Ocumension Therapeutics, has received approval of the New Drug Application (NDA) to commercialize Zerviate (cetirizine ophthalmic solution), 0.24% in China for ocular itching associated with allergic conjunctivitis. 23 September 2024
On Friday, the USA’s Federal Trade Commission (FTC) brought action against the three largest prescription drug benefit managers (PBMs) - Caremark Rx, Express Scripts (ESI), and OptumRx 23 September 2024
The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM). 23 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
The European Commission (EC) has approved an advance purchase agreement in which Johnson & Johnson’s Janssen unit will supply 200 million doses of its COVID-19 vaccine candidate to European Union (EU) member states following regulatory approval. 8 October 2020
India has initiated a probe into alleged dumping of an active pharmaceutical ingredient (API), ceftriaxone sodium sterile, from China, following complaints by domestic manufacturers. 7 October 2020
The UK’s Competition and Markets Authority (CMA) will investigate whether the pharmaceutical company Essential Pharma, which was recently bought by a Swiss private equity firm Gyrus Capital, has abused a dominant position in relation to lithium-based medicines for treating bipolar disorder. 7 October 2020
On Tuesday, the US Food and Drug Administration issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19. 7 October 2020
Japan remains on balance an attractive pharmaceutical market, with favorable volume dynamics, generally attractive pricing and broad and unfettered market access, writes Patrick Branch from LEK Consulting, in an Expert View piece. 7 October 2020
Shares of Acacia Pharma closed up 4.5% at 2.22 euros today, as the UK company revealed that the US Drug Enforcement Administration (DEA) has designated its procedural sedative Byfavo (remimazolam injection) as a Schedule IV medicine. 6 October 2020
Less than a week after the European Medicines Agency (EMA) started the first ‘rolling review’ of a COVID-19 vaccine, the regulator has begun another. 6 October 2020
South Korea’s Samsung Bioepis and Biogen today announced that the European Medicines Agency (EMA) has accepted for review its Marketing Authorization Application for SB11, a proposed biosimilar referencing Lucentis (ranibizumab). 6 October 2020
In what is not an unexpected decision, the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has proposed that Makena (hydroxyprogesterone caproate injection) be withdrawn from the market because the required post-market study failed to verify clinical benefit and it has been concluded that the available evidence does not show Makena is effective for its approved use. 6 October 2020
After 13 years of research, India's first personalized medicine for Duchenne muscular dystrophy (DMD) has received the green signal from the Drug Controller General of India (DCGI), paving the way for clinical trials. 5 October 2020
At the October 2020 meeting of the European Medicines Agency’s management board, the particular focus was on the Agency’s activities in response to the COVID-19 pandemic. 5 October 2020
Executives from Amgen, Novartis and Mallinckrodt were the second group to spend an uncomfortable day in front of the US House Committee on Oversight and Reform. 5 October 2020
The US Food and Drug Administration had issued a Complete Response Letter to Mesoblast's Biologics License Application (BLA) for Ryoncil (remestemcel-L) for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD). 5 October 2020
The US Food and Drug Administration has approved Opdivo (nivolumab) + Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM). 3 October 2020
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of a safety signal to assess reports of acute kidney injury in some patients with COVID-19 taking Veklury (remdesivir). 3 October 2020
Family-owned Italian firm Chiesi Farmaceutici and Israeli biopharma Protalix BioTherapeutics have announced the launch of an expanded access program (EAP) in the USA for pegunigalsidase alfa for the proposed treatment of Fabry disease. 2 October 2020
The European Commission (EC) has approved Crysvita (burosumab) for use in older adolescents and adults with the rare disease X-linked hypophosphatemia (XLH), Japanese drugmaker Kyowa Kirin announced today. 2 October 2020
AstraZeneca’s Farxiga (dapagliflozin) is already a blockbuster, boasting 2019 sales of $1.47 billion based on an initial approval as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes (T2D) and to reduce the risk of hospitalization for heart failure (hHF) in patients with T2D and established cardiovascular (CV) disease or multiple CV risk factors. 2 October 2020