Regulation
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Pharmaceutical
The US Food and Drug Administration (FDA) yesterday announced the approval of Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. 25 April 2024
Biosimilars
On Wednesday, the US Food and Drug Administration (FDA) announced a revised draft guidance to answer questions biologics companies may have when developing promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars. 25 April 2024
Pharmaceutical
San Diego, USA-based Travere Therapeutics and CSL Vifor today announced that the European Commission has granted conditional marketing authorization (CMA) for Filspari (sparsentan). 24 April 2024
Biotechnology
Day One Biopharmaceuticals closed Tuesday’s trading 8% higher on positive regulatory news. 24 April 2024
Biotechnology
The US Food and Drug Administration has approved Lutathera (lutetium Lu 177 dotatate, from Advanced Accelerator Applications USA, a Novartis company). 24 April 2024
Biotechnology
US biopharma Abeona Therapeutics was trading nearly 50% lower in Tuesday morning’s trading after announcing a regulatory update for prademagene zamikeracel (pz-cel). 23 April 2024
Biotechnology
Following an earlier snub, the US Food and Drug Administration has now approved Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG). 23 April 2024
Pharmaceutical
San Diegan cancer company Kura Oncology has picked up Breakthrough Therapy designation for its menin inhibitor ziftomenib. 23 April 2024
Biotechnology
A first-in-class treatment for paroxysmal nocturnal hemoglobinuria (PNH), Voydeya (danicopan), has been granted marketing authorization in Europe. 23 April 2024
Pharmaceutical
Following a positive recommendation last month by the European Medicines Agency’s (EMA) human medicines committee (CHMP), today the European Commission (EC) granted marketing authorization for Emblaveo (aztreonam-avibactam) from Pfizer. 22 April 2024
Biotechnology
The European Commission (EC) has approved a Type II variation for Carvykti (ciltacabtagene autoleucel; cilta-cel). 22 April 2024
Biotechnology
The European Commission (EC) has granted marketing authorization for the interleukin (IL)-17A and IL-17F inhibitor Bimzelx (bimekizumab), from Belgian drugmaker UCB's, for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy. 22 April 2024
Biosimilars
The European Commission (EC) has granted marketing authorization for Pyzchiva (biosimilar ustekinumab), said Swiss generics and biosimilars company Sandoz. 22 April 2024
Pharmaceutical
The European Federation of pharmaceutical Industries Associations (EFPIA) and its members support the European Union (EU) leaders call for a new European Competitiveness Deal and call for a dedicated Health and Life Sciences Strategy as part of the wider strategy. 22 April 2024
Biotechnology
The US Food and Drug Administration (FDA) has posted a safety communication to inform the public and healthcare providers that the agency has required and approved labeling changes to the US Prescribing Information (USPI) for all licensed BCMA-directed and CD19-directed genetically modified autologous CAR-T cell immunotherapies. 20 April 2024
Biotechnology
Japanese pharma giant Takeda has picked up a new approval for subcutaneous Entyvio (vedolizumab), for maintenance therapy of severely active Crohn’s disease. 19 April 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved the first and only ALK inhibitor for people with ALK-positive early-stage NSCLC (eNSCLC). 19 April 2024
Biotechnology
American biopharma companies have criticised new European pharmaceutical legislation designed to make medicines more available, accessible and affordable. 18 April 2024
Pharmaceutical
US biotech Vertex Pharmaceuticals’ shares gained ground in early trading today after the company signaled progress in the development of its experimental non-opioid pain treatment. 18 April 2024
Biosimilars
A division of Medicines for Europe, the trade group representing the region's generics and biosimilars firms, has called for a new strategy to promote the biosimilars sector. 18 April 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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