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The German company on Thursday said it is launching three late-stage studies of its obesity drug candidate after the injectable showed up to 19% weight loss after 46 weeks in a mid-stage trial.
Scott Boller, CPA, brings more than 25 years of financial and accounting leadership in the tech, software, and pharmaceutical industries to ATCC.
Some experts question the value of recently issued FDA guidance that aims to address gaps in the quality of unapproved laboratory tests for cancer.
After two prior setbacks, the regulator has finally approved Ipsen’s palovarotene to treat fibrodysplasia ossificans progressiva. It’s the first treatment for the ultra-rare bone disease.
Mifepristone’s legal saga continues as the U.S. 5th Circuit Court of Appeals ruled for steep restrictions on the drug’s access, though its effectivity is pending the Supreme Court’s review.
The company’s first-in-class small molecule imipridone, ONC201, showed strong efficacy results in two early-stage clinical trials of 71 pediatric patients with H3K27M-mutant diffuse midline gliomas.
The clinical trial testing Seagen’s tyrosine kinase inhibitor Tukysa, in combination with Genentech’s Kadcyla, met the primary endpoint of progression-free survival in HER-2 breast cancer patients.
The regulator informed bluebird bio that it will not convene an advisory committee meeting to discuss the company’s application for the gene therapy being developed for sickle cell disease.
Following a nearly decade-long effort, Delcath Systems finally won the FDA’s greenlight for its Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma.
Amid strong performance in the first half of 2023, Stada Arzneimittel’s private equity owners are considering a potential sale, though there are still no definite plans, according to CEO Peter Goldschmidt.
Biotech startups often struggle with hiring decisions. Incubators can help through mentorship opportunities and by bringing in potential talent.
Employee resource groups can benefit employee engagement, retention, recruitment and business objectives, according to a new report from BioSpace.
PRESS RELEASES
The acquisition expands scalable trial operations across real-world care settings
Interim clinical data has exceeded the recommended guidelines of the International Bladder Cancer Group for complete response and duration of complete response
Now Accepting Nomination Submissions for the Prestigious Annual Award