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Pharmaceutical
German drugmaker STADA Arzneimittel has started building a new 50 million euro ($52.4 million) medicines supply-chain hub in Romania. 28 November 2022
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a conditional marketing authorization for US pharma giant Merck & Co’s Lagevrio (molnupiravir) in Great Britain and a temporary Regulation 174 authorization for Northern Ireland to ensure supply across all of the UK. 28 November 2022
Biotechnology
Singapore-based YS Biopharma today announced that its manufacturing facility for PIKA recombinant COVID-19 vaccine successfully passed an audit by a European Union (EU) Qualified Person (QP) and received QP declaration of its GMP equivalence to European Union Good Manufacturing Practice (EU GMP). 25 November 2022
Pharmaceutical
Ireland-headquartered fish oil-based heart drug specialist Amarin Corp plans to drive forward the next phase of its commercial expansion with the major new appointment of Scott Curley to its UK and Ireland team as general manager. 24 November 2022
Biotechnology
Japanese drug developer Daiichi Sankyo has secured full Japanese approval for Enhertu (trastuzumab deruxtecan), a third generation HER2-directed antibody-drug conjugate (ADC). 24 November 2022
Biotechnology
US biotech Incyte has appointed Peter Williams as general manager for Incyte Biosciences UK and Ireland. 23 November 2022
Biotechnology
Rentschler Biopharma chief executive Frank Mathias is to leave his post in order to take the reins at British cell and gene therapy company Oxford Biomedica. 22 November 2022
Pharmaceutical
British contract development and manufacturing organization (CDMO) Ergomed has appointed Michael Spiteri as chief transformation and technology officer. 21 November 2022
Biotechnology
Along with its third-quarter 2022 financial results on Friday, German immune-oncology firm Immatics Biotechnologies revealed that, on October 24, 2022, UK pharma major GSK provided Immatics with notice of its decision to terminate their collaboration. 21 November 2022
Pharmaceutical
As the European Commission (EC) comes to the end of a multi-year process for revising the general pharmaceutical legislation framework, drugmakers are urging lawmakers to prioritize research. 21 November 2022
Biotechnology
The US Food and Drug Administration yesterday approved a new Monday-Wednesday-Friday dosing regimen for Jazz Pharmaceuticals' Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn), with the news edging the drugmaker’s shares up 1.4% to $147.18. 19 November 2022
Pharmaceutical
India’s Sun Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has approved Sezaby (phenobarbital sodium powder for injection) for the treatment of neonatal seizures. 18 November 2022
Pharmaceutical
A new drug discovery company in California has launched with $78 million in a series A financing led by SR One, a16z Bio + Health and Norwest Venture Partners. 18 November 2022
Biotechnology
The British medicines regulator has granted marketing authorization to Upstaza (eladocagene exuparvovec), a one-time gene replacement therapy developed by PTC Therapeutics. 17 November 2022
Pharmaceutical
Privately-held German drugmaker Boehringer Ingelheim has welcomed the updated 2023 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report. 17 November 2022
Pharmaceutical
Shares of Everest Medicines leapt more than 19% to HK$12.22 today, as it announced that its New Drug Application (NDA) for Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN) has been accepted by China’s National Medical Products Administration 15 November 2022
Biotechnology
A Dutch company with a novel business model, Avanzanite Bioscience, is looking to expand patient access to medicines for rare diseases in Europe. 15 November 2022
Pharmaceutical
Belgian biopharma UCB has announced that the US Food and Drug Administration has accepted for review a New Drug Application for zilucoplan. 14 November 2022
Biosimilars
Industry analyst PharmaVentures have releases a new white paper examining the market landscape and key success factors for biosimilars. 14 November 2022
Pharmaceutical
The chief executive of Bristol Myers Squibb has warned that the US pharmaceutical company could divert investment away from the UK because of the expansion of a levy designed to limit the National Health System (NHS) medicines bill, told the Financial Times. 14 November 2022
Biotechnology
Privately-held US biotech Alloy Therapeutics has announced a strategic collaboration and license agreement with Takeda Pharmaceutical. 21 November 2024
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Pharmaceutical
Germany's Merck has spent more than 25 years researching and developing solutions for advancing multiple sclerosis (MS) care. 21 November 2024
Biotechnology
San Diego-based Cidara Therapeutics, a biotech using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, has entered into a securities purchase agreement with certain investors to raise up to around $105 million. 21 November 2024
Pharmaceutical
Swiss pharma giant Novartis today announced an upgrade to its mid-term guidance, in advance of its Meet Novartis Management event for investors and analysts in London. 21 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
Eli Lilly is not resting on its laurels when it comes to the fast-growing field of obesity treatments, an area in which it is already a leader. 21 November 2024
Biotechnology
Aizen Therapeutics, an AI-driven biotech headquartered in San Diego, has officially launched from stealth mode, introducing its drug discovery platform, DaX. 21 November 2024
Biotechnology
San Diego-based Valora Therapeutics, a biotech that boasts of having a novel approach to immunotherapy, has announced the successful closing of a $30 million seed funding round. 21 November 2024
Biotechnology
Astellas Pharma has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol). 21 November 2024
article
The UK government has reappointed BioIndustry Association (BIA) chairman Daniel Mahony as its Life Sciences Investment Envoy. 21 November 2024
Pharmaceutical
Sage Therapeutics will down tools on its dalzanemdor program, after the Phase II DIMENSION trial missed both primary and secondary endpoints. 21 November 2024
Biotechnology
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
Biotechnology
HCW Biologics has announced a worldwide licensing agreement with WY Biotech to develop and commercialize one of its preclinical immunotherapy candidates. 21 November 2024
Pharmaceutical
Shanghai-based Leading Tac Pharmaceutical has announced the successful completion of a series A financing round, raising over 100 million yuan ($14 million). 21 November 2024
Biotechnology
Dutch clinical-stage biotech NewAmsterdam Pharma, which is focused on non-statin medicines for patients at risk of cardiovascular disease (CVD), has announced positive top-line data from its Phase III TANDEM clinical trial. 21 November 2024
Biotechnology
US biotech major Amgen has announced that Dr Howard Chang will join the company as senior vice president of research, effective December 16, 2024. 21 November 2024
Biotechnology
US clinical-stage biotech Vyriad has entered into a strategic collaboration with Swiss pharma giant Novartis to discover and develop in vivo chimeric antigen receptor (CAR) T-cell therapies. 21 November 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Biotechnology
Bioplatform company builder Flagship Pioneering has announced its companies Ampersand Biomedicines and Montai Therapeutics have entered into agreements to identify targeted molecules that could potentially be further developed as treatments for obesity and lung cancer. 20 November 2024
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