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Trump’s HHS defends Biden-era stance on 340B rebate models

The Trump administration defended HHS’ rejection of drugmakers' 340B rebate models “at this time,” but suggested that the agency could be open to further consideration. The comments, made in response...

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FDA staff return to White Oak campus after Trump administration push

Packed parking, long security lines and traffic greeted returning FDA workers on Monday, who were called back to the agency's main White Oak campus as part of the Trump administration's effort to force...

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Sofinnova raises €165M for new early-stage biotech fund

European life sciences investor Sofinnova Partners disclosed a €165 million acceleration fund on Tuesday to back early-stage science in Italy, France, United Kingdom and Denmark. The fund, Biovelocita...

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CRISPR startup Arbor Biotechnologies raises $73.9M as it nears first trial

Arbor Biotechnologies, a startup founded by CRISPR pioneer Feng Zhang nine years ago, has closed a $73.9 million Series C financing to bring its first therapy into clinical trials — a treatment that...

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Novartis revamps commercial strategy as Entresto patent cliff looms 

With its decadelong US patent for Entresto set to expire in a few months, Novartis has started to overhaul its commercial approach. The drugmaker is laying off hundreds of employees and will instead...

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Japan's RegCell raises $45.8M for Treg cell therapies, will move to US

Cell therapy biotech RegCell is hoping to bridge science from Japan with the US biotech industry to develop new cell therapies for autoimmune conditions. It announced Tuesday that it raised $45.8...

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Foodsmart names former Amwell executive Kurt Knight as CEO

Nutrition telehealth company Foodsmart tapped Kurt Knight, a former Amwell executive, to be its new CEO. The San Francisco-based company matches users with virtual dietitians and provides personalized...

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Sixteen-year-old dies after receiving Sarepta’s Duchenne therapy Elevidys

A teenage boy who received Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys died from liver failure, the biotech said Tuesday morning. Sarepta told Endpoints News he was 16 years old and was...

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Stoke CEO Ed Kaye to depart shortly after inking Biogen pact and before its...

In a surprise move, the longtime CEO of Stoke Therapeutics is leaving the company, weeks before the Phase 3 trial of its lead drug is slated to start. The biotech

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Empress Therapeutics confirms layoffs; Nanobiotix amends J&J deal terms

Plus, news about Pyxis Oncology, Kiromic BioPharma, TC BioPharm, EnteroBiotix, Liquidia, Compass Pathways, Vincerx Pharma and Neurizon: Empress Therapeutics undergoes layoffs: A spokesperson for the...

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HHS extends administrative leave for probationary workers after court order

Following a court order, HHS won't fire more than 2,800 probationary employees it sought to cut — but it won't let them come back to work, either. The department's update was filed Monday ...

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Stem cell company bit.bio lays off quarter of staff

The British stem cell company bit.bio has reduced its workforce by 25%, impacting most of the therapeutics division, founder and board member Mark Kotter confirmed to Endpoints News. About 150...

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Servier licenses Black Diamond’s RAS- and RAF-targeted drug

Black Diamond Therapeutics has found a buyer for an early-stage targeted cancer drug, which was brushed to the side last year as it focused resources on developing a next-generation lung cancer...

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Flagship's Ampersand gets Eli Lilly's support in $65M Series B

Ampersand Biomedicines, a biotech working on medicines "similar in principle" to antibody-drug conjugates, has secured $65 million in a Series B round. Eli Lilly took part in the funding round...

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Roche inks $1B+ biobucks deal with Oxford BioTherapeutics for new antibody...

Roche has forged a multiyear partnership with Oxford BioTherapeutics to find new targets for antibody-based cancer treatments with an upfront payment of $36 million. The partners will work together to...

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Updated: Immunovant will not take rare disease drug to regulators despite...

Immunovant will not seek approval for its candidate for the autoimmune disorder myasthenia gravis (MG), despite a reasonable showing in its pivotal trial. Instead, the company said Wednesday that it...

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Pfizer fully exits Haleon in $3.3B stake sale

Pfizer will get about $3.3 billion from its final stake sale in Haleon, according to a Wednesday filing with the London Stock Exchange. The New York pharma giant is fully exiting ...

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Regenxbio shares new Duchenne gene therapy data ahead of big readout next year

Regenxbio has biomarker data on the first patient younger than 4 years old dosed with its Duchenne muscular dystrophy gene therapy, showing that the patient expressed levels of a shortened version of a...

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Ahead of FDA decision, Alnylam faces the big question: Can it make money?

Despite pioneering RNAi drug development and getting four therapies approved, Alnylam still isn’t profitable. That may change as soon as next year. The FDA is expected to decide by Sunday whether to...

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Cargo Therapeutics scraps R&D pipeline, axes bulk of workforce as it looks...

As Cargo Therapeutics looks for a permanent solution to its troubles, the biotech is dropping its remaining clinical programs and laying off the majority of staff in a second round of cuts. The San...

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