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
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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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 National Institute for Health and Care Excellence (NICE) has recommended access Vabysmo (faricimab) for the treatment of adults with visual impairment due to macular oedema secondary to branched and central retinal vein occlusion. 13 September 2024
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024
The US Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC) injection for patients in the USA, Swiss pharma giant Roche subsidiary Genentech announced yesterday. 13 September 2024
The Russian Ministry of Health wants to speed registration of drugs that are not localized in the Russian Federation at the time of the application submitted by domestic pharmaceutical companies, explaining such changes by "unpredictable geopolitical situation," reports The Pharma Letter’s local correspondent. 12 September 2024
The US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). 12 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Sanofi’s mega blockbuster drug Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. 12 September 2024
Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) will come under the microscope when the US Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee meets on Friday. 12 September 2024
Following its review of all available information, the US Food and Drug Administration (FDA) on Friday said it has concluded that the osteoporosis medicine Prolia (denosumab) increases the risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD), particularly patients on dialysis. 20 January 2024
The UK's National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending Talzenna (talazoparib) for HER2- negative, locally advanced or metastatic breast cancer with germline BRCA1 or BRCA2 mutations in adults. 19 January 2024
Medicines regulator Swissmedic has authorized Hemgenix (etranacogene dezaparvovec), from Australian biotech CSL Limited//0/0, the first and currently only gene therapy for the treatment of male adults aged >18 years with severe or moderately severe hemophilia B (congenital Factor IX deficiency). 19 January 2024
US healthcare lobbyist Vital Transformation has released a document outlining objections to the expansion of drug pricing policies under the Inflation Reduction Act (IRA). 19 January 2024
Generics and biosimilars trade group Medicines for Europe and its members are strongly concerned by the first judgement on the Supplementary Protection Certificate (SPC) manufacturing waiver issued by the Munich District Court, Germany, in October 2023. 19 January 2024
The Cell and Gene Therapy Catapult (CGT Catapult), a government-funded body encouraging the development of the advanced therapy sector, has published a report into trial activity in the UK. 18 January 2024
The Medicines Control Authority of Zimbabwe (MCAZ) has signed a Memorandum of Understanding (MoU) with the South African Health Products Regulatory Authority (SAHPRA). 18 January 2024
Following recent approvals in Europe and the USA, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has now also granted marketing authorization for Zilbrysq (zilucoplan). 18 January 2024
While 2023 saw the approval of many notable new drugs by the US Food and Drug Administration (FDA), the past year also featured many holds being imposed on clinical trials. 18 January 2024
Dutch immunology specialist argenx has announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) approved Vyvdura (efgartigimod alfa and hyaluronidase-qvfc; also marketed under the Vyvgart brand name) injection subcutaneous (SC). 18 January 2024
Global spending and demand for medicines will increase over the next five years to approximately $2.3 trillion by 2028 as more patients get access to new and better medicines, according to a new report from the IQVIA Institute for Human Data Science titled, “The Global Use of Medicines 2024 – Outlook through 2028.” 17 January 2024
Just a month after winning its first US approval for sickle cell disease (SCD), Casgevy (exagamglogene autotemcel [exa-cel]) has won a second Food and Drug Administration (FDA) approval. 17 January 2024
After first approving the drug in 2014 for the treatment of primary immunodeficiency (PI) in adults, the US Food and Drug Administration (FDA) has now approved a new indication for HyQvia [immune globulin Infusion 10% (Human) with recombinant human hyaluronidase]. 17 January 2024
The European Commission has granted marketing authorization for yet another indication for Swiss pharma giant Roche’s cancer drug Tecentriq SC (atezolizumab; subcutaneous). 16 January 2024
Switzerland’s medicines regulator, Swissmedic, has updated its guidance regarding the authorization of generic medicines with certain active pharmaceutical ingredients (API). 16 January 2024
The Indian government has urged the United States to enhance the frequency of inspections carried out by the US Food and Drug Administration (FDA) in India, aiming to boost pharmaceutical exports. 16 January 2024
French healthcare non-profit Médecins Sans Frontières (MSF) has called on European lawmakers to amend a proposed law which would result in an effective export ban. 16 January 2024