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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The conditional marketing authorization for Advanz Pharma’s liver disease treatment Ocaliva has been revoked following a decision by the General Court of the European Union, the company announced...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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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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On heels of MariTide data, Danish obesity biotech discloses €80M Series A

Versant is out with its third obesity biotech of the year, leading an €80 million Series A for Antag Therapeutics, a Danish company developing a drug that uses a similar approach as Amgen's...

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GSK makes another ADC deal, this time with BioNTech's partner DualityBio

GSK is returning to China for another antibody-drug conjugate deal, and it's tapping into a company that already has alliances with BioNTech, Adcendo and others. The UK pharma is ...

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Lilly wins head-to-head weight loss trial against Novo Nordisk

The market for first-generation weight loss treatments has been dominated by two major players, Eli Lilly and Novo Nordisk. But new data provide the clearest evidence yet that one may have an edge. On...

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Atea blueprints Phase 3 for hepatitis C combo after mid-stage win

Atea Pharmaceuticals touted data from a mid-stage trial studying its hepatitis C drug combo on Wednesday, announcing that it had hit both safety and efficacy primary endpoints. The 275-patient trial...

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Dewpoint partners its ALS program, eyes JPM to raise a Series D

Molecular condensates startup Dewpoint Therapeutics has signed on its latest partner, this time forging a future for its ALS program with Mitsubishi Tanabe Pharma Corporation in a pact worth up to $480...

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Ro’s weight loss business more than doubled in the last year. Now it’s trying...

With direct-to-patient services for obesity drugs facing scrutiny, the telehealth startup Ro is trying to prove that its online weight loss program is up to snuff. To that end, the startup released ...

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