10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Icelandic biosimilars company and Humira (adalimumab) challenger Alvotech has scored a major win in a lawsuit brought by AbbVie, alleging theft of trade secrets. 8 October 2021
Fortress Biotech subsidiary Cyprium Therapeutics, with support from its licensing partner Sentynl Therapeutics, which is wholly-owned by India’s Cadila Healthcare, today announced positive results from an efficacy and safety analysis of data integrated from two completed pivotal studies in patients with Menkes disease treated with CUTX-101, copper histidinate (CuHis). 8 October 2021
US drugmaker Bristol Myers Squibb has sought to portray a Phase II failure for deucravacitinib as a rare setback for its selective tyrosine kinase 2 (TYK2) inhibitor. 8 October 2021
Carima Andrady, senior regulatory writer at PharmaLex, provides an Expert View on a key consideration when seeking to secure an Orphan Drug designation (ODD) in Europe. 8 October 2021
The US Food and Drug Administration’s Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend use of maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease with genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients. 8 October 2021
AbbVie yesterday announced positive top-line results from the first of two studies of the Phase III SELECT-AXIS 2 clinical trial evaluating the efficacy and safety of Rinvoq (upadacitinib; 15mg, once daily) in patients with active ankylosing spondylitis (AS) who had an inadequate response to biologic DMARD therapy. 8 October 2021
Shares of US clinical-stage biotech Allogene Therapeutics plunged more than 40% in after-hours trading yesterday, following its revelation of a Food and Drug Administration hold on the company’s AlloCAR T clinical trials. 8 October 2021
At a meeting this month, an Institute for Clinical and Economic Review (ICER) committee will assess the comparative clinical effectiveness and value of Bristol Myers Squibb’s mavacamten for the treatment of hypertrophic cardiomyopathy (HCM). 7 October 2021
South Korean contract development and manufacturing organization (CDMO) Samsung Biologics and US drug developer Enzolytics have signed a strategic CDMO partnership agreement. 7 October 2021
Canada-based ImmunoPrecise Antibodies (TSX Venture: IPA) and French drugmaker Pierre Fabre today announced that IPA's subsidiary, Talem Therapeutics and Pierre Fabre have entered a multi-year, multi-target research collaboration with the goal to discover and develop therapeutics antibodies for up to nine targets. 7 October 2021
Swiss privately-held ophthalmics company Oculis has appointed Dr Joanne Chang as chief medical officer and head of portfolio management. 7 October 2021
UK-based medical cannabis R&D company Kanabo Group has signed a partnership agreement with MedoCann Pharma for the development of unique new products with exclusive distribution rights into the German and UK markets. 7 October 2021
Neumora Therapeutics, a US clinical-stage biotech focussed on brain diseases through the integration of data science and neuroscience, announced its launch today. 7 October 2021
Privately-held Danish vaccines company MinervaX has provided an update on clinical progress and announced changes to its executive and scientific advisory boards. 7 October 2021
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents aged 12 years and older with inadequate response to existing therapies. 7 October 2021
UK pharma major GlaxoSmithKline (LSE: GSK), having largely missed out in the race for COVID-19 vaccines, has scored a goal in the fight against a malaria. 7 October 2021
Swedish drugmaker Calliditas Therapeutics has now taken full control of France-headquartered Genkyotex, a leader in NOX inhibition therapies, after the completion of a centralized squeeze out offer to all minority shareholders. 7 October 2021
The value of US gene therapy company Voyager Therapeutics doubled in Wednesday’s early trading following news of a deal with the world’s largest pharma company. 6 October 2021
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024
Swiss generic and biosimilar medicines major Sandoz today announced that it has launched a generic paclitaxel formulation in the USA, the first generic to its reference medicine to be approved by the US Food and Drug Administration (FDA). 11 October 2024
California-based AI company Suki has raised $70 million in new funding to accelerate the growth of its AI-powered voice solutions in healthcare. 11 October 2024
Pfizer is to present initial findings from its CULTIVATE study of its sphingosine-1-phosphate (S1P) receptor modulator Velsipity (etrasimod) in Crohn’s disease (CD) at United European Gastroenterology Week 2024. 11 October 2024
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Switzerland-based KeyBioscience and US pharma major Eli Lilly have agreed to extend their collaboration on the development of dual amylin calcitonin receptor agonists (DACRA), a new class of potential treatments for obesity and related disorders. 11 October 2024
Booster Therapeutics, a biotechnology company pioneering a new class of proteasome activator medicines to treat neurodegenerative and other diseases, has launched with the support of a $15 million financing. 11 October 2024
South Korea’s Samsung Bioepis has released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States. 11 October 2024
German cancer specialist Immatics has announced the pricing of its $150 million public offering, with Jefferies, BofA Securities, and Leerink acting as joint book runners. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
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