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GSK’s Nucala bags another China approval, but biggest test yet to come

GSK’s blockbuster respiratory drug Nucala has secured a China label expansion for certain patients with inflamed sinuses. But a more important challenge on the way to hitting its multibillion-dollar...

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Novo petitions FDA over Victoza compounding as first generic wins approval

Novo Nordisk is continuing its citizen petition crusade at the FDA, this time aiming to stop the compounding of Victoza, its blockbuster GLP-1. The push comes as the regulator late last month

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Eli Lilly seeks to join lawsuit over end of tirzepatide shortage

Eli Lilly has asked to intervene in litigation between a compounding pharmacy trade group and the FDA over the agency’s decision to remove Lilly’s blockbuster obesity and diabetes drug tirzepatide from...

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Florida car dealer joins insulin pricing fight against Eli Lilly, Sanofi

A Florida-based car dealer has joined mounting litigation against Eli Lilly, Novo Nordisk and Sanofi over what it calls the “exorbitant” price of insulin. Braman Motors is the first private company to...

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Neumora fails Ph3 depression study; Our review of 2024 megarounds; Pfizer...

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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New FDA guidance on accelerated approvals, AI, clinical trials

With two weeks until President-elect Donald Trump's administration takes over, the FDA on Monday released dozens of new draft and final guidance documents covering everything from how to reliably use...

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Teoxane issues competing buyout bid for Revance and its Botox rival

Revance Therapeutics’ contract dispute with a Swiss partner has caused hiccups in its plan to be acquired by Crown Laboratories. Now that partner says it can offer Revance a better deal. Teoxane on...

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Updated: Acelyrin’s stock drops due to mixed Phase 2 data in thyroid eye disease

Acelyrin has offered a more detailed look at mid-stage results for its thyroid eye disease drug candidate as it tees up its next development steps. In the latter part of a Phase 1/2

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Exclusive: Forbion-backed cardio biotech rebrands to RyCarma with Phase 2 plans

A 20-year-old biotech working on small molecule treatments for cardiovascular and skeletal muscle diseases has rebranded and plans to enter Phase 2 in heart failure later this year. Formerly known as...

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Highlander Health acquires Target RWE to improve clinical trials

Highlander Health, the clinical trial startup co-founded by former Verily execs Amy Abernethy and Brad Hirsch, is acquiring data company Target RWE. Launched in September, Highlander wants to make it...

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Ken Song's Candid licenses a T cell engager from WuXi Bio

Candid Therapeutics is committing up to $925 million for the rights to a trispecific T cell engager candidate developed by WuXi Biologics, further expanding its autoimmune disease pipeline. WuXi is...

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Vertex signs in vivo gene editing delivery pact for sickle cell and...

Vertex Pharmaceuticals signed a three-year deal with Orna Therapeutics to use the RNA biotech’s delivery particles to develop its next iteration of gene editing treatments for sickle cell disease and...

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Profluent debuts AI model for CRISPR gene editing design

Bay Area biotech Profluent has taken another step in using AI to design new CRISPR gene editing systems, CEO Ali Madani exclusively told Endpoints News. The startup posted a preprint Monday ...

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Exclusive: Avenzo picks up another ADC, this time with multi-partnered...

Avenzo Therapeutics, a well-funded biotech that has in-licensed treatment candidates from Chinese drug developers, has forged its third deal since reassembling much of the Turning Point Therapeutics...

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XyloCor raises $67.5M Series B, updates pivotal gene therapy trial plans

XyloCor Therapeutics has closed a $67.5 million Series B round to fund mid-stage development of its cardiac gene therapy. Two years ago, the biotech said it hoped its next trials of the ...

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J&J's combo beats Tagrisso on survival in first-line lung cancer

Johnson & Johnson said its recently approved Rybrevant and Lazcluze combination therapy topped Tagrisso on overall survival in a Phase 3 trial, notching a key win in its rivalry against the...

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Metsera’s long-acting GLP-1 looks competitive in Phase 2 obesity study

Data from a mid-stage obesity trial of Metsera’s long-acting injectable GLP-1 agonist suggest it could be competitive with approved incretins and several investigational compounds. The Phase 2a trial...

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Novo Nordisk partners with Variant Bio; Aviceda raises $207M in Series C

Plus, news about Alebund Pharmaceuticals, Capsida Biotherapeutics, CytomX Therapeutics and Generation Bio: Novo Nordisk’s latest obesity partner: The Danish pharma giant is teaming up with a small...

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Pfizer extends AI drug discovery pact with PostEra, adding ADCs to deal

Pfizer has re-upped its drug discovery deal with AI startup PostEra to develop small molecule drugs and new warheads for antibody-drug conjugates, a major area of focus for the drugmaker following its...

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Immuneering touts positive pancreatic cancer data for MEK inhibitor

Immuneering’s shares rocketed in premarket trading on Tuesday on the back of positive mid-stage data for its MEK inhibitor in pancreatic cancer, sparking plans to add more combination arms. Three out...

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