Chinese biopharma Hutchmed on Friday announced that it has voluntarily withdrawn its supplemental New Drug Application (NDA) in China for fruquintinib. 2 September 2024
Shares of US protein-based vaccine developer Novavax closed up 8.6% and added a further 1.8% to $12.60 in after-hours trading on Friday, on a positive development for its COVID-19 vaccine. 31 August 2024
Pierre Fabre Laboratories has announced that the European Commission (EC) has approved Braftovi (encorafenib) in combination with Mektovi (binimetinib) for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation. 30 August 2024
US RNAi therapeutics company Alnylam Pharmaceuticals today announced what is called positive detailed results from the HELIOS-B Phase III study of vutrisiran, in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). 30 August 2024
While it may already be one of the world’s top-selling drugs across any therapy area, Merck & Co’s Keytruda (pembrolizumab) has not been successful in every indication and combination that it has been tried in across the anti-PD-1 therapy’s vast development program in oncology. 30 August 2024
Johnson & Johnson said yesterday that it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking the first approval of nipocalimab. 30 August 2024
Finnish biotech Rokote Laboratories has partnered with 3PBioVian to produce the drug substance and product for its intranasal COVID-19 vaccine, FINCoVac 2.1, ahead of Phase I trials. 29 August 2024
Marseille-based ImCheck Therapeutics has received 20.2 million euros ($22.4 million) in non-dilutive funding as part of the i-Démo call for projects under the France 2030 Plan operated by Bpifrance on behalf of the French government. 29 August 2024
Roche subsidiary Genentech will lay off nearly 100 employees at its San Francisco site, according to a California Worker Adjustment and Retraining Notification (WARN) notice. 29 August 2024
US firm Lindy Biosciences has announced a multitarget exclusive global licensing agreement and strategic collaboration with the US subsidiary of Swiss pharma giant Novartis. 29 August 2024
German pharma major Bayer today announced it has entered into a collaboration and license agreement with US biotech start-up NextRNA Therapeutics to develop small molecule therapeutics targeting lncRNAs in oncology. 28 August 2024
Chinese biotech DualityBio has shown that it means business in a filing to the Hong Kong stock exchange that reveals its plans for an initial public offering (IPO). 28 August 2024
Novartis today announced positive top-line results from twice-yearly Leqvio (inclisiran) in the Phase III V-MONO study, which met its primary endpoints. 28 August 2024
Chugai Pharmaceutical has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved an additional indication for Alecensa (alectinib). 28 August 2024
The European Commission (EC) has approved a Type II extension of indication for Johnson & Johnson’s Rybrevant (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed). 27 August 2024
The European Commission has approved PiaSky (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5, from Swiss pharma giant Roche. 27 August 2024
Privately-held US biotech Alloy Therapeutics has announced a strategic collaboration and license agreement with Takeda Pharmaceutical. 21 November 2024
San Diego-based Cidara Therapeutics, a biotech using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, has entered into a securities purchase agreement with certain investors to raise up to around $105 million. 21 November 2024
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Eli Lilly is not resting on its laurels when it comes to the fast-growing field of obesity treatments, an area in which it is already a leader. 21 November 2024
Aizen Therapeutics, an AI-driven biotech headquartered in San Diego, has officially launched from stealth mode, introducing its drug discovery platform, DaX. 21 November 2024
San Diego-based Valora Therapeutics, a biotech that boasts of having a novel approach to immunotherapy, has announced the successful closing of a $30 million seed funding round. 21 November 2024
Astellas Pharma has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol). 21 November 2024
San Diego-based Kura Oncology and Japan’s Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib. 21 November 2024
HCW Biologics has announced a worldwide licensing agreement with WY Biotech to develop and commercialize one of its preclinical immunotherapy candidates. 21 November 2024
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
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
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
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
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
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
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
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