20 November 2024 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.
Swedish Orphan Biovitrum, the Nordic biotech company also known as Sobi, today announced significantly improved financial results for the third quarter of 2024, sending the firm’s shares up 2.5% to 333.60 kronor in early trading. 24 October 2024
Ocuphire Pharma has announced its acquisition of Opus Genetics, a clinical-stage gene therapy company focused on treating inherited retinal diseases. 24 October 2024
Editas Medicine has announced plans to seek a partner or buyer for its lead CRISPR program, reni-cel, as the company continues to shift its strategy. 23 October 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved US pharma major Eli Lilly’s (NYSE: LLY) Kisunla (donanemab) for people in Britain with mild cognitive impairment or those in the early stages of Alzheimer’s disease. 23 October 2024
France-based clinical-stage biotech Duhn Therapeutics (which is co-founded by Landmark BioVentures) and Swiss firm OM Pharma announced an exclusive license agreement to advance a pipeline of lipid-based cancer immunotherapies. 23 October 2024
US clinical-stage biotech AvenCell Therapeutics announced that it has raised $112 million in Series B financing, which was led by global life sciences investor Novo Holdings. 23 October 2024
Shares in Sangamo Therapeutics surged around 40% on Tuesday, following the announcement that the US Food and Drug Administration has granted the company a faster path to approval for its gene therapy ST-920 (isaralgagene civaparvovec) for Fabry disease. 23 October 2024
South Korean firm SK bioscience announced that Indonesia’s Food and Drug Agency, BPOM (Badan Pengawas Obat dan Makanan), has approved the Biologics License Application (BLA) for the SKYCellflu quadrivalent prefilled syringe. 23 October 2024
UCB today announced that the company has regained all global rights to bepranemab following termination of a collaboration agreement with Swiss pharma giant Roche and its US subsidiary Genentech. 22 October 2024
Regenxbio and AbbVie have announced encouraging Phase II data for their partnered gene therapy, ABBV-RGX-314, at the American Academy of Ophthalmology meeting. 22 October 2024
Otsuka Pharmaceutical today announced positive top-line interim data from the ongoing Phase III clinical trial of sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgA nephropathy) in adults. 22 October 2024
Japanese clinical-stage biotech Aculys Pharma announced that pitolisant (BF2.649), a histamine H3 receptor antagonist/inverse agonist, has achieved its primary endpoint in a Phase III clinical trial targeting Japanese patients with narcolepsy. 22 October 2024
US healthcare giant Johnson & Johnson’s subcutaneous (SC) Tremfya (guselkumab) demonstrated strong results in the Phase III GRAVITI trial, marking a major breakthrough in the treatment of Crohn's disease (CD). 22 October 2024
Boston, USA-based Seaport Therapeutics has announced the closing of an oversubscribed $225 million Series B financing round, adding to the $100 million it pulled in along with its launch in April. 21 October 2024
Biotech firm Gilead Sciences has announced plans to voluntarily withdraw the US accelerated approval for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. 21 October 2024
Merck has announced encouraging data from a Phase IIb/III clinical trial for clesrovimab, its investigational antibody designed to prevent respiratory syncytial virus (RSV) in infants. 21 October 2024
As India's bioeconomy soars to a remarkable valuation of $151 billion, the government's Biotechnology Industry Research Assistance Council (BIRAC) has underscored the critical need for innovation and private sector investment to unlock further growth. 21 October 2024
Swiss pharma giant Roche (ROG: SIX) on Friday released positive top-line one-year results from the open-label, single-arm phase IV ELEVATUM study evaluating Vabysmo (faricimab) for the treatment of diabetic macular edema (DME) in people from racial and ethnic groups that are often underrepresented in clinical trials. 21 October 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
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
Sign up to receive email updates Join industry leaders for a daily roundup of biotech & pharma news
Company Spotlight
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining.