Regulation
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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
Pharmaceutical
Texas, USA-based drug developer Reata Pharmaceuticals says that the US Food and Drug Administration (FDA) accepted for filing the Prior Approval Supplement (PAS) to update the drug substance specification for Skyclarys (omaveloxolone). 16 June 2023
Biotechnology
Swiss cancer giant Roche has secured approval for Columvi (glofitamab-gxbm), a treatment for certain people with diffuse large B-cell lymphoma (DLBCL). 16 June 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for momelotinib by three months to provide time to review recently submitted data, according to a stock exchange filing by UK pharma major GSK. 16 June 2023
Biotechnology
USA-based Mersana Therapeutics has announced that the US Food and Drug Administration (FDA) has issued a partial clinical hold pausing patient enrollment in UP-NEXT and UPGRADE-A, the trials of UpRi in platinum-sensitive ovarian cancer. 16 June 2023
Biotechnology
The European Medicines Agency (EMA) has validated and accepted for regulatory review the marketing authorization application (MAA) for fruquintinib. 16 June 2023
Biosimilars
Medicines for Europe has said that it sees the revision of European Union (EU) pharmaceutical legislation as an opportunity to accelerate patient access to safe, effective, and affordable medicines and to improve security of supply. 15 June 2023
Biotechnology
Advanced cellular and tissue-engineered therapies offer ground-breaking opportunities for the treatment of diseases. Recent years have seen an uptick in the development and regulatory approval of revolutionary biological therapies across the globe.1 15 June 2023
Biotechnology
Japanese drugmaker Chugai Pharmaceutical said today it has filed a regulatory application with the Ministry of Health, Labor and Welfare (MHLW) for the anti-C5 antibody crovalimab for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 14 June 2023
Pharmaceutical
As a functional, practical and intelligent way to regulate medical products in today’s globalized world—especially with increasing public health needs, limited resources and demand for faster and better treatments—the use of regulatory decisions from other jurisdictions represents a powerful and effective alternative. 14 June 2023
Pharmaceutical
India is to join an international system - the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S) - that fosters cooperation between countries and regulatory authorities on good manufacturing practices (GMPs) in order to improve the quality of its medical products. 14 June 2023
Pharmaceutical
Just months after France’s Ipsen bought liver disease specialist Albireo (Nasdaq: ALBO), the company’s main product Bylvay (odevixibat) has won a new US nod. 14 June 2023
Biotechnology
Soliris (eculizumab), from the AstraZeneca subsidiary Alexion, has won a new approval in China. 13 June 2023
Pharmaceutical
The US Food and Drug Administration (FDA) late yesterday said it has approved Linzess (linaclotide) capsules to treat functional constipation in pediatric patients aged six to 17 years. 13 June 2023
Biosimilars
Generic and biosimilar medicines significantly lower healthcare treatment costs and are essential for enabling competition and vastly improved access to medicines, says a leading European trade group. 13 June 2023
Pharmaceutical
Spanish drugmaker PharmaMar and China-based Luye Pharma have revealed that the New Drug Application (NDA) submission of lurbinectedin has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). 12 June 2023
Pharmaceutical
The US regulator is to review a submission from British drugmaker AstraZeneca for capivasertib, in combination with Faslodex (fulvestrant), under the Priority Review scheme. 12 June 2023
Biotechnology
A New Drug Application (NDA) was filed on June 9, 2023 with Japan's Ministry of Health, Labor and Welfare (MHLW) for zolbetuximab. 12 June 2023
Biotechnology
Shares of US gene and cell therapy company Abeona Therapeutics closed down 6.5% at $4.01 on Friday, when it announced receipt of feedback from the US Food and Drug Administration (FDA) regarding EB-101. 12 June 2023
Biotechnology
Having won accelerated approval in January this year, Alzheimer’s drug Leqembi (lecanemab) now looks set to get full approval from the US Food and Drug Administration (FDA) as early as next month. 10 June 2023
Pharmaceutical
The Windsor Framework sets out a long-term solution for the supply of medicines into Northern Ireland as part of the revized agreement relating to the UK’s Brexit. 9 June 2023
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