Regulation
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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
Pharmaceutical
The US Food and Drug Administration (FDA) has approved the recent supplemental New Drug Application (sNDA), submitted by Spanish dermatology focused drugmaker Almirall, to expand the use area for its drug Klisyri (tirbanibulin) to up to 100 cm. 10 June 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved UK pharma major GSK’s Arexvy (respiratory syncytial virus [RSV] vaccine, adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk. 10 June 2024
Biotechnology
Swiss pharma giant Roche (ROG: SIX) has announced that the European Commission (EC) has approved Alecensa (alectinib) monotherapy, as adjuvant treatment following tumor resection for adults with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) at high risk of recurrence. 10 June 2024
Pharmaceutical
In a blog post, the general counsel of European trade group EFPIA - the European Federation of Pharmaceutical Industries and Associations - has argued for effective incentives to be included in the EU general pharmaceutical legislation. 10 June 2024
Pharmaceutical
The Chinese National Medical Products Administration (NMPA) held a meeting recently to carry out the 2023 annual review of the vaccine regulatory quality management system (QMS). 10 June 2024
Biotechnology
The US Food and Drug Administration (FDA) is to hold an advisory committee meeting on Monday to discuss whether data support a favorable benefit-risk assessment for the use of Eli Lilly’s donanemab for Alzheimer’s disease (AD). 7 June 2024
Biotechnology
The recent approval by the US Food and Drug Administration (FDA) of Moderna’s (Nasdaq: MRNA) respiratory syncytial virus (RSV) vaccine mRESVIA represents a significant development in the field and will likely encourage the use of mRNA technology across other disciplines. 7 June 2024
Pharmaceutical
The US Food and Drug Administration (FDA) late Thursday announced the approved of Geron Corporation’s Rytelo (imetelstat), an oligonucleotide telomerase inhibitor. 7 June 2024
Pharmaceutical
Shares in Californian company Biomea Fusion were down almost 60% ahead of the opening bell on Friday, after news of a regulatory setback. 7 June 2024
Biotechnology
Moderna has announced that the US Food and Drug Administration has selected mRNA-3705 for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. 6 June 2024
Biotechnology
A report from industry analyst GlobalData finds that reforms to the European Union's general pharmaceutical legislation have become a pivotal policy development for the pharma industry. 6 June 2024
Pharmaceutical
Italy’s Philogen and Indian drugmaker Sun Pharmaceutical Industries have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of Nidlegy (daromun). 5 June 2024
Pharmaceutical
Lykos Therapeutics’ hopes of being the first to market with a hallucinogenic medicine suffered a major blow Tuesday during a meeting of the US Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC). 5 June 2024
Pharmaceutical
Privately-held neurology company Tris Pharma has received approval from the US Food and Drug Administration for Onyda XR (clonidine hydrochloride). 3 June 2024
Biotechnology
Biotech firm Moderna has won US Food and Drug Administration (FDA) approval for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. 31 May 2024
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended eight novel drugs for approval at its May 2024 meeting. 31 May 2024
Biotechnology
The US Food and Drug Administration yesterday approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) for adult patients with relapsed or refractory mantle cell lymphoma (MCL). 31 May 2024
Biotechnology
The US Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). 31 May 2024
Pharmaceutical
Biogen has announced European approval for Qalsody (tofersen), for certain amyotrophic lateral sclerosis (ALS) patients, under exceptional circumstances. 31 May 2024
Pharmaceutical
Danish allergy immunotherapy specialist ALK Abell today revealed that its European regulatory filing for Itulazax (tree sublingual allergy immunotherapy [SLIT] tablet) in young children has been accepted for review by the relevant health authorities. 30 May 2024
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