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
Global specialist HIV company ViiV Healthcare, which is majority owned by GSK, has been granted marketing authorization by the European Medicines Agency (EMA) for Triumeq PD. 22 February 2023
USA-based Akebia Therapeutics said yesterday that it has received a second interim response from the US Food and Drug Administration (FDA) to its formal dispute resolution request regarding the Complete Response Letter (CRL) for vadadustat received in March 2022, with the news sending the firm’s plunging 25.5% to $0.65. 22 February 2023
Authorization has been granted by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for a new version of the Moderna’s ‘bivalent’ COVID-19 vaccine. 21 February 2023
Japanese drugmaker Astellas closed Monday’s trading 2% lower following some news on fezolinetant, its investigational agent for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. 21 February 2023
Karyopharm Therapeutics and privately-held Italian drugmaker Menarini Group today announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted full Marketing Authorization for Nexpovio (selinexor) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. 21 February 2023
The European Commission has granted conditional marketing authorization (CMA) for Hemgenix (etranacogene dezaparvovec), the first and only one-time gene therapy for the treatment of severe and moderately severe hemophilia B (congenital Factor IX deficiency) in adults without a history of Factor IX inhibitors. 21 February 2023
Netherland-based biotech Azafaros today announced its progress in ongoing interactions with health authorities regarding its lead asset, AZ-3102. 20 February 2023
Australian medicines regulator the Therapeutic Goods Administration (TGA) has granted provisional approval to US messenger RNA (mRNA) specialist Moderna’s bivalent COVID-19 vaccine: elasomeran and davesomeran (Spikevax bivalent original/Omicron BA.4-5) for use as a booster dose in individuals aged 12 years and older. 20 February 2023
A recent survey by SVB Securities’ MEDAcorp unit of 48 urologists and medical oncologists suggests that Seagen and Astellas’ Padcev (enfortumab vedotin-ejfv) +/- Merck & Co’s Keytruda (pembrolizumab) may rapidly displace platinum chemo +/- Merck KGaA’s Bavencio (avelumab) maintenance as the frontline standard of care over the next three years. 20 February 2023
The US Food and Drug Administration (FDA) has granted accelerated approval for Travere Therapeutics’ Filspari (sparsentan) to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g. 20 February 2023
The US Food and Drug Administration (FDA) on Friday approved retinal disease specialist Apellis Pharmaceuticals' drug for geographic atrophy secondary to age-related macular degeneration (AMD) after pushing back its planned decision by three months to review more data. 18 February 2023
The US Food and Drug Administration (FDA) has approved Austedo XR (deutetrabenazine) extended-release tablets, a new once-daily formulation indicated in adults for tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). 18 February 2023
Long approved in Europe, family-owned Italian drugmaker Chiesi Farmaceutici has now received marketing authorization for its Lamzede (velmanase alfa-tycv) in the USA. 17 February 2023
US pharma giant Pfizer on Thursday said a Phase III study combining its breast-cancer drug Talzenna (talazoparib), with its prostate-cancer drug Xtandi (enzalutamide) showed a 37% reduction in the risk of disease progression or death in men with metastatic castration-resistant prostate cancer (mCRPC). 17 February 2023
The US Food and Drug Administration (FDA) has completed its filing review and accepted the company’s New Drug Application (NDA) for Zimura (avacincaptad pegol; ACP), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD), says US biopharma Iveric Bio. 17 February 2023
Patients in India suffering from cystic fibrosis are petitioning the Indian government to allow generic versions of Vertex Pharmaceuticals’ (Nasdaq: VRTX) Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) and Orkambi (lumacaftor/ivacaftor). 17 February 2023
Dutch rare disease specialist Pharming has suffered a setback in the European approval process for its leniolisib, a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency. 16 February 2023
The Secretary of the US Department of Health and Human Services (HHS) has selected three new models for testing by the Centers for Medicare & Medicaid Services’ (CMS) Innovation Center to help lower the high cost of medicines in the USA. 15 February 2023
Indian generics major Zydus Lifesciences has received tentative approval from the US Food and Drug Administration (FDA) to market canagliflozin tablets, 100mg and 300mg. 15 February 2023
US rare diseases specialist Soligenix closed 19% lower after Tuesday’s trading following news of a setback with its lead drug candidate. 15 February 2023