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
The US Food and Drug Administration (FDA) has granted Enhertu (trastuzumab deruxtecan), Breakthrough Therapy designation (BTD) for unresectable or metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2-based regimens. 4 October 2021
Seattle, USA-based biotech Omeros Corporation saw its shares plummet 38% to $8.54 on Friday, as it revealed that the US Food and Drug Administration notified the company that its marketing application for narsoplimab could not be approved. 4 October 2021
The US Food and Drug Administration has granted approval for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), scoring a first for Kite. 2 October 2021
Three generic pharmaceutical manufacturers, Taro Pharmaceuticals USA, Sandoz, the biosimilars and generics business of Novartis and Apotex Corp, have agreed to pay a total of $447.2 million to resolve alleged violations of the False Claims Act arising from conspiracies to fix the price of various generic drugs. 2 October 2021
European customers are growing increasingly concerned about the origin of their medicine and expect government to support investment to avoid over dependency on countries outside of Europe. 2 October 2021
At the latest pharmacovigilance risk assessment meeting of the European Medicines Agency, the organization initiated a review of medicines containing nomegestrol and chlormadinone. 1 October 2021
The Russian government, together with the Federal Antimonopoly Service (FAS), have agreed to raise prices for more than 30 drugs from the list of vital and essential since January of the current year, reports The Pharma Letter’s local correspondent. 1 October 2021
In the UK, a positive reimbursement decision has paved the way for certain people with advanced thyroid cancer to receive treatment with Eli Lilly’s Retsevmo (selpercatinib). 1 October 2021
Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry (ABPI), has written to the UK’s Chancellor of the Exchequer, Rishi Sunak, outlining the case for investing in pharma. 30 September 2021
Indian drugmaker Glenmark Pharmaceuticals today announced it has received marketing approval for its fixed-dose combination nasal spray Ryaltris (olopatadine Hcl and mometasone furoate), in 13 countries across the European Union and the UK. 30 September 2021
Mirum Pharmaceuticals, a leader in rare liver disease, says that the US Food and Drug Administration has approved Livmarli (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) one year of age and older. 30 September 2021
On Wednesday, the US Food and Drug Administration issued the draft guidance for industry, “Benefit-Risk Assessment for New Drug and Biological Products.” 30 September 2021
Chicago-based drugmaker AbbVie has had another calcitonin gene-related peptide (CGRP) receptor antagonist approved in the migraine space by the US Food and Drug Administration (FDA). 29 September 2021
A new analysis of five-year data for the gene therapy PTC-AADC shows “profound improvements” in children with aromatic L-Amino acid decarboxylase (AADC) deficiency. 29 September 2021
In the UK, Advanced Accelerator Applications (AAA) has been granted a Promising Innovative Medicine (PIM) designation for 177Lu-PSMA-617, an investigational radioligand therapy. 29 September 2021
HIV specialist ViiV Healthcare, which is majority owned by GlaxoSmithKline, today announced an exclusive collaboration and license agreement with Shionogi for S-365598, a third-generation investigational integrase strand transfer inhibitor (INSTI) with potential for use in ultra long-acting HIV regimens (regimens with dosing intervals of three months or longer). 28 September 2021
Japanese drug major Eisai said today that it has initiated a rolling submission to the US Food and Drug Administration of a Biologics License Application (BLA) for lecanemab (BAN2401), the company’s investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease (early AD). 28 September 2021
Saphnelo (anifrolumab) has been approved in Japan for the treatment of adult patients with systemic lupus erythematosus (SLE), a serious autoimmune disease, who show insufficient response to currently available treatment. 28 September 2021
The European Medicines Agency has begun evaluating an application for the use of a booster dose of Moderna’s coronavirus vaccine, Spikevax. 28 September 2021
Excessive regulation of the Russian pharmaceutical market and the lack of drug insurance system is leading to a shortage of some vital and effective drugs in the local market, according to recent statements by representatives of producers and analysts. 28 September 2021