Press Releases

Sumitomo Pharma America, Inc. (SMPA) today announced that the European Medicines Agency (EMA) granted Orphan Drug Designation to nuvisertib (TP-3654), an oral investigational highly selective inhibitor of PIM1 kinase, for the treatment of patients with myelofibrosis (MF). Orphan Drug Designation is granted by the EMA to investigational therapies addressing rare diseases or conditions that affect not more than 5 in 10,000 people in the European Union, and for which there is no satisf

Europe’s pharmaceutical sector stands at a pivotal juncture. Geopolitical upheaval, rising ESG demands, and rapid digital innovation are reshaping how leaders protect reputation, build trust, and future-proof their organisations. This November, senior pharma and healthcare communications professionals will convene in London to tackle these critical challenges head-on.

Dr. Falk Pharma GmbH, a research-based pharmaceutical company specializing in digestive and metabolic medicine, Allianthera (Suzhou) Biopharmaceuticals Co., Ltd., and its affiliate Allianthera Boston, Inc., a clinical stage biotechnology company focusing on novel drug research and development in immunology and inflammatory diseases, (Allianthera), are pleased to announce the signing of an agreement on the co-development, license option, manufacturing, and commercialization of the novel small

Bayer advances its blockbuster pipeline submitting registration applications for icafolin-methyl in the European Union, following completed applications in Brazil, United States and Canada, the company announced today. Icafolin is agriculture's first new mode of action for post-emergent weed control for broadacre crops in over 30 years. With estimated peak sales potential around €750 million, Bayer expects Icafolin will be launched from 2028 onward with initial availability in Brazil

Entera Bio Ltd., a leader in the development of oral peptides and protein replacement therapies, announced today that in a written response to a Type A meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company’s proposal that the NDA marketing application filing for EB613 would be supported by a single multinational, randomized, double-blind, placebo-controlled, 24 month phase 3 study in women with postmenopausal osteoporosis, where change in total hip BMD is

Tigermed a leading global provider of clinical research solutions across the full lifecycle of global biopharmaceutical and medical device products, today announces the completion of its acquisition of CRO company Micron,Inc. Founded in 2005 and headquartered in Tokyo, Micron is a Japan-based Contract Research Organization (CRO) focusing in medical imaging and clinical trial services with over 160 employees. Micron brings nearly two decades of expertise in clinical research and the

Solvias, a global provider of chemistry, manufacturing, and controls (CMC) analysis, today announced that its recently opened Center of Excellence for biologics and novel modalities in Research Triangle Park (RTP), North Carolina, is now Current Good Manufacturing Practice (cGMP) ready. This milestone enables the RTP facility to deliver fully compliant, high-quality analytical testing and release services for advanced therapies from early-stage development through commercialization.

TCG Labs Soleil, a venture firm integrating dedicated capital with an in-house biotech R&D hub, today announced that it has raised an additional $400 million. This new funding builds on the firm’s inaugural raise of $400 million in 2024, expanding its ability to efficiently advance single-asset portfolio companies through clinical proof of concept and position them for strategic partnerships. With a fully integrated structure, TCG Labs Soleil retains full authority over as

AscellaHealth, a global partner delivering customizable solutions to support the specialty pharmaceutical industry, announces service and infrastructure enhancements designed to help specialty and rare disease drug manufacturers respond to accelerating market disruption across the pharmaceutical landscape. From sudden formulary exclusions and loss of preferred status to the growing impact of biosimilars, generics and aggressive cost-containment measures by payers, manufacturers rely upon a st

Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, announces the launch of a new affiliate, Neuraxpharm Australia, led by newly appointed Head of Commercial, Avendran Naidu, as the Company continues to expand globally. The launch of Neuraxpharm Australia continues the Company's international growth strategy following the opening last year of Neuraxpharm Middle East and the estab