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Generics
Advancing complex generic drug development is a critical part of the US Food and Drug Administration’s (FDA) goal to help patients access safe, effective and high-quality generic medicines, the agency stated. 9 February 2024
Biotechnology
Johnson & Johnson has submitted to broaden the label for Rybrevant (amivantamab) in Europe, to include combination use with lazertinib in the first-line treatment of non-small cell lung cancer (NSCLC). 8 February 2024
Pharmaceutical
Luye Pharma Group has entered into an agreement with Myung In Pharm, granting the latter the exclusive rights to commercialize rivastigmine twice weekly transdermal patch in South Korea. 7 February 2024
Biotechnology
Denmark’s Evaxion Biotech today announced that, on February 5, it received a notification letter from the Listing Qualifications Department of the Nasdaq Stock Market stating that the company had regained compliance with the minimum bid price requirement set forth under Nasdaq Listing Rule 5550(a)(2). 7 February 2024
Biotechnology
Australian biotech CSL Limited and Arcturus Therapeutics today announced the results of a follow-up analysis of a Phase III study evaluating a booster dose of ARCT-154. 5 February 2024
Biotechnology
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) submitted by USA-based Regeneron Pharmaceuticals for linvoseltamab. 3 February 2024
Pharmaceutical
The impact of the Corporate Transparency Act on healthcare organizations, increased scrutiny by regulators of private equity investments in healthcare, and the subsectors that are seeing the most mergers and acquisitions, joint ventures and other transactions, are among the topics covered by a new report. 2 February 2024
Biotechnology
Cambridge, UK-based Maxion Therapeutics has appointed Arndt Schottelius as chief executive, part of what the company said was a “planned succession process.” 1 February 2024
Biotechnology
US biotech major Biogen today announced plans to reprioritize its resources in Alzheimer’s disease (AD), a strategic therapeutic area expected to drive near and long-term growth. 31 January 2024
Biotechnology
Lobbying group No Patient Left Behind (NPLB) is leading a campaign urging the US Congressional Budget Office (CBO) to change its approach to federal drug pricing legislation. 31 January 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application and granted Priority Review for Roche subsidiary Genentech’s ALK inhibitor Alecensa (alectinib) as adjuvant treatment following surgery for early-stage lung cancer (NSCLC). 30 January 2024
Pharmaceutical
German pharma and crop sciences major Bayer saw it shares drop more than 6% to 30.37 euros by early afternoon today, on the news that it has been ordered to pay in damages, the highest amount yet in its ongoing litigation linked to an alleged carcinogenic effect of its Roundup weedkiller. 29 January 2024
Biotechnology
US pharma giant Pfizer and Japan’s Astellas Pharma announced that on January 26 the European Medicines Agency (EMA) validated for review a Type II variation application for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). 27 January 2024
Biotechnology
USA-based biotech Locus Biosciences is to receive $23.9 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services. 25 January 2024
Biotechnology
Shares of Canada-based clinical-stage precision cancer drugs developer Repare Therapeutics edged up 3% to $6.51, as it announced that, under its worldwide license and collaboration agreement with Roche for the development and commercialization of camonsertib, it has earned a $40 million milestone payment from the Swiss pharma giant upon dosing the first patient with camonsertib in Roche’s TAPISTRY trial. 25 January 2024
Biosimilars
South Korea-based Celltrion’s US subsidiary says it has now launched an 80mg dose of Yuflyma (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of AbbVie’s Humira biosimilar, in the USA. 22 January 2024
Biotechnology
Massachusetts, USA-based biotech Viridian Therapeutics has submitted paperwork for a public offering of common and preferred stock. 21 January 2024
Biotechnology
Beijing-based biotech Sinovac has received a partial tender offer from Alternative Liquidity, to acquire up to 10,000,000 common shares at $0.03 per share. 21 January 2024
Biotechnology
Swiss contract development and manufacturing organization (CDMO) Lonza has cut around 200 jobs at a manufacturing facility in California, USA. 19 January 2024
Pharmaceutical
USA-based gastroenterology specialist Ironwood Pharmaceuticals announced that new data from the Phase III study that evaluated linaclotide in children and adolescents aged 6-17 years with functional constipation were published in The Lancet Gastroenterology & Hepatology. 15 January 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
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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