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
US pharma major Eli Lilly has announced that the National Institute for Health and Care Excellence (NICE) has recommended Emgality (galcanezumab) as an option for the prevention of migraine in adults with episodic and chronic migraine in England and Wales. 18 November 2020
HIV specialist ViiV Healthcare says that the US Food and Drug Administration has granted Breakthrough Therapy designation for its long-acting, injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP). 18 November 2020
Two weeks after Americans voted in the presidential election, the losing candidate, Donald Trump, remains in denial over the outcome of the poll. 18 November 2020
The US Food and Drug Administration has accepted for priority review the Biologics License Application (BLA) for avalglucosidase alfa for long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid α-glucosidase deficiency). 18 November 2020
On November 17, USA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration announced additional steps to increase transparency regarding CDER and CBER’s review of the scientific information supporting the issuance of or revisions to an emergency use authorizations (EUAs) to promote public confidence in FDA’s scientific process and the appropriate use of authorized products. 18 November 2020
US pharma major Eli Lilly’s monoclonal antibody (MAb) bamlanivimab is unlikely to face payer pushback, despite its broad label, after recent Food and Drug Administration emergency use authorization (EUA), experts told Manasi Vaidya, pharma writer for the investigative news team at data and analytics company GlobalData. 17 November 2020
While much of the world’s focus is on what pharma can do to end the coronavirus pandemic, the rest of the industry is continuing its work ensuring innovative medicines reach those most in need. 17 November 2020
The European Commission has announced a deal with CureVac, securing up to 225 million doses of the firm’s coronavirus vaccine, with an option for 180 million more doses. 17 November 2020
The Russian government may consider increasing state funding for public procurements of drugs in the next several years, according to recent statements, made by an official spokesman of the federal government and some local media reports. 17 November 2020
The high and rising cost of prescription drugs in the United States remains a concern for patients, physicians, payers, and policy makers. It is also a key priority for the US Food and Drug Administration, the Trump administration, and the Department of Health and Human Services (HHS). 16 November 2020
The new head of the European Medicines Agency, Emer Cooke, has formally started work in the role, kicking off a five-year renewable mandate as executive director. 16 November 2020
Brazil’s pharmaceutical industry is the largest in Latin America and currently the seventh biggest in the world though, according to projections from IQVIA, it could be in fifth position in 2023. 16 November 2020
Japanese pharma major Eisai has received approval from the European Commission for the use of its in-house discovered and developed anti-epileptic agent (AED) Fycompa (perampanel) in the treatment of pediatric patients. 16 November 2020
On Friday, the Food and Drug Administration granted accelerated approval for Keytruda (pembrolizumab), in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test. 14 November 2020
The European Medicines Agency’s human medicines committee (CHMP) recommended new five medicines for approval at its November 2020 meeting. 13 November 2020
The UK National Institute of Health and Care Excellence (NICE) has issued a positive final appraisal document (FAD) for the use of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. 12 November 2020
French pharma major Sanofi has announced that the UK National Institute for Health and Care Excellence (NICE) has recommended Cablivi (caplacizumab) with plasma exchange and immunosuppression, as an option for treating an acute episode of acquired thrombotic thrombocytopenic purpura (TTP) in adults and in young people aged from 12 years who weigh at least 40 kg. 12 November 2020