get their drug, called Lyfgenia, and that the first dose was “imminent. “It takes about 4 months to prepare patients for the single infusion of Lyfgenia, and Bluebird is only paid for at the time of administration. The company said it expects to post its first profit from the solution in the third quarter of this year.
Bluebird’s stock value fell about 12% following the news, reflecting Wall Street’s concerns about patient demand for the company’s sickle cell gene therapy. Bluebird will compete for patient care with Vertex Pharmaceuticals and CRISPR Therapeutics, whose genome-editing treatment for sickle cell disease was approved on the same day as Lyfgenia.
Hello Readout readers. This is Adam Feuerstein, with interesting news to share with you. I’m launching a new subscriber-only newsletter, Adam’s Biotech Scorecard, in which I’ll offer authoritative, unfiltered reporting at the intersection of Wall Street. and biotechnology.
In your inbox every Thursday morning, Adam’s Biotech Scorecard will include candid research into the news, events, and others who are transforming the worlds of biotech and finance. You’ll get exclusive insight into the triumphs and failures that make the biotech industry so captivating, enhanced through the attitude that only a journalist with more than two decades of award-winning biotech policy can offer. This newsletter will be informative and spicy. Promise.
The first factor comes out tomorrow. If you are a STAT subscriber, you can sign up here. Thank you!
CAR-T treatments have been shown to be curative for some blood cancer patients, but their maximum costs (selling for between $350,000 and $475,000 in the U. S. ) are costly. U. S. (largely similar to production costs) have limited access in much of the world.
The Brazilian government will now see if it can drastically reduce those prices. On Tuesday, Fiocruz, a base of the government’s Health Breakdown, signed a three-year agreement with a three-year U. S. nonprofit called Caring Cross. As part of the agreement, Caring Cross will supply the equipment, tissues and expertise needed to scale up CAR-T treatments at one-tenth of the current cost.
This is part of a new movement to produce CAR-T at a lower price in hospitals or other fitness centers, rather than in centralized factories owned by the pharmaceutical industry. Caring Cross will install mobile production equipment at multiple sites and support Fiocruz, which manufactures Covid vaccines for much of Brazil, produces viruses and remodels cells. If it works, you could find a model to manufacture CAR-T available in Latin America and much of the world, adding at a lower price in the United States. .
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Your go-to place for the latest biopharma and life sciences news and information