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Ionis Completes Enrollment in Phase 3 REVEAL Study for Angelman Syndrome
Ionis has completed enrollment in the pivotal Phase 3 REVEAL study of obudanersen for Angelman syndrome, with topline clinical trial results expected in the second half of 2027.
Sofinnova Partners Announces Myricx Bio Agrees to Be Acquired by Novartis
Sofinnova Partners announced that portfolio company Myricx Bio has agreed to be acquired by Novartis, strengthening the company's oncology pipeline and ADC capabilities.
Emcure's Marcan Pharma to Acquire Remaining Stake in Mantra Pharma
Emcure Pharmaceuticals' subsidiary Marcan Pharmaceuticals has signed agreements to acquire the remaining Class E Special Shares of Canada's Mantra Pharma, making the company a wholly owned subsidiary.
US FDA Issues Complete Response Letter for Ascelia Pharma's Orviglance NDA
Ascelia Pharma has received a Complete Response Letter from the US FDA for its New Drug Application for Orviglance, prompting the company to seek further regulatory discussions while reaffirming its commitment to advancing the rare oncology therapy.
UK MHRA Approves Wegovy for Treatment of MASH in Adults with Liver Fibrosis
The UK's Medicines and Healthcare products Regulatory Agency has conditionally approved Novo Nordisk's Wegovy (semaglutide) for treating metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced liver fibrosis, subject to ongoing confirmatory clinical data.
Oliva Therapeutics to Commercially Launch Amerithroid for Hypothyroidism Treatment
Oliva Therapeutics is set to launch Amerithroid, a US-manufactured desiccated thyroid extract developed in partnership with Jerome Stevens Pharmaceuticals, strengthening its endocrine care portfolio with a naturally derived treatment for hypothyroidism.
Ascletis Submits 2 IND Applications to the US FDA for the Treatment of Obesity
Ascletis has submitted two IND applications to the US FDA for once-monthly obesity therapies, including ASC36_35, a first-in-class triple-target candidate acting on amylin receptor, GLP-1R and GIPR.
Immunomic Therapeutics Doses First Patient in Phase 1 Trial of Japanese Cedar Allergy Vaccine
Immunomic Therapeutics has initiated Phase 1 clinical testing of ITI-9001 after dosing the first participant in Japan, advancing the development of a next-generation therapeutic vaccine for Japanese cedar pollen allergy.
Granules India secures Sole First-to-File ANDA status for Sodium Oxybate Extended-Release for Oral Suspension, strengthening its US complex generics portfolio.
Glenmark Pharmaceuticals Launches Olanzapine for Injection 10 mg/vial Single-Dose Vial in US
Glenmark Pharmaceuticals Inc., USA has launched Olanzapine for Injection 10 mg/vial, a bioequivalent and therapeutically equivalent generic to Zyprexa IntraMuscular Injection.
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