10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline, has announced that Apretude (cabotegravir), the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually-acquired HIV-1, has been approved in the USA. 21 December 2021
Some 55 Indian pharmaceutical manufacturing companies may be fulfilling the technical requirements and quality standards needed to produce mRNA COVID-19 vaccines, according to a global report. 21 December 2021
US biotech Moderna has announced preliminary neutralizing antibody data against the Omicron variant following the company’s booster candidates at 50 µg and 100 µg dose levels. 21 December 2021
Clearly French pharma major Sanofi’s appetite for M&A has not been satisfied yet, as the company today announced its sixth acquisition this year. 21 December 2021
Topical dermatology specialist DermBiont has raised $28 million in a series A financing, at the same time as acquiring clinical-stage biotech Chromaderm. 21 December 2021
The European Commission (EC) has granted US biotech Novavax conditional marketing authorization (CMA) for its Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adults. 21 December 2021
AstraZeneca has announced that a supplemental Biologics License Application (sBLA) for Ultomiris (ravulizumab-cwvz) in adults with generalised myasthenia gravis (gMG) has been accepted for Priority Review by the US Food and Drug Administration. 21 December 2021
Shares of bluebird bio closed down 18% at $10.03 yesterday, after it announced that the FDA has placed its clinical program for lovotibeglogene autotemcel (lovo-cel) - previously known as LentiGlobin - as a gene therapy for sickle cell disease (SCD) on partial clinical hold for patients under the age of 18. 21 December 2021
The Food and Drug Administration yesterday approved the second biosimilar insulin product, Eli Lilly’s Rezvoglar (insulin glargine-aglr). 21 December 2021
US biotech Lineage Cell Therapeutics and its subsidiary, Cell Cure Neurosciences, have entered into an exclusive worldwide collaboration and license agreement with Swiss pharma giant Roche and its Genentech affiliate for the development and commercialization of a retinal pigment epithelium (RPE) cell therapy for the treatment of ocular disorders, including advanced dry age-related macular degeneration (dry AMD) with geographic atrophy (GA). 21 December 2021
In March 2021, the US Food and Drug Administration (FDA) announced its continued support for rare disease programs.1 So far, giant strides have been made in the search to find cures for diseases that affect a small percentage of the population, but are devastating in effect. 21 December 2021
Swiss pharma giant Novartis has announced top-line results from PEARL 1 and PEARL 2 Phase III studies in chronic spontaneous urticaria (CSU). 20 December 2021
US biotech Moderna has taken a more conciliatory approach in a row with the National Institutes of Health (NIH) over who is responsible for the creation of the Spikevax coronavirus vaccine. 20 December 2021
In a bid to rescue its controversially approved Alzheimer’s drug that has failed to produce significant sales, US biotech Biogen today announced that, effective January 1, 2022, it will reduce the wholesale acquisition cost (WAC) of Aduhelm (aducanumab-avwa) 100mg/mL injection for intravenous use in the USA by around 50%. 20 December 2021
Swiss pharma giant Novartis has signed an option, collaboration and license agreement with Chinese biotech BeiGene for ociperlimab (BGB-A1217), expanding the company’s R&D activities in immuno-oncology. 20 December 2021
US pharma giant Pfizer and Germany’s BioNTech will amend the clinical study evaluating the safety, tolerability, and immunogenicity of their Comirnaty COVID-19 vaccine in children six months to under five years of age. 20 December 2021
Japanese drug major Eisai today announced an agreement with US biotech Gilead Sciences for the commercialization and distribution of Jyseleca (filgotinib), an oral, JAK1 preferential inhibitor for indications of rheumatoid arthritis (RA), ulcerative colitis, and Crohn's disease in Asia (South Korea, Taiwan, Hong Kong and Singapore). 20 December 2021
German pharma and life sciences group Merck KGaA today announced a strategically focused expansion of its neurology pipeline with the acquisition of the rights to develop cladribine (marketed as Mavenclad for multiple sclerosis) for the treatment of generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). 20 December 2021
The US Food and Drug Administration has granted accelerated approval for Oxbryta (voxelotor), from USA-based Global Blood Therapeutics, to treat sickle cell disease in pediatric patients aged four up to 11 years. 20 December 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