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J&J prevails in schizophrenia drug patent spat against Teva

Johnson & Johnson beat back Teva's patent challenge in a federal appeals court ruling that closes out a yearslong fight over J&J’s antipsychotic medication Invega Sustenna. The US Court of...

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Federal judge sides with FDA on its mifepristone rules

The FDA acted within its purview when it maintained some safety requirements for the abortion pill mifepristone following an agency review, a federal court in Washington ruled. “The Court cannot find,...

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FDA’s pediatric adcomm votes to continue surveillance of 21 drugs, three...

The FDA’s pediatric advisory committee voted almost unanimously to continue monitoring 21 drugs and three vaccines for side effects, including blockbusters such as Novartis’ heart drug Entresto and...

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Aqtual raises $31M to guide rheumatoid arthritis treatments

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Swiss and German radiopharma biotech Nuclidium collects $99M Series B

For the second day in a row, a European radiopharma company said it has bagged a large venture funding round. Basel and Munich-based startup Nuclidium has pulled together a CHF 79 million (about $99...

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Kidney health biotech Renasant Bio emerges with $54M to follow in Vertex’s...

A Berkeley, CA-based biotech that wants to replicate Vertex’s success with corrector and potentiator medicines has raised a $54.5 million seed round. The funding, disclosed Thursday morning, will help...

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Ultragenyx, Mereo’s bone disease drug fails second interim analysis, stocks...

Ultragenyx Pharmaceutical and Mereo BioPharma’s antibody for a rare bone disease failed a second interim analysis in its pivotal trial, the companies revealed late on Wednesday. The study will continue...

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Biotech’s Q2 numbers paint a picture of the good, the bad and the ugly

The numbers aren’t all bad in biotech. But you’d be forgiven if you thought they were. And you’d be in good company. Once again, Chris Dokomajilar at DealForma has been checking the data for us ...

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Endpoints livestream: Curie.Bio CEO Zach Weinberg on China biotech competition

Today on Post-Hoc Live, we're talking about China — and how some in biotech want to make it harder for US companies to do deals there. The drug industry has turned to China for new molecules ...

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A state bill threatens to ban AI therapists, forcing health tech startups to...

AI therapists could soon be banned for the first time in the US under an Illinois bill, as mental health companies scramble to comply. The Wellness and Oversight for Psychological Resources Act forbids...

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DHL’s $700M+ expansion in UK and Ireland; Novo Nordisk’s quality testing site...

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. DHL Supply Chain has invested £550 million ($748 million) to expand...

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Soleno's first wave of rare disease drug sales beats expectations

The first full quarter sales for Soleno Therapeutics’ rare disease drug Vykat XR are in, and they have exceeded investor forecasts. Soleno said Thursday morning that Vykat XR ...

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For first time ever, FDA publishes drug rejection letters

In a historic first, the FDA on Thursday released about 200 novel and generic drug rejection letters, bucking the agency's former unwillingness to release the documents. But it's a small step ...

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AstraZeneca hands over opioid addiction pill to Eolas; TandemAI, Perpetual...

Plus, news about Pfizer and Astellas' Xtandi, BeOne Medicines, Biocytogen and Rhythm: Eolas Therapeutics takes opioid addiction pill from AstraZeneca: The biotech will assume full development rights ...

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AbbVie inks $700M deal with IGI for multiple myeloma trispecific antibody

AbbVie will spend $700 million upfront, plus future payments, on a trispecific antibody for blood cancer from IGI Therapeutics, adding to a slow but steady trend of deals for multi-target drugs. AbbVie...

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Jazz taps current COO Renée Galá to replace CEO and co-founder Bruce Cozadd

Jazz Pharmaceuticals has named its next conductor. Renée Galá, the Dublin-based company’s current president and COO, will become CEO on August 11. She will succeed Jazz’s co-founder Bruce Cozadd, who...

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Varda raises $187M to advance drug manufacturing in space

Varda Space Industries has raised $187 million in a private funding round as the company leverages microgravity to overcome formulation issues that have long plagued drug development. Active...

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FDA approves Moderna's Covid shot for at-risk kids

The FDA on Thursday approved Moderna’s Covid-19 shot for kids six months through 11 years old who are at higher risk of severe disease, the latest move that fits the agency’s new vaccine framework. ...

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Century Therapeutics lays off half of its staff, CFO departs as it narrows...

Cell therapy maker Century Therapeutics is cutting its workforce by around half in an effort to “right-size” the business as it homes in on therapeutic programs with the most potential. The...

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Sally Susman waves goodbye to Pfizer; Xaira's new president and COO

→ Sally Susman will say goodbye to Pfizer at the end of 2025, capping an 18-year career leading the corporate affairs function at the global pharma giant. Susman played a big role in ...

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FDA hands Capricor a CRL for its Duchenne cell therapy  

Capricor Therapeutics said on Friday it received a Complete Response Letter from the FDA for its lead cell therapy for Duchenne muscular dystrophy (DMD), citing the agency was not satisfied with its...

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#IAS25: As researchers come together for HIV conference, few biotechs can...

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Antag says it is confident ahead of 'imminent' Phase 1 obesity readout for...

Antag Therapeutics is taking an unusual, although not unknown, approach to obesity. Where drugs like Eli Lilly’s Zepbound and other compounds from Roche and Viking Therapeutics have mechanisms partly...

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Manufacturing layoffs at Pacira; Oak Hill Bio’s Phase 1 Angelman data

Plus, news about Milestone Pharma: Pacira BioSciences cuts manufacturing staff: The company is laying off 71 employees at its Science Center Campus in San Diego, according to a California WARN notice....

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