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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
Biotechnology
The US Food and Drug Administration (FDA) has accepted the Biologics License Applications (BLAs) for the investigational treatment exagamglogene autotemcel (exa-cel) for severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT) that has been submitted by US biotech Vertex Pharmaceutical. 9 June 2023
Biosimilars
Sandoz, the generics and biosimilars unit of Novartis, has outlined an ambitious plan for its newly-independent future once the spin-out from its parent is complete. 9 June 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has published guidance entitled Clinical Drug Interactions Studies with Combined Oral Contraceptives. 9 June 2023
Biotechnology
The US Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) yesterday voted unanimously 21 to 0 that nirsevimab has a favorable benefit risk profile for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in new-borns and infants born during or entering their first RSV season. 9 June 2023
Pharmaceutical
The number of medicines recalled by manufacturers due to defects has increased 153% in the UK since 2017, according to new figures from the Medicines and Healthcare products Regulatory Agency (MHRA), with relaxed regulations during Covid one possible factor behind the increase. 8 June 2023
Biotechnology
Ahead of a key meeting from the US Food and Drug Administration’s scientific advisory panel, briefing notes reveal a broadly positive view of Eisai and Biogen’s new Alzheimer’s med. 8 June 2023
Biotechnology
Legend Biotech and Janssen have announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) relating to their partnered asset Carvykti (ciltacabtagene autoleucel). 8 June 2023
Pharmaceutical
The European Commission has authorized Arexvy (respiratory syncytial virus vaccine, adjuvanted), developed by UK pharma major GSK, for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. 8 June 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has announced the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials. 7 June 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has approved a new indication for Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]) following a priority review. 7 June 2023
Biotechnology
The US Food and Drug Administration (FDA) has published briefing papers on AstraZeneca and Sanofi's Beyfortus (nirsevimab) ahead of Thursday’s meeting of the agency’s Antimicrobial Drugs Advisory Committee Meeting. 7 June 2023
Biotechnology
The European Commission (EC) has granted marketing authorization for Bimzelx (bimekizumab) for the treatment of adults with active psoriatic arthritis (PsA) and adults with active axial spondyloarthritis (axSpA) including non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axSpA. 7 June 2023
Biotechnology
The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) alongside chemotherapy for mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. 6 June 2023
Pharmaceutical
A joint statement on adapted COVID-19 vaccines and considerations for their use during the upcoming fall 2023 vaccination campaigns has been issued today by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). 6 June 2023
Biotechnology
Belgium’s largest pharma company UCB today revealed that its developmental treatment for adults with hidradenitis suppurativa (HS) has been granted Promising Innovative Medicine (PIM) designation in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA). 5 June 2023
Biotechnology
The coverage of medicine costs in the USA has come under further question, particularly related to Alzheimer’s disease treatments. 2 June 2023
Biotechnology
As anticipated, Pfizer as secured US Food and Drug Administration approval for its bivalent RSV vaccine, targeting disease caused by RSV in people over the age of 60. 1 June 2023
Biotechnology
Dutch biotech firm Pharming said today that it has entered into a definitive agreement with Swiss pharma giant Novartis to sell its Rare Pediatric Disease Priority Review Voucher (PRV) to Novartis. 1 June 2023
Pharmaceutical
Following a mixed advisory panel vote in late April, the US Food and Drug Administration FDA) said yesterday that it has approved UK pharma major AstraZeneca’s Lynparza (olaparib). 1 June 2023
Pharmaceutical
Shares of US biotech Amylyx Pharmaceuticals fell more than 3% by close of trading Tuesday and a further 2.2% to $23.51 in pre-market activity today, after it said that a European regulatory panel had taken a negative view on its amyotrophic lateral sclerosis (ALS) treatment 31 May 2023
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