10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Privately-held German biotech Ariceum Therapeutics, which is focused on developing radiopharmaceutical products for the diagnosis and systemic targeted radiation therapy of certain hard-to-treat cancers, has named Serge Sagodira its chief business officer. 7 July 2022
US development-stage mRNA-technology company Kernal Biologics today announced the completion of a $25 million Series A led by Hummingbird Ventures. 7 July 2022
Cambridge, USA-based gene therapy company Sarepta Therapeutics has released positive data from multiple studies investigating its Duchenne muscular dystrophy (DMD) candidate SRP-9001. 7 July 2022
Shares in Minneapolis-based DiaMedica Therapeutics, a biopharma focused on developing novel treatments for neurological disorders and kidney diseases, were down by a third in pre-market trading on Thursday. 7 July 2022
China-based WuXi STA, a subsidiary of WuXi AppTec (SHA: 603259), today announced the opening of a new large-scale oligonucleotide and peptide manufacturing facility at its Changzhou campus. 7 July 2022
The US Food and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir) for the treatment of COVID-19, to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. 7 July 2022
It is an exciting time within the schizophrenia market as numerous monotherapies and adjunctive therapies are being developed to address some of the most important unmet needs observed with current antipsychotic treatments. 7 July 2022
Biotech BeiGene has entered into a worldwide strategic collaboration with InnoRNA, a privately-held LNP-based delivery technology and mRNA drug discovery specialist. 6 July 2022
The US Association for Accessible Medicines’ (AAM) Biosimilars Council has released an update on major developments in the biosimilars sector by executive director Craig Burten. 6 July 2022
German companies Evotec and Boehringer Ingelheim have joined forces with French diagnostics firm bioMérieux to form a joint venture to fight antimicrobial resistance (AMR). 6 July 2022
Privately-held US biotech Skyhawk Therapeutics has announced an exclusive worldwide collaboration agreement with French pharma major Sanofi to discover and develop novel small molecules that modulate RNA splicing for challenging oncology and immunology targets. 6 July 2022
Japanese drugmaker Eisai’s shares gained almost 6% to 6,167 yen after, along with partner Biogen, it announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) under the accelerated approval pathway for lecanemab (BAN2401). 6 July 2022
Norwegian biopharma Nordic Nanovector has provided a disappointing update on PARADIGME, its Phase IIb trial of Betalutin (177Lu lilotomab satetraxetan) in third-line relapsed and anti-CD20 refractory follicular lymphoma. 6 July 2022
Excited by the prospect of renewed regulatory support for amyotrophic lateral sclerosis (ALS) candidate AMX0035, investors bought up shares in Amylyx Pharmaceuticals before the opening bell on Tuesday. 6 July 2022
Trials of a potentially curative remedy for type 1 diabetes (T1D) will continue, after the US Food and Drug Administration lifted a clinical hold on the candidate. 6 July 2022
Shares of Swiss pharma giant Roche edged up 2% to 325.35 francs this morning, after it announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for Lunsumio (mosunetuzumab). 6 July 2022
With rapidly increasing worldwide prevalence, Alzheimer’s disease (AD) has been identified as a major global health threat by the international medical community. 6 July 2022
Urovant Sciences has entered into an exclusive license agreement with French drugmaker Pierre Fabre to register and commercialize vibegron, trade named Gemtesa, for the treatment of overactive bladder (OAB) in certain countries. 5 July 2022
Gene expression company Syros Pharmaceuticals is to acquire TYME Technologies in a deal that values the oncology-focused biotech at around $60 million. 5 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