10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Russian drugmaker and global pharma companies will significantly reduce the production of anti-COVID-19 vaccines, however the same plans are not considered in case of other drugs, according to recent statements by representatives of producers and some media, reports The Pharma Letter’s local correspondent. 1 March 2022
South African biopharma Biovac has teamed up with a consortium of nine development partners to expand the firm’s vaccine manufacturing plant capacity, and enable the production of the Pfizer and BioNTech COVID-19 jab and other vaccines. 1 March 2022
US pharma major AbbVie has recently submitted a supplementary new drug application (sNDA) to the US Food and Drug Administration for Vraylar (cariprazine) as the adjunctive treatment of major depressive disorder (MDD). 1 March 2022
Legend Biotech, a clinical stage CAR-T immuno-oncology biotech spun out of Hong Kong-listed GenScript Biotech, says that the US Food and Drug Administration has approved its first product, Carvykti (ciltacabtagene autoleucel; cilta-cel). 1 March 2022
Shares of Ireland-headquartered rare diseased biotech Amryt Pharma fell as much as 31% yesterday, after it announced the receipt of a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application (NDA) for Oleogel-S10. 1 March 2022
Shares of Belgium biotech Celyad Oncology closed down 13.8% at 2.46 euros yesterday, after it announced it has taken the decision to voluntarily pause the CYAD-101-002 (KEYNOTE-B79) Phase Ib trial (NCT04991948). 1 March 2022
Are multinational pharmaceutical companies losing ground in India? The ongoing restructuring and overhaul taking place at several multinational drug companies based in India, including the sale of brands and the closing of non-core units, came up for discussion at a recent event, reports The Pharma Letter’s India correspondent. 1 March 2022
Swiss company Vifor Pharma today announced the Swiss launch of Rayaldee (extended-release calcifediol), the first and only oral therapy approved in Europe for the treatment of secondary hyperparathyroidism (SHPT). 1 March 2022
US biotech Affinivax yesterday announced it has reacquired the exclusive worldwide rights to ASP3772, a novel vaccine candidate targeting Streptococcus pneumoniae, from Japanese pharma major Astellas Pharma. 1 March 2022
Further data has been presented on AstraZeneca and Amgen’s Tezspire (tezepelumab), which was recently approved in the USA for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. 28 February 2022
Arbutus Biopharma’s shares were up 4.3% at $3.21 after, along with, Genevant Sciences, today filed a lawsuit in the US District Court for the District of Delaware against Moderna and one of its affiliates. 28 February 2022
In a European worksharing procedure (WSP), Germany’s Merck KGaA Glucophage (metformin hydrochloride) and its immediate and extended release versions have been approved as the first oral anti-diabetic medication to be used safely during pregnancy. 28 February 2022
US precision therapy company Blueprint Medicines’ shares dipped more than 2% to $61.62 early today, after it announced a strategic collaboration with Proteovant Therapeutics to advance novel targeted protein degrader therapies to address important areas of medical need. 28 February 2022
Meletios Therapeutics, a French biotechnology company formed in 2020, announced it has signed an exclusive license agreement with the Institut Pasteur for the development of a new class of antiviral treatments. 28 February 2022
Bold investments in BlueRock, AskBio and Vividion have shown the ambition of Bayer’s new approach towards R&D, and another sign of intent was the German company’s appointment of Christian Rommel in late 2020. 28 February 2022
South Korea’s GC Pharma saw its shares fall 6.2% to 182,000 won, after it revealed it has received a Complete Response Letter (CRL) from the US Food and Drug Administration in response to its Biologics License Application (BLA) for Alyglo (immune globulin intravenous (human), 10% liquid). 28 February 2022
Spanish plasma-derived medicines company Grifols has entered into a collaboration with Endpoint Health, a US precision-medicine therapeutics company dedicated to addressing urgent needs in immune-driven critical care, to develop and commercialize an antithrombin III (AT-III) therapy to treat sepsis. 28 February 2022
Brazil’s Oswaldo Cruz Foundation (Fiocruz), through the Immunobiological Technology Institute (Biomanguinhos), provides the first doses of the COVID-19 vaccine (recombinant) produced with the national Active Pharmaceutical Ingredient (API). 28 February 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