10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Seeking to assess the rationality and status of fixed-dose combination (FDCs) drugs licensed prior to 1988, India's Central Drugs Standard Control Organization (CDSCO) has asked stakeholders to submit information on the safety and efficacy of 19 FDCs that bagged the green signal pre-1988. Asking pharmaceutical companies to justify their cocktail of medicines, the CDSCO has opened old wounds, reports The Pharma Letter’s India correspondent. 12 August 2021
Central nervous system (CNS) specialist Axsome Therapeutics will hope a positive report from GlobalData could take the sting out of a recent run of bad news. 12 August 2021
German CNS specialist atai Life Sciences has announced the launch of Revixia Life Sciences, a wholly-owned subsidiary developing Salvinorin A (SalA) to treat a variety of mental health disorders. 12 August 2021
Specialty UK pharma company Shield Therapeutics has entered into an exclusive licence agreement for Accrufer/Feraccru (ferric maltol) with Korea Pharma in the South Korea. 12 August 2021
The US Food and Drug Administration (FDA) has issued a new approval for the combination of Merck & Co’s anti-PD-1 therapy, Keytruda (pembrolizumab) and Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. 12 August 2021
Japanese drugmaker Chugai says it has launched Evrysdi (risdiplam) Dry Syrup 60mg for the treatment of spinal muscular atrophy (SMA). Evrysdi had been approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) on June 23, 2021, and was listed on the national health insurance (NIH) reimbursement price list this week. 12 August 2021
The World Health Organization (WHO) has announced the next phase in its Solidarity trial: Solidarity PLUS will enroll hospitalized patients to test three new drugs in hospitalized COVID-19 patients. 12 August 2021
Eli Lilly has won a positive reimbursement decision in the UK for Verzenios (abemaciclib) as an option for people with advanced HR+ HER2-breast cancer. 12 August 2021
The US Food and Drug Administration (FDA) has recently lifted a clinical hold on the spinal muscular atrophy (SMA) drug OAV-101, an intrathecal (IT) formulation of Zolgensma (onasemnogene abeparvovec). 11 August 2021
UK clinical-stage biotech PureTech Health today announced that Imbrium Therapeutics, a subsidiary of Purdue Pharma, has exercised a license option under the companies’ R&A collaboration agreement to develop PureTech’s LYT-503/IMB-150 (formerly designated as ALV-107), a non-opioid therapeutic candidate being developed for interstitial cystitis/bladder pain syndrome (IC/BPS). 11 August 2021
Yet another public listing via special purpose acquisition company (SPAC) demonstrates the growing popularity of the approach, as an alternative to the traditional initial public offering. 11 August 2021
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients. 11 August 2021
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Marketing Authorization in Great Britain for Ponvory (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features. 11 August 2021
Australia’s Therapeutic Goods Administration (TGA) granted provisional determination for Merck & Co’s molnupiravir, which will be processed by the US pharma major’s Merck Sharp & Dohme (Australia) Pty Ltd (MSD) unit. 11 August 2021
Japan’s Otsuka Pharmaceuticals has been handed a grant for up to $17.8 million from the Bill & Melinda Gates Foundation to support the clinical trial of a treatment-shortening regimen in drug-sensitive tuberculosis (TB). 11 August 2021
In a further move to increase its COVID-19 and other vaccines production capacity, US messenger RNA (mRNA) therapeutics and vaccines company Moderna on Tuesday announced a Memorandum of Understanding (MoU) with the government of Canada to build a state-of-the-art messenger RNA (mRNA) vaccine manufacturing facility in Canada including access to Moderna’s mRNA development engine. 11 August 2021
In the latest twist in the battle to acquire Vectura, the board of the UK inhaled therapies maker today acknowledged that Carlyle, one of the two bidders, has announced it will not improve its 155 pence per share offer for the company, as declared on August 6, through its Murano Bidco vehicle. 11 August 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