Appeals court upholds halt on Minnesota generic drug pricing law
A Minnesota drug pricing law violates the Constitution by allowing the state to essentially control prices outside of its borders, an appeals court ruled on Thursday. The US Court of Appeals for the...
View ArticleModerna wins FDA approval for expanded use of RSV shot in more adults
A little more than a week after Moderna’s new Covid-19 vaccine was approved, the FDA has expanded who can receive the company’s RSV shot. The agency approved mRESVIA on Thursday for at-risk adults 18...
View ArticleAstraZeneca, CSPC ink AI drug development deal for $110M upfront
AstraZeneca is further tightening its relationship with China, announcing a new research partnership with CSPC Pharmaceuticals on Friday. CSPC will receive $110 million upfront for the partners to...
View ArticleBristol Myers gets a key strategist with 'Team Shibs'; Idorsia to change CEOs...
Just a few months ago, Chris Shibutani was asking Bristol Myers Squibb executives about their strategy during the drugmaker's quarterly earnings calls. As of Monday, the recently departed Goldman Sachs...
View ArticleRein Therapeutics study on clinical hold; Beam updates sickle cell therapy data
Plus, news about Enliven Therapeutics, Merck's Keytruda and Celldex: FDA places hold on Rein study: The agency has “non-clinical requests” for Rein Therapeutics’ Phase 2 trial in idiopathic pulmonary...
View ArticleWith 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 ArticleSarepta halts Duchenne gene therapy in some patients after second death
Sarepta Therapeutics reported a second patient death due to liver failure related to its Duchenne muscular dystrophy gene therapy, and said it's suspending shipments of the treatment Elevidys for the...
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,
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