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
Following consultation with members – and heeding the concerns of the Consumers Health Forum (CHF) and patient groups – pharma trade group Medicines Australia reiterates its call to have finalization of the new National Medicines Policy (NMP) delayed until after the federal election. 10 February 2022
The US Food and Drug Administration said yesterday that it has taken new steps aimed at fostering the development of non-addictive alternatives to opioids to manage acute pain and decreasing exposure to opioids and preventing new addiction. 10 February 2022
The US regulator has accepted for Priority Review a bid to broaden the label for the antibody Dupixent (dupilumab) in moderate-to-severe atopic dermatitis. 10 February 2022
GlobalData has identified that drug pricing pressures are seen as the major hindrance to the growth of the pharmaceutical industry in 2022, forcing companies to reassess their pricing strategies and market focus. 10 February 2022
The recent US Food and Drug Administration approval of the first T-cell receptor (TCR) therapy, UK biotech Immunocore’s Kimmtrak (tebentafusp-tebn), for the treatment of uveal melanoma offers such a clear benefit to patients that it will become the standard of care in the USA. 8 February 2022
Positive signs from a post hoc analysis of the Phase II NOSTRA and Phase III NOSTRA III studies have shown the way forward for Germany’s vasopharm. 8 February 2022
India’s domestic pharmaceutical market is estimated at $42 billion in 2021 and likely to reach $65 billion by 2024 and further expand to reach $120-130 billion by 2030, according to India's Economic Survey. 8 February 2022
UK health technology assessor the National Institute for Health and Care Excellence (NICE) today issued a final appraisal determination (FAD) recommending the use of GlaxoSmithKline’s Jemperli (dostarlimab) via the Cancer Drugs Fund (CDF) as a treatment option for patients with a common and aggressive form of advanced endometrial cancer (cancer of the womb lining). 8 February 2022
Proposed reforms to the way that the National Institute of Health and Care Excellence (NICE) assesses whether drugs deserve reimbursement in the UK have been criticized for not going far enough. 7 February 2022
The US Food and Drug Administration has approved Enjaymo (sutimlimab-jome) to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease (CAD). 5 February 2022
UK and USA-based biotech firm Orchard Therapeutics’ shares closed up 7.6% and rose a further 4.4% to $1.18 in after-hours trading on Friday, after the company gained clearance for Nation Health Service use in England and Wales for its stem cell therapy Libmeldy (atidarsagene autotemcel). 5 February 2022
The National Institute for Health and Care Excellence (NICE) has recommended that Jardiance (empagliflozin), from German family-owned pharma major Boehringer Ingelheim and marketed in partnership with Eli Lilly, will be recommended as a clinical and cost-effective treatment option for adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF) as an add-on to optimized standard care. 4 February 2022
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending Opdivo (nivolumab) plus Yervoy (ipilimumab) for patients with previously untreated advanced renal cell carcinoma (RCC) that is intermediate- or poor-risk, US pharma major Bristol Myers Squibb has revealed. 4 February 2022
Pharma trade group Medicines Australia is calling for the new National Medicines Policy (NMP) to be pushed back until after the federal election, expected in May. 4 February 2022
UK-based Alliance Pharma (AIM: APH) saw its shares close down 6.9% at 105.54 pence today, after it provided an update on the Competition and Markets Authority (CMA) investigation first announced in May 2019 in which four companies, including Alliance, have been subject to a lengthy investigation. 3 February 2022