Latest Pharma and Biotech News
Biosimilars
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.
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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
Biotechnology
Privately-held US biotech Georgiamune has announced the appointment of Mark Avagliano as chief business officer (CBO). 19 November 2024
Biotechnology
Massachusetts, USA-based firm VBI Vaccines has initiated a nationwide voluntary recall of PreHevbrio (hepatitis B vaccine), as it proceeds with bankruptcy and the shutdown of its operations. 19 November 2024
Biotechnology
Australia’s CSL Limited plans to shut down its Californian R&D facility focused on cell and gene therapies by January 2025, signaling a shift away from ex vivo lentiviral-based technology. 19 November 2024
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Biotechnology
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
Pharmaceutical
UK pharma major AstraZeneca, which has invested heavily in China, hosted a sell-side analyst call on Wednesday (November 6) to discuss the recent media reports about ongoing investigations in China. 7 November 2024
Pharmaceutical
US drugmaker Sarepta Therapeutic saw its shares gain 2.4% to $127.97 as it reported financial results for the third quarter 2024. 7 November 2024
Biotechnology
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
Pharmaceutical
Around half of the pharmaceutical products launched in the USA in 2023 underperformed, and 39% overperformed, according to Trinity Life Sciences. 6 November 2024
Pharmaceutical
PrognomiQ has announced a series D financing round of $34 million, led by Seer, bringing the firm’s total funding to over $135 million since its founding in September 2020. 6 November 2024
Pharmaceutical
USA-based Acadia Pharmaceuticals has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million upon the closing of the transaction. 6 November 2024
Biotechnology
India’s Sun Pharma has been blocked in its efforts to launch its JAK inhibitor Leqselvi (deuruxolitinib) in the USA. 6 November 2024
Pharmaceutical
Some of the UK’s leading academics and industry professionals have welcomed Chancellor Rachel Reeves’ £520 million ($669 million) pledge to develop the country’s medicine manufacturing capabilities. 6 November 2024
Pharmaceutical
The market for ROS1 inhibitors, targeted treatments primarily used in non-small cell lung cancer (NSCLC), is set to see significant growth as novel therapies gain traction and a precision medicine approach reshapes the oncology landscape. 6 November 2024
Generics
Teva Pharmaceutical Industries’ shares were up 4% at 7,323 shekels today reported results for the quarter ended September 30, 2024. 6 November 2024
Pharmaceutical
Syndax Pharmaceuticals has entered into a $350 million royalty funding agreement with Royalty Pharma. 6 November 2024
Biotechnology
GSK’s Arexvy (RSV vaccine) has received an expanded approval in Canada to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50-59 who are at increased risk. 6 November 2024
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) issued final guidance recommending reimbursement of Ayvakyt (avapritinib) from USA-based Blueprint Medicines. 6 November 2024
Biotechnology
French drugmaker Sanofi has revealed the results from the Phase III LUNA 3 trial of rilzabrutinib, an oral bruton tyrosine kinase (BTK) inhibitor, in persistent or chronic immune thrombocytopenia (ITP). 6 November 2024
Pharmaceutical
Intra-Cellular Therapies has announced positive results from Study 304 evaluating the efficacy and safety of Caplyta (lumateperone) 42mg for the prevention of relapse in adult patients with schizophrenia. 6 November 2024
Biotechnology
French pharma major Sanofi’s Dupixent (dupilumab), which notched up sales of 3.5 billion euros ($3.8 billion) in third-quarter 2024, +23.8% year-on-year, has picked up yet another indication in collaboration with Regeneron. 6 November 2024
Pharmaceutical
Plus Therapeutics, an American firm advancing radiotherapeutics for central nervous system (CNS) cancers, has signed a new manufacturing services agreement with SpectronRx. 6 November 2024
article
The US Food and Drug Administration (FDA) has announced approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) 6 November 2024
Biotechnology
Beam Therapeutics will detail new clinical and preclinical data on its sickle cell disease (SCD) therapies at the upcoming American Society of Hematology (ASH) meeting. 6 November 2024
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