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
The U S Food and Drug Administration has granted Emergency Use Authorization (EUA) for investigational bamlanivimab (LY-CoV555) 700mg and etesevimab (LY-CoV016) 1,400mg together. 10 February 2021
The US Food and Drug Administration has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. 10 February 2021
A key scientific panel of the US medicines regulator has voted unanimously to wait for more data before deciding on a bid to broaden the label for Keytruda (pembrolizumab). 10 February 2021
Bristol Myers Squibb has won approval in Europe for Inrebic (fedratinib), to treat enlarged spleen in certain people with myelofibrosis, a rare bone marrow disorder. 9 February 2021
The Russian government has officially approved a procedure for the purchase of some high-priced drugs for children with orphan diseases, according to recent statements by the press-service of the Russian government. 9 February 2021
UK Bioindustry Association (BIA) chief executive Steve Bates yesterday released an update on the biotech sector, including on investment and COVID-19 developments. 9 February 2021
European approval has been granted to Viiv Healthcare for Rukobia (fostemsavir) 600mg extended-release tablets, for use alongside other antiretroviral (ARV) therapies for the treatment of adults with multidrug-resistant HIV-1 infection, for whom it is otherwise not possible to construct a suppressive anti-viral regimen. 8 February 2021
The Russian Ministry of Health has begun centralized procurements of Ocrevus (ocrelizumab) - a drug for the treatment of the most severe form of multiple sclerosis, reports The Pharma Letter’s local correspondent. 8 February 2021
The European Commission (EC) has authorized the expanded use of Spravato (esketamine nasal spray), co-administered with oral antidepressant therapy in adults with a moderate to severe episode of major depressive disorder (MDD). 8 February 2021
On Friday, the US Food and Drug Administration granted accelerated approval for Ukoniq (umbralisib), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon. 8 February 2021
The US Food and Drug Administration on Friday at last approved Breyanzi (lisocabtagene maraleucel – liso-cel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. 8 February 2021
Janssen Biotech has submitted an application to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. 5 February 2021
The US Food and Drug Administration is again alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. 5 February 2021
Biocon Biologics, a subsidiary of India’s Biocon Ltd, has signed an agreement with the Clinton Health Access Initiative (CHAI) to expand access to lifesaving cancer biosimilars in over 30 countries in Africa and Asia as a part of the Cancer Access Partnership (CAP). 4 February 2021
The China National Medical Products Administration (NMPA) has granted conditional approval to Xospata (gilteritinib) for the treatment of adult patients who have relapsed (disease that has returned) or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+) detected by a fully validated test. 4 February 2021
A scientific panel of the European Medicines Agency has kicked off a rolling review of NVX-CoV2373, a COVID‑19 vaccine being developed by US biotech Novavax. 4 February 2021
AstraZeneca’s Forxiga (dapagliflozin) has been approved in China to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF). 4 February 2021
The US Food and Drug Administration late yesterday granted accelerated approval to Tepmetko (tepotinib), from EMD Serono, the US healthcare business of Germany’s Merck KGaA for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. 4 February 2021
Californian biopharma Durect Corporation has announced that the US Food and Drug Administration (FDA) has approved Posimir (bupivacaine solution). 3 February 2021
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued final guidance recommending Beovu (brolucizumab) as an option in the National Health Service (NHS) for the treatment of neovascular (wet) age-related macular degeneration (AMD) in adults. 3 February 2021