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.
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
New research has been published in the Journal of Allergy and Clinical Immunology (JACI) that shows treatment with amlitelimab, an anti-OX40 ligand antibody, significantly reduced symptoms of atopic dermatitis (AD) and was maintained even after treatment stopped. 9 November 2024
South Korea’s Alteogen has signed an exclusive licensing agreement with Japanese pharmaceutical company Daiichi Sankyo for its human hyaluronidase, ALT-B4. 9 November 2024
US mRNA specialist Moderna today announced Health Canada has approved mRESVIA (respiratory syncytial virus mRNA vaccine) for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. 8 November 2024
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Genmab announced during its third-quarter earnings call on Wednesday that it has discontinued three antibody programs as part of a pipeline overhaul. 8 November 2024
Japanese ophthalmology company Santen Pharmaceutical has crossed the East China Sea in its latest collaboration, announced on Thursday. 8 November 2024
US biotech major Amgen and the UK’s AstraZeneca have announced positive top-line results from the Phase III WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]). 8 November 2024
Asklepios BioPharmaceutical (AskBio) today announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug designation from the US Food and Drug Administration (FDA) for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 7 November 2024
The global market for Duchenne muscular dystrophy (DMD) therapeutics is projected to grow by $4.4 billion between 2024 and 2028, fueled by artificial intelligence and strong demand for new treatments. 7 November 2024
According to UNICEF's State of the World's Children 2023 report, in Latin America
and the Caribbean, 6.8 million children did not benefit from vaccination during the
time of the pandemic and in the following two years, progress has not been as
expected either. 7 November 2024
US biotech venture fund Aditum Bio and China’s Leads Biolabs today announced the formation of Oblenio Bio, marking the thirteenth company launched by Aditum. 7 November 2024
US biotech major Gilead Sciences was trading nearly 2% higher in pre-market on Thursday after announcing its third-quarter 2024 financial results and latest guidance for 2024 as a whole. 7 November 2024
Moderna has reported third-quarter 2024 revenues of $1.9 billion, marking a slight increase from the $1.8 billion posted in the same period in 2023. 7 November 2024
Oncology-focused biotech company Tango Therapeutics announced an update on its PRMT5 program. Tango noted that, based on positive data from the dose escalation and early dose expansion cohorts of the TNG462 Phase I/II clinical trial, it has selected TNG462 to move forward into full development. 7 November 2024
Maryland-based MacroGenics, a biopharma focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, has provided an update on its lead antibody-drug conjugate (ADC) vobramitamab duocarmazine (vobra duo). 7 November 2024
US clinical-stage drug developer Acumen Pharmaceuticals has appointed Amy Schacterle as chief regulatory officer and head of quality, reporting to Jim Doherty, president and chief development officer at Acumen. 7 November 2024
Results from the ARC-10 Phase III study of Arcus Biosciences and Gilead Sciences’ domvanalimab and zimberelimab combination therapy indicate a significant reduction in mortality risk for patients with certain advanced lung cancers. 7 November 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.