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
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized Sanofi’s SARS-CoV-2 spike protein (B.1.351 strain) vaccine for the prevention of COVID-19 disease in adults in Great Britain. 21 December 2022
Months after estimating that a fair US price for Pfizer’s Paxlovid (nirmatrelvir/ritonavir) would be between $3,600 and $5,800, the Institute for Clinical and Economic Review (ICER) has drastically changed its view. 21 December 2022
UK pharma major AstraZeneca today announced two approvals from the European Commission for expanded indications for its blockbuster cancer drugs, one for Imfinzi (durvalumab) and the other for Lynparza (olaparib). 21 December 2022
The European Commission (EC) has granted conditional marketing authorization for the use of Zynlonta (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), Swedish Orphan Biovitrum, also known as Sobi, and Switzerland’s ADC Therapeutics announced today. 21 December 2022
Russian patients with Parkinson's disease have faced a shortage of life-saving drugs based on levodopa, as, according to latest data of the Russian analyst agency RNC Pharma, the supply of these drugs has decreased by 49% in a year. 21 December 2022
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Applications (sBLAs) for Seagen and Astellas’ Padcev (enfortumab vedotin-ejfv) and Merck & Co’s Keytruda (pembrolizumab). 20 December 2022
Switzerland-based Idorsia today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for aprocitentan, the firm’s investigational, novel dual endothelin receptor antagonist, for the treatment of patients with difficult-to-control hypertension. 20 December 2022
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralized clinical trials (DCTs). 20 December 2022
Chinese biopharma Hutchmed has started the filing of a rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for fruquintinib. 19 December 2022
The European Commission (EC) has granted marketing authorization for Ebvallo (tabelecleucel)vas a monotherapy for treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein Barr virus positive post transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. 19 December 2022
The US Food and Drug Administration has approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating (cannot multiply in human cells) adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. 19 December 2022
The European Medicines Agency’s human medicines committee (CHMP) recommended four novel medicines for approval at its December 2022 meeting. A final approval decision from the European Commission can be expected within the next two or three months. 16 December 2022
Big pharma pairing AstraZeneca and Merck & Co announced a rare setback with their blockbuster PARP inhibitor Lynparza (olaparib) in prostate cancer on Thursday. 16 December 2022
Of the 20 drugs currently being developed for primary progressive multiple sclerosis (PPMS), three are now in Phase III development, offering hope to the patients, who have very few treatment options in comparison to patients affected by relapsing remitting multiple sclerosis (RRMS). 16 December 2022
The Association of the British Pharmaceutical Industry (ABPI) has warned UK lawmakers that an existing pricing agreement is unsustainable, and that the cost of agreed rebates are too high. 15 December 2022
The European Commission has granted marketing authorization for Livmarli (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) aged two months and older. 15 December 2022
Adding to a string of approved indications for the interleukin (IL) and IL-4 blocking antibody, the European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. 15 December 2022
Prices for a wide range of drugs in the Russian pharmaceutical retail sector are steadily growing due to a significant reduction of their supplies and disappearance from retail shelves. 15 December 2022
The Russian government together with some leading domestic financial corporations will provide support to domestic producers of active pharmaceutical ingredients (APIs) that will primarily be in the form of provision of preferential loans and other benefits for them, reports The Pharma Letter’s local correspondent. 15 December 2022