Regulation
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Biosimilars
The European Union is currently reviewing its pharmaceutical legislation, and the latest IQVIA white paper “Assessing the biosimilar void” sheds light on the growing biological medicines market and the opportunity to improve equitable access with biosimilar medicines competition. 26 October 2023
Biotechnology
Gene editing company Verve Therapeutics has been cleared by the US regulator to go ahead with what will be the first in-human base editing study in the country, 26 October 2023
Biotechnology
Independent data monitors have recommended that French microbiome specialist MaaT Pharma continues its Phase III ARES study without modification. 26 October 2023
Pharmaceutical
Danish diabetes care giant Novo Nordisk recently revealed that its FLOW trial, which studies Ozempic (semaglutide) in diabetic patients with chronic kidney disease (CKD), will come to a halt almost one year prior to the planned completion date, as interim results alone were sufficient in proving that the treatment was successful in treating kidney failure in this patient group. 26 October 2023
Pharmaceutical
China’s National Medical Products Administration (NMPA) has approved ViiV Healthcare’s Vocabria (cabotegravir injection) used in combination with Rekambys (rilpivirine long-acting injection) for the treatment of HIV-1 infection. 26 October 2023
Pharmaceutical
USA-based BioXcel Therapeutics on Wednesday revealed that an independent third-party review of the data from a site in its TRANQUILITY II Phase III trial showed "positive findings." 26 October 2023
Generics
Indian generics major Zydus Lifesciences has announced the US Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Zituvio (sitagliptin) tablets, 25mg, 50mg, and 100mg. 25 October 2023
Pharmaceutical
The US Food and Drug Administration yesterday approved Tibsovo (ivosidenib), from French independent pharm major Servier, for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test. 25 October 2023
Pharmaceutical
Privately-held French company Orphelia Pharma, which is focused on pediatric and orphan medicines, has filed a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Kizfizo, the first oral liquid formulation of temozolomide. 24 October 2023
Pharmaceutical
Medicines regulator Health Canada has approved Orgovyx (relugolix), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of men with advanced prostate cancer, Japanese drugmaker Sumitomo Pharma announced. 24 October 2023
Generics
The European Commission has today adopted a set of actions to better prevent and mitigate critical medicine shortages in the European Union (EU), this winter, next winter and beyond. 24 October 2023
article
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Byooviz (ranibizumab-nuna) as a biosimilar product interchangeable with Lucentis (ranibizumab). 24 October 2023
Biosimilars
The US business of South Korea's Celltrion Healthcare has secured approval for Zymfentra (infliximab-dyyb), a subcutaneous reformulation of infliximab. 24 October 2023
Biotechnology
Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC). 23 October 2023
Pharmaceutical
The US Food and Drug Administration (FDA) on Friday approved Penbraya (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides coverage against the five most common serogroups causing meningococcal disease in adolescents and young adults aged 10 through 25 years. 23 October 2023
Biotechnology
As drugmakers around the world rush to embrace the potential of artificial intelligence (AI) in the design and development of new medications, the World Health Organization has urged caution. 23 October 2023
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today authorized a new medicine called, Tepkinly (epcoritamab), as a treatment for diffuse large B-cell lymphoma (a type of blood cancer) in adults. 20 October 2023
Biotechnology
Californian advanced therapy company Nkarta moving forward with plans to leverage the potential of natural killer (NK) cell-based treatments outside of oncology. 19 October 2023
Biotechnology
The European Commission (EC) has now approved Adcetris (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma. 19 October 2023
Biotechnology
After scientific advisors recommended that the US regulator not approve a new amyotrophic lateral sclerosis (ALS) therapy, developer BrainStorm Cell Therapeutics has opted to withdraw its submission. 19 October 2023
Biotechnology
Zhongshan-based biopharma company Akeso will await the verdict of the Chinese medicines regulator on a penpulimab-based combo therapy. 22 November 2024
Pharmaceutical
The nomination of Robert F Kennedy Jr — known as RFK Jr — for the role of US Secretary of the Department of Health and Human Services (HHS) President-elect Donald Trump sent shares in vaccine companies sharply downwards. 22 November 2024
Biotechnology
British pharma major AstraZeneca is facing challenges in its bid to secure full approval for its anticoagulant reversal therapy, Andexxa (andexanet alfa), in the USA. 22 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024
Biotechnology
Astellas Pharma has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol). 21 November 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Pharmaceutical
Anthony Harnden has been appointed as the new chair of the UK’s Medicine and Healthcare products Regulatory Agency (MHRA). 20 November 2024
Pharmaceutical
Australia’s Therapeutic Goods Administration (TGA) yesterday warned that health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under six years of age. 20 November 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday approved the medicine Filspari (sparsentan) from Vifor France to treat primary immunoglobulin A nephropathy (IgAN). 19 November 2024
Biosimilars
Following US approval in May this year, South Korea’s Samsung Bioepis and US biotech Biogen have now won approval from the European Commission (EC) for their Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing Regeneron and Bayer’s Eylea (aflibercept). 18 November 2024
Biotechnology
Shanghai-based Junshi Biosciences has received UK regulatory approval for Loqtorzi (toripalimab) in nasopharyngeal carcinoma (NPC) and esophageal squamous cell carcinoma (ESCC). 18 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent(dupilumab), Regeneron and partner Sanofi revealed late Friday. 18 November 2024
Pharmaceutical
The Danish government’s newly-unveiled health reform has been praised for tackling chronic disease care and health inequalities while driving health innovation. 18 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals’ Revuforj (revumenib). 18 November 2024
Pharmaceutical
Johnson & Johnson has taken legal action to defend a contentious rebate initiative, filing a lawsuit in the US District Court for the District of Columbia. 15 November 2024
Biotechnology
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Novavax’s Nuvaxovid jab targeting the latest subvariant. 15 November 2024
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November meeting, notable among which was a reversal of a previous rejection of Alzheimer’s drug Leqembi (lecanemab). 15 November 2024
Biotechnology
Oxford, UK-based rare respiratory diseases focused AlveoGene today revealed it has been granted a Rare Pediatric Disease designation (RPDD) by the US Food and Drug Administration (FDA) for AVG-002, its novel, inhaled gene therapy for lethal neonatal surfactant protein B (SP-B) deficiency. 15 November 2024
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