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Biotechnology
UK pharma major AstraZeneca and Japan’s Daiichi Sankyo today revealed that their Enhertu (trastuzumab deruxtecan) has been approved by China’s National Medical Products Administration (NMPA). 12 July 2023
Biotechnology
Dublin-headquartered protein specialist Prothena has outlined research it intends to present at the upcoming Alzheimer’s Association International Conference (AAIC). 12 July 2023
Pharmaceutical
Central nervous system (CNS) specialist Neuraxpharm has established outposts in Brazil and Mexico, as part of its strategy to globalize its operations outside Europe. 12 July 2023
Pharmaceutical
Swedish enzyme technology firm Hansa Biopharma announced that the Australian Therapeutic Goods Administration (TGA) has provisionally approved Idefirix (imlifidase) as desensitization treatment for highly sensitized patients prior to kidney transplantation from both living and deceased donors. 11 July 2023
Biotechnology
French biotech Abionyx Pharma will treat a fourth patient with its rare kidney disease candidate CER-001, following a compassionate access authorization (CAA). 11 July 2023
Biotechnology
Gene therapy and neurology specialist Voyager Therapeutics has appointed Jacquelyn Fahey Sandell as chief legal officer. 10 July 2023
Pharmaceutical
Switzerland-headquartered Idorsia and its US subsidiary today announced that, effective immediately, pharmacy benefit managers (PBM) CVS is covering Quviviq (daridorexant) CIV on the Performance Drug List (PDL). 10 July 2023
Biotechnology
French biotech Flash Therapeutics has appointed Jerome Bedier as president. 6 July 2023
Pharmaceutical
Cambridge, UK-based Metrion Biosciences, a specialist ion channel contract research and drug discovery company, today announced the appointments of Dr Robert Kirby to chief operating officer and Dr Edward Stevens to chief scientific officer. 6 July 2023
Biosimilars
UK biopharma Arecor Therapeutics has entered into an agreement with an unnamed ‘leading biopharmaceutical company’ to support the ongoing development of a biosimilar product. 5 July 2023
Biotechnology
British antibody-drug conjugate (ADC) company Pheon Therapeutics has inked an exclusive license agreement with China’s Biocytogen Pharmaceuticals. 5 July 2023
Pharmaceutical
The USA’s Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of xanomeline tartrate/trospium chloride, known as KarXT, from Karuna Therapeutics, for the treatment of schizophrenia. 5 July 2023
Biotechnology
Sweden’s Hansa Biopharma has written up certain intangible assets, following a conditional approval in the EU and UK for Idefirix (imlifidase). 4 July 2023
Pharmaceutical
Japanese drugmaker Eisai has entered into an agreement to transfer all future economic rights for elacestrant, approved for the treatment for breast cancer in the USA, to Canada-headquartered DRI Healthcare Trust. 3 July 2023
Generics
A California federal jury cleared Gilead Sciences and Teva Pharmaceutical Industries on Friday in a $3.6 billion antitrust case claiming the pharmaceutical giants struck an illegal "pay for delay" patent deal that inflated prices for two HIV medications. 1 July 2023
Biotechnology
US biotech major Biogen presented interim clinical outcomes results from the RESPOND study highlighting the potential benefit of Spinraza (nusinersen) in infants and toddlers with spinal muscular atrophy (SMA) who have unmet clinical needs after treatment with gene therapy Zolgensma (onasemnogene abeparvovec). 30 June 2023
Biotechnology
In a second flop within a month, PTC Therapeutics announced today that the MIT-E trial of vatiquinone for the treatment of mitochondrial disease associated seizures (MDAS) failed to achieve its primary endpoint of reduction in observable motor seizures. 30 June 2023
Biotechnology
Australian LAG-3 specialist Immutep has raised $53 million to support its late-stage and pipeline development work, including taking eftilagimod alpha into a new Phase III trial in lung cancer. 28 June 2023
Biotechnology
US pharma major Eli Lilly has received Medicines and Healthcare products Regulatory Agency (MHRA) marketing authorization in Great Britain for mirikizumab, a ground-breaking therapy for ulcerative colitis (UC). 28 June 2023
Biotechnology
UK breakthrough inflammatory disease and immuno-oncology company Mestag Therapeutics and VIB, the leading life science research institute in Flanders. 27 June 2023
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
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Biosimilars
Sweden-based Xbrane Biopharma and Intas Pharmaceuticals have announced an exclusive global licensing and co-development agreement for the former company’s Opdivo (nivolumab) biosimilar candidate. 20 November 2024
Biotechnology
A pair of industry veterans have teamed up to create Jupiter Bioventures, a San Francisco-based biotech venture foundry promised to build bold, science-driven therapeutics companies. 20 November 2024
Pharmaceutical
California, USA-based biotech Cytokinetics saw its shares fall as much as 4% to $9.67 yesterday, after it announced a deal with Germany’ Bayer. 20 November 2024
Pharmaceutical
Anthony Harnden has been appointed as the new chair of the UK’s Medicine and Healthcare products Regulatory Agency (MHRA). 20 November 2024
Biotechnology
The landscape of atopic dermatitis (AD) treatment is advancing with approvals of oral and topical Janus kinase (JAK) inhibitors across the seven major pharmaceutical markets (7MM; USA, France, Germany, Italy, Spain, UK and Japan). 20 November 2024
Biotechnology
Johnson & Johnson and partner Protagonist Therapeutics have reported positive topline results from two Phase III studies testing a first-in-class oral peptide. 20 November 2024
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 November 2024
Biotechnology
Samsung Biologics, the biotech arm of Korea's Samsung Group, has announced a new manufacturing agreement worth $668 million. 20 November 2024
Biotechnology
Mirai Bio has announced the appointment of Jens Vogel as the company’s president and chief operating officer (COO). 20 November 2024
Pharmaceutical
Australia’s Therapeutic Goods Administration (TGA) yesterday warned that health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under six years of age. 20 November 2024
Biotechnology
German biotech CatalYm has followed up a groundbreaking 2023 with an impressive 2024. 19 November 2024
Biotechnology
US pharma giant Merck & Co today announced positive top-line results from the pivotal Phase III MK-3475A-D77 trial for its mega blockbuster drug Keytruda (pembrolizumab) in subcutaneous form. 19 November 2024
Biotechnology
Aclaris Therapeutics has announced an exclusive licensing agreement with Biosion for broad rights to two new antibodies. 19 November 2024
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