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Sanofi and Regeneron’s Dupixent wins EU nod in COPD ahead of September PDUFA

Sanofi and Regeneron’s Dupixent has notched another indication in the EU, this time for a common lung disease, marking the first-ever targeted therapy for the condition in the region. The French...

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Pfizer adds ex-State Street CEO to the board; Two Merus execs head for the exit

A few comings and goings before the Independence Day holiday in the US: Cyrus Taraporevala → Pfizer has welcomed former State Street Global Advisors president and CEO Cyrus Taraporevala to the board of...

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Apollomics plans to lay off staff, narrow focus for lung cancer trial

Apollomics is making major cost cuts and leadership changes to stay afloat. The oncology biotech announced Wednesday morning that co-founder and president Sanjeev Redkar and chief medical officer Peony...

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In biotech's uneven recovery, 50 startups raised megarounds in first half of...

The list of nine-figure financings for private biotechs is starting to look like the scrolling receipts from CVS or Walgreens. If that pace continues, it could top the heydays of 2020 and 2021. In the...

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Mississippi judge rejects efforts by Novartis, PhRMA to block 340B state law

A Mississippi federal judge has denied efforts by Novartis and industry trade group PhRMA to thwart a state law that would keep drugmakers from imposing some restrictions around the federal drug...

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Experts want to make it easier to get RSV vaccines. Did they make it harder...

Last week, experts on the CDC’s panel that sets vaccine recommendations created new guidance for who should get RSV shots heading into the second-ever season of vaccination for the respiratory disease....

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Federal judge rules against Boehringer Ingelheim in IRA lawsuit

A Connecticut federal judge threw out Boehringer Ingelheim’s case against the Inflation Reduction Act on Wednesday, marking another win for the federal government as the first Medicare negotiations...

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Roche’s TIGIT drug tiragolumab fails Phase 3 lung cancer trial

Roche will halt a late-stage study of tiragolumab after it failed to help certain lung cancer patients, adding to a string of registrational disappointments for the drug in recent years. The anti-TIGIT...

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Avid Bio’s 2024 revenue drops; Lotte Bio breaks ground on new $3.3B site 

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Avid Bioservices’ revenue for fiscal year 2024 dropped by 6% to $140...

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UK’s PMCPA criticizes Novo, Novartis, Pfizer and Otsuka for code breaches

A British watchdog has criticized four drugmakers, including Novo Nordisk, for violating the Association of the British Pharmaceutical Industry’s code of practice, marking the third time the Danish...

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Innovent reworks deal with IASO; Granza raises $7M

Plus, news about Kvantify: China’s Innovent takes a stake in CAR-T partner: After bringing the BCMA CAR-T therapy Fucaso to market in China, Innovent and IASO Biotechnology are reworking their deal....

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Circle Pharma raises $54M as part of Series D while macrocycles heat up

Circle Pharma, a startup working on macrocycles for the “undruggable,” is seeking about $117 million for a Series D. The company recently closed the first part of the round, reeling in about $54...

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Eli Lilly’s Alzheimer’s OK; GSK picks its mRNA bets; Megaround tally;...

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...

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Ideaya Biosciences reports Phase 2 data for MAT2A inhibitor IDE397

Fresh Phase 2 data are adding weight to Ideaya Biosciences’ case for a targeted therapy it believes could be a first-in-class treatment option for certain types of urothelial cancer and lung cancer. In...

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Vanqua raises $45M; Aerovate to look for strategic alternatives

Plus, news about GSK, iTeos, Oxolife and SmallCella: Vanqua Bio reels in $45M: The Chicago neuroscience biotech extended its Series B, a spokesperson confirmed to Endpoints News. The company originally...

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Gene insertion startup Komo Biosciences launches with new integrase...

Scientists at the University of Hawaii have improved tools for making large changes to genomes and have licensed the technology to a new startup called Komo Biosciences, its leaders told Endpoints News...

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HilleVax's stock tumbles after Phase 2b norovirus vaccine fails in infants

Takeda spinout HilleVax’s stock $HLVX sunk over 85% on Monday morning after the company announced its norovirus vaccine candidate failed a mid-stage trial in infants. While the vaccine, dubbed HIL-214,...

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Infections are major cause of non-relapse deaths after CAR-T cell therapy,...

A meta-analysis of CAR-T cell therapy studies found that just over half of cancer patient deaths that are not because of relapse are due to infections. “The main takeaway as clinicians is infections,...

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Digital health deals rallied in the first half of 2024, though funding still...

(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.)   Digital health startups raised $5.7 billion in the first half of 2024, slightly less than the $6.1...

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When can pharma companies correct online misinformation? FDA explains

The FDA on Monday laid out its latest expectations for how pharma companies can correct misinformation spreading online about their medical products. The draft guidance, which comes in the form of a...

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