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. Other positive recommendations were issued for antibody-drug conjugates from Astrazeneca plc and Astellas and for the tablet formulation of Novo Nordisk A/S’ obesity drug, Wegovy (semaglutide).

MEK inhibitor delivers 17.3-month OS for pancreatic cancer

Immuneering Corp. reported a median overall survival (OS) 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.” The company disclosed the finding shortly after the American Society of Clinical Oncology released full abstracts for its upcoming annual meeting in Chicago, where detailed phase IIa data from 55 patients enrolled will be presented in an oral presentation on June 1. Immuneering’s shares (NASDAQ:IMRX) climbed nearly 13%, or 67 cents, to $5.89 in early trading May 22.

Daewoong takes over Turn Bio’s longevity platform from Hanall

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. Securing exclusive global rights to the “partial reprogramming” technology, aimed at reversing aging while maintaining the inherent characteristics of cells, marks Daewoong’s full-scale development of treatments for intractable human aging diseases, according to the company’s disclosure on the Korea Exchange.

China’s new IIT rules expected to wipe out ‘gray market’

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. State Council Order No. 818, “Regulations on the Administration of Clinical Research and Clinical Translation of New Biomedical Technologies,” offers an alternative pathway to the IND drug registration pathway if certain conditions are met.

Newco news: Oorja launches with $30M for IPF

Oorja Bio Inc. is using an in-licensing approach to develop drugs for idiopathic pulmonary fibrosis (IPF) and other fibrotic and cardiopulmonary diseases. The company secured $30 million from founding investor Westlake Biopartners in a series A financing round to advance its first drug, ORJ-001, into phase II development. The peptide drug activates β-1 integrin, which stimulates alveolar epithelial type 2 (AEC2) cells to divide and differentiate into AEC1 cells, promoting alveolar repair and reducing the inflammatory and fibrotic signaling that leads to pulmonary fibrosis.

Menstrual ‘footprints’ may act as broad personal health markers

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.

Lilly’s oral GLP-1 milestone highlights a steady April for FDA approvals

The U.S. FDA cleared two new molecular entities in April. Eli Lilly and Co.'s Foundayo (orforglipron) became the second oral glucagon-like peptide-1 receptor agonist approved for weight loss in the U.S., following Novo Nordisk A/S’ Wegovy (semaglutide) pill cleared in December. Merck & Co. Inc.’s Idvynso (doravirine/islatravir) was approved a week ahead of April 28 PDUFA date, for adults with HIV-1 infection who are virologically suppressed.

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Also in the news

Adagio, Aim Immunotech, Akari, Ampersand, Apyx, Bayer, Biocardia, Biomarin, Carisma, Corbus, Eli Lilly, Genethon, Gilead, Grundium, Hanmi, Hutchmed, Immix, Immorta, Implantica, Infex, Innovent, Junshi, Jupiter, Leo Cancer, Livanova, Maat, Mabwell, Mink, Neurophet, Organon, Palvella, Prolocor, Ray, Realize, Recode, Reflow, Relay, Theralase, Theromics, Tubulis, United Immunity, Visiopharm