Teva loses IRA drug pricing challenge in DC federal court
Teva’s challenge against Medicare negotiations fell flat in DC federal court, marking another loss for the pharma industry. US District Judge Sparkle Sooknanan said Thursday that Teva’s constitutional...
View ArticleAstraZeneca to onshore rare disease portfolio as part of its $50B pledge to...
AstraZeneca will invest $2 billion to expand its presence in Maryland, its latest move to boost US manufacturing as part of a larger $50 billion pledge, the company announced Friday. The UK-based...
View ArticleTop Makary aide Jain-Nagpal remains at the FDA after White House pushback
A close confidant and aide of FDA Commissioner Marty Makary won't be forced to resign after running afoul of the White House, but also won't be promoted into a senior role at the regulator. ...
View ArticleMakary’s user fee comments; M&A activity stays hot; A new use for prime...
Welcome back to another edition of Endpoints Weekly. Our Saturday newsletter will be off next week for Thanksgiving, so let us be the first to wish you all a happy and healthy holiday! I’m personally ...
View ArticleNobel laureate Carolyn Bertozzi to rejoin Lilly board
Carolyn Bertozzi is rejoining the board of Eli Lilly on Dec. 8, the pharma giant disclosed in a Friday evening SEC filing. The 2022 Nobel laureate, who has ...
View ArticleCraig Crews, Mikael Dolsten raise $32M for Quarry Thera
During his daughter's wedding weekend last year, Mikael Dolsten was running through a flurry of emotions. He was thinking about the marriage, but also about starting a new biotech. The former Pfizer...
View ArticleNovo Nordisk's semaglutide misses in closely-watched Alzheimer’s trials
Novo Nordisk’s bet on semaglutide in Alzheimer’s disease was always a long shot, and like most long shots, it has missed the mark. The GLP-1 agonist failed to delay disease progression in patients in...
View ArticleBayer’s stock rallies as next-gen blood thinner beats the odds with Phase 3 win
Bayer’s factor XIa inhibitor slashed the risk of recurrent stroke in a late-stage trial in certain patients, breathing new life into a class of drugs that has suffered a string of high-profile...
View ArticleBiogen pens I&I deal with new Versant macrocycle developer Dayra Therapeutics
Versant Ventures’ latest startup is debuting with a partnership with Biogen to make oral macrocycles for immune and inflammatory diseases, a booming area of biopharma investment. Biogen is paying Dayra...
View ArticleSarepta to pay $200M milestone to Arrowhead; Enlivex reports osteoarthritis data
Plus, news about Clearside Biomedical, Pfizer, Astellas, Merck, MindImmune Therapeutics and Poxel: 💵 Sarepta to pay Arrowhead $200M as it continues type 1 myotonic dystrophy study: Sarepta
View ArticleKelun's TROP2 ADC plus Keytruda improves outcomes in first-line lung cancer
Merck’s partner on an experimental antibody-drug conjugate has reported a Phase 3 win in first-line lung cancer, and will take the data to Chinese regulatory authorities. Chengdu-based Kelun-Biotech...
View ArticleJ&J’s tau-targeting antibody fails Phase 2 Alzheimer's study
Johnson & Johnson’s anti-tau monoclonal antibody failed to slow the progression of Alzheimer’s in patients with early-stage disease, marking the end of one of the company's most promising...
View Article#ASH25: Kelonia’s first in vivo CAR-T data; Lilly, J&J and Novartis spell out...
Late-breaking abstracts from the annual American Society of Hematology meeting are early this year, coming right before Thanksgiving instead of the previously planned drop on Dec. 1. Big pharma...
View ArticleUK-US drug pricing deal could come as early as this week, sources say
A major drug price deal between the US and UK government could be finalized as early as this week, two UK-based sources familiar with the matter told Endpoints News on Monday. The two governments have ...
View ArticleFDA's Pazdur is said to raise questions about commissioners actions, new voucher
That didn't take long. Less than two weeks since appointing Richard Pazdur to lead the FDA's drug center, Commissioner Marty Makary is already finding himself in disagreement with his new deputy,...
View ArticleNovartis was the sole bidder in $12B deal to buy Avidity
It took 14 calls between chief executives, four months of negotiations and four hiked proposals for Novartis and Avidity Biosciences to come to their $12 billion agreement in October, according to a ...
View ArticleFDA approves Novartis’ Itvisma for older patients with spinal muscular atrophy
Novartis has secured FDA approval for a new version of its one-time gene therapy for spinal muscular atrophy (SMA) that it says could benefit a much broader swathe of patients. The Swiss drugmaker
View ArticleNovartis plans to lay off 550 workers at Swiss factory
Novartis plans to reorganize two Swiss facilities, which it says could result in 550 layoffs as it discontinues some manufacturing at its site in Stein. The company intends to discontinue tablet and...
View ArticleNovo Nordisk’s amycretin cuts body weight, blood sugar in Phase 2 diabetes trial
Novo Nordisk’s amylin combination shot amycretin allowed patients with diabetes to lose up to 14.5% of their body weight in just over eight months. Patients in the same mid-stage trial who were given a...
View ArticleFDA OKs Sarepta study of new immune suppression approach with Elevidys;...
Plus, news about Nuvalent and Phrontline: 🟢 FDA clears Sarepta’s next step: Sarepta said it will study its Duchenne muscular dystrophy gene therapy Elevidys with a new ...
View ArticlePharma faces deadline to bring IRA fight to Supreme Court as first set of...
Court battles over Medicare drug price negotiations are coming to a head. Two drugmakers are up against deadlines next month to appeal their Inflation Reduction Act challenges to the US Supreme Court....
View ArticleWhat a team of ex-Amazon employees are building next in healthcare
The team behind PillPack (and their colleague from Amazon) launched their new startup, General Medicine, about six months ago. It aims to be a better way for consumers to shop ...
View ArticleCMS unveils IRA prices for Ozempic, Wegovy and other drugs from second round
The government on Tuesday announced final prices for the second round of drugs negotiated by Medicare under the Inflation Reduction Act, including for Novo Nordisk’s blockbuster semaglutide products...
View ArticleOtsuka’s anti-APRIL antibody gets FDA approval for kidney disease IgAN
Otsuka secured FDA accelerated approval for its antibody drug in a disease that impacts the kidneys’ ability to filter waste. The Japanese drugmaker said late Tuesday the agency greenlit sibeprenlimab...
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