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UK to limit access to Lilly’s Zepbound; VivaVision’s positive Phase 2

Plus, news about Atlas Venture: NICE plans a limited rollout of Eli Lilly’s Zepbound: The UK’s drug price watchdog confirmed its prior recommendation for the weight loss drug, but it plans to ...

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Genmab licenses second monoclonal antibody from Scancell

Genmab is licensing a second investigational anti-glycan monoclonal antibody from Scancell as part of an agreement inked between the two companies in 2022. Scancell, a British immunotherapy biotech,...

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National Resilience's new CEO; Moderna opens Australian manufacturing site

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. National Resilience is replacing its CEO effective immediately with...

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Merck’s Eliav Barr on its LaNova deal and the unknowns of VEGF bispecifics

Merck’s top medical exec said its recent bet on a VEGF bispecific antibody — one of the hottest areas in R&D — is not a form of “insurance” against future competition for Keytruda. The pharma...

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Protara’s stock nearly doubles as biotech divulges new bladder cancer data

Protara Therapeutics reported that 13 of 18 bladder cancer patients who received its experimental cell therapy saw no signs of their cancer at six months. Two of three patients who received ...

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Amgen deepens roots in North Carolina with latest $1B factory build 

Amgen is investing $1 billion for a second factory in North Carolina after already allocating more than half a billion dollars for a separate facility in the state. The latest factory in Holly Springs...

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Biosecure compromise could add review process for named companies, sources say

Lawmakers are considering a compromise to legislation targeting Chinese life science companies that would add an executive branch review instead of automatically barring biopharma companies from...

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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...

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FDA 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...

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Health 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...

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USPTO 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...

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Lilly 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...

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Merus 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...

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BioNTech, 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...

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Mark 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...

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AstraZeneca 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...

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UK’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...

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Teva 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...

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National 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 ...

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Novartis 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...

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