FDA finalizes long-awaited rule to bring lab tests under its purview
The FDA on Monday finalized a long-awaited rule that outlines how it will regulate laboratory-developed tests (LDTs) as medical devices, even though some critics say the FDA is overstepping its...
View ArticleFDA converts Pfizer's Tivdak to full approval in cervical cancer
Pfizer’s new cervical cancer drug Tivdak has been converted from an accelerated to a full approval. The Seagen and Genmab-parterned drug, also known as tisotumab vedotin-tftv, was first approved via...
View ArticleFederal judge throws out two drugmaker IRA lawsuits in win for government
A New Jersey federal judge on Monday tossed cases brought by Johnson & Johnson and Bristol Myers Squibb against the Inflation Reduction Act, another victory for the law while Medicare works through...
View ArticleDNA sequencing firm PacBio to lay off workers and shutter San Diego office
Pacific Biosciences is letting go of 190 employees, according to the company, as part of cost-cutting measures after disappointing sales of its DNA sequencers. The company employed just under 800...
View ArticleNovartis hands PeptiDream $180M upfront to extend radiopharma discovery pact
Novartis is looking to build on its radiopharma research machinery. The maker of Lutathera and Pluvicto has expanded its longstanding peptide discovery deal with PeptiDream to bolster their work on...
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In one of JP Morgan's first biotech bets, Enlaza raises $100M for its...
Enlaza Therapeutics raised $100 million to develop permanently binding antibody-drug conjugates for cancer with a goal of bringing them into the first-ever human studies. The company announced Tuesday...
View ArticleLilly boosts sales guidance by $2B, but GLP-1 supply constraints still a focus
Rising demand for Eli Lilly’s diabetes and obesity drugs have buoyed first-quarter sales to $8.77 billion, pushing the company to raise its full-year guidance by $2 billion. Its shares $LLY were up...
View ArticleWalmart exits live and virtual care business, five years after push into care...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Walmart is shutting down its healthcare business. The retail giant said Tuesday that it will close its...
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Harmony Biosciences buys small epilepsy biotech for $35M, plus milestones
Rare neurological disease drug developer Harmony Biosciences acquired Epygenix Therapeutics and its pipeline of treatments for rare epilepsy conditions. Harmony paid $35 million upfront, and could pay...
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Real Chemistry debuts a one-stop dashboard for all things GLP-1
Real Chemistry plans to harness the “Wild West” of GLP-1 social media and reams of competitive data in the drug category with a new platform called IRIS. An all-in-one dashboard sits at the center of...
View ArticleLilly scraps trials of Verzenio, Jardiance and a gene therapy from Prevail
As part of its quarterly cleaning, Eli Lilly removed a few trials from its pipeline, including late-stage studies of approved cancer drug Verzenio and its Boehringer Ingelheim-partnered drug Jardiance....
View ArticleDaré's royalty deal; Qlaris Bio raises $24M
Plus, news about Newron and SynOx: Daré Bioscience inks royalty deal with XOMA: The company received $22 million, which is expected to help progress a pair of women’s health therapies through Phase 3....
View ArticleUnitedHealth CEO reveals cyberattack origins ahead of Change Healthcare hearings
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) UnitedHealth Group’s CEO Andrew Witty is set to testify before lawmakers on Wednesday to explain how the...
View ArticleMarketingRx roundup: Moderna debuts social media science series; Boehringer...
Moderna introduces scientist social series: Moderna is inviting LinkedIn and Instagram scrollers to take a break with its scientists in a Coffee Break Science series that started this week. The short...
View ArticleFDA asks for public input on advisory committee reforms
As the FDA considers an overhaul of the advisory committee process, the agency is asking for public input on how the panels are used and how their purpose can be made clearer. The agency announced...
View ArticleFTC targets more drug patents, going after obesity, diabetes and asthma...
Antitrust regulators at the Federal Trade Commission expanded their campaign on what they call “junk” patents, sending a new round of warning letters to drug companies about their products for obesity,...
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Neurocrine wins approval of Ingrezza 'sprinkle' formulation for patients with...
Neurocrine Biosciences won FDA approval on Tuesday for a new formulation that may help Ingrezza go down in a more delightful way. Eric Benevich The oral granules are designed to be opened and sprinkled...
View ArticlePiction Health raises $6M to cut wait times for skin conditions
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Piction Health, which started as a mobile app that uses AI to recognize skin conditions from pictures,...
View ArticlePfizer makes small pipeline changes in first-quarter update
Pfizer trimmed a handful of programs from its pipeline Wednesday morning as part of its first-quarter earnings update. The company discontinued development of VTX-801, a recombinant AAV gene therapy...
View ArticleGSK still riding vaccine sales wave, pushing 2024 forecasts higher
GSK’s vaccines portfolio is front and center as it kicks off 2024. The UK pharma said its non-Covid vaccine sales grew 22% in the first three months of the year to £2.27 billion ($2.83 billion)...
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