10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Biotech major Gilead Sciences has announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with azacitidine. 12 April 2022
The UK is set to become the first country to pay pharmaceutical companies a fixed fee for supplying antibiotics in an effort to tackle the growing global crisis over resistance to the drugs, according to a draft guidance published today by health technology assessor the National Institute of Health and Care Excellence (NICE). 12 April 2022
US pharma major Bristol Myers Squibb has revealed details results of the Phase III CheckMat -816 trial in patients with resectable non-small cell lung cancer (NSCLC). 12 April 2022
Australia’s Telix Pharmaceuticals saw its shares edge up 2.3% to A$4.51 as it revealed it has licensed exclusive worldwide rights from Eli Lilly to develop and commercialize radiolabelled forms of olaratumab for diagnosis and treatment of soft tissue sarcoma. 12 April 2022
Privately-held UK biotech Engitix has entered into an agreement with Japan’s Takeda to expand an existing collaboration to now include the discovery and development of novel therapeutics for fibrostenotic inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis. 12 April 2022
The new pledge from member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA) should drastically increase the availability of innovative medicines in EU countries and decrease the time patients must wait for new medicines by several months. 12 April 2022
At 16 weeks, 70% of patients with moderate-to-severe atopic dermatitis (AD) receiving lebrikizumab combined with standard-of-care topical corticosteroids (TCS) achieved at least 75% improvement in overall disease severity (EASI-75) in the ADhere trial. 12 April 2022
Miami-based Veru has announced positive efficacy and safety results from a planned interim analysis of the Phase III COVID-19 trial evaluating oral sabizabulin 9mg versus placebo in 150 hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS). 11 April 2022
Unofficial US drug price watchdog the Institute for Clinical and Economic Review (ICER) has published a new white paper in collaboration with researchers at NORC at the University of Chicago. 11 April 2022
Global investment firm Carlyle announced today that it has agreed to acquire Abingworth, a transatlantic life sciences investment firm with over $2 billion in assets under management (AUM), to bolster Carlyle’s leading global healthcare franchise and enter the biotech financing arena. 11 April 2022
Confirming it has a lot more to offer than just the highly successful COVID-19 vaccine Comirnaty, Germany’s BioNTech has presented data from its ongoing first-in-human Phase I/II trial evaluating the safety and preliminary efficacy of the company’s novel CAR-T cell therapy candidate, BNT211, in patients with advanced solid tumors. 11 April 2022
Lundbeck recently completed a global Phase IV, randomized, comparative study exploring the role of vortioxetine as a treatment option between SSRIs and serotonin–noradrenaline reuptake inhibitors (SNRIs), the Danish CNS specialist announced today. 11 April 2022
New data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2022 in New Orleans, showing that patients with non-small cell lung cancer (NSCLC) who received the targeted therapy sotorasib experienced extended survival and good quality of life. 11 April 2022
The UK’s National Institute for Health and Care Excellence (NICE) has issued an update on a recent appraisal consultation which took place for the following drugs for treating atopic dermatitis: 11 April 2022
US biotech Seagen announced that a jury in the US District Court for the Eastern District of Texas found that Japanese pharma major Daiichi Sankyo infringed Seagen’s US Patent No 10,808,039 by selling its cancer drug Enhertu (trastuzumab deruxtecan; DS-8201) in the USA. 11 April 2022
Danish CNS specialist Lundbeck said on Friday it has has appointed Joerg Hornstein as chief financial officer (CFO) and member of its executive management. He will assume the role no later than September 1, 2022, and he will be registered with the Danish Business Authority. 11 April 2022
Australia’ Therapeutic Goods Administration (TGA) has provisionally approved the Pfizer COVID-19 vaccine, Comirnaty, for use as a booster in individuals aged 12 to 15 years old. The TGA provisional approval is the first step in the two green light approval process consistently applied throughout the COVID 19 Vaccine program. 11 April 2022
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
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