10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
US clinical-stage biotech Pieris Pharmaceuticals (Nasdaq: PIRS) today announced the promotions of Thomas Bures to chief financial officer and Ahmed Mousa to chief business officer. 6 October 2021
Johnson & Johnson has announced a new analysis of Stelara (ustekinumab), using safety data from 13 clinical studies across approved indications. 6 October 2021
Healthcare giant Johnson & Johnson has submitted data to the US Food and Drug Administration (FDA) to support use of a booster shot of its COVID-19 vaccine in adults. 6 October 2021
Japan’s largest drugmaker Takeda Pharmaceutical saw its shares fall 6.4% to 3,340 yen this morning, after it revealed that a safety signal has emerged in Phase II studies of TAK-994, an investigational oral orexin agonist. 6 October 2021
New research conducted by Pfizer and published in The Lancet shows effectiveness of the firm’s coronavirus jab waning over time, although not due to the Delta variant of the virus. 6 October 2021
German family-owned drug major Boehringer Ingelheim today inaugurated its state-of-the-art biopharmaceutical production facility Large Scale Cell Culture (LSCC) in Vienna, Austria. 6 October 2021
USA-based microbiome company Vedanta Biosciences says that its Phase II clinical trial of VE303, an orally administered investigational live biotherapeutic product in development for the prevention of recurrent Clostridium difficile infection (CDI) in high-risk patients, met its primary endpoint of preventing disease recurrence through Week 8. 6 October 2021
Australia’s Therapeutic Goods Administration (TGA) has granted provisional determination to the local subsidiary of US pharma giant Pfizer in relation to a new combination therapy containing PF-07321332 and ritonavir, for the treatment of adult patients with symptomatic, confirmed coronavirus infection. 6 October 2021
Spanish plasma specialist Grifols says it has closed its issuance of senior unsecured notes for the equivalent of 2 billion euros ($2.32 billion) to finance its investment in Biotest AG.
The issuance, launched on September 6 October 2021
For the first time in 20 years, a new therapy for sickle cell disease is to be made available on the UK's National Health Service (NHS). 5 October 2021
Ireland-headquartered biotech Horizon Therapeutics has announced the publication of a post-hoc analysis from the N-MOmentum Phase II/III pivotal trial of Uplizna (inebilizumab-cdon), which highlights a sustained effect on attack risk with no new safety signals in people with neuromyelitis optica spectrum disorder (NMOSD) who received the treatment for four or more years. 5 October 2021
US biotech Xencor saw its shares gain 5.5% by close of trading and a further 2% to $36.23 after hours, following its revelation of a second deal with US health care giant Johnson & Johnson. 5 October 2021
The global antibacterial drugs market is projected to grow at a modest compound annual growth rate (CAGR) of 2.6% between 2021 and 2031, according to a Fact MR report. 5 October 2021
UK pharma major AstraZeneca has submitted a request to the US Food and Drug Administration for an Emergency Use Authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination, for prophylaxis of symptomatic COVID-19. 5 October 2021
The list of rare (orphan) diseases, which consists of more than 200 diseases in Russia, needs to be updated, according to recent statements by Galina Izotova, deputy chairman of the Russian Audit Chamber. 5 October 2021
US biotech Enanta Pharmaceuticals has delivered an update on its two clinical stage farnesoid X receptor (FXR) agonists, EDP-305 and EDP-297, in non-alcoholic steatohepatitis (NASH). 5 October 2021
Pushing ahead in the race to develop a vaccine for respiratory syncytial virus (RSV), Johnson & Johnson has announced impressive Phase II data and the initiation of late-stage testing. 5 October 2021
Xenon Pharmaceuticals saw its shares rise more than a 100% in regular trading and a further 5% to $33.01 after-hours yesterday, as it released encouraging clinical results with its epilepsy candidate. 5 October 2021
The European Medicines Agency’s human medicines committee (CHMP) has concluded that an extra dose of the COVID-19 vaccines Comirnaty, from Pfizer and BioNTech, as well as Spikevax, marketed by Moderna, may be given to people with severely weakened immune systems, at least 28 days after their second dose. 5 October 2021
The illegal drug market in Russia is estimated to be worth 15–20 billion roubles ($205-274 million), according to a recent study, conducted by analysts at RNC Pharma, one of Russia’s leading pharma analytics agencies. 5 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