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
A report from the UK BioIndustry Association (BIA) and Informa Pharma Intelligence reveals robust levels of investment in the UK biotech sector, indicating that companies raised £1.3 billion ($1.7 billion) in 2019. 22 January 2020
The US Food and Drug Administration has granted Priority Review status to a submission from British drugmaker GlaxoSmithKlinefor belantamab mafodotin. 21 January 2020
Indian drugmaker Strides Pharma Science says its step-down subsidiary, Strides Pharma (SPI), has received a positive Establishment Inspection Report (EIR) from the US Food and Drug Administration for its facility in Riviera Beach, Florida, USA. 21 January 2020
Danish cancer specialist Genmab has been awarded marketing authorization in the EU for a combination therapy of Darzalex (daratumumab) plus bortezomib, thalidomide and dexamethasone. 21 January 2020
Swiss pharma giant Roche today announced that the European Commission has granted conditional marketing authorization for Polivy (polatuzumab vedotin), in combination with bendamustine plus MabThera (rituximab) (BR). 21 January 2020
In a second new drug approval on Monday, the European Commission cleared Sunosi (solriamfetol) to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP). 21 January 2020
The European Commission (EC) has approved Mayzent (siponimod) for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity. 20 January 2020
A new report has been published by the joint Big Data Task Force of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA). 20 January 2020
A US Food and Drug Administration (FDA) advisory panel vote on whether to approve Durect Corporation’s painkiller Posimir (bupivacaine) ended in a tie. 20 January 2020
A bid from Lynparza (olaparib) co-developers AstraZeneca and Merck & Co to broaden the label in the USA has been granted Priority Review status. 20 January 2020
According to the UK’s health technology assessor, German pharma major Bayer’s Vitrakvi (larotrectinib), a new treatment for a range of cancers, can’t be recommended for use in the National Health Service (NHS) because at its current price, it doesn’t have the potential to be cost-effective. 20 January 2020
Years of campaigning for a renewed drive in antibiotic (AB) drug development have not yet delivered a healthy pipeline that will end the crisis soon, says the World Health Organization (WHO). 17 January 2020
At its January meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine’s safety. 17 January 2020
India’ National Pharmaceutical Pricing Authority has allowed both Cipla and Glenmark Pharma to enhance pricing for two of their respiratory products after they were termed innovative compared to other similar products available in the market. 17 January 2020
The BioMarin hemophilia A gene therapy Valrox (valoctocogene roxaparvovec) could become the world’s priciest drug, it is being reported. 17 January 2020
The US Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) have issued another negative vote on a opioid alternative pain drug within a matter of days. 17 January 2020
A coveted Rare Pediatric Disease (RPD) designation has been issued to Fortress Biotech’s partner for its investigational Menkes disease candidate CUTX-101. 17 January 2020
The Hungarian government’s health department has decided to include 26 new medicinal products and indications into the subsidy system, affecting several therapeutic fields, announced Miklós Kásler, Minister of Human Capacities. 17 January 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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