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.
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
TRIANA Biomedicines has entered into a strategic collaboration and licensing agreement with US pharma giant Pfizer to discover novel molecular glue degraders for multiple targets in several disease areas, including oncology. 16 October 2024
Johnson & Johnson has reported positive results from its Phase II/III Vibrance-MG trial, setting up potential competition in the treatment of generalized myasthenia gravis (gMG). 16 October 2024
US biotech major Amgen has further strengthened the growing evidence for the use of Uplizna (inebilizumab-cdon) in severe autoimmune diseases. 15 October 2024
Denmark’s Commit Biologics, a specialist in the activation of the complement system to treat cancer and autoimmune disease, has announced the appointment of Mikkel Wandahl Pedersen as chief scientific officer (CSO). 15 October 2024
US clinical-stage genetic meds company MeiraGTx Holdings has released positive top-line data from its clinical bridging study of AAV-GAD for the treatment of Parkinson’s disease, MGT-GAD-025. 15 October 2024
Eli Lilly has released new data demonstrating more patients with moderately to severely active Crohn's disease treated with mirikizumab – Johnson & Johnson’s (NYSE: JNJ) Stelara -achieved histologic response at Week 52 compared to ustekinumab, regardless of prior biologic experience. 15 October 2024
In Hong Kong, Akeso Biopharma has successfully raised $250 million through a share placement, marking its second major fundraising effort of 2024. 15 October 2024
Antibody-drug conjugates (ADCs) represent a transformative class of cancer therapy that combine the targeting ability of antibodies with the cell-killing potential of cytotoxic drugs. 15 October 2024
At last month’s European Academy of Dermatology and Venereology (EADV) congress in Amsterdam, Novartis presented new early and long-term Phase III data for remibrutinib in chronic spontaneous urticaria (CSU). 14 October 2024
A recent study published in The New England Journal of Medicine has detailed seven cases of blood cancer in patients treated with the gene therapy Skysona (elivaldogene autotemcel). 14 October 2024
UK pharma major AstraZeneca and Japanese drugmaker Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has won conditional approval in China. 14 October 2024
French biotech Innate Pharma has appointed Jonathan Dickinson as its new chief executive (CEO) and chairman of the executive board, effective November 1, 2024. 14 October 2024
Roche has presented positive two-year data from the ongoing RAINBOWFISH study assessing the efficacy and safety of Evrysdi (risdiplam) in children with spinal muscular atrophy (SMA) who were treated pre-symptomatically as infants before six weeks of age. 14 October 2024
Stealth BioTherapeutics has received a favorable vote from a US Food and Drug Administration advisory committee regarding its lead product, elamipretide. 14 October 2024
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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.