For next round of IRA price negotiations, US says it will meet with companies...
The Centers for Medicare & Medicaid Services wants earlier and more flexible communication with drugmakers during the next round of Medicare negotiations, it announced Wednesday. The first round of...
View ArticleSepterna files for Nasdaq listing as biotech IPOs come to life
Septerna is joining biotech’s IPO on-deck circle, preparing for a public offering with two other startups that have recently announced similar plans. It announced its plans in securities filing...
View ArticleResolution raises $85M to test macrophage therapies in end-stage liver disease
By the end of the year, a British biotech plans to start testing a new kind of cell therapy based on macrophages, a roaming immune system sentinel known for gobbling up dead and dying cells throughout...
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Investor Kurma Partners raises €140M for latest Europe-focused biotech fund
Kurma Partners has closed the first part of its latest biotech-focused fund, following a pair of M&A exits for drug developers backed by its third fund. Rémi Droller The Paris-based investment firm...
View ArticleEnara Bio’s $32.5M Series B to support lead dark antigen program for GI cancers
Enara Bio has snagged $32.5 million in a Series B fundraise, backed in part by Pfizer’s venture arm, to help develop a preclinical pipeline of T cell receptor-based therapies targeting dark antigens...
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Eli Lilly resolves shortage for tirzepatide, potentially ending compounders' run
Eli Lilly’s blockbuster GLP-1 drug tirzepatide is finally back on track in the US after two years of intermittent shortages driven by high demand, the FDA said Wednesday. Tirzepatide is sold as...
View ArticleFDA lifts partial hold on Avidity’s myotonic dystrophy drug; Orum's IPO in...
Plus, news about Caliway Pharmaceuticals, argenx, Halozyme Therapeutics, Verrica, Liquidia and Pharmosa: FDA lifts partial clinical hold on Avidity Biosciences’ drug: The treatment, called delpacibart...
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Flagship partners with key Singapore R&D agency as it boosts APAC investment
Flagship Pioneering’s roots in Singapore are growing less than a year after the biotech incubator first unveiled its ambitions in the Asia-Pacific region. The Cambridge, MA-based investor said...
View ArticlePfizer lays off staff in Ireland; Baxter closes NC facility due to hurricane...
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Pfizer is laying off employees across its manufacturing facilities in...
View ArticleOpdivo gets FDA approval for use around lung cancer surgery, following...
The FDA has given the green light to Bristol Myers Squibb’s Opdivo for use before and after surgery for non-small cell lung cancer. A regimen of Opdivo plus chemotherapy before surgery, followed by...
View ArticleNovo and Lilly outline plans to mitigate disruptions from US port strikes
Novo Nordisk and Eli Lilly, whose obesity drugs are some of the most in-demand drugs in the US, have drafted plans to avoid supply disruptions from seaport strikes across the East and Gulf Coasts, the...
View ArticleFDA's drug center launches new coordinating body for modeling and simulation
The FDA’s Center for Drug Evaluation and Research on Wednesday officially launched a new center of excellence to better coordinate simulation and modeling work, covering everything from drug...
View ArticleWuXi companies may sell units impacted by Biosecure — report
WuXi AppTec and WuXi Biologics are reportedly looking to sell part of their operations that have struggled because of proposed federal legislation that’s targeting the companies on national security...
View ArticleRelay Therapeutics cuts another 10% of company, citing continued streamlining...
Relay Therapeutics is laying off 10% of its staff, or about 30 employees, in an additional round of job cuts after a smaller downsizing in July. A spokesperson for the biotech confirmed the layoffs in...
View ArticleUK government proposes phased rollout of Eli Lilly's weight loss drug
The UK’s publicly funded healthcare system has proposed phasing its rollout of Eli Lilly’s weight loss treatment tirzepatide to ensure those who need it most get early access. An estimated quarter of a...
View ArticleEli Lilly obesity drug shortage ending threatens access to compounded...
Telehealth companies and patients are grappling with the potential loss of access to cheaper, alternative versions of Eli Lilly’s popular GLP-1 weight loss drug tirzepatide after the FDA said its...
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After $14B exit, Karuna co-founder finds next bet; Ex-Regenxbio CEO Ken Mills...
Andrew Miller Andrew Miller has quickly made his first move after the technology he invented, KarXT, secured an FDA approval last week. The regulator’s nod for Bristol Myers Squibb’s Cobenfy (KarXT)...
View ArticleSanofi sells rare disease drug Enjaymo to Recordati for $825M upfront
Sanofi is offloading its rare autoimmune disease medicine Enjaymo to an Italian pharmaceutical company for $825 million upfront. Recordati, based in Milan, said Friday it will pay up to an additional...
View ArticleBiotech's third quarter was relatively bright — with a few caveats
The weather is getting cooler, but biotech’s recovery is heating up. After a years-long wait-and-see game exhausted many industry insiders, recent signals indicate a mostly promising direction for drug...
View ArticleEditas sells future CRISPR license fees; Plus, news about Oncolytics Biotech
Editas sells future CRISPR licensing fees from Vertex: DRI Healthcare Trust is paying $57 million upfront to the gene editing company in exchange for future licensing payments from Vertex, which struck...
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