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
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 Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) met on Friday to discuss Intercept Pharmaceuticals’ supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA). 16 September 2024
Oligonucleotide therapeutics are rapidly emerging as a promising class of drugs capable of addressing a variety of genetic and complex diseases by targeting RNA sequences.1 16 September 2024
Shares of French biotech Maat Pharma (Euronext Paris: MAAT) edged up more thatn 2% to 9.70 euros this morning, after it revealed that the US Food and Drug Administration (FDA) has lifted the clinical hold and cleared it Phase III Investigational New Drug (IND) application for lead microbiome ecosystem therapy (MET) candidate, MaaT013, in patients with acute Graft-versus-Host Disease (aGvHD). 24 April 2023
The European Medicines Agency (EMA) has opened a public consultation on a reflection paper that discusses key concepts for single-arm clinical trials submitted as pivotal evidence in support of marketing authorization applications. 21 April 2023
The European Commission has granted a marketing authorization for Opzelura (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. 21 April 2023
The Russia government has updated the existing draft strategy for the development of the domestic pharmaceutical industry - Pharma-2030, reports The Pharma Letter’s local correspondent. 20 April 2023
Following a positive advisory committee meeting last month, the US Food and Drug Administration (FDA) has approved Polivy (polatuzumab vedotin-piiq). 20 April 2023
US biopharma SAB Biotherapeutics has received both Breakthrough and Fast Track designations for SAB-176 from the US Food and Drug Administration (FDA) in the past week. 20 April 2023
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental new drug application (sNDA) for Lonsurf (trifluridine/tipiracil), Taiho Oncology Inc and Taiho Pharmaceutical, subsidiaries of Japanese drugmaker Otsuka Holdings, have revealed. 19 April 2023
While the US regulator’s scientists have given a positive opinion for Innoviva’s (Nasdaq: INVA) new antibiotic, the details appear not to have impressed investors, with shares falling 5% on Tuesday. 19 April 2023
The US Department of Health ad Human Services (HHS) has announced the HHS Bridge Access Program for COVID-19 vaccines and treatment, which is aimed at maintaining broad access to COVID-19 vaccines for millions of uninsured Americans. 19 April 2023
Chicago-USA-based drugmaker AbbVie has announced that the US Food and Drug Administration (FDA) has approved expanding the indication of Qulipta (atogepant) for the preventive treatment of migraine in adults. 18 April 2023
India's first mRNA-based Omicron-specific COVID-19 booster shot from Gennova Biopharmaceuticals, a needle-free vaccine, is under scrutiny by the subject experts' committee (SEC) under the drug regulatory authority 18 April 2023
The European Commission (EC) has approved Rinvoq (upadacitinib) as the first oral Janus Kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. 18 April 2023
Research from industry analyst GlobalData highlights the significance of the pediatric treatment opportunity for Novartis’ Entresto (sacubitril/valsartan). 18 April 2023
The US Food and Drug Administration yesterday approved Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery of neutrophils (a subset of white blood cells) in the body and reduce the risk of infection. 18 April 2023
South Korean biosimilars company Samsung Bioepis has released the first edition of its Biosimilar Market Report which explores latest market trends for all biosimilars commercially available in the USA. 18 April 2023
The Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee of the US Food and Drug Administration’s (FDA) on Friday discussed supplemental New Drug Application (sNDA) of Rexulti (brexpiprazole) for the treatment of agitation associated with Alzheimer’s dementia (AAD). 17 April 2023
In 2022, 91% of prescriptions in the USA were filled by generic drugs, which in turn accounted for only 18.2% of the country’s pharmaceutical spending.1 17 April 2023