Innovation Passport Designation Aims to Accelerate Time to Market and Facilitate Patient Access to Innovative Medicines NEW YORK / Dec 05, 2024 / Business Wire / Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the "Company" or "MindMed"), a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that MM120 ODT, a pharmaceutically optimized form of lysergide...Read more
BOSTON, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) has expanded the marketing authorization for IMCIVREE® (setmelanotide) to include the treatment of obesity...Read more
Great Britain is the third major market where donanemab has received approval Donanemab was first approved in the United States in July 2024 and then approved in Japan in September 2024 INDIANAPOLIS, Oct. 23, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for donanemab, an injection for intravenous infusion...Read more
VIENNA, Va. / Sep 04, 2024 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported it has received a decision letter from the United Kingdom’s Healthcare Products Regulatory Agency (MHRA) granting Multikine (Leukocyte Interleukin, Injection)* a product specific waiver for the treatment of head and neck cancer in a pediatric population of people up to 18 years of age. As a result, CEL-SCI will not be required to evaluate...Read more
Approval follows recommendation from global public health bodies to develop JN.1 COVID-19 vaccines At present, the JN.1 group of subvariants remain dominant in the UK The updated vaccine will be available for eligible groups as part of the NHS autumn vaccination program, and will also be available to purchase privately in the UK for the first time CAMBRIDGE, MA / ACCESSWIRE / September 3, 2024 / Moderna, Inc. (Nasdaq:MRNA) today...Read more
In Great Britain, lecanemab is indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers1 Great Britain becomes the first country in Europe to authorize the medicine, which targets an underlying cause of AD1 TOKYO and CAMBRIDGE, Mass., Aug. 22, 2024 /PRNewswire/ -- Eisai Co., Ltd....Read more
Award recognizes the potential for INO-3107 to be the first therapeutic option in the United Kingdom for patients suffering from Recurrent Respiratory Papillomatosis (RRP) PLYMOUTH MEETING, Pa., July 11, 2024 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced...Read more
UK MHRA marketing authorization follows recent European Commission Marketing Authorization for LYTENAVA™ (bevacizumab gamma) in the EU for the treatment of wet AMD Initial commercial launches of LYTENAVA™ (bevacizumab gamma) in the EU and UK anticipated in calendar Q1 2025 Strategic partnership with Cencora (formerly AmerisourceBergen) to support the planned commercial launches of LYTENAVA in UK and EU ISELIN, N.J., July 08, 2024...Read more
UK submission for national MAA review follows recently received positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) concerning the authorization of ONS-5010/LYTENAVA™ (bevacizumab gamma) ISELIN, N.J., May 13, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval for the first authorized use...Read more
COPENHAGEN, Denmark, April 24, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for YORVIPATH® (palopegteriparatide; developed as TransCon™ PTH) in Great Britain as a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, and has...Read more
CAMBRIDGE, Mass., March 26, 2024 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced the clearance of its clinical trial authorisation (CTA) application by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency for BEAM-302, an in vivo base editor, as a potential treatment for patients with alpha-1 antitrypsin...Read more
CHICAGO, IL / ACCESSWIRE / March 19, 2024 / Cosmos Health Inc. ("Cosmos Health" or the "Company'') (NASDAQ:COSM), a diversified, vertically integrated global healthcare group engaged in innovative R&D, owner of proprietary pharmaceutical and nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, announced today it is in the final stages of securing regulatory approval to sell...Read more
LONDON, March 12, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that following the most recent GMP inspection by the MHRA in February 2024, Autolus’ Nucleus manufacturing facility in Stevenage has obtained a Manufacturer’s Importation Authorisation (MIA) together with the accompanying GMP certificate....Read more
Full EAMS designation would allow treatment of patients with sebetralstat prior to receiving a Marketing Authorization from UK CAMBRIDGE, Mass. & SALISBURY, England / Mar 12, 2024 / Business Wire / KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today announced the UK Medicines and...Read more
BOSTON, March 04, 2024 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has authorized its Clinical Trial Application (CTA) to initiate the CONNECT2-EDO51 Phase...Read more
Increases dose level in line with Cohort 2 in IND Changes from "in patient" to "out patient" procedure EDINBURGH, Scotland, Feb. 22, 2024 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announced that the MHRA has officially accepted its proposed...Read more
Provides entry to UK Innovative Licensing and Access Pathway (ILAP), which aims to accelerate time to market and facilitate patient access to innovative medicines Late-breaking sebetralstat phase 3 data to be presented at the upcoming 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting CAMBRIDGE, Mass. & SALISBURY, England / Feb 20, 2024 / Business Wire / KalVista Pharmaceuticals, Inc. (NASDAQ:...Read more
The UK MHRA approval follows approvals by the U.S. FDA and the European Commission Cidara is entitled to receive a milestone payment of approximately $2.8 million from Mundipharma SAN DIEGO, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that the...Read more
DALLAS, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Spectral MD, Inc. (“SMD”), a subsidiary of Spectral AI, Inc. (NASD: MDAI; MDAIW) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced the submission of an application in the United Kingdom for its predictive software DeepView AI®-Burn to be registered as UK Conformity...Read more
REDWOOD CITY, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the innovative medicine designation, the Innovation Passport, to RZ358 for the treatment of...Read more
Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
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