Press Releases

Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and AnHeart Therapeutics Co., Ltd ("AnHeart"), a clinical-stage biopharmaceutical company committed to developing novel first-in-class or best-in-class precision oncology therapeutics, today jointly announced the interim clinical data from a Phase 2 trial (TRUST) evaluating

Part one of the 2021 CPhI Annual Report predicts an increasingly bullish outlook for CDMOs in the next 2-3 years, with macro factors significantly driving up demand and prices for mergers and acquisitions. The full findings (featuring 10+ experts and insights from 350 companies) will be launched in Milan at the CPhI Worldwide (9-11 November, 2021 at Fiera Milano and 25 October – 19 November online), the world's largest pharma event. However, an advanced copy will be sent to anyone w

Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced publication of complete results from a pivotal Phase 3 clinical trial of NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate with Matrix-M™ adjuvant, in The Lancet Infectious Diseases (Lancet ID). The trial evaluated the immunogenicity and safety of NanoFlu in older adults compared to a leadin

EVONETIX LTD , the synthetic biology company developing a desktop platform for scalable, high-fidelity and rapid gene synthesis, today announced it has been granted patent GB 2576304 for its novel method for DNA data storage and retrieval. DNA has significant potential as a long-term data storage media due to the information density that it can achieve in comparison with tape-based storage. However, the use of DNA as a storage medium is hampered by complexities associated with its w

Small Pharma Inc. a neuropharmaceutical company focused on psychedelic-assisted therapies, today announced both the successful completion of the Phase I part of the combined Phase I/IIa clinical trial and the initiation of the Phase IIa part in combination with psychotherapy of its lead candidate, SPL026, for the treatment of Major Depressive Disorder ("MDD"). Peter Rands, CEO of Small Pharma, said: "We are delighted to have made such swift and excellent progress in t

Mirum Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited announced that the companies have entered into an exclusive licensing agreement for the development and commercialization of maralixibat in Japan for Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC), and biliary atresia (BA). Maralixibat, an investigational, orally administered medication, is being evaluated globally in ALGS, PFIC, and BA. Under the terms of the agreement, Takeda will

Rhizen Pharmaceuticals AG, a clinical-stage oncology & inflammation-focussed biopharmaceutical company, today announced that the first patient has been dosed in a Phase 2 clinical trial of RP7214, a small molecule oral dihydroorotate dehydrogenase (DHODH) Inhibitor. The randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy & safety of oral RP7214, in covid-19 patients with mild, symptomatic disease with an underlying risk factor on the background of pr

Genmab A/S and Seagen Inc.  today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to TIVDAK™ (tisotumab vedotin-tftv), the first and only approved antibody-drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is approved under the FDA’s Accelerated Approval Program based on tumor response and the durability of the response. Con

 Forge Biologics, a gene therapy-oriented contract development and manufacturing organization, today announced that it has received additional designations and regulatory comments from the Agency European Medicines Agency (EMA) and the United States Food & Drug Administration (FDA), thereby accelerating the manufacturing capabilities of its own AAV gene therapies and those of its customers. The EMA has granted the company orphan drug designation for clinical phase FBX-101 g

Exelixis, Inc. today announced detailed results from the expanded cohort 6 of the phase 1b COSMIC-021 trial of cabozantinib in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer (CRPC). Cohort 6 included patients with metastatic CRPC who had been previously treated with the novel hormone therapies (NHT) enzalutamide and/or abiraterone acetate used along with prednisone. The data are being presented during the Proffered Paper Session: GU Tumours, Pro