NextCure inks ADC deal with Simcere Zaiming
NextCure will be paying up to $745 million for the ex-Greater China rights to an early-stage antibody-drug conjugate developed by a Shanghai-based drug developer. Simcere Zaiming's asset, called...
View ArticleIncyte’s promising thrombocythemia drug; Crescent Biopharma raises $200M in PIPE
Plus, news about D&D Pharmatech and Jasper Therapeutics: Incyte’s thrombocythemia win: The company’s antibody INCA033989, which targets and reduces cells with mutant calreticulin (mutCALR), allowed...
View ArticleRoche moves ahead with Phase 3 Parkinson’s study despite mixed trial results
Roche and Prothena said they're planning to proceed with a Phase 3 study of an experimental Parkinson’s antibody called prasinezumab, even though two previous mid-stage trials failed to meet their...
View ArticleAbbVie's Venclexta fails Phase 3 study in other bone marrow cancers
AbbVie said Venclexta did not improve survival in patients with myelodysplastic syndromes when combined with another commonly prescribed drug. The drugmaker announced Monday that Venclexta combined...
View ArticleFDA chief Makary predicts a universal flu vaccine in next five years
WASHINGTON — When it comes to pharma innovation over the next several years, the heads of the FDA and European Medicines Agency are expecting quite a few transformational advances. Speaking at the Drug...
View ArticleEli Lilly makes all Zepbound doses available in single-dose vials
Eli Lilly said it will make the two highest doses of its popular obesity drug Zepbound available to certain patients in cheaper, single-dose vials. The company first launched single-dose vial...
View ArticlePurdue opioid settlement gets backing from 55 attorneys general
Nearly every state in the US has agreed to a $7.4 billion settlement with Purdue Pharma and the Sackler family that would resolve a yearslong legal battle over the country’s opioid epidemic. The deal...
View ArticleFired vaccine advisors defend ACIP's work in joint editorial
All 17 ousted members of a key CDC vaccine panel say their abrupt dismissals “have left the US vaccine program critically weakened,” according to a new co-authored editorial. The article,
View ArticleImmuneering reports Phase 2a MEK pill data in first-line pancreatic cancer
Immuneering’s oral MEK inhibitor allowed 94% of pancreatic cancer patients in a Phase 2a trial to survive six months when used first-line in combination with chemotherapy, the company said Tuesday. ...
View ArticleEli Lilly to buy gene editing biotech Verve Therapeutics for up to $1.3B
It appears that Eli Lilly couldn’t wait to get its hands on Verve Therapeutics’ PCSK9 program. Lilly said Tuesday that it will buy the gene editing biotech for about $1 billion at $10.50 per share ...
View ArticleAlphabet-backed Isomorphic Labs to open US office, hires ex-Relay CMO
Isomorphic Labs has hired its first chief medical officer to help establish the company's first US office, the Alphabet-backed biotech said Tuesday. Isomorphic has quickly become a leading startup...
View ArticleDyne pivots on primary endpoint, delays filing for DM1 drug
Dyne Therapeutics met with the FDA to discuss what's needed for the accelerated approval of its myotonic dystrophy drug, and it settled on a different primary endpoint than expected. The company also
View ArticleMineralys' lorundrostat gets a Phase 2 win in certain patients with hypertension
Mineralys Therapeutics said Tuesday that its blood pressure med lorundrostat has succeeded in a Phase 2 trial in subjects with hypertension and comorbid chronic kidney disease (CKD). The data will be...
View ArticleProthena moves forward with layoffs; Aldeyra resubmits dry eye drug to FDA
Plus, news about Ventyx Biosciences, Gilead Sciences, Insilico Medicine and Enliven Therapeutics: Prothena lays off 91 workers: The company previously disclosed plans for a "substantial" workforce...
View ArticleLyell’s lymphoma data for recently acquired CAR-T receive lukewarm reception...
Lyell Immunopharma’s recently acquired CAR-T doesn't appear to impress Wall Street. The company said Tuesday that its dual-targeting CD19/CD20 CAR-T called LYL314 induced 22 responses in a cohort of 25...
View ArticleAI biotech Xaira unveils virtual cell research paper
Last spring, Xaira Therapeutics launched with over a billion dollars, a star-studded team and big dreams to remake R&D with AI. The South San Francisco-headquartered startup has been fairly quiet...
View ArticleFDA unveils pilot to speed some new drugs to market in just one month
A new FDA pilot program unveiled Tuesday aims to significantly cut drug review times to support what agency Commissioner Marty Makary deems "national priorities." The one-year pilot will test out a new...
View ArticleFDA approves CSL’s prophylactic for severe swelling condition
CSL Behring won FDA approval on Monday for its once-monthly preventive treatment for a rare, genetic condition that causes swelling episodes. Andembry is approved to prevent attacks of hereditary...
View ArticleOrphan drug, PBM changes fall out of Trump tax bill in Senate version
The Senate Finance Committee’s version of a massive tax cut package omits some PBM reforms and other provisions from the House-passed version that change how orphan drugs are treated under the Medicare...
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