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 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
In a change of stance from its earlier proposal, India's Health Ministry has proposed that either the state or central authorities be empowered to regulate drugs and cosmetic manufacture, instead of only the Central Drugs Standard Control Organization (CDSCO). 26 July 2023
The SGLT2 inhibitor drug Jardiance (empagliflozin), developed and marketed by family-owned German pharma major Boehringer Ingelheim and the USA’s Eli Lilly, has won approval from the European Commission for the new indication of chronic kidney disease (CKD). 25 July 2023
The US Food and Drug Administration (FDA) has approved Ycanth (cantharidin), a drug/device for the topical treatment of molluscum contagiosum in adult and pediatric patients two years of age and older. 25 July 2023
The US Food and Drug Administration (FDA) is working closely with Pfizer to assess the impact of the damage at its facility at Rocky Mount, North Carolina. 24 July 2023
The US affiliate of Israel’s Teva Pharmaceutical Industries and Icelandic firm Alvotech have agreed to expand their existing strategic partnership agreement. Teva will also acquire subordinated convertible bonds to be issued by Alvotech. 24 July 2023
The US Food and Drug Administration (FDA) has approved Cyfendus (anthrax vaccine adsorbed, adjuvanted), previously known as AV7909, developed by US biotech Emergent BioSolutions, whose shares closed up 8% on the news. 24 July 2023
A drug shortage is defined by the Federal Food, Drug, and Cosmetic (FD&C) Act as a period of time when the demand or projected demand for a drug in the US exceeds its supply.1 22 July 2023
At its July meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three new biosimilars and rejected one application, as well as recommending 10 novel drugs. 21 July 2023
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended 10 novel medicines, as well as some biosimilars and indication extensions, for approval at its July 2023 meeting. 21 July 2023
Vanflyta (quizartinib) has won US approval alongside standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for newly-diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive. 21 July 2023
Following the success of the European Medicines Agency’s OPEN initiative in dealing with vaccines and treatments regulation during the height of the COVID19 pandemic, the EMA has now expanded the scope of the scheme to a wider range of medicines. 21 July 2023
The Indian government is to make 'Schedule M' compulsory for medium, small, and micro enterprises (MSMEs) involved in drug manufacturing, to help in quality assurance and also reduce compliance burden in the pharmaceutical sector. 20 July 2023
Not surprisingly given the negative opinion from the European Medicines Agency’s (EMA) human medicines committee (CHMP), the European Commission has followed guidance and has not granted marketing authorization for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva (FOP). 20 July 2023
US healthcare conglomerate Johnson & Johnson and Japanese drugmaker Astellas have joined a growing list of companies and groups that are suing the US government over its Medicare price-setting policies. 20 July 2023
The Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy designation (BTD) for the combination of fruquintinib and sintilimab (a PD-1 antibody). 20 July 2023
Negotiations over the future of drug pricing in the UK are off to a rocky start, as the UK government seeks to sustain the high rebate rates in the current statutory regime. 20 July 2023
Prices for imported active pharmaceutical ingredients (APIs) are rising again in Russia after the decline in 2022. This year the growth is equivalent to by 40%-100% year-on-year due to the devaluation of the rouble and the need to use intermediaries for these procurements, reports The Pharma Letter’s local correspondent. 20 July 2023
Leading Russian patient communities have once again called on the state to increase public procurements of HIV drugs – in a move to prevent the risks of a shortage of antiretroviral (ARV) drugs in the second half of 2023, reports The Pharma Letter’s local correspondent. 19 July 2023
The European Medicines Agency (EMA) has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines. 19 July 2023