10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Californian cytokine storm specialist Humanigen lost 80% of its market value on Wednesday based on the results of the National Institute of Allergy and Infectious Diseases’ (NIAID) ACTIV-5/BET-B trial. 14 July 2022
Shares of US drug developer Theravance Biopharma were up more than 17% at $10.14 pre-market, following the announcement late Wednesday that it has entered into a definitive agreement to sell all of its units in Theravance Respiratory Company, representing its 85% economic interest in the sales-based royalty rights on worldwide net sales of UK pharma major GSK's (LSE: GSK) Trelegy (fluticasone furoate/ umeclidinium/vilanterol) Ellipta to Royalty Pharma. 14 July 2022
A possible new indication for Sanofi’s IL-13 and IL-4 blocking antibody Dupixent (dupilumab) is on the cards, after a successful Phase III trial. 14 July 2022
Family-owned drugmaker Grünenthal today announced an agreement with fellow Germany-based Bayer to acquire Nebido, a long-acting depot preparation of testosterone undecanoate and a well-known brand for the treatment of male hypogonadism, and its associated brands. 14 July 2022
India's Department for Promotion of Industry and Internal Trade (DPIIT) has been instructed by the Kerala High Court to consider compulsory licensing for the breast cancer drug ribociclib, marketed by Swiss pharma giant Novartis under the brand names Kisqali and Kryxana, reports The Pharma Letter’s local correspondent. 14 July 2022
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended the use of Piqray (alpelisib) for use in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2), locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine-based therapy. 14 July 2022
US biotech Gilead Sciences has announced that the National Institute for Health and Care Excellence (NICE) has recommended the use of Trodelvy (sacituzumab govitecan) in England within its marketing authorization. 14 July 2022
SIGA Technologies saw its shares gain almost 8% to $14.05 today, after it announced around $28 million of procurement orders for oral TPOXX (tecovirimat). 13 July 2022
South Korean firm SK bioscience has announced that SKYCovione, the Asian country’s first COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, has been authorized by the Korean Ministry of Food and Drug Safety. 13 July 2022
Belgian biotech Agomab Therapeutics has extended its series B financing round with an additional close of $40.5 million, bringing the total to $114 million. 13 July 2022
An expert review of data from 79 real-world studies showed that AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [recombinant]) and the available mRNA COVID-19 vaccines provide equally effective protection against hospitalization and death from COVID-19 following two doses. 13 July 2022
US biopharma company Greenwich LifeSciences , which is focused on the development of GLSI-100, announced that the Food and Drug Administration (FDA) has removed the clinical hold permitting the Flamingo-01 Phase III clinical trial to proceed. 13 July 2022
Positive results from the A-SURE study were presented at the 30th International Society on Thrombosis and Hemostasis (ISTH) Congress in London, demonstrating improved prophylactic effectiveness in Elocta (efmoroctocog alfa) treated patients compared to a matched treatment group on SHL FVIII treatments, according to Swedish Orphan Biovitrum, also known as Sobi. 13 July 2022
Shares of Finnish drugmaker Orion Corporation jumped 7.6% to 47.60 euros by mid-morning, as it announced an important collaboration with US pharma giant Merck & Co. 13 July 2022
Agios Pharmaceuticals, a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, today announced that effective August 8, 2022, Jackie Fouse will transition to the role of chairwomen of the board of directors and Brian Goff will assume the role of chief executive officer. 13 July 2022
A firm developing a novel vaccine technology, which could offer safer and more effective protection against infectious diseases, has appointed a new chief executive officer. 13 July 2022
The cell regeneration medicines market is currently valued at $30.3 billion and is anticipated to reach the valuation of $34.3 billion by the end of 2032 by growing at a CAGR of 14.4%, according to the latest report published by Future Market Insights. 13 July 2022
Centauri Therapeutics, a UK-based immunotherapy company focused on the treatment of infectious diseases, has announced three senior appointments at once. 12 July 2022
Early research conducted at the University of Birmingham, UK, shows that the novel ATM blocker AZD1390 can promote regeneration of damaged nerve cells, potentially restoring sensory and motor function after a spinal injury. 12 July 2022
Israeli generics giant Teva Pharmaceutical Industries today announced that its US subsidiary has reached an agreement with the City and County of San Francisco and the People of the State of California that settles opioid-related claims asserted on behalf of the County and City of San Francisco. 12 July 2022
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
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