10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
The US Food and Drug Administration on Friday said it has approved Ztalmy (ganaxolone) to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two years of age and older. 19 March 2022
Due to Russia’s military invasion of the Ukraine, global pharma companies are massively refusing to conduct clinical trials of their drugs in Russia, which means that the launch of these drugs in the local market will be impossible 19 March 2022
The British business of Japanese pharma major Takeda Pharmaceutical has secured conditional approval in the UK for its first-in-class oral tyrosine kinase inhibitor (TKI) Exkivity (mobocertinib). 18 March 2022
An Expert View from Jennifer Romanski, a principal of Porzio, Bromberg & Newman and a co-chair of its Life Sciences Compliance and Regulatory Counseling Department. She is also a senior vice president at Porzio Life Sciences, a wholly-owned subsidiary of the law firm. 18 March 2022
Rare diseases specialist Swedish Orphan Biovitrum, also known as Sobi, today announced that China’s National Medical Products Administration (NMPA) has approved Gamifant (emapalumab) for use in China. 18 March 2022
China’s Ignis Therapeutics and Germany’s STADA Arzneimittel’s Britannia Pharmaceuticals UK affiliate today jointly announced the signing of an exclusive licensing agreement under which Ignis Therapeutics will develop and commercialize subcutaneous apomorphine for Parkinson's disease in mainland China, Hong Kong and Macau. 18 March 2022
French drugmaker Sanofi has moved forward with the Euronext listing of EUROAPI, which has been billed as the future leading European company dedicated to the development, production and marketing of active pharmaceutical ingredients (API). 18 March 2022
Chiesi Global Rare Diseases, a business unit of privately-held Italian drugmaker Chiesi Farmaceutici, and Israeli firm Protalix BioTherapeutics today announced final results from the Phase III BRIGHT study evaluating pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease. 18 March 2022
Following the release of a draft text for the World Trade Organization (WTO)-led waiver on intellectual property (IP) for COVID-19 vaccines, the European Federation of Pharmaceutical Industries and Associations (EFPIA) calls on governments across Europe and around the world to urgently rethink discussions on a COVID vaccine waiver and instead focus on the real barriers to global vaccine equity. 18 March 2022
US mRNA specialist Moderna is the latest to request to the US Food and Drug Administration (FDA) for an amendment to the emergency use authorization (EUA) to allow for a fourth dose of its COVID-19 vaccine (mRNA-1273). 18 March 2022
The US Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. 18 March 2022
In Germany and France, a new research collaboration will investigate the neurodegenerative disease spinocerebellar ataxia type 3 (SCA3), in collaboration with Servier Laboratories. 18 March 2022
The Medicines Patent Pool (MPP) has signed agreements with 35 companies to manufacture the generic version of Pfizer’s oral COVID-19 treatment Paxlovid (nirmatrelvir/ritonavir) to be supplied in 95 low- and middle-income countries. 17 March 2022
Shares of CNS focussed US pharma firm Impel NeuroPharma were up 5.3% at $6.98 early afternoon, having risen as high as $7.24, after it announced two separate transactions with funds managed by Oaktree Capital Management, totaling $100 million in gross funding. 17 March 2022
RNAi therapeutics company Alnylam Pharmaceuticals has begun patent infringement proceedings in respect of technologies used to develop two novel coronavirus vaccines. 17 March 2022
Boston, USA-based pricing watchdog The Institute for Clinical and Economic Review (ICER) has published a revised assessment of the relative merits of two possible competitors in hematology. 17 March 2022
France-based biotech OSE Immunotherapeutics’ shares closed up more than 5% at 7.54 euros yesterday, after it announced positive analysis of the long-term immune T cell responses of CoVepiT, its prophylactic vaccine candidate against COVID-19. 17 March 2022
Privately-held Danish dermatology specialist LEO Pharma today report financials for full-year 2021, noting that net sales grew 5% to 9,957 million kroner ($1.47 billion) when excluding discontinued and divested products. 17 March 2022
Swiss biopharma Relief Therapeutics’ subsidiary, APR Applied Pharma Research, has reported final data from its clinical trial of nasal spray, Sentinox, in SARS-CoV-2 infected patients. 17 March 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