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Acadia snaps up an essential tremor drug after field's summer setbacks

A few weeks after gaining about $100 million from a priority review voucher, Acadia Pharmaceuticals is putting its money to work by in-licensing an experimental essential tremor medicine. The San Diego...

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PTC reports Phase 2 ALS fail, sells priority review voucher for $150M

PTC Therapeutics is staying busy ahead of the Thanksgiving holiday. On Tuesday afternoon, the company announced that a Phase 2 trial evaluating its experimental ALS drug utreloxastat failed on the...

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Norbert Bischofberger's time as Kronos CEO ends as biotech seeks new life

Kronos Bio is letting go nearly all its employees after flashing red lights earlier this month. As part of an 83% workforce downsizing, CEO Norbert Bischofberger is heading out the door and handing the...

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Bristol Myers sues the federal government over 340B, following other drugmakers

Bristol Myers Squibb is the latest pharma company to sue the federal government over its rejection of a proposed new model for distributing 340B drug discounts. Under the drugmaker's plan, hospitals...

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Recursion reduces workforce; Oxford Nanopore teams up with UK Biobank

Plus, news about Portage Biotech: Recursion’s layoffs: After merging with fellow AI-driven biotech Exscientia this fall, Recursion Pharmaceuticals laid off less than 20% of the combined company, a...

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Outlook's shares crash as wet AMD drug flunks Phase 3 test

After the FDA rejected Outlook Therapeutics’ ophthalmic formulation of bevacizumab last year, the experimental therapy has now failed a late-stage study in patients with a degenerative eye disease. In...

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Advanz Pharma faces revocation of European authorization for liver disease...

The conditional marketing authorization for Advanz Pharma’s liver disease treatment Ocaliva has been revoked following a decision by the General Court of the European Union, the company announced...

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Novartis to cut 139 jobs in NJ as part of commercial refocus

Novartis is laying off 139 employees in East Hanover, NJ, as the company shifts its commercial resources away from two “well-established” medicines. The layoffs will mainly affect members of the...

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Satsuma's NDA filing after CMC woes; Hovione's Irish and US expansion

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FDA is looking into hematology risks after patients take Bluebird's Skysona...

The FDA said Wednesday that it is investigating "serious risk of hematologic malignancy" following the administration of bluebird bio's Skysona, a gene therapy approved for the rare disease known as...

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Applied Therapeutics' rare disease drug gets a CRL

The FDA rejected Applied Therapeutics’ experimental treatment for a rare disease called classic galactosemia, citing deficiencies with the application. The company, while “disappointed with the FDA’s...

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Cartesian tees up Phase 3 mRNA CAR-T study in myasthenia gravis

Cartesian Therapeutics reported longer-term results from a mid-stage study of its mRNA CAR-T therapy for myasthenia gravis, suggesting that the therapy is durable beyond the initial three-month study...

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Relay licenses lirafugratinib to Elevar for $75M

Relay Therapeutics said last year it would delay the regulatory filing of lirafugratinib in bile duct cancer. Now it's stepping away from the drug’s development altogether, having licensed the oral...

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Ipsen secures rights to T cell engager in $610M pact with Biomunex

Ipsen has inked yet another licensing deal in an effort to bolster its cancer pipeline, this time for a preclinical T cell engager developed by another Paris-based drugmaker. The French pharma company...

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Coherus makes final, $483M pivot away from biosimilars

Coherus BioSciences' stock surged on Tuesday after the company announced plans to sell off the last biosimilar in its portfolio. Intas Pharmaceuticals has agreed to purchase Coherus’ Neulasta...

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Applied Therapeutics gets FDA warning letter for rare disease drug

Following the FDA's rejection last week of Applied Therapeutics' experimental drug for a rare disease called classic galactosemia, the company announced Monday that it also received a warning letter...

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Eli Lilly, Pfizer stress independence of telehealth partners in response to...

In response to lawmakers' concerns, Pfizer and Eli Lilly said last week that they do not influence telehealth partners and their clinicians to prescribe their brand-name drugs. Both companies launched...

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Kiromic and SEC settle over undisclosed clinical trial holds

The SEC said Tuesday that it settled charges filed against Kiromic BioPharma, a tiny immuno-oncology startup based in Texas, for failing to disclose clinical holds on two experimental cancer drugs...

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GSK terminates Phase 2 trial of HBV therapeutic vaccine

GSK has axed a Phase 2 study of a chronic hepatitis B therapeutic vaccine, adding to a string of treatment R&D hurdles for the liver infection. The termination of the study of GSK3528869 was the ...

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Lilly removes body mass ranges from FDA label for weight loss drug

Eli Lilly has removed the commonly used clinical measure of body mass index from the FDA label for its weight loss drug Zepbound, a move that could give physicians greater leeway to decide who should ...

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