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Pharmaceutical
Swiss specialty pharmaceutical company Santhera Pharmaceuticals has announced the launch of Agamree (vamorolone) in Germany. 15 January 2024
Pharmaceutical
The European Medicines Agency (EMA) has adopted a positive scientific opinion for arpraziquantel for the treatment of schistosomiasis in preschool children (3 months to 6 years old), the Brazilian research organization Fiocruz has announced. 15 January 2024
Biotechnology
The International Society for Cell and Gene Therapy (ISCT) has announced the publication in Nature Medicine of a commentary addressing a statement from the US Food and Drug Administration (FDA) that it is investigating serious risk of T-cell malignancy in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapy. 12 January 2024
Generics
A generics drugmaker has had its Abbreviated New Drug Application for the radiopharmaceutical 177Lu-PNT2003 accepted by the US Food and Drug Administration. 12 January 2024
Pharmaceutical
Swiss specialty pharma Santhera Pharmaceuticals has announced that Agamree (vamorolone) has been approved in the UK for Duchenne muscular dystrophy (DMD) in patients four years of age and older, independent of the underlying mutation and ambulatory status. 12 January 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 (GLP-1) receptor agonists. 12 January 2024
Biotechnology
The New Drug Application (NDA) for China-based Hutchmed’s sovleplenib as a treatment of adult patients with primary immune thrombocytopenia (ITP) has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA). 11 January 2024
Biotechnology
The European Commission (EC) has granted conditional marketing authorization for Krazati (adagrasib), from US biotech Mirati Therapeutics. 11 January 2024
Biotechnology
Japanese drugmaker Eisai announced today that the Scientific Advisory Group (SAG) will convene to discuss the marketing authorization application (MAA) of its Alzheimer’s disease drug Leqembi (lecanemab) which is currently under review by the European Medicines Agency (EMA). 11 January 2024
Biotechnology
China’s National Medical Products Administration (NMPA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older. 10 January 2024
Biosimilars
Authorities in Europe have granted marketing authorization for Uzpruvo (ustekinumab), a biosimilar of Johnson & Johnson’s Stelara. 10 January 2024
Pharmaceutical
China-based Innovent Biologics has announced that the first Phase III clinical trial of mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with overweight or obesity (GLORY-1) met the primary endpoints and all key secondary endpoints. 10 January 2024
Pharmaceutical
The US Food and Drug Administration has published a list of the novel drug that it approved for marketing in 2023. 10 January 2024
Pharmaceutical
The novel type 2 oral polio vaccine (nOPV2), developed by a team including scientists from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), has now been quality-assured (prequalified) by the World Health Organization (WHO). 10 January 2024
Biotechnology
The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of Tivdak (tisotumab vedotin-tftv) to full approval. 9 January 2024
Biotechnology
Japanese drugmaker Astellas has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics License Application (BLA) for zolbetuximab. 9 January 2024
Biotechnology
The European Commission (EC) has approved US pharma giant Pfizer’s Talzenna (talazoparib) in combination with Xtandi (enzalutamide), for the treatment of adult patients with metastatic castration-resistant 9 January 2024
Biotechnology
Shares of UK blood disease drug developer Hemogenyx Pharmaceuticals were down 7.5% at 2.13 pence as trading drew to a closed today, despite announcing the successful completion of its Process Qualification (PQ) run of the end-to-end process for the manufacture of HEMO-CAR-T cells. 8 January 2024
Biotechnology
Belgium’s UCB has won European Commission (EC) approval for Rystiggo (rozanolixizumab) as an add-on to standard therapy for generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. 8 January 2024
Pharmaceutical
The US Food and Drug Administration has authorized a drug importation program in Florida, as the state seeks to benefit from lower cost medicines across the border. 8 January 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
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
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