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Biotechnology
Shares of Theseus Pharmaceuticals rose 7% to $3.96 pre-market, on the news that it has received a takeover bid from Concentra Biosciences, in an all-cash deal worth at least $172.5 million. 22 December 2023
Biotechnology
The US Food and Drug Administration (FDA) has approved a label update for Gilead Sciences subsidiary Kite’s Yescarta (axicabtagene ciloleucel). 22 December 2023
Biotechnology
Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) together with a New Drug Application (NDA) seeking the approval of Rybrevant (amivantamab-vmjw) in combination with lazertinib. 21 December 2023
Biotechnology
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for BNT323/DB-1303 for the treatment of advanced endometrial cancer in patients who progressed on or after treatment with immune checkpoint inhibitors. 21 December 2023
Pharmaceutical
US pharma major Eli Lilly today announced the extension of the expiration of the tender offer to acquire all of the issued and outstanding shares of POINT Biopharma Global. 20 December 2023
Pharmaceutical
Irish-American specialty pharma company Shorla Oncology and Eversana, a provider of commercialization services to the life sciences industry, have announced the US commercial launch of Jylamvo (methotrexate) oral solution, the first and only oral methotrexate solution approved in the USA for use in adults. 19 December 2023
Pharmaceutical
Today, New York-based Neurogene, a specialist in rare neurological diseases, announced the close of its merger with Neoleukin Therapeutics they announced in July, and has begun trading on the NASDAQ Global Market under the ticker “NGNE.” 19 December 2023
Biotechnology
Spanish contract development and manufacturing organization (CDMO) Leanbio is to invest an additional $22 million in a facility currently under construction near Barcelona. 18 December 2023
Generics
Indian drugmaker Sun Pharmaceutical has increased its bid to acquire Israeli generics firm Taro Pharma, up to $43 per share from its previous offer of $38 per share. 14 December 2023
Biotechnology
Eisai and Biogen announced that their humanized antisoluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab, 200mg, 500mg) intravenous infusion for the treatment of Alzheimer’s disease will be launched in Japan on December 20. 14 December 2023
Biotechnology
Sino-American biotech LianBio says that its board of directors unanimously determined not to pursue the unsolicited proposal from Concentra Biosciences to acquire 100% of the equity of LianBio for $4.30 per share in cash, plus a contingent value right representing the right to receive 80% of the net proceeds payable from any license or disposition of LianBio’s programs. 8 December 2023
Pharmaceutical
US pharma major AbbVie has announced a definitive agreement under which AbbVie will acquire Cerevel Therapeutics and its robust pipeline. of assets focused on best-in-class potential for psychiatric and neurological disorders where significant unmet needs remain. 7 December 2023
Biotechnology
Shares of Wuxi Biologics (Cayman) were halted in Hong Kong after sliding 24% on guidance for lower profit and weaker-than-expected revenue, reported US financial services company Morningstar analyst Ben Otto. 4 December 2023
Pharmaceutical
Japanese drugmaker Teijin Pharma as enter into an exclusive licensing agreement with Denmark’s Ascendis Pharma regarding the research, development, manufacturing and sales in Japan. 30 November 2023
Pharmaceutical
Two American firms, Evommune and Accutar Biotechnology, have announced a strategic partnership focused on the discovery of novel small molecules in chronic inflammatory diseases. 29 November 2023
Biotechnology
Japanese discovery and development biotech PRISM BioLab has announced a license and collaboration agreement with US pharma major Eli Lilly. 29 November 2023
Biotechnology
Today, US drug major AbbVie and Denmark’s Genmab announced regulatory updates from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory (R/R) follicular lymphoma (FL). 27 November 2023
Pharmaceutical
Danish diabetes and obesity giant Novo Nordisk today announced the investment of more than 16 billion Danish kroner ($2.3 billion) starting in 2023 to expand the existing production site in Chartres, France, for the current and future product portfolio within serious chronic diseases. 23 November 2023
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday issued a final rule to amend its prescription drug advertising regulations, titled “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format.” 21 November 2023
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency’s (MHRA) announced that the forthcoming International Recognition procedure (IRP) moved a step closer today, with the launch of the Agency’s new online ‘Eligibility Checker’ tool. 20 November 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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