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
Cancer giant Bristol Myers Squibb has secured a new European approval for its checkpoint blocker Opdivo (nivolumab), in non-small cell lung cancer (NSCLC). 30 June 2023
The US Food and Drug Administration yesterday approved Lantidra (donislecel), the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. 30 June 2023
Italy’s privately-held Italfarmaco Group has taken another pivotal step towards approval of its proprietary histone deacetylase (HDAC), givinostat, in Duchenne muscular dystrophy (DMD). 29 June 2023
The US Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted in favor of investigational palovarotene as an effective treatment, with a positive risk-benefit profile, for people living with the ultra-rare bone disease, fibrodysplasia ossificans progressiva (FOP). 29 June 2023
As part of an initiative to reduce global dependence on China for the supply of crucial pharmaceutical and active pharmaceutical ingredient (API) requirements, India and the USA have agreed to collaborate on the development of APIs and vaccine materials. 28 June 2023
Research from industry analyst GlobalData suggests that Pfizer’s newly-approved PARP inhibitor-based combo could achieve sales of around $650 million by the end of the decade. 28 June 2023
US pharma giant Pfizer says the US Food and Drug Administration (FDA) has approved Ngenla (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone. 28 June 2023
US drug major Bristol Myers Squibb’s Sotyktu (deucravacitinib), a once-daily oral tablet, has been recommended for use on the National Health Service (NHS) in England as an option for treating certain adults with moderate to severe plaque psoriasis. 28 June 2023
The UK has recently announced a two-year pilot scheme aimed at tackling obesity, which has become a significant financial burden on the National Health Service (NHS). 28 June 2023
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for aflibercept 8mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR), solely due to an ongoing review of inspection findings at a third-party filler. 28 June 2023
Mounjaro (tirzepatide) has not been recommended in draft guidance issued by the National Institute for Health and Care Excellence (NICE) on Tuesday for treating type 2 diabetes in adults alongside diet and exercise. 27 June 2023
AstraZeneca has called on the Russian Ministry of Health to change the conditions for registering prices for generics in Russia, as the current rules, according to the company, prevent original drugmakers from participating in public procurements, reports The Pharma Letter’s local correspondent. 27 June 2023
Mid-size French drugmaker Ipsen is hoping to be lucky third time around in its bid to gain US Food and Drug Administration (FDA) approval for palovarotene for the prevention of heterotopic ossification in patients with fibrodysplasia ossificans progressiva (FOP). 27 June 2023
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment of adults with hemophilia B, said US pharma giant Pfizer. 27 June 2023
A new Pompe disease therapy has been approved by the European Medicines Agency, with Amicus Therapeutics picking up authorization for the enzyme stabilizer Opfolda (miglustat). 27 June 2023
Bristol Myers Squibb has announced that the European Commission (EC) has approved Camzyos (mavacamten) to treat symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (HCM). 27 June 2023
China’s National Medical Products Administration (NMPA) has approved Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily fixed-dose combination, for the treatment of adults with type-2 diabetes (T2D) as an adjunct to diet and exercise to improve glycemic control, from UK pharma major AstraZeneca. 27 June 2023
A new antibody from Brussels-based UCB has been approved by the US Food and Drug Administration, for the treatment of certain adults with generalized myasthenia gravis (gMG). 27 June 2023
The newly-elected presidency team of Europe’s leading trade body has met to discuss the industry’s growing concern over the impact of proposed changes to pharmaceutical legislation in the region. 26 June 2023