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Biotechnology
The Japanese Ministry of Health, Labor and Welfare (MHLW) has accepted for review a supplementary new drug application (sJNDA) for UK Pharma major GSK’s Nucala (mepolizumab). 1 September 2023
Pharmaceutical
Swiss rare disease specialist Relief Therapeutics has entered into a new exclusive licensing agreement with Acer Therapeutics for Olpruva (sodium phenylbutyrate). 31 August 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a final guidance for industry titled Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drugs and Biological Products. 31 August 2023
Biotechnology
US healthcare giant Johnson & Johnson’s subsidiary Janssen Pharmaceuticals has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for the expanded approval of Rybrevant (amivantamab-vmjw). 26 August 2023
Biotechnology
Swedish biotech Oncopeptides has revealed details regarding the US Food and Drug Administration's withdrawal of approval of Pepaxto (melphalan flufenamide). 25 August 2023
Pharmaceutical
German infectious disease specialist AiCuris Anti-infective Cures has received a milestone payment of around $32.5 million from partner Merck & Co after a new US approval for Prevymis (letermovir). 23 August 2023
Biotechnology
FORE Biotherapeutics today announced the closing of its $75 million Series D financing. 23 August 2023
Biotechnology
US biopharma Novavax’ updated protein-based XBB COVID vaccine candidate induced neutralizing antibody responses to the EG.5.1 and XBB.1.16.6 subvariants in small animal and non-human primate studies, the company has announced. 22 August 2023
Biotechnology
UK gene and cell therapy group Oxford Biomedica says that it has expanded its license and supply agreement (LSA) with US biotech Cabaletta Bio. 22 August 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted Swedish firm Calliditas Therapeutics’ submission for the supplemental New Drug Application (sNDA) and granted Priority Review for the full approval of Tarpeyo (budesonide) for the treatment of IgA nephropathy (IgAN). 18 August 2023
Biotechnology
Chinese pharma company Jiangsu Hengrui Pharmaceuticals has granted USA-based ONEBIO exclusive rights to its anti-TSLP monoclonal antibody SHR-1905 in a deal covering everywhere except China. 15 August 2023
Pharmaceutical
US legislators have proposed two new bills that aim to bolster the Vaccine Injury Compensation Program and help vaccines gain the general public's acceptance, the first being the Vaccine Injury Compensation Modernization Act and the second The Vaccine Access Improvement Act. 15 August 2023
Pharmaceutical
Germany’s Ketabon GmbH, a joint venture between HMNC Brain Health and Develco Pharma, today announced today top-line results from its Phase II KET01-02 Ketabon study with lead asset KET01. 14 August 2023
Biotechnology
In the UK, the Liverpool School of Tropical Medicine (LSTM) has partnered with the LifeArc medical research group to establish a $3.4 million Translational Development Fund. 11 August 2023
Biotechnology
A company launched by leading biotech incubator Flagship Pioneering has raised $109 million in a series B round led by its founder and a number of top-tier investors. 10 August 2023
Biotechnology
Cell therapy company Gracell Biotechnologies has raised about $100 million in a private share placement, with another $50 million to follow, should investors take the option within two years. 9 August 2023
Biotechnology
Along with its financial results yesterday, Denali Therapeutics revealed that Japan’s Takeda has made a strategic decision to discontinue development of TAK-920/DNL919 (ATV:TREM2) in Alzheimer’s disease based on data from the Phase I study and the rapidly evolving treatment landscape. 9 August 2023
Pharmaceutical
Shares of Japanese drugmaker Daiichi Sankyo (TYO: 4568) moved up almost 2% to 4,279 yen today, as it revealed a decision to close its Japanese research and development (R&D) subsidiary, Daiichi Sankyo RD Novare, headquartered in Edogawa-ku, Tokyo. 7 August 2023
Pharmaceutical
Danish vaccine developer Bavarian Nordic says that the US Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the US Department of Health and Human Services, has placed a new order valued at $120 million, primarily covering the manufacturing of new bulk product for the company’s Imvanex (marketed as Jynneos in the USA) smallpox/monkeypox vaccine. 4 August 2023
Biosimilars
South Korea’s Samsung Bioepis is considering acquiring the biosimilar business unit of US biotech Biogen for around 1 trillion won ($775.3 million) to improve its presence in the US market, according to local media reports on Wednesday. 3 August 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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