10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
The European Medicines Agency (EMA) has recommended granting a marketing authorization for COVID-19 Vaccine (inactivated, adjuvanted) Valneva, developed by developed by French company Valneva, for use in the primary vaccination of people from 18 to 50 years of age. 23 June 2022
Detailed results from the positive FoCus Phase III trial in Wilson disease showed that ALXN1840, an investigational once-daily, oral medicine, met its primary endpoint demonstrating three-times greater copper mobilization from tissues compared to the standard of care (SoC) arm (Least Square Mean Difference [LSM Diff] 2.18 µmol/L; p< 0.0001), including in patients who had been treated previously for an average of 10 years. 23 June 2022
Shares in Athira Pharma, a US biopharma focused on developing small molecules to restore neuronal health and slow neurodegeneration, closed nearly 70% lower on Wednesday. 23 June 2022
Swiss pharma giant Novartis has received an Accelerated Approval in the USA for its combination BRAF/MEK inhibitor therapy, for certain biomarker-defined tumors. 23 June 2022
Swiss pharma giant Novartis today announced that the European Commission (EC) approved Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. 23 June 2022
invoX Pharma, a wholly-owned subsidiary of Sino Biopharmaceutical that is focused on research and development (R&D) and business development activities outside of China, today announced that it has entered into a definitive agreement to acquire all of the issued and outstanding shares of F-star Therapeutics’ common stock. 23 June 2022
US biotech Moderna announced new clinical data on its bivalent (Omicron) COVID-19 booster candidate, mRNA-1273.214, leading the company’s share price to close 5% higher on Wednesday. 23 June 2022
US pharma giant Merck & Co has announced that Chirfi Guindo will lead Human Health Marketing as chief marketing officer for Merck Human Health, and will join Merck’s executive team, effective July 1, 2022. 23 June 2022
When Sierra Oncology announced positive top-line results from the MOMENTUM trial earlier this year, certain execs at Gilead Sciences may have had a sinking feeling. 23 June 2022
Despite tremendous political-economic challenges that Egypt faced in last two decades, Egypt still remains the largest producer and consumer of pharmaceuticals in the entire Middle East and Africa region with a market value of EGP 56.6billion (US$2.9 billion) in 2022 for pharmaceutical sales. 23 June 2022
Emerging US biopharma firm Mycovia Pharmaceuticals has shared top-line results from evaluating Vivjoa (oteseconazole) capsules in patients suffering from recurrent vulvovaginal candidiasis (RVVC). 23 June 2022
Serum Institute of India’s (SII) Cervavac - a quadrivalent human papillomavirus (qHPV) vaccine - is likely to be the first indigenous qHPV vaccine to be approved in India. 23 June 2022
The US Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) unanimously voted to include Vaxneuvance (pneumococcal 15-valent conjugate vaccine) as a recommended option for vaccination in infants and children, including routine use in children under two years of age, US pharma giant Merck & Co announced yesterday. 23 June 2022
Just three months after Nutcracker Therapeutics’ announcement of receiving $167 million in Series C funding, three new leadership positions have been filled alongside the release of its oncology and disease-focused pipeline. 22 June 2022
UK-based biotech Roquefort Therapeutics is to acquire Oncogeni in an all-share transaction which sources value at around £4 million ($4.9 million). 22 June 2022
Swiss independent dermatology specialist Galderma today announced the phase III OLYMPIA 2 trial met all primary and key secondary endpoints, showing nemolizumab as monotherapy significantly improved skin lesions and pruritus (itch) compared with placebo in adult patients with moderate to severe prurigo nodularis. 22 June 2022
The 32nd edition of EY’s Beyond borders report found that despite global upheavals, including geopolitical complexities and the COVID-19 pandemic, the US and European biotechnology industries have not only stayed on course, but thrived on innovation. 22 June 2022
One of the most important coronavirus vaccine developers and a pioneer in mRNA technologies, Moderna, is to launch a major manufacturing and R&D hub in the UK. 22 June 2022
Belgian biotech company Galapagos (Euronext: GLPG) announced that it will acquire Dutch cell therapy company CellPoint and AboundBio to boost access to next-generation cell therapies, for around $250 million. 22 June 2022
The stock markets took a liking to Precision BioSciences, a gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, on Tuesday and Wednesday. 22 June 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