9 October 2024 US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company.
Health authorities in Europe have urged countries to use newly-authorized adapted COVID-19 vaccines as part of autumn and winter vaccination campaigns. 7 September 2022
Privately-held Seattle, USA-based drug developer Good Therapeutics says it has entered into a definitive agreement to be acquired by Swiss pharma giant Roche. 7 September 2022
California’s Arsenal Biosciences, a privately-held programmable cell therapy company engineering advanced CAR-T therapies for solid tumors, has closed a $220 million Series B financing. 7 September 2022
Based in Cambridge, Massachusetts, USA, Orbital Therapeutics launched today with a vision of enhancing global health by unleashing the full potential of RNA medicines to treat human disease in ways that were not previously possible. 7 September 2022
US biotech Rhythm Pharmaceuticals yesterday announced that the European Commission (EC) has expanded the marketing authorization for Imcivree (setmelanotide) to include the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) in adult and pediatric patients six years of age and older. 7 September 2022
Competition for one of the best-selling medicines of all time is gaining traction, with new three-year data for Hadlima (adalimumab-bwwd), a biosimilar of adalimumab developed by Samsung Bioepis. 7 September 2022
Belgium’s largest pharma company UCB has announced new three-year results from the BE BRIGHT open-label extension study of bimekizumab. 7 September 2022
The European Commission (EC) has approved CAR-T cell therapy Tecartus (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL), developed by Kite, a part of Gilead Sciences. 7 September 2022
Germany-headquartered drugmaker Fresenius Kabi says that the US Food and Drug Administration (FDA) has approved its biosimilar, Stimufend (pegfilgrastim-fpgk), for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. 7 September 2022
Results from the DESTINATION Phase III extension trial showed Tezspire (tezepelumab) demonstrated an overall long-term safety and efficacy profile consistent with the previous PATHWAY Phase II and NAVIGATOR Phase III trials, sustained over 104 weeks in a broad population of patients with severe asthma. 7 September 2022
La Jolla, California-based immunology specialist Equillium and Metacrine have entered into a definitive merger agreement whereby Equillium will acquire Metacrine in an all-stock transaction, edging the latter’s shares up 2.7% to $0.47 by close of trading on Tuesday. 7 September 2022
STORM Therapeutics, a UK biotech discovering and developing small molecule therapies targeting RNA modification enzymes for oncology and other diseases, has announced the appointment of Gerald McMahon as president, chief executive and board director. 7 September 2022
The US Food and Drug Administration has lifted a clinical hold on research into SRP-5051, a candidate under development by rare disease company Sarepta Therapeutics. 6 September 2022
US biopharma Iveric Bio has announced positive top-line results from GATHER2, the company’s second Phase III trial of Zimura (avacincaptad pegol), a novel investigational complement C5 inhibitor, for the treatment of geographic atrophy (GA). 6 September 2022
New findings from the XALOC program support the real-world effectiveness of UK pharma major AstraZeneca’s Fasenra (benralizumab) in the management of patients with severe eosinophilic asthma (SEA), showing reductions in annualized asthma exacerbation rate (AAER), improvements in asthma control and the ability to achieve clinical remission. 6 September 2022
Confirming an earlier reimbursement decision, leading PARP blocker Lynparza (olaparib) has not been recommended for regular use in England and Wales, dealing a blow to people with prostate cancer. 6 September 2022
Nodus Oncology, a novel biotech company focused on developing first and best-in-class molecules inhibiting novel DNA damage response (DDR) targets, has launched with seed funding from Cumulus Oncology and announced a partnership with the Lead Discovery Center (LDC). 6 September 2022
Dutch antibody-drug conjugate (ADC) specialist Synaffix and Germany’s Emergence Therapeutics today announced they have entered into a licensing agreement, providing Emergence access on a target-specific basis to Synaffix’ proprietary antibody drug conjugate (ADC) technologies comprising GlycoConnect, HydraSpace and SYNtecan E linker-payload. 6 September 2022
Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly. 10 October 2024
Pfizer released positive top line results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide). 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Cancer start-up Black Diamond Therapeutics has announced a significant restructuring as part of its plan to focus resources on its lead drug, BDTX-1535. 10 October 2024
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
Beijing’s InnoCare Pharma has announced encouraging Phase II results for its novel TYK2 inhibitor, ICP-488, aimed at treating moderate-to-severe plaque psoriasis. 10 October 2024
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
USA-based Kezar Life Sciences announced this week that it was pausing its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 10 October 2024
Advances in gene editing, such as the FDA approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) in December 2023 for the treatment of beta thalassemia and sickle cell disease, have fueled significant interest in innovative epigenetic drugs. 10 October 2024
GSK has reached a settlement with 10 plaintiff firms, resolving 93% of the Zantac (ranitidine) product liability cases it faced in state courts across the USA. 10 October 2024
Gene therapy start-up GEMMA Biotherapeutics (GEMMABio) has announced a significant partnership with Brazil's Fiocruz, a key supplier for the Brazilian Ministry of Health. 10 October 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon. 10 October 2024
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
California’s Arda Therapeutics, a biotech focused on targeted cell depletion therapies for chronic diseases, has announced the successful completion of a $43 million Series A financing round. 9 October 2024
Purespring Therapeutics, a gene therapy company focused on transforming the treatment of kidney diseases, has raised £80 million ($105 million) in a Series B financing. 9 October 2024
Sage Therapeutics’ share price fell 11% to $6 in pre-market activity on Tuesday, after it announced disappointing top-line results from LIGHTWAVE. 9 October 2024