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Eyenovia's stock falls after it halts late-stage myopia trial

Eyenovia stopped a Phase 3 trial following a review of the data that found its experimental myopia treatment wasn't going to hit the study's primary endpoint. The ophthalmic company is now considering...

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European drug regulators offer wave of positive recommendations following...

The European Medicines Agency’s human medicines committee handed down a slew of positive recommendations for drugs on Friday, including Merck’s blockbuster cancer drug Keytruda and InflaRx’s monoclonal...

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What is the future of the Trump administration's pharmaceutical policies?

President-elect Donald Trump has just set up a showdown for the future of biopharma policy during his administration. On one side is Trump’s pick to lead the Department of Health and Human Services,

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Illumina seeks to dismiss shareholder lawsuit, denies secret $800M stake

Illumina has moved to dismiss a securities lawsuit against the company and former board members over the $8 billion Grail deal, after claiming to refute allegations around a secret financial stake that...

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Trump picks RFK Jr. for HHS; AbbVie's psych implosion; Merck tries staving...

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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Eisai terminates Phase 3 trial of Dravet drug lorcaserin

Eisai has stopped the Phase 3 clinical development of an adjunctive treatment for Dravet syndrome, a spokesperson confirmed to Endpoints News on Friday afternoon. The Tokyo drugmaker terminated the...

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Exclusive: Scottish biotech Trogenix debuts with viral immunotherapy platform...

Trogenix has emerged from stealth to advance its pipeline of viral immunotherapies for cancer, starting with a lead candidate targeting an aggressive type of brain tumor. A spinout of the University of...

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Intellia touts first clinical outcomes on CRISPR-based ATTR amyloidosis asset

In one of the most closely-watched arenas in biotech, Intellia says its gene editing treatment for a heart muscle disease can stabilize or improve outcomes where other treatments have only been shown...

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Exclusive: Athena Countouriotis' Avenzo taps Shanghai biotech for ADC, adds...

San Diego biotech Avenzo Therapeutics has secured the exclusive option to in-license another asset, this time looking at global ex-China rights to a bispecific in the bustling antibody-drug conjugate...

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Cybin reports high remission rates for psilocin drug in Phase 2 depression test

Cybin said its psilocin analog has the potential to wipe out symptoms in most patients with a serious form of depression, which marks a major step over just using antidepressants. In a small Phase 2 ...

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Novartis strikes radiopharma deal with Ratio worth up to $745M

Novartis is making another pact in radiopharma, promising as much as $745 million to a Boston-based startup. Ratio Therapeutics will get an undisclosed upfront payment as part of the exclusive...

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Atlas Venture targets $450M for 14th biotech venture fund

Atlas Venture, one of biotech's go-to VC firms, is eyeing a $450 million 14th fund, partner Bruce Booth said in its annual review presentation. In the review, recorded on Nov. 7 and

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Aclaris makes a deal, aims to raise $80M; Emmecell’s Ph1 update in corneal edema

Plus, news about Keymed Biosciences, Ouro Medicines, Recode, Intellia, Quell, VBI Vaccines and Zai Lab: Aclaris adds two anti-TSLP programs, seeks $80M: The new pipeline candidates come from a...

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As cardiomyopathy market expands, Alnylam offers look at Phase 1 data in...

Alnylam’s experimental RNAi treatment for a rare form of cardiomyopathy has shown signs of efficacy in an early-stage trial of healthy volunteers, but analysts said development could be challenging as...

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A rare neurological disease is Sage’s last, best hope after failures in...

In 2010, neuroscientist and former Eli Lilly research leader Steve Paul started a company that he hoped would spark a revolution in drug discovery, built around a class of compounds dubbed...

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Regenxbio shares first data showing Duchenne gene therapy improves muscle...

Regenxbio said its gene therapy improved muscle function in a handful of boys with Duchenne muscular dystrophy across two doses. The gene therapy company said Monday that it dosed the first patient in...

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FDA offers more guidance on developing cell and gene therapies

The FDA on Monday offered new draft guidance to help drugmakers understand the nuts and bolts of FDA processes for developing and submitting an application for a new cell or gene therapy, from pre-IND...

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CSL Behring will close California office as part of shrinking ex vivo work

CSL Behring is closing a Pasadena, CA-based R&D site and moving the operations to Massachusetts as part of a larger repositioning of the company’s gene therapy research. A spokesperson for the...

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Syndax's Revuforj wins FDA approval in aggressive form of leukemia

Syndax Pharmaceuticals won the first FDA approval last week in a new class of medicines called menin inhibitors. The treatment, Revuforj, will be available as soon as this month for patients with an...

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Neurogene patient had life-threatening side effect in Rett syndrome study

Neurogene has released details of an adverse event in a clinical trial testing its gene therapy for Rett syndrome, after news of the safety issue first emerged last week. On Monday, the company said ...

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