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Pharmaceutical
The US Food and Drug Administration’s pulmonary-allergy drugs advisory committee (PADAC) on Friday held an advisory committee (AdCom) meeting to discuss US pharma giant Merck & Co’s P2X3 inhibitor, gefapixant in chronic cough. 18 November 2023
Pharmaceutical
US clinical-stage biopharma Apollomics (Nasdaq: APLM) leapt on the announcement yesterday that its partner in China, Avistone Biotechnology, has received conditional approval from the National Medical Products Administration (NMPA) of China for the commercialization of vebreltinib to treat patients with MET exon 14 skipping non-small cell lung cancer (NSCLC). 17 November 2023
Pharmaceutical
As part of UK Prime Minister Rishi Sunak’s Cabinet reshuffle today, Victoria Atkins has been named as Secretary of State for Health and Social Care, replacing Steve Barclay. 13 November 2023
Biotechnology
CSL Seqirus has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to extend the indication of its cell-based quadrivalent influenza vaccine (QIVc) to children aged six months and older in the UK. 13 November 2023
Biotechnology
The European Medicines Agency has approved a Type II variation to the Yescarta (axicabtagene ciloleucel) Summary of Product Characteristics (SmPC) to include the overall survival (OS) analysis of the landmark Phase III, Gilead Sciences’ Kite subsidiary announced today. 10 November 2023
article
The UK’s NHS Business Service Authority (NHSBSA) today released a report a report on the prescribing cost in hospitals and the community in 2023. 9 November 2023
Pharmaceutical
Eli Lilly's tirzepatide, which is already approved for the treatment of diabetes under the trade name Mounjaro, late Wednesday was also authorized by the US FDA for the treatment of chronic weight management. 8 November 2023
Biotechnology
Following approval by the US Food and Drug Administration in August this year, Biogen and Sage Therapeutics have said their Zurzuvae (zuranolone) is expected to be commercially available for adults with PPD in December 2023 . 8 November 2023
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today authorized a new medicine, Krazati (adagrasib), a treatment for a type of non-small cell lung cancer (NSCLC) in adults that has a mutation and produces a rare protein called KRAS G12C. 3 November 2023
Pharmaceutical
Indian drugmaker Zydus Lifesciences, through its wholly-owned subsidiary Zydus Pharmaceuticals UK, announced the acquisition of the UK headquartered LiqMeds Group of companies. 31 October 2023
Pharmaceutical
A posting on the website of the German pharma trade group, the VFA, reveals a new report on evaluating the impact of the country’s SHI Financial Stabilization Act on patient access to medicines and on German business location. 30 October 2023
Biotechnology
China’s National Medical Products Administration (NMPA) has recently approved the listing of the Class 1 innovative drug ritlecitinib under the trade name Lefenox, applied for by US pharma giant Pfizer through the priority review process. 28 October 2023
Biotechnology
The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Immatics’ IMA203 cell therapy in multiple PRAME-expressing tumors including cutaneous and uveal melanoma, ovarian cancer and other cancer types. 24 October 2023
Biotechnology
South Korean contract development and manufacturing organization (CDMO) Samsung Biologics and Kurma Partners, a European venture capital firm in healthcare and biotechnology, today announced a strategic partnership for the development and manufacturing of biologics for Kurma Partners’ portfolio companies. 23 October 2023
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US pharma major Eli Lilly has agreed to acquire Mablink Bioscience, a French biotech focused on antibody-drug conjugates for cancer, according to Endpoints News, citing Lilly’s chief scientific officer Dan Skovronsky. 18 October 2023
Biotechnology
Soliris (eculizumab), one of UK pharma major AstraZeneca’s top selling drugs, has been approved in China for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive (Ab+). 18 October 2023
Biotechnology
Chinese gene therapy company Gritgen Therapeutics has announced the launch of operations at its commercial GMP facility in Suzhou Industrial Park. 18 October 2023
Biotechnology
The European Commission (EC) has approved Keytruda (pembrolizumab), Merck & Co’s $20 billion+ anti-PD-1 therapy, as a monotherapy for the adjuvant treatment of adults with non-small cell lung cancer (NSCLC) who are at high risk of recurrence following complete resection and platinum-based chemotherapy. 16 October 2023
Pharmaceutical
Danish diabetes care giant Novo Nordisk on Friday announced that the sales and operating profit growth at constant exchange rates (CER) for the first nine months of 2023 and the full-year sales and operating profit outlook at CER have been raised. 14 October 2023
Biosimilars
Canadian trade group Biosimilars Canada has announced a new switching policy for the province of Prince Edward Island (PEI). 13 October 2023
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
Biotechnology
Privately-held US biotech Georgiamune has announced the appointment of Mark Avagliano as chief business officer (CBO). 19 November 2024
Biotechnology
Massachusetts, USA-based firm VBI Vaccines has initiated a nationwide voluntary recall of PreHevbrio (hepatitis B vaccine), as it proceeds with bankruptcy and the shutdown of its operations. 19 November 2024
Biotechnology
Australia’s CSL Limited plans to shut down its Californian R&D facility focused on cell and gene therapies by January 2025, signaling a shift away from ex vivo lentiviral-based technology. 19 November 2024
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