With HIV prevention under attack, how might Gilead’s new PrEP injection fare?
A groundbreaking new therapy that can almost entirely prevent HIV is days away from an FDA decision — but a mix of recent federal politics and historically slow launches may get in its way. At stake ...
View ArticleFDA Commissioner Marty Makary calls for more consolidation
FDA Commissioner Martin Makary sent an email to staff this week announcing plans to further consolidate the agency’s operations outside of medical product reviews and inspections. Human resources,...
View ArticleFDA's oncology adcomm to review GSK's Blenrep relaunch plans
The FDA’s Oncologic Drugs Advisory Committee will meet on July 17 to discuss a potential relaunch of GSK’s multiple myeloma drug Blenrep. The committee will consider GSK's application to bring Blenrep ...
View ArticleKalVista says FDA delayed decision on HAE drug, citing ‘heavy workload’
KalVista Pharmaceuticals said Friday that the FDA pushed back its decision on whether to approve its on-demand oral drug for hereditary angioedema, citing “heavy workload and limited resources” at the...
View ArticleFormer CEO Anne Wojcicki wins bid for 23andMe
23andMe said it agreed to sell itself to co-founder and former CEO Anne Wojcicki for $305 million, ending a bidding war for the struggling consumer genetic testing company. Wojcicki’s price of ...
View ArticleRFK removes all ACIP members, names new ones; National Resilience to close...
Welcome back to Endpoints Weekly! It was another busy news week, so let’s dive in. Our reporters tracked a number of updates from DC, including the removal of all 17 members of the CDC’s vaccine ...
View Article#EHA25: Gilead, Arcellx continue to tout safety of multiple myeloma cell...
Gilead and Arcellx reported that their multiple myeloma CAR-T therapy continued to show potentially better safety than Legend Biotech and Johnson & Johnson’s Carvykti, with comparable efficacy....
View ArticleLilly posts encouraging early-stage weight loss data on amylin candidate
Eli Lilly’s under-the-radar amylin analog allowed obese patients in a Phase 1 trial to lose up to 11.3% of their body weight. The drug appears to be more effective than similar offerings from companies...
View ArticleSupernus to acquire Sage Therapeutics for about $561M
Sage Therapeutics has finally found a buyer. It will be acquired by Supernus Pharmaceuticals for approximately $561 million, the companies announced Monday morning. Supernus is paying $8.50 per share,...
View ArticleNextCure 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 ...
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