10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
USA-based Tiziana Life Sciences has moved fast to strengthen its management team following this week’s announcement of the resignation of Kunwar Shailubhai as chief executive, chief scientific officer and board director, effective as of August 1. 19 July 2022
Along with providing a program update on GTX-102 for the treatment of Angelman syndrome (AS), Ultragenyx Pharmaceuticals today announced it will acquire GeneTx Biotherapies, its partner on the candidate. 19 July 2022
US biotech Gilead Sciences and the European Commission today signed a new joint procurement agreement (JPA) that will ensure continued rapid and equitable access to Veklury (remdesivir) for participating member states across the European Union (EU) and European Economic Area (EEA). 19 July 2022
US biopharma firm Apellis Pharmaceuticals today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review designation for the intravitreal pegcetacoplan New Drug Application (NDA). 19 July 2022
Swedish rare disease specialist Hansa Biopharma has entered into an agreement with USA-based NovaQuest Capital Management, securing $70 million in non-dilutive financing, with the news propelling Hansa’s shares 30% higher to 72.70 kronor. 19 July 2022
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. 19 July 2022
Novartis has reported slightly lower than expected revenues for the second quarter, which came in at $12.78 billion, a 1% decline from the same period of last year. 19 July 2022
Swedish Orphan Biovitrum today released financial results covering the second quarter of 2022, showing that revenues came in at 3,876 million kronor ($369 million), a rise of 21% (+10% at constant exchange rates). 19 July 2022
Shares of US biotech firm Sesen Bio plunged nearly 32% to $0.62 yesterday, after it announced that it has made the strategic decision to voluntarily pause further development in the USA of its lead asset, Vicineum (oportuzumab monatox-qqrs). 19 July 2022
Japanese drugmaker Daiichi Sankyo today announced today that the US Patent and Trademark Office (PTO) has granted Seagen’s request for rehearing of the decision to institute post-grant review, and therefore decided not to proceed with the post-grant review process in which Daiichi Sankyo was contesting the patentability of certain claims within Seagen’s US patent 10,808,039 (the ’039 patent). 19 July 2022
Belgian biotech Bone Therapeutics has announced changes to the statistical analysis and the implementation of an interim analysis for the ongoing Phase IIb trial of its allogeneic bone cell therapy product, ALLOB. 18 July 2022
The UK’s National Institute for Health and Care Excellence (NICE) has issued guidance that recommends Imcivree (setmelanotide) as an option for treating hyperphagia and obesity and controlling hunger caused by pro-opiomelanocortin (POMC) deficiency, including proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency in people six years of age and over. 18 July 2022
India’s healthcare and pharmaceutical sector recorded hectic deal activity with the value of merger and acquisitions (M&A) in the first six months of 2022 scaling a record high to touch $4.32 billion compared to $2.02 billion in the comparative period last year, and crossing the total deal value of $3.35 billion in 2021. 18 July 2022
Member companies of trade group Pharmaceutical Research and Manufacturers of America (PhRMA) continued investment in research and development (R&D) has led to new medicines transforming human health. 18 July 2022
Qulipta (atogepant) has taken another step on its way to becoming a significant force in the world of calcitonin gene-related peptide (CGRP) receptor blocking migraine drugs. 18 July 2022
The Russian Associations of cancer patients have called on the European Coalition of Cancer Patients and the Russian Ministry of Health to conduct additional talks with US pharma major Bristol-Myers Squibb, to continue the supplies of some of the company’s anticancer drugs to the Russian market, reports The Pharma Letter’s local correspondent. 18 July 2022
Swiss biopharma company Relief Therapeutics today announced that its collaboration partner, Acer Therapeutics for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders (UCDs), has resubmitted its New Drug Application (NDA) for ACER-001 to the US Food and Drug Administration (FDA). 18 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