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
As the year draws to a close, this article presents some of the wins of the orphan drug community in terms of US FDA approvals, while highlighting challenges faced by the sector and looking ahead to the expectations of the next year. 15 December 2022
As anticipated, following a positive decision from its scientific committee, the European Medicines Agency has granted marketing authorization for Pluvicto (vipivotide tetraxetan). 14 December 2022
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF) in adults with a forced vital capacity (FVC) above 80% predicted. 14 December 2022
The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted eight to three that the benefits of omecamtiv mecarbil do not outweigh its risks for the treatment of heart failure with reduced ejection fraction (HFrEF). 14 December 2022
Biosimilar medicines deliver access for patients suffering from serious and debilitating conditions such as cancer, auto immune diseases, and diabetes. 13 December 2022
Drugmakers Novo Nordisk, Daiichi-Sankyo, Lundbeck, AstraZeneca, UCB and Biogen have been named and shamed by the UK pharma trade group. 12 December 2022
On December 9, the US Food and Drug Administration (FDA) approved Tecentriq (atezolizumab), from Genentech, a USA-based subsidiary of Swiss pharma giant Roche, for adult and pediatric patients two years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS). 12 December 2022
The US Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (BLA) submitted by biotech major Biogen for BIIB800, a biosimilar candidate referencing Roche’s Actemra, an anti-interleukin-6 receptor monoclonal antibody. 12 December 2022
The US Food and Drug Administration (FDA) has issued the Investigational New Drug (IND) Application Annual Reporting proposed rule to replace the current regulations. 9 December 2022
USA-based clinical-stage biotech Akero Therapeutics (Nasdaq: AKRO) saw its shares gain 3.4% to $43.60 by close of trading yesterday, after it has announced that efruxifermin (EFX) has received a Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the treatment of non-alcoholic steatohepatitis (NASH). 9 December 2022
Earlier this month, US President Biden told a Carlsbad, Calif. audience that America’s future rests on major breakthroughs in technology and science. “Other countries are closing in fast,” he elaborated. “The CHIPS and Science Act sets us on a path to move up again.” 8 December 2022
Swedish biotech Oncopeptides saw its shares plunge 36% to 12.00 Swedish kronor yesterday, after it revealed that the US Food and Drug Administration (FDA) has requested a withdrawal of the US marketing authorization for its multiple myeloma drug Pepaxto (melphalan flufenamide). 8 December 2022
The Office of the US Trade Representative (USTR) yesterday announced support for extending the deadline to decide whether the World Trade Organization’s (WTO) intellectual property (IP) waiver should be expanded to COVID treatments and diagnostics -a sign the 0USTR’s position could be shifting. 7 December 2022
The marketing authorization application (MAA) for momelotinib, an investigational oral treatment for myelofibrosis, submitted by UK pharma major GSK, has been accepted by the European Medicines Agency (EMA). 7 December 2022
Following a review, the European Medicines Agency’s (EMA) Emergency Task Force (ETF) has concluded that adapted mRNA bivalent vaccines targeting the original strain and Omicron BA.4-5 subvariants of SARS-CoV-2 may be used for initial vaccination. 7 December 2022
Trodelvy (sacituzumab govitecan-hziy), an antibody-drug conjugate (ADC) developed by California’s Gilead Sciences, has performed well in a post hoc analysis of the Phase III TROPiCS-02 study. 7 December 2022
The US Food and Drug Administration (FDA) has approved a second indication for Brexafemme (ibrexafungerp tablets) for the reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC). 6 December 2022
Despite its multiple negative impacts, the COVID-19 pandemic had the more positive effect of showing that having a strong and innovative research-based pharmaceutical industry is crucial, as the sector was able to mobilize quickly to produce effective vaccines. 5 December 2022