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The Berlin Heals Holding AG has developed the C-MIC device, a revolutionary and life-saving treatment for patients with heart failure.

After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ govorestat for galactosemia, citing “deficiencies” with the application. The biotech plans to meet with the regulator to discuss the best way forward for the drug.

The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical trial—including a dosing error for govorestat—claims that the company said it had already addressed.

Berlin Cures, a biotechnology company in Phase II clinical trial for a treatment against Long COVID, appoints six distinguished scientists to a new advisory board.

At Drexel University’s Graduate School of Biomedical Sciences and Professional Studies, graduate students and active professionals can take interdisciplinary, career-oriented programs designed to help launch their careers and take them to the next level.

Applied DNA Sciences, Inc., a leader in PCR-based DNA technologies, announced the pricing of a public offering with gross proceeds to the Company expected to be approximately $12.0 million, before deducting placement agent fees and other estimated expenses payable by the Company.

Berlin Cures announced the successful completion of patient screening for its pan-European Phase II trial of BC 007, a novel therapeutic candidate for the treatment of Long COVID.

Novartis, Gilead, Roche and Takeda commit to new partners in a spate of mid-sized collaborations this week. Meanwhile, Applied Therapeutics’ stock tanks 80% after govorestat is denied approval, Intra-Cellular Therapies seeks to expand Caplyta into major depressive disorder and the FDA investigates the safety of bluebird bio’s Skysona.

Berlin Cures, a clinical-stage biotechnology company, has reached a significant milestone in its Europe-wide clinical trial for Long COVID, effectively enrolling over 50% of the targeted 114 patients and expanding the study’s inclusion criteria.

Applied Therapeutics, Inc. announced the appointment of Dale Hooks as Chief Commercial Officer, replacing Adam Hansard, effective immediately.