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 Russian government plans to take additional measures to further increase the share of domestic drugs in the local market, as pressure from the West on the country and its pharmaceutical sector is growing. 7 April 2023
The US Food and Drug Administration announced the final decision to withdraw approval of Makena (hydroxyprogesterone caproate injection) - a drug that had been approved under the accelerated approval pathway and marketed by privately-held Swiss drugmaker Covis Pharma. 7 April 2023
The UK’s BioIndustry Association (BIA) has published research suggesting that the country’s medicines evaluation body is basing its methods and processes for evaluating drugs for rare diseases on outdated evidence. 6 April 2023
There have been huge changes in the way highly regulated markets operate in recent years – caused by new regulations, technologies and demands. 6 April 2023
TheUK's National Institute for Health and Care Excellence (NICE) has recommended the provision of Lynparza (olaparib) for National Health Service (NHS) patients with forms of early-stage breast cancer and prostate cancer in England and Wales. 6 April 2023
A number of changes in how the US Food and Drug Administration (FDA) perceives rigorous trial design have been noted in a report on the evolving FDA approval processes for biotech companies in Asia Pacific, Europe, and the USA, including typical impediments to success. 5 April 2023
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the use of Germany-headquartered clinical-stage biotech InflaRx Gohibic (vilobelimab) injection. 5 April 2023
A Citizen Petition (CP) has been filed on behalf of Swiss biotech Idorsia Pharmaceuticals, urging the USA’s Drug Enforcement Administration (DEA) to de-schedule the dual orexin receptor antagonist (DORA) class of chronic insomnia medications based on a review of evidence from available data, including post-marketing surveillance data. 5 April 2023
The US Food and Drug Administration (FDA) has placed a partial clinical hold on all trials of Gossamer Bio’s GB5121, in response to serious adverse events that have been observed in the Phase Ib/II STAR-CNS study, including atrial fibrillation, a sudden death event and a fatal intracranial hemorrhage. 5 April 2023
The US Food and Drug Administration (FDA) has granted accelerated approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab), with the decision coming ahead of anticipated date of April 21. 4 April 2023
Dermatology company Botanix Pharmaceuticals has safely navigated the US Food and Drug Administration (FDA) mid-cycle review with sofpironium bromide. 4 April 2023
The administrators of the USA’s public insurance scheme, Medicare, are getting ready to implement the measures included in the Inflation Reduction Act. 4 April 2023
Japanese drugmaker Eisai (TYO: 4523) has entered into an agreement with the National Cancer Center to collaborate on investigator-initiated clinical research for the EZH2 inhibitor Tazverik (tazemetostat hydrobromide) based on “Patient-Proposed Healthcare Services” system, which will be conducted by the National Cancer Center Hospital. 3 April 2023
The COVID-19 pandemic brought into the spotlight, at European level and particularly in Greece, the gaps in the national health systems, which are mainly due to underfunding and long-standing distortions, commented the Hellenic Association of Pharmaceutical Companies (SFEE). 3 April 2023
The Irish Minister of International Development and Diaspora, Sean Fleming, visited Brazil’s research institute Fiocruz last month to discuss partnership projects between the country and Fiocruz. 3 April 2023
Improving the availability of innovative medicines in Latin America is a key priority for the pharmaceutical industry, policymakers, and patients. 31 March 2023
At its March 2023 meeting, the European Medicines Agency’s human medicines committee (CHMP) came up with positive recommendations for six novel medicines. 31 March 2023
Draft EU regulatory proposals have been described by the leading European trade body as “sabotage” of the industry. We consider the fallout with Maarten Meulenbelt, partner and expert on EU regulatory affairs at Sidley Austin. 31 March 2023
Two years after the US regulator concluded it was necessary to increase label warnings on safety for certain JAK inhibitors, the European Medicines Agency has followed suit. 31 March 2023
Chinese biopharma Hutchmed today revealed that it completed the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for fruquintinib, its highly selective and potent oral inhibitor of VEGFR-1, -2 and -3, for the treatment of refractory metastatic colorectal cancer (CRC). 31 March 2023