Astrazeneca plc is acquiring rare diseases specialist Amolyt Pharma SA in a $1.05 billion deal, taking ownership of eneboparatide (AZP-3601), which is in phase III development for the treatment of hypoparathyroidism. Of the total, $800 million will be paid up front, with the balance of $250 million contingent upon achievement of a regulatory milestone. Read More
After hearing two conflicting presentations of the safety and efficacy of Geron Corp.’s imetelstat, the U.S. FDA’s Oncology Drugs Advisory Committee (ODAC) voted 12-2 March 14 that the drug’s benefit outweighed its risks as a treatment for transfusion-dependent anemia in adults with low- to intermediate-1 risk myelodysplastic syndromes in patients who have failed or no longer respond to erythropoiesis stimulating agents (ESAs), or who are not eligible for ESA treatment. Read More
Spruce Biosciences Inc.’s results from two studies with tildacerfont in adult and pediatric classic congenital adrenal hyperplasia (CAH) spurred Wall Street to speculate – further, again – about the prospect’s odds against a drug in the works from Neurocrine Biosciences Inc. Read More
Top-line phase II results of privately held Ocuterra Therapeutics Inc.’s novel selective small-molecule RGD integrin inhibitor, nesvategrast (OTT-166), showed it failed to meet primary and key secondary endpoints in patients with diabetic retinopathy, prompting the Boston-based company to seek strategic alternatives. Read More
Wuxi Apptec quit its membership in the Biotechnology Innovation Organization (BIO) after U.S. Congressman Rep. Mike Gallagher (R-Wis.) sent a March 5 letter to Attorney General Merrick Garland, asking the Department of Justice to investigate BIO because its lobbying efforts on behalf of Wuxi suggested it was operating as an unregistered agent of a foreign company while advancing the interests of the People’s Republic of China and the Chinese Communist Party. Read More
Antibody-drug conjugate (ADC) specialist Tubulis GmbH has closed a hefty €128 million (US$139.4 million) series B2 round, more than double the €60 million it raised in its series B1 two years ago. Read More
Atrogi AB is raising a €30 million to €35 million (US$32.9 million to $38.4 million) series B round after announcing positive clinical data for ATR-258, a novel beta-2 adrenergic receptor agonist that is being lined up as a potential first-in-class insulin-independent treatment for type 2 diabetes. Read More
Asgard Therapeutics AB has raised €30 million (US$32.8 million) in a series A round to advance a novel approach to cancer immunotherapy, in which it is proposed to reprogram cancer cells into functional antigen-presenting dendritic cells in vivo, activating a host immune response against the tumor. Read More
Hyundai Bioscience Corp. is set to become the largest shareholder of ADM Korea Inc., a Seoul, South Korea-based contract research organization (CRO) firm, by purchasing 5.02 million shares for ₩20.4 billion (US$15.5 million) – a 23% stake. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allergy, Astrazeneca, Atsena, Crinetics, Dimerix, Ionis, Longboard, Neurobo, Ocugen, Silence, Takeda. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aderans, Aignostiocs, Annocca, Astrazeneca, Bayer, Coherus, ERS Genomics, Emendobiom, Eyenovia, ICER, Nicox, Novartis, Novabay, Ricoh, Stemson. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzprotect, Astrocyte, Bavarian Nordic, Clearmind, Cybin, Imunon, Innocare, Pacira, Pepgen, Pfizer, Prilenia, Psyence, Puretech. Read More
