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
Biosimilars manufacturers can get a bad rap.
Derided as offering mere "copycats," piggybacking off the success of true innovators, companies such as South Korea's Samsung Bioepis have struggled to break into established markets that favor brand names. 6 December 2019
Joining the protest a day earlier from AusBiotech, trade group Medicines Australia also says it is disappointed that proposed changes to the country’s Research and Development Tax Incentive were tabled without notice or consultation in the Parliament yesterday – despite the recommendations of a Senate Committee inquiry this year to defer the Bill until further consideration was given to the effects of the reforms. 6 December 2019
The US Food and Drug Administration has issued an update on its investigation into the presence of genotoxic impurities, called nitrosamines, in certain types of drugs. 6 December 2019
A New Drug Application (NDA) submission to the US Food and Drug Administration seeking approval of fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV-1 infection has been completed by specialist HIV company ViiV Healthcare. 5 December 2019
US pharma giant Merck & Co, known as MSD outside North America, today revealed that its new treatment for HIV-1 infection – doravirine – has been recommended for National Health Service (NHS) use in England. 5 December 2019
Lynparza (olaparib) has won approval in China as a front-line maintenance treatment for certain adults with epithelial ovarian, fallopian tube or primary peritoneal cancer. 5 December 2019
The Australian biotech industry has voiced consternation at the government’s decision to move forward with a plan to cut R&D incentives in the country. 5 December 2019
Zydus Cadila, part of the Cadila Healthcare has filed the New Drug Application (NDA) for saroglitazar magnesium in the treatment of non-alcoholic steatohepatitis (NASH) with the Drug Controller General of India (DCGI). 5 December 2019
The introduction of the Universal Health Care (UHC) Act coupled with business and corporate tax regulatory reforms in the Philippines is likely to open up new avenues for the Indian pharma industry, according to a new analysis. 4 December 2019
A new initiative from the US Department of Health and Human Services (HHS) aims to make medications for pre-exposure prophylaxis (PrEP) available for free to people without insurance. 4 December 2019
The US Food and Drug Administration has approved Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. 4 December 2019
Texan biopharma Lexicon Pharmaceuticals lost more than 10% of its marke
t value on Monday as the company suffered a new setback in the development of Zynquista (sotagliflozin). 3 December 2019
French healthcare non-profit Médecins Sans Frontières (MSF) has called on Gavi, the Vaccine Alliance, to stop payments to pharma majors Pfizer and GlaxoSmithKline for their pneumococcal vaccine. 3 December 2019
Global drugmakers will continue to the use the policy of dumping in the Russian pharmaceutical market in years to come, in an attempt to get a better access to public procurements in Russia, according to recent statements by some local analysts in the field of pharmaceuticals and senior officials of the Russian Ministry of Health, reports The Pharma Letter’s local correspondent. 3 December 2019
The European Medicines Agency has begun its review of a marketing application for Vascepa (icosapent ethyl), from USA-based cardiovascular specialist Amarin. 3 December 2019
Cancer patients in India have lauded the approval bagged by Roche from the Indian drug regulatory authority for Tecentriq (atezolizumab), a new treatment for extensive-stage small cell lung cancer (ES-SCLC). The drug was launched in India late last month, reports The Pharma Letter’s India correspondent. 3 December 2019
The European pharmaceutical industry has signalled its objections over new proposals for European regulations on health technology assessment, arguing that Europe cannot afford an “inefficient system for joint clinical assessments.” 2 December 2019
Lenvima(lenvatinib), the orally available kinase inhibitor discovered by Japanese pharma major Eisai, has been accepted by the National Medical Products Administration (NMPA) of China for an application for the additional indication of differentiated thyroid cancer. 2 December 2019
The Food and Drug Administration (FDA), under the strong leadership of Commissioner Dr Scott Gottlieb, moved into 2019 with a clear direction to address its most urgent priorities. 2 December 2019
"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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