The Foundation for Economic and Industrial Research and Greek pharma trade group the Hellenic Association of Pharmaceutical Companies have presented two studies reflecting the industry’s importance. 23 September 2024
The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have published an updated Code of Practice for drugmakers. 23 September 2024
Shares of California, USA-based precision medicines IDEAYA Biosciences were down 6.3% at $32.5 mid-morning after it revealed what is described as “positive” developments for its darovasertib. 23 September 2024
The Foundation for Economic and Industrial Research and Greek pharma trade group the Hellenic Association of Pharmaceutical Companies have presented two studies reflecting the industry’s importance. 23 September 2024
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Hetronifly (serplulimab). 23 September 2024
The US Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). 23 September 2024
Ocumension Therapeutics, has received approval of the New Drug Application (NDA) to commercialize Zerviate (cetirizine ophthalmic solution), 0.24% in China for ocular itching associated with allergic conjunctivitis. 23 September 2024
On Friday, the USA’s Federal Trade Commission (FTC) brought action against the three largest prescription drug benefit managers (PBMs) - Caremark Rx, Express Scripts (ESI), and OptumRx 23 September 2024
The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM). 23 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
Swiss oncology giant Roche has announced an extension to the US review of its risdiplam New Drug Application (NDA) in spinal muscular atrophy (SMA). 8 April 2020
As part of the UK government’s announcement of a new five pillar plan to increase testing for COVID-19, French clinical diagnostics company Novacyt is collaborating with AstraZeneca, GlaxoSmithKline and the University of Cambridge to take action to support this national effort. 8 April 2020
Among several actions take this week in in its ongoing response effort to the COVID-19 pandemic, the Food and Drug Administration approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine Sulfate Tablets USP, 200mg. for the treatment of: 8 April 2020
Global regulators are discussing how data generated during clinical practice could “complement evidence” from clinical trials in COVID-19. 7 April 2020
US RNAi therapeutics company Alnylam Pharmaceuticals has announced the completion of the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO), in development for the treatment of primary hyperoxaluria type 1 (PH1). 7 April 2020
After US President Donald Trump hinted at retaliatory measures, India is to export the anti-malarial drug hydroxychloroquine (HCQ) to some countries. 7 April 2020
Following a positive opinion from the European Medicines Agency’s advisory body the CHMP in late February, Japanese pharma giant Takeda today announced that the European Commission has extended the current marketing authorization of Alunbrig (brigatinib). 6 April 2020
The European Commission has approved both Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe) for use in adults with primary hypercholesterolemia or mixed dyslipidemia in Europe. 6 April 2020
The European Commission has granted marketing authorization for Rybelsus (oral semaglutide), for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycemic control as an adjunct to diet and exercise. 6 April 2020
The US Food and Drug Administration has approved Reblozyl (luspatercept-aamt), the first and only erythroid maturation agent (EMA), for the treatment of anemia failing an erythropoiesis stimulating agent. 6 April 2020
Netherlands regulator the Medicines Evaluation Board (MEB) said last week that it has been informed by Danish firm LEO Parma that the production of the antibiotic Fucidin (sodium fusidate) is to be terminated for the Dutch market for business-economic reasons. This concerns the 250mg film-coated tablet (RVG 01369). 6 April 2020
The US Food and Drug Administration on Wednesday approved Sevenfact (coagulation factor VIIa [recombinant]-jncw) for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies). 2 April 2020
As the number of cases of COVID-19 continues to increase rapidly in the UK, California’s Gilead Sciences has kicked off Phase III studies of its investigational treatment remdesivir in the country. 2 April 2020
After contending with quality issues at its new Malaysia plant for several years, Indian biotech Biocon appears to be closer to getting its insulin glargine (Semglee) product onto the US market. 2 April 2020
As China’s active pharmaceutical ingredient (APIs) makers restart operations, the first consignment of raw materials has already touched Indian shores. Imports from all Chinese provinces, barring one, have commenced to India, with supplies expected to buck up in the coming weeks, reports The Pharma Letter’s India correspondent. 1 April 2020
Following a positive European Medicines Agency advisory recommendation in January this year, the European Commission has now granted formal marketing authorization in the European Union for Nubeqa (darolutamide), an oral androgen receptor inhibitor (ARi). 1 April 2020
The US Food and Drug Administration has dropped an investigation into Novartis company AveXis, related to the novel spinal muscular atrophy (SMA) Zolgensma (onasemnogene abeparvovec-xioi). 1 April 2020
"IDEAYA is an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics."
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