As generic versions of its blockbuster drug Ofev (nintedanib) start to hit the market, Boehringer Ingelheim GmbH looks to have swerved the patent cliff, with European and Japanese regulators both approving a potential replacement, Jascayd (nerandomilast), this week. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use also recommended Novartis AG’s Vijoice (alpelisib) be given conditional approval in the treatment of PIK3CA-related overgrowth spectrum disorders. Read More
Immuneering Corp. reported a median overall survival of 17.3 months in first-line metastatic pancreatic cancer patients treated with its MEK inhibitor atebimetinib (IMM-1-104) plus modified gemcitabine/nab-paclitaxel in a phase IIa trial. Mizuho analyst Graig Suvannavejh called the results “astounding … easily beating current standard-of-care treatments.” Read More
Daewoong Pharmaceutical Co. Ltd. announced after South Korean market hours May 21 that it gained successive rights to Turn Biotechnologies Inc.’s mRNA-based cellular rejuvenation platform from Hanall Biopharma Co. Ltd. Read More
New regulations tighten regulatory oversight of China’s investigator-initiated trials (IITs) but legitimize the pathway that will be open to other modalities beyond cell and gene therapies. Read More
Oorja Bio Inc., named after the phonetic spelling of “energy” in Sanskrit, secured $30 million from founding investor Westlake Biopartners in a series A financing round to advance its in-licensing approach to develop drugs for idiopathic pulmonary fibrosis (IPF) and other fibrotic and cardiopulmonary diseases. Read More
WAVES, an algorithm designed to extract menstrual-cycle metrics from physiological signals such as basal body temperature, which oscillates with sex hormones, shows how different parameters change with age and helps determine whether each person maintains a stable individual pattern or personal footprint. A study based on data from 5,674 cycles from 753 women demonstrates through this tool that age is associated with higher temperatures, shorter cycles, and greater irregularity. In addition, several metrics show within-person stability, suggesting they could serve as personalized health markers. Read More
New hires and promotions in the biopharma and med-tech industries, including: Antag, Corbus, Immorta, Livanova, Neurophet, Ray, Realize, Theromics. Read More
Biopharma and med-tech companies raising money in public or private financings, including: Aim Immunotech, Akari, Immix, Jupiter, Relay, Theralase. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Apyx, Biomarin, Eli Lilly, Immix, Infex, Jupiter, Mink, Palvella, Palvella, Prolocor, Recode, Reflow. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Ampersand, Biocardia, Carisma, Genethon, Gilead, Grundium, Hanmi, Implantica, Organon, Tubulis, United Immunity, Visiopharm. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Adagio, Bayer, Hutchmed, Innovent, Junshi, Leo Cancer, Maat, Mabwell. Read More
