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
Ipsen shares began trading around 2% higher on Thursday morning, after the French biotech announced today it would restart the global Phase III MOVE trial, in people over the age of 14. 26 March 2020
Sino-America immuno-oncology biotech firm BeiGene today announced that, on March 25, 2020, the China National Medical Products Administration (NMPA) suspended the importation, sales and use of Abraxane (nanoparticle albumin-bound paclitaxel) in China supplied to BeiGene by Celgene, now a Bristol-Myers Squibb company. 25 March 2020
Ono Pharmaceutical has received manufacturing and marketing approval for Velexbru (tirabrutinib) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of recurrent or refractory primary central nervous system lymphoma, in Japan. 25 March 2020
Germany’s Merck KGaA has won Japanese approval for Tepmetko (tepotinib), for the treatment of certain people with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC). 25 March 2020
As the world watches aghast, the novel coronavirus continues to spread its tentacles around the globe, with cases of COVID-19 rising to nearly 375,000 on Tuesday, an increase of 75,000 from the day before. 25 March 2020
The Russian government has approved a package of measures aimed at ensuring regular supplies of drugs and avoiding their shortages in the domestic market this year, according to recent statements by an official spokesman of state press-service and some local media, reports The Pharma Letter’s local correspondent. 24 March 2020
The US Food and Drug Administration (FDA) has issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during what it calls the ‘public health emergency’ of the COVID-19 crisis. 23 March 2020
Japanese pharma major Takeda Pharmaceutical has picked up an approval in China for Entyvio (vedolizumab), for moderate to severe active ulcerative colitis (UC) or Crohn's disease (CD). 23 March 2020
The US Food and Drug Administration has issued a complete response letter (CRL) for the supplemental New Drug Application (sNDA) of the investigational drug empagliflozin 2.5mg as an adjunct to insulin for adults with type 1 diabetes. 23 March 2020
The US Food and Drug Administration on Friday issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test. 22 March 2020
UK biotech Synairgen saw its share leap more than 52% to 49.00 pence by close of trading on Friday, after it revealed it has received approvals from the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) to conduct a Phase II trial of its lead product SNG001 (inhaled interferon-beta-1a) in coronavirus (COVID-19) patients. 21 March 2020
The UK BioIndustry Association (BIA) has welcomed revised proposals put forward by the government to ensure that genuine biotech companies are not penalised by a cap on R&D tax credits. 20 March 2020
The European Medicines Agency’s first Management Board meeting of 2020 was held virtually in view of the rapidly changing situation in the context of the COVID-19 pandemic. 20 March 2020
The US Food and Drug Administration yesterday approved a supplemental application for Epclusa (sofosbuvir and velpatasvir) to treat hepatitis C virus (HCV) in children aged six years and older or weighing at least 37 pounds (17 kilograms) with any of the six HCV genotypes—or strains—without cirrhosis (liver disease) or with mild cirrhosis. 20 March 2020
The European Medicines Agency has issued a call to drug developers and others in the European research community, urging a collective effort on combating COVID-19. 20 March 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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