Regulation
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Pharmaceutical
The European Commission (EC) has authorized Biogen’s Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older. 13 February 2024
Biotechnology
On Friday, the US Food and Drug Administration (FDA) issued a final rule to amend its regulations concerning the use of master files for biological products. 12 February 2024
Generics
Following an inspection from the US medicines regulator, a manufacturing site run by Indian active pharmaceutical ingredient (API) specialist Aparna Pharmaceuticals has received a VAI classification. 12 February 2024
Pharmaceutical
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with the COVID-19 treatment Paxlovid (nirmatrelvir and ritonavir). 9 February 2024
Biotechnology
Crovalimab, a humanized complement inhibitor C5 monoclonal antibody discovered by Japan’s Chugai Pharmaceutical (TYO: 4519), has been approved by China’s National Medical Products Administration (NMPA) for treatment of PNH. 8 February 2024
Biotechnology
Gilead Sciences announced it has discontinued the Phase III ENHANCE-3 study of magrolimab in acute myeloid leukemia (AML). 8 February 2024
Biotechnology
Hong Kong-listed biotech BeiGene has received Health Canada authorization for Brukinsa (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory grade 1, 2 or 3a follicular lymphoma (FL). 8 February 2024
Biotechnology
The UK's Medicines and Healthcare Regulatory Agency (MHRA) has licensed subcutaneous (SC) injectable Vyvgart (efgartigimod alfa) as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive. 7 February 2024
Biotechnology
In late 2023, Vertex Pharmaceuticals and CRISPR Therapeutics’ made history by gaining the first FDA approval for a CRISPR-based drug, Casgevy (exagamglogene autotemcel) for the treatment of sickle cell disease with vaso-occlusive crisis. 6 February 2024
Pharmaceutical
UK pharma major GSK’s Arexvy (respiratory syncytial virus vaccine, adjuvanted) is currently undergoing regulatory review with the potential of being approved in Europe for use in adults aged between 50 and 59 who are at an increased risk for respiratory syncytial virus (RSV) infection. 5 February 2024
Biotechnology
Adaptimmune Therapeutics saw its shares leap almost 10% by close of trading Wednesday and a further 5.2% to $1.01 in after-hours trading as it announced a regulator development for its cell therapy. 1 February 2024
Biosimilars
The US Food and Drug Administration (FDA) yesterday released the Revised Biosimilar User Fee Amendment (BsUFA) Research Roadmap to provide updated information about the biosimilar regulatory science research pilot program research priorities. 1 February 2024
Pharmaceutical
All ongoing clinical trials in the European Union (EU) must be transitioned to the Clinical Trials Information System (CTIS) by January 31, 2025. 31 January 2024
Pharmaceutical
Private company Defender Pharmaceuticals has had its submission for a new motion sickness treatment rejected by the US Food and Drug Administration. 31 January 2024
Biotechnology
UK pharma major GSK today announced that its Omjjara (momelotinib) has now been granted Marketing Authorization (MA) in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA), following approval by the European Commission earlier this week. 31 January 2024
Pharmaceutical
Indian drugmaker Orchid Pharma's antibiotic drug Exblifep (cefepime/enmetazobactam) has received approval from the European Medicines Agency (EMA), leading to a 20% surge in the company's stock. 30 January 2024
Biotechnology
Britain’s medicines regulator has approved a novel antibiotic developed by Cidara Therapeutics, a biotechnology company based in San Diego, California. 30 January 2024
article
Following on from its recent approval of Hyqvia (immune globulin) in Europe, Japanese pharma major Takeda has picked up a US approval for another CIDP product. 30 January 2024
Pharmaceutical
Having first authorized US pharma giant Pfizer’s (NYSE: PFE) Paxlovid (nirmatrelvir and ritonavir) for emergency use, the US Food and Drug Administration (FDA) is now making another amendment. 30 January 2024
Pharmaceutical
Takeda has secured European approval for Hyqvia (immune globulin) as maintenance therapy for people with chronic inflammatory demyelinating polyneuropathy (CIDP). 29 January 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
Biosimilars
Swiss generic and biosimilar medicines major Sandoz today announced that the European Commission (EC) has granted marketing authorization for Afqlir (aflibercept) 2mg vial kit and pre-filled syringe for intravitreal injection. 15 November 2024
Pharmaceutical
Danish dermatology specialist LEO Pharma today announced that Swissmedic, Switzerland’s national regulatory agency for approving and overseeing therapeutic products, has granted marketing approval for Anzupgo (delgocitinib) cream. 14 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of PTC Therapeutics’ gene therapy for the treatment of AADC (aromatic L-amino acid decarboxylase) deficiency, making it the first-ever gene therapy approved in the USA that is directly administered to the brain. 14 November 2024
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