Avidity CEO says it's ‘full steam ahead’ in DMD as stock rallies on Phase 1/2...
The Duchenne muscular dystrophy community received some rare good news on Friday when Avidity Biosciences reported surprisingly positive clinical results in DMD and plans to advance its RNA therapy....
View ArticleAutoimmune CAR-Ts are under the microscope after Cabaletta’s safety issue in...
Eyes are on CAR-T therapy clinical trials in autoimmune diseases for potentially more serious side effects, after Cabaletta Bio’s candidate was linked with a high-grade neurotoxicity event in one lupus...
View Article23andMe trades drug discovery for GLP-1 weight loss prescriptions
23andMe is shutting down its internal drug discovery group and getting into prescription weight loss drugs in an effort to turn the struggling consumer genetic testing company around. The company said...
View ArticleAlfasigma's PBC treatment Ocaliva to face an FDA adcomm in September
Italian pharma Alfasigma will face an FDA advisory committee next month to discuss the full approval of its rare liver disease treatment Ocaliva, a drug the company acquired less than a year ago. The...
View ArticleGenentech, Gilead push FDA to modernize research inspections
Roche’s Genentech, Gilead, Sanofi and other drugmakers weighed in on the FDA’s recent draft guidance on research inspections, with the companies calling for clarity and further commitment from the...
View ArticleHello, neffy: FDA approves first nasal spray for severe allergic reactions
Over the last 40 years, twin packs of EpiPens became a fixture for people and parents with children experiencing severe allergic reactions. Now, ARS Pharmaceuticals hopes that a new intranasal option...
View Article'Amgen India' to be operational later this year
With operations beginning in the fourth quarter, Amgen said Friday that it is opening a new site in Hyderabad, India, with 3,000 employees. Dubbed a tech and innovation facility to “accelerate digital...
View ArticleOhio federal judge dismisses IRA suit brought by US Chamber of Commerce
The federal government has defeated another lawsuit against the Inflation Reduction Act, this time brought by the US Chamber of Commerce. An Ohio federal judge dismissed the case on Thursday,...
View ArticleLykos’ MDMA-assisted PTSD treatment rejected by FDA after troubled trial and...
The FDA has rejected Lykos’ MDMA-assisted treatment for patients with post-traumatic stress disorder, a major setback for the company that had hoped to translate more than two decades of research into...
View ArticleLatest on MDMA rejection; Novo vs. Lilly earnings; Recursion, Exscientia to...
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FDA delays approval decision on Humacyte’s lab-grown blood vessels
A potential medical breakthrough more than two decades in the making will have to wait a little longer before becoming widely available. Humacyte, which has developed lab-grown blood vessels to treat...
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Halda adds $126M to test oral drugs for prostate, breast cancer
Connecticut biotech Halda Therapeutics, created by Arvinas founder Craig Crews, has reeled in another $126 million to start clinical testing of its oral molecules for solid tumors. With the new money,...
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Pfizer touts strength of RSV vaccine in subgroup of younger immunocompromised...
A few months after touting its RSV vaccine’s effects on younger adults, Pfizer said a sub-study focusing on immunocompromised adults is also positive. The data could offer another boost to its efforts...
View ArticleAscendis scores FDA approval for hypoparathyroidism candidate to replace...
Ascendis Pharma announced Monday that it won FDA approval for its hypoparathyroidism drug, offering the small community of those suffering from insufficient levels of parathyroid hormone another...
View ArticleTenax raises $100M; Sanofi buys into MeiraGTx
Plus, news about scPharmaceuticals and BiVictriX: Tenax Therapeutics’ $100 million PIPE: The company plans to put the money toward a second Phase 3 trial of an oral heart failure drug called...
View ArticleThree papers on MDMA are retracted by medical journal, just a day after...
Three articles detailing the mid-stage trial results of Lykos Therapeutics’ MDMA-assisted therapy were retracted by the medical journal that published them, citing a failure by the authors to disclose...
View ArticleNovo Nordisk gears up for FDA filing with late-phase insulin plus semaglutide...
Novo Nordisk, with data on-hand from a late-stage trial of IcoSema, is preparing for an FDA filing in type 2 diabetes slated for the second half of the year. IcoSema is a combination of Novo’s insulin...
View ArticleRevance to be acquired for $900M+ as Botox trade secrets lawsuit continues
Revance Therapeutics, the maker of Botox competitor Daxxify, will be acquired for more than $900 million. Crown Laboratories will buy out all of Revance’s stock for $6.66 per share, valuing Revance at...
View ArticleLegend continues Carvykti factory builds to cement CAR-T territory with J&J
Legend Biotech says it plans to further boost Carvykti manufacturing as the company and its partner Johnson & Johnson look to stay ahead in the CAR-T race against competitors Bristol Myers Squibb...
View ArticlePressure from anti-China legislation begins to ripple through biopharma
A latest round of SEC filings from biopharma companies shows at least a dozen companies highlighting the Biosecure Act as a major incoming risk, as they would have to transition away from many Chinese...
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