10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Shares in Merck & Co were 3% down at lunchtime Friday after the company and its partner Ridgeback Biotherapeutics provided an update on the MOVe-OUT study of molnupiravir, an investigational oral antiviral medicine for COVID-19. 26 November 2021
Not many companies in the pharmaceutical sector can say that they have kept growing and targeting growth through the pandemic, while maintaining the same commitment to their values, patients and employees. 26 November 2021
Preventing regulatory delays from slowing down the journey of new medicines from laboratory to patients in Europe is the ambition behind a new report endorsed by trade associations, patient groups and other organizations. 26 November 2021
US RNA-targeted drug developer Ionis Pharmaceuticals announced on Wednesday that partner Pfizer has provided an update on the Phase IIb study of vupanorsen, formerly IONIS-ANGPTL3-LRx. 26 November 2021
The UK subsidiary of Italian family-owned Chiesi Farmaceutici announced yesterday that pegunigalsidase alfa (PRX-102) was awarded Innovation Passport status by the UK Medicines and Healthcare products Regulatory Agency (MHRA) on August 25, 021. 26 November 2021
Japanese drug majors Takeda Pharmaceutical and Sumitomo Dainippon Pharma announced today that Takeda will succeed the manufacturing and marketing approval and the marketing rights of Replagal (agalsidase alfa) for Fabry disease, an α-galactosidase enzyme intravenous (IV) infusion, as of February 15, 2022. 26 November 2021
Fitusiran, an investigational siRNA therapeutic targeting antithrombin for the treatment of hemophilia, has shown its efficacy in late-stage trials. 25 November 2021
Japanese mid-size drugmaker Mochida Pharmaceutical and Ayumi Pharmaceutical announced that Adalimumab BS MA (adalimumab biosimilar, code: LBAL) has now been launched in Japan as the NHI (National Health Insurance) drug price has been listed today. 25 November 2021
Privately-held Italian biopharma company Dompé Farmaceutici has announced the sale of six brands to French drugmaker Substipharm, which specializes in niche generic and mature pharmaceutical products. 25 November 2021
Japanese drugmaker Ono Pharmaceutical and its partner Bristol Myers Squibb have announced the approval for the use of Opdivo (nivolumab) in two new indications in Japan. 25 November 2021
The European Medicines Agency’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged five to 11. 25 November 2021
Swiss anti-counterfeit medicine group Fight the Fakes Alliance (FTF Alliance) is gearing up for a week of action to help raise awareness around the issue of fake medicines. 25 November 2021
British specialty medicines firm Essential Pharma today announced the closing of two transactions with fellow UK-based Rosemont Pharmaceuticals. 25 November 2021
US pharma major Eli Lilly says that, following a decision by the UK’s National Institute for Health and Care Excellence (NICE), adults with advanced RET fusion-positive non-small cell lung cancer (NSCLC) will now have access to Retsevmo (selpercatinib), a targeted treatment option, via the Cancer Drugs Fund (CDF) in England. 25 November 2021
Members of the European Parliament (MEPs) yesterday put forward proposals to make medicines more affordable and boost transparency on prices and promote joint European Union public procurement. 25 November 2021
The leading Australian trade group for the pharmaceutical industry has welcomed the delivery of a report into the medicines approval process in the country. 25 November 2021
Livtencity (maribavir), an antiviral from Japanese drugmaker Takeda, has won an approval from the US Food and Drug Administration (FDA). 24 November 2021
A life-changing drug that can improve mobility in children and adults with a rare genetic condition will be available on the National Health Service (NHS) following a new commercial deal, chief executive Amanda Pritchard announced. 24 November 2021
Shares of US biotech firm Kura Oncology slumped nearly 23% to $16.60 premarket today, after it announced that the US Food and Drug Administration has placed the KOMET-001 Phase Ib study of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML) on a partial clinical hold. 24 November 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
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