Merck, a leading science and technology company, is investing more than € 300 million in a new research center at its global headquarters in Darmstadt, Germany. In the Advanced Research Center, the Life Science business sector will research solutions for manufacturing antibodies, mRNA applications and additional products required for biotechnological production, among other things. As of the start of 2027, it will provide space for around 550 employees. Today, Merck laid the cornerstone for the building together with German Federal Chancellor Olaf Scholz. The new building is part of an i ..read more

Regeneron Pharmaceuticals, Inc. and Mammoth Biosciences, Inc., announced a collaboration to research, develop and commercialize in vivo CRISPR-based gene editing therapies for multiple tissues and cell types. Regeneron is developing adeno-associated viral vectors (AAVs) using antibody-based targeting to enhance delivery of genetic medicine payloads to specific tissues and cell types. Mammoth is developing novel ultracompact nucleases and associated gene editing systems, with a variety of editing functionalities at a significantly smaller size than other CRISPR-based system ..read more

Novartis announced that the U.S. Food and Drug Administration (FDA) approved Lutathera (USAN: lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide) for the treatment of pediatric patients 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs. This approval makes Lutathera the first therapy specifically reviewed and approved for use in pediatric patients with GEP-NETs. “Lutathera is now the very first therapy approved specifically for children with GEP-NETs, offering new ..read more

Incyte and Escient Pharmaceuticals, a clinical-stage drug discovery and development company advancing novel small molecule therapeutics for systemic immune and neuro-immune disorders, have entered into a definitive agreement under which Incyte has agreed to acquire Escient, including EP262, a first-in-class, potent, highly selective, once-daily small molecule antagonist of Mas-related G protein-coupled receptor X2 (MRGPRX2) and EP547, a first-in-class oral MRGPRX4 antagonist. “As a company dedicated to innovation and the discovery of transformative medicines, we are excited to add EP262 and E ..read more

Positive results from the LUNA 3 phase 3 study demonstrated that rilzabrutinib 400 mg twice daily orally achieved the primary endpoint of durable platelet response in adult patients with persistent or chronic immune thrombocytopenia (ITP). The safety profile of rilzabrutinib was consistent with that reported in previous studies. LUNA 3 study met its primary endpoint demonstrating a significantly higher proportion of patients receiving rilzabrutinib achieved the primary endpoint of durable platelet response versus placebo. This clinically and statistically significant result was achieved in a ..read more

Ipsen and Skyhawk Therapeutics announced the signing of an exclusive worldwide collaboration to discover and develop novel small molecules that modulate RNA for rare neurological diseases. The agreement includes an option pursuant to which Ipsen would acquire exclusive license for the worldwide rights to develop successful development candidates (DC). Following successful DC nomination, Ipsen will be responsible for all activities. Skyhawk’s unique platform accelerates building RNA-targeting small molecules across several therapeutic areas, including rare neurological diseases. “We are deligh ..read more

Ochre Bio, a pioneer in chronic liver disease medicine development, announced a partnership with Boehringer Ingelheim focused on the discovery and development of novel, first-in-class regenerative treatments for chronic liver diseases (CLDs), such as late-stage metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis. Within the partnership, Ochre Bio will utilise its proprietary discovery platform combining machine learning with human big data, including advanced imaging and deep genomic phenotyping, as well as in-house RNA chemistry, and the unique ability to employ proprietary ex ..read more

Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for EMBLAVEO (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis. It is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options. “For healthcare teams treating patients with serious Gram-negative bacterial infect ..read more

ImmunityBio, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. “The FDA’s approval of ANKTIVA marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “ANKTIVA not only proliferates ..read more

TriLink BioTechnologies (TriLink), a Maravai LifeSciences company and global provider of life science reagents and services, has announced the grand opening of its new cGMP mRNA manufacturing facility. The 32,000-square-foot facility was specifically designed for mRNA manufacturing to support late-phase drug developers from Phase 2 to commercialization via TriLink’s robust mRNA manufacturing capabilities. The milestone opening is expected to help advance the field of mRNA-based medicine as developers flock to leverage the promising modality for a growing list of indications. Located ..read more