Regulation
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Biotechnology
The European Commission (EC) has approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for a number of new lymphoma indications. 3 May 2023
Pharmaceutical
Indian drug major Sun Pharma Industries dipped just 1% to 962.60 rupees, despite the company announcing a setback in the development of its newly-acquired product candidate deuruxolitinib. 3 May 2023
Pharmaceutical
Health Canada has granted marketing authorization for Quviviq (daridorexant) for the management of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. 3 May 2023
Pharmaceutical
A third of the value of Travere Therapeutics stock has been wiped out following the failure of the Phase III DUPLEX study of sparsentan. 3 May 2023
Pharmaceutical
The US Food and Drug Administration announced yesterday it is taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites. 3 May 2023
Pharmaceutical
The Franco-Israeli partnership of MedinCell and Teva Pharmaceutical Industries has announced today that the US Food and Drug Administration (FDA) has approved Uzedy (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. 2 May 2023
Biotechnology
Shares of Danish biotech Ascendis Pharma leapt, despite the company revealing that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the TransCon PTH (palopegteriparatide) New Drug Application (NDA) for the treatment of adults with hypoparathyroidism. 2 May 2023
Pharmaceutical
A 12% jump in the stock price of Avadel Pharmaceuticals on Monday reflects market confidence in the firm’s newly-approved cataplexy med Lumryz (sodium oxybate). 2 May 2023
Biotechnology
Australian medicines regulator the Therapeutic Goods Administration (TGA) has approved the application from the local subsidiary of US mRNA vaccines specialist Moderna to transition its COVID-19 vaccine, Spikevax (elasomeran), from provisional to full registration. 28 April 2023
Pharmaceutical
The European medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its April 2023 meeting. 28 April 2023
Pharmaceutical
When it comes to getting a novel foreign-made treatment into China as quickly as possible, companies should also look into the local policies in some high-profile special zones. 27 April 2023
Pharmaceutical
Shares of US drugmaker Vertex Pharmaceuticals closed down 2.6% at $323.30 yesterday, despite the firm announcing that the US Food and Drug Administration (FDA) has approved the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor). 27 April 2023
Pharmaceutical
The US Food and |Drug Administration (FDA) has released briefing documents for the April 28, 2023, Advisory Committee Meeting (AdCom) discussing the supplemental new drug application (sNDA) for UK AstraZeneca’s Lynparza (olaparib) in first-line (1L) metastatic castration-resistant prostate cancer (mCRPC). 27 April 2023
Pharmaceutical
The European Commissiont has issued a long-anticipated set of proposals to reform the legislative framework for medicines in the region. 26 April 2023
Generics
The International Council for Harmonization (ICH) has initiated the process for a new guideline on bioequivalence requirements for the approval of medicines, which is an important milestone for global convergence. 26 April 2023
Biotechnology
The US Food and Drug Administration (FDA) yesterday approved Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS). 26 April 2023
Pharmaceutical
Kidney disease specialist Akebia Therapeutics saw its shares lifted over 6% on Monday, following a European approval for Vafseo (vadadustat). 26 April 2023
Biotechnology
Foghorn Therapeutics’ shares slid as much as 21% in pre-market activity on Monday, and closed down 7.9% at $6.19, after the US cancer-focused biotech announced a setback on the FHD-609 program in synovial sarcoma and SMARCB1-deleted tumors. 25 April 2023
Pharmaceutical
The European Medicines Agency has provided Johnson & Johnson with its first regulatory approval for Akeega (niraparib/abiraterone acetate). 24 April 2023
Biotechnology
French gene therapy company GenSight Biologics saw its shares crash 69% by close of trading on Friday, and fall a further 10.3% to 0.66 euros in early trading today, after it announced the withdrawal of its European regulatory filing for what could be the first gene therapy for Leber hereditary optic neuropathy (LHON) patients. 24 April 2023
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
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