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
Australia’s medicine regulator, the Therapeutic Goods Administration (TGA), today revealed that, effective March 22, 2023, it can approve the temporary import or supply of an overseas-approved medicine as a substitute for one that is in short supply if it has been previously registered in Australia. 24 March 2023
US biopharma PTC Therapeutics has come to an agreement with National Health Service (NHS) England for the reimbursement of its rare disease drug Upstaza (eladocagene exuparvovec). 24 March 2023
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published a new guidance (TA877) recommending the use of finerenone (10mg and 20mg) by NHS England as an option for treating chronic kidney disease (CKD) (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults, German pharma major Bayer announced. 24 March 2023
US biotech Biogen is focusing on the positives after a US Food and Drug Administration (FDA) advisory committee (AdCom) meeting on tofersen, an investigational product for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). 23 March 2023
Cidara Therapeutics saw its shares fall 10% to $1.71 in after-hours trading yesterday, despite receiving a regulatory approval for a new drug. 23 March 2023
US pharma major AbbVie closed down almost 2% at $153.67 yesterday, after it revealed a regulatory setback for its investigational Parkinson’s treatment. 23 March 2023
On 22 March 2023, the provisional registration of Tecentriq (atezolizumab) for the treatment of metastatic triple-negative breast cancer (mTNBC) will lapse, meaning that Tecentriq will no longer be approved for this use, Australian medicines regulator the Therapeutics Goods Administration (TGA) announced today. 22 March 2023
The US National Institutes of Health (NIH) on Tuesday rejected a petition urging the government to lower the price of the prostate cancer drug Xtandi (enzalutamide) by using the so-called march-in rights to take control of the patents on the treatment. 22 March 2023
Australian Health Technology Assessment (HTA) Review Terms of Reference were released today, and will continue to advocate for bold policy reform to speed up access to innovative medicines. 22 March 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said today it will introduce a series of new measures, with support from partners to make it faster and easier to gain approval and to run clinical trials in the UK. 21 March 2023
Sandoz, the soon to be spun-out generics and biosimilars unit of Swiss pharma giant Novartis, today announced that the US Food and Drug Administration (FDA) approved a citrate-free high-concentration 21 March 2023
Zydus Lifesciences today revealed it has received final approval for Tofacitinib Tablets, 5mg and tentative approval for Tofacitinib Tablets, 10mg, generic versions of US pharma giant Pfizer’s Xeljanz from the US Food and Drug Administration (FDA). 21 March 2023
Drugmakers have welcomed the European Commission’s commitment to a “competitiveness check,” related to the legislative environment in the region. 21 March 2023
Patient Voice Aotearoa’s Dr Malcolm Mulholland appeared before the Health Select Committee to voice opposition to parts of the Therapeutic Products Bill on behalf of patients in New Zealand. 21 March 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Lynparza (olaparib) for use as combination therapy with abiraterone and prednisone or prednisolone, for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. 20 March 2023
Patient advocacy groups have expressed regret at Janssen’s decision to hit the pause button on its UK launch of Carvykti (ciltacabtagene autoleucel). 20 March 2023
The UK’s National Institute for Health and Care Excellence (NICE) has issued a final decision recommending the use of Oxlumo (lumasiran) on the National Health Service (NHS) in England as an option for treating primary hyperoxaluria type 1 (PH1) in people of all ages, US RNAi therapy specialist Alnylam Pharmaceuticals (Nasdaq: ALNY) announced today. 20 March 2023
A meeting was held last week between the president of the Greek government’s Negotiation Committee, Nadia Gogozotou, and representatives of SFEE, the Hellenic Association of Pharmaceutical Companies. 20 March 2023