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
Japanese drugmaker Ono Pharmaceutical has announced its South Korean subsidiary has received a marketing approval for Velexbru (tirabrutinib hydrochloride) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, from the Ministry of Food and Drug Safety (MFDS) in South Korea for the treatment of recurrent or refractory B-cell primary central nervous system lymphoma. 8 November 2021
The National Institute for Health and Care Excellence's (NICE) consultation on the proposed changes to its methods and processes of health technology assessment closed on October 13. Here Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE, provides an Expert View on the proposed fresh approach to health technology assessment and how this will allow continued fair and fast access to medicines in the National Health Service (NHS). 5 November 2021
Although lagging several other vaccine makers in getting regulatory approvals and market launch, US biotech Novavax today announced the completion of its rolling submission to the World Health Organization (WHO) for emergency use listing (EUL) of NVX-CoV2373, its COVID-19 vaccine candidate. 5 November 2021
Anglo-Swedish pharma major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) has issued an Appraisal Consultation Document (ACD) for Forxiga (dapagliflozin) within its marketing authorization for the treatment of adults with chronic kidney disease (CKD). 5 November 2021
Japanese drugmaker Chugai Pharmaceutical has received an approval from its national medicines regulator for Ronapreve (casirivimab/imdevimab). 5 November 2021
Campaigners were furious last week at the news that US President Joe Biden’s Build Back Better framework would exclude a plan permitting Medicare to use its bargaining power to lower the price of prescription drugs for Americans. 4 November 2021
US health technology assessor the Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of tezepelumab. 4 November 2021
The Sustainable Markets Initiative (SMI), a network of global CEOs and private sector corporations targeting planet-friendly growth, has created a new task force focused on the healthcare sector. 4 November 2021
The coronavirus vaccine developed by Bharat Biotech, Covaxin, has been approved by the World Health Organization (WHO) under its emergency use listing (EUL) process. 4 November 2021
The European Medicines Agency has terminated its rolling review of Eli Lilly’s coronavirus treatments bamlanivimab and etesevimab, at the company’s request. 3 November 2021
Copycat biologics are helping to expand access to care for cancer patients, according to a report from the Association for Accessible Medicines (AAM), which represents the USA’s generics and biosimilars companies. 3 November 2021
US CNS-focussed drug biotech Amylyx Pharmaceuticals says it has now submitted a New Drug Application (NDA) to the US Food and Drug Administration for AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). 3 November 2021
The US Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) target date for ciltacabtagene autoleucel (cilta-cel) to February 28, 2022. 2 November 2021
The COVID-19 vaccine developed by US biotech Novavax and its partner the Serum Institute of India (SII) has been granted a regulatory approval for the first time. 2 November 2021
The US Food and Drug Administration (FDA) has told Moderna that it will need more time to complete its assessment of the Emergency Use Authorization (EUA) request for the use of the company’s COVID-19 vaccine at the 100µg dose level in adolescents aged 12 to 17 years. 1 November 2021
Groups campaigning for lower US drug prices reacted with exasperation last week when President Joe Biden announced the framework for his Build Back Better Agenda and Bipartisan Infrastructure Bill. 1 November 2021
Market reaction was positive for Immutep, with the Australian biotech announcing progress for its lead candidate, a novel LAG-3 related immunotherapy treatment for cancer and autoimmune disease, with its shares rising 2.6% to A$0.58. 1 November 2021
Shares of Otsuka Holdings were up 2.8% at 4,620 yen today, as the Japanese drugmaker announced that its Dutch subsidiary has submitted an initial marketing authorization application (MAA) to the European Medicines Agency for vadadustat. 1 November 2021
The US Food and Drug Administration has approved Scemblix (asciminib) for the treatment of chronic myeloid leukemia (CML) in two distinct indications. 1 November 2021