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
Shares of Canada-based Bausch Health Companies were up 14.6% at $8.56 on Wednesday, after it said that a US district court stuck with an earlier judgment that prevented an application for a rival generic version of its Xifaxan (rifaximin) irritable bowel syndrome drug from getting US Food and Drug Administration (FDA) approval until 2029. 19 May 2023
The US Food and Drug Administration (FDA) yesterday approved Rinvoq (upadacitinib) for adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. 19 May 2023
Following positive briefing documents from the agency’s staff, the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the efficacy and safety of US pharma giant Pfizer unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate RSVpreF or PF-06928316. 19 May 2023
German pharma major Bayer has secured a positive reimbursement decision from the UK’s health technology assessor for Nubeqa (darolutamide). 19 May 2023
The US Food and Drug Administration has published product-specific guidance for generics drugmakers with the goal of facilitating pipeline development and promoting access. 19 May 2023
As part of its ongoing inquiry into pharmacy benefit managers (PBMs) and their impact on the accessibility and affordability of prescription drugs, the USA’s Federal Trade Commission (FTC) has issued compulsory orders to two group purchasing organizations (GPOs) that negotiate drug rebates on behalf of other PBMs. 18 May 2023
The US Food and Drug Administration (FDA) has eased the partial clinical hold on AOC 1001, allowing Avidity Biosciences, the drug’s developer, to double the number of participants in the MARINA Open-Label Extension (MARINA-OLE) study receiving 4 mg/kg of AOC 1001. 18 May 2023
New guidance has been developed by the European Medicines Agency to help the pharmaceutical industry maintain continuity of supply and prevent shortages. 18 May 2023
Today’s announcement that the UK’s National Institute for Health and Care Excellence (NICE) has published Final Draft Guidance (FDG) recommending dapagliflozin for adult patients with symptomatic chronic heart failure (HF) with preserved or mildly reduced ejection fraction (LVEF of more than 40%) in England and Wales is a significant day for patients and the wider cardiology community. 18 May 2023
Shares of US drug developer Intercept Pharmaceuticals closed down 14.7% at $13.83 yesterday, after the US Food and Drug Administration released briefing document ahead of the FDA’s Gastrointestinal Drugs Advisory Committee. 18 May 2023
The US Food and Drug Administration (FDA) has accepted Japanese pharma major Takeda’s Biologics License Application (BLA) for TAK-755, an enzyme replacement therapy for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP), an ADAMTS13 deficiency disorder, for priority review. 17 May 2023
Scientists at the US Food and Drug Administration have outlined a positive stance towards an RSV vaccine developed by Pfizer, ahead of a formal meeting to discuss the firm’s regulatory submission for the candidate. 17 May 2023
As soon as US biotech giant Amgen announced that it is to acquire Horizon Therapeutics in a deal worth $27.8 billion, concerns were voiced that the US competition regulator would take a serious look at monopoly and anti-competitiveness implications. 16 May 2023
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biological License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985), under development by Dutch clinical-stage biotech Byondis. 16 May 2023
Medicines regulator Health Canada has accepted a New Drug Submission (NDS), submitted by Japan’s Eisai and US biotech Biogen, for Leqembi (lecanemab). 16 May 2023
India's pharmaceutical industry captains have voiced their plea to the government, urging an expansion of the bulk drugs park scheme beyond its current scope. 16 May 2023
The UK's National Institute for Health and Care Excellence (NICE) has recommended the use of Hepcludex (bulevirtide) for the treatment of chronic hepatitis delta virus (HDV) infection on the National Health Service (NHS) in England. 15 May 2023
Adding to regulatory approvals in the USA and European Union, US pharma major Bristol Myers Squibb said today that its first drug in psoriasis, Sotyktu (deucravacitinib), has been granted Marketing Authorisation (MA) in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA). 15 May 2023