Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program. 19 September 2024
The European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 September 2024
Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 2024
Basilea Pharmaceutica announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) has awarded Basilea an Other Transaction Agreement (OTA), under OTA number 75A50124C00033. 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program. 19 September 2024
Applied Therapeutics saw its stock price climb by over two-thirds after an encouraging update on the US Food and Drug Administration review of govorestat. 19 September 2024
Daiichi Sankyo’s today revealed that its Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine National Health Service (NHS) commissioning in England and Wales. 19 September 2024
Pharma giant Merck & Co has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 18 September 2024
Novo Nordisk is under increasing pressure over the cost of its blockbuster drugs in the USA, as chief executive Lars Fruergaard Jørgensen prepares to testify before a powerful Senate committee. 18 September 2024
In a lawsuit filed in federal court in Missouri, USA, Health insurer Cigna (NYSE: CI) and its pharmacy benefit manager (PBM) Express Scripts demanded that the Federal Trade Commission (FTC) retract its July 2024 report. 18 September 2024
AstraZeneca’s Fasenra (benralizumab) has been approved in the USA for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA, the UK pharma major announced today. 18 September 2024
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024
Bayer has submitted a Marketing Authorization Application (MAA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the investigational compound elinzanetant. 17 September 2024
The US Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), from Swiss pharma giant Roche. 16 September 2024
A new supply agreement between the research-based biopharmaceutical industry and the State will improve patients’ access to the latest innovative medicines, according to the Irish Pharmaceutical Healthcare Association (IPHA), the representative organization for medicines innovators. 24 December 2021
The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) to patritumab deruxtecan (HER3-DXd), a potential first-in-class HER3 directed antibody drug conjugate (ADC) from Japan’s Daiichi Sankyo. 24 December 2021
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved the marketing authorization to extend the license in Great Britain for Swiss pharma giant Novartis’ Piqray (alpelisib). 24 December 2021
Johnson & Johnson’s pharma arm Janssen has won a positive reimbursement decision in the UK, from the country’s health technology assessor. 24 December 2021
Hot on the heels of Japanese rejection of a regulatory filing for their controversially US approved Aduhelm (aducanumab), Eisai and Biogen today announced that lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer’s disease (AD), has been granted Fast Track designation by the US Food and Drug Administration. 24 December 2021
Following an Antimicrobial Drugs Advisory Committee narrow vote of 13-10 last month in favor of the anitviral’s benefits, the US Food and Drug Administration today issued an emergency use authorization (EUA) for Merck & Co’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19). 23 December 2021
US biotech Biogen and Japanese partner Eisai today announced that the First Committee on New Drugs (NDC) of the Pharmaceutical Affairs and Food Sanitation Council, which advises the Japanese Ministry of Health, Labor and Welfare (MHLW), has decided to continue deliberations on the application for the manufacturing and marketing approval of Aduhelm (aducanumab) for the treatment of Alzheimer’s disease. 23 December 2021
USA-based biotech Aimmune Therapeutics, which is now fully owned by Swiss foods giant Nestle, today announced that the UK’s National Institute for Health and Care Excellence (NICE) has recommended Palforzia [defatted powder of Arachis hypogaea L, semen (peanuts)] or use within the National Health Service (NHS) for the treatment of peanut allergy in patients aged four to 17. 23 December 2021
Wednesday saw Swiss pharma giant Novartis gain approval from the US Food and Drug Administration for Leqvio (inclisiran) and an added indication for Cosentyx (secukinumab). 23 December 2021
On Wednesday, the US Food and Drug Administration issued an emergency use authorization (EUA) for pharma giant Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19). 23 December 2021
US healthcare giant Johnson & Johnson subsidiary Janssen today welcomed the decision from the UK’s National Institute for Health and Care Excellence (NICE) recommending the use of Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd) as induction and consolidation treatment for untreated multiple myeloma in adults, when an autologous stem cell transplant (ASCT) is suitable. 22 December 2021
Japan’s largest drugmaker Takeda Pharmaceutical yesterday announced that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration in response to its New Drug Application (NDA) for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus. 22 December 2021
The US regulator has placed a clinical trial hold on research into a Duchenne muscular dystrophy (DMD) candidate under development by New York-based pharma giant Pfizer. 22 December 2021
US biotech Intra-Cellular Therapies saw its shares gain 6.3% to $48.20, after it revealed that the US Food and Drug Administration has approved Caplyta (lumateperone tosylate) for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate. 22 December 2021
Russia is faced with a significant delay of drug supplies to the domestic market, as producers delay signing of contracts with the local state in an attempt to make a deal with higher prices for them, according to a recent report published by the Institute of State and Municipal Administration of the Higher School of Economics (ISMU), one of Russia’s leading research institutions in the field of finance, reports The Pharma Letter’s local correspondent. 22 December 2021
The Russian Ministry of Health has approved the use of Zolgensma (onasemnogene abeparvovec), the world’s most expensive drug against spinal muscular atrophy (SMA) in the domestic market, reports The Pharma Letter’s local correspondent. 22 December 2021
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline, has announced that Apretude (cabotegravir), the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually-acquired HIV-1, has been approved in the USA. 21 December 2021
The European Commission (EC) has granted US biotech Novavax conditional marketing authorization (CMA) for its Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adults. 21 December 2021
AstraZeneca has announced that a supplemental Biologics License Application (sBLA) for Ultomiris (ravulizumab-cwvz) in adults with generalised myasthenia gravis (gMG) has been accepted for Priority Review by the US Food and Drug Administration. 21 December 2021
Shares of bluebird bio closed down 18% at $10.03 yesterday, after it announced that the FDA has placed its clinical program for lovotibeglogene autotemcel (lovo-cel) - previously known as LentiGlobin - as a gene therapy for sickle cell disease (SCD) on partial clinical hold for patients under the age of 18. 21 December 2021