Hopes in postpartum depression (PPD) with an oral version of brexanolone – a synthetic formulation of the endogenous neurosteroid allopregnanolone, approved by the U.S. FDA in 2019 when given intravenously for PPD – were dashed, at least near term, when Lipocine Inc. reported that the candidate failed in a phase III placebo-controlled trial. Read More
The EMA has given initial endorsement to a new approach to early toxicity testing in which live animals will be replaced by virtual counterparts. The virtual control groups will be derived from data generated in animals that have been used as controls in previous studies. The historical database has been brought together in an EU-funded project to which 20 pharma and crop sciences companies contributed. While limited in scope, this is the first time the EMA has formally endorsed the use of a new approach methodology (NAM) to generate data that could eventually be included in an application for marketing approval. Read More
Chiesi Group’s idebenone faced a regulatory setback last month after the U.S. FDA issued a complete response letter (CRL) to the company’s NDA for Leber hereditary optic neuropathy (LHON), a rare inherited disorder that causes sudden vision loss.But a chance missed for Chiesi may be an opportunity for gene therapies, including Gensight Biologics SA’s lenadogene nolparvovec (Lumevoq; GS-010). Read More
Med-tech deal value, excluding M&As, totaled $628.41 million in the first quarter (Q1) of 2026, an increase of about 322% from the $149.08 million recorded in Q1 2025 though a 36% drop from Q4 2025‘s $978.58 million. Read More
Ambrosia Biosciences Inc., named after the drink of the Greek gods, secured a $100 million series B to advance its preclinical pipeline of oral obesity drugs. The startup formed after Pfizer Inc. shuttered its Boulder, Colo.-based research facility that the pharma gained through its 2019 acquisition of Array Biopharma Inc. Read More
Hematopoietic stem cell research over the past century has shown that leukemia may be driven by an invisible hand of inflammation. The bone marrow and inflammation, then, may hold the keys to preventing blood cancers, according to John E. Dick’s plenary session at the 2026 Korean Society of Hematology International Conference, held March 26, 2026. Read More
New hires and promotions in the biopharma and med-tech industries, including: Aavantgarde, Airos, Alloy, Ardelyx, Bayer, Bruker, Corwave, Evotec, Expres2ion, Femasys, Mosaic, Nanoscope, Nocion, Orionis and Zymeworks. Read More
Biopharma and med-tech companies raising money in public or private financings, including: Apollomics, Aprea, Bonus, Fibrobiologics, Innocan, Inspira, Newcelx, Venus Concept. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Anixa, Bambusa, Biotronik, Braveheart, Bridgebio, Caris, Corvista, Edwards, Electrocore, Enveda, Gan & Lee, Hengrui, Hoth, Maia, Tonix. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Amgen, BMS, Briacell, Briapro, Daiichi, Frontier, IO Biotech, Iterum, Janux, LG Chem, Maat, Merit Medical, Nuvation, Oncolytics, View Point, Zai Lab. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: A2 Biotherapeutics, Abbisko, Baebies, Bioxcel, Chiesi, Cogent, Orca, Ray, Restore Robotics, Serenity, Vertex. Read More
