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

Evotec SE and Variant Bio, Inc. announced a collaboration agreement to identify a best-in-class treatment for diseases caused by fibrosis. Fibrosis is characterised by marked and pathogenic build-up of the tissue matrix, leading to tissue degeneration in organs, including the liver and lungs. Fibrotic disease contributes substantially to global mortality and morbidity. Despite the chronic nature of fibrotic conditions, widespread impact on various organs, and substantial disease burden, there is currently no curative treatment for these conditions. The strategic partnership leverages Variant ..read more

Vertex Pharmaceuticals Incorporated announced important advancements across its suzetrigine pain program, which has the potential to be the first new class of medicine for acute and neuropathic pain in more than two decades. Suzetrigine is an oral selective NaV1.8 pain signal inhibitor (formerly known as VX-548). Following the positive Phase 3 results in acute pain announced in January 2024, the Food and Drug Administration (FDA) has granted a rolling New Drug Application (NDA) submission for suzetrigine in moderate-to-severe acute pain. Vertex has started t ..read more

Outrun Therapeutics (“Outrun”), the E3 ligase inhibitor and protein stabilisation specialist, exits from stealth following a $10m seed financing round. Outrun’s platform has enabled it to rapidly build a pipeline of highly selective, small molecule, first-in-class E3 ligase inhibitors, as well as identify novel E3 ligase targets across multiple disease areas. Outrun’s lead programme is focused on hard-to-treat solid tumours. E3 ligase inhibition in protein stabilisation is of very high interest as a therapeutic approach to treating many diseases. Cells have evolved highly sophistica ..read more

IGM Biosciences, Inc. announced that the Company’s exclusive worldwide collaboration agreement with Sanofi to create and develop IgM agonist antibodies will now focus exclusively on immunology/inflammation targets. IGM will retain global rights to its proprietary technology related to the oncology targets nominated by Sanofi under the collaboration. “We are very pleased with our collaboration with Sanofi and with the preclinical data that we have generated in both the immunology/inflammation and the oncology portions of the collaboration,” said Fred Schwarzer, Chief Executive Officer of ..read more

Essential Pharma, an international specialty pharma group focused on ensuring that patients have sustainable access to low volume, clinically differentiated, niche pharmaceutical products across key therapeutic areas, announces that it has completed the acquisition of Reminyl oral capsules from Janssen Pharmaceutica NV, a Johnson & Johnson company. Reminyl, a cholinesterase inhibitor, is an established central nervous system (CNS) drug indicated for the treatment of mild to moderately severe dementia of the Alzheimer type. Under the terms of the acquisition, Essential Pharma has acquired ..read more

Clearmind Medicine Inc. announced an exclusive licensing agreement with Yissum Research Development Company of the Hebrew University of Jerusalem. This partnership marks a significant step in harnessing generation 3.0 psychedelic compounds, methods of their preparation, and uses thereof in the treatment of addiction and mental disorders.‍ Dr. Adi Zuloff-Shani, CEO of Clearmind, commented, “We are witnessing a renaissance within psychedelic medicine, including broad acknowledgment of these therapies and their potential by the medical community. While our existing IP portfolio includes mol ..read more

Innate Pharma SA announced that the first patient was dosed in the Phase 2 dose expansion part of the Sanofi-sponsored clinical trial of SAR443579 / IPH6101 (NCT05086315), evaluating SAR443579 as a monotherapy for the treatment of blood cancers with high unmet needs, including relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia and high-risk myelodysplasia. SAR443579 is an investigational trifunctional anti-CD123 NKp46xCD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi. SAR443579 received FDA Fast Track Desig ..read more

Neumora Therapeutics, Inc. announced that the Phase 1 trial of NMRA-266 has been placed on clinical hold by the U.S. Food and Drug Administration (FDA). NMRA-266 is a positive allosteric modulator (PAM) of the M4 muscarinic receptor and is part of the Company’s M4 PAM franchise. The clinical hold determination follows recently available pre-clinical data showing convulsions in rabbits. Following this action, the Phase 1 single ascending dose / multiple ascending dose study with NMRA-266 has been paused. Approximately 30 participants have been dosed in the Phase 1 study, with no evidence ..read more

Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in MarVax, the subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, for “the prevention and post-exposure prophylaxis against MARV infection.” The U.S. Orphan Drug Act ..read more