Imfinzi snags another FDA nod to treat lung cancer, this time for...
The FDA has approved AstraZeneca’s Imfinzi to treat limited-stage small cell lung cancer, adding another lung cancer indication to one of the pharma’s best-selling drugs. The decision, announced by the...
View ArticleFDA spells out expedited withdrawal process for accelerated approvals
The FDA on Thursday released new details on how it plans to expedite the withdrawal of certain accelerated approvals when drugs fail to show clinical benefit in confirmatory trials, as recently...
View ArticleHealth execs' security in spotlight after UnitedHealthcare CEO killing
The cold-blooded shooting death of UnitedHealthcare CEO Brian Thompson on Wednesday sent shockwaves through corporate America, highlighting the threats increasingly faced by healthcare executives and...
View ArticleUSPTO withdraws proposed patent rule criticized by pharma industry
The US Patent and Trademark Office has withdrawn its controversial proposal for a new rule that would make it easier to challenge groups of patents in court. The proposal received more than 300 public...
View ArticleLilly continues to expand its empire of GLP-1 factories with new $3B buildout
PLEASANT PRAIRIE, WI — A four-minute drive north of the Illinois-Wisconsin border in "America's Dairyland," Eli Lilly is staking one of its largest-ever manufacturing bets to continue its dominance in...
View ArticleMerus receives FDA accelerated approval to treat NRG1+ cancers
The Dutch biotech Merus received the first-ever FDA accelerated approval for a systemic treatment targeting a specific genetic fusion in patients with either non-small cell lung cancer or pancreatic...
View ArticleBioNTech, DualityBio report promising ADC data in solid tumors
Duality Biologics and BioNTech say interim data on one of their partnered ADCs look encouraging, with a preliminary cut from the trial showing that nearly a third of treated patients had unconfirmed...
View ArticleMark Alles’ ADC bet TORL poaches J&J medical exec; Samsung Bioepis makes...
TORL BioTherapeutics, the antibody-drug conjugate startup led by former Celgene chief Mark Alles, has brought aboard a chief medical officer with big pharma chops. Aran Maree will be overseeing...
View ArticleAstraZeneca and Daiichi report pooled ADC data in mutant lung cancer
AstraZeneca and Daiichi Sankyo have unveiled new data on their TROP2-directed ADC in pretreated lung cancer patients with EGFR-mutated disease, adding to their case for a potential US approval. In the...
View ArticleUK’s local vaccine production stymied by budget cuts, government committee says
A UK political committee says the country is underprepared for future pandemics due to “worrying developments” on domestic vaccine manufacturing. The UK’s House of Lords’ Science and Technology...
View ArticleTeva to divest business venture in Japan; Layoffs at Rome Therapeutics
Plus, news about Cyclacel Pharmaceuticals, MediciNova and Revolution Medicines: Teva will divest its Japan business venture to private equity firm: The company said Friday that it agreed to transfer...
View ArticleNational Resilience to cut 105 employees at Florida site as new CEO takes over
The same day that National Resilience announced a new CEO, it said that it will cut more than 100 jobs in Florida. The company on Thursday disclosed a mass layoff in ...
View ArticleNovartis bolsters Fabhalta data in competition with AstraZeneca
Novartis’ Fabhalta improved hemoglobin levels in patients with a rare blood disorder who switched from anti-C5 therapies, bolstering the drug’s case against AstraZeneca’s competing treatments. Fabhalta...
View ArticleEuropean Commission greenlights $16.5B Novo-Catalent acquisition
Despite months of biopharma industry pushback, the European Commission has unconditionally approved Novo Holdings’ $16.5 billion acquisition of Catalent. The Federal Trade Commission’s decision is...
View ArticleInsurance executive killing puts spotlight on security measures at JP Morgan...
The usual enhanced security measures are expected to be in place in San Francisco next month when the healthcare industry descends on the city for the JP Morgan healthcare conference. But it's not yet...
View ArticleBioAge Labs scraps Phase 2 obesity trial just months after IPO
BioAge Labs is scrapping a Phase 2 trial testing its anti-obesity drug, a few months after its flashy $198 million initial public offering. After a brief trading halt, the biotech’s shares ...
View ArticleLilly beats Novo in weight loss; Apogee plots Dupixent challenge; Biosecure...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
View ArticleBiosecure bill is left out of end-of-year defense package
Legislation targeting popular Chinese biotech contractors like WuXi AppTec wasn't included in must-pass defense legislation that represented its best chances as this session of Congress draws to a...
View Article#ASH24: AstraZeneca outlines Phase 1 data for CD19 bispecific T cell engager...
SAN DIEGO — AstraZeneca is getting ready to step on the gas in the world of bispecific T cell engagers. The company presented some of its first Phase 1 data for its CD3xCD19 bispecific known ...
View Article#ASH24: Beam shares results from seven patients who received gene-edited...
SAN DIEGO — Beam Therapeutics now has trial data from seven patients who have received its gene-edited sickle cell therapy, showing promising early signs that the therapy could be used to treat severe...
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