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
Indian drugmaker Glenmark Pharmaceuticals says that partner Seqirus has received marketing approval for Ryaltris (olopatadine hydrochloride [665mcg] and mometasone furoate [25mcg]) from Australia’s Therapeutic Goods Administration (TGA), Australia. 20 December 2019
The Johnson & Johnson unit Janssen has announced that the European Commission (EC) has approved an indication for Spravato (esketamine), the first antidepressant medicine with a new mechanism of action in more than 30 years. 20 December 2019
Shares of US company Paratek Pharmaceuticals had soared more than 40% to $4.15 by late morning trading today, on the news that it had received a lucrative government contract. 19 December 2019
East Coast, USA-based cancer specialist Epizyme has scored a unanimous vote in favor of its candidate tazemetostat, from the US regulator's cancer advisory panel. 19 December 2019
The European Commission (EC) has approved Kadcyla (trastuzumab emtansine) for the adjuvant treatment of adults with HER2-positive early breast cancer (eBC) who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy. 19 December 2019
Seattle Genetics and development partner Astellas have been awarded accelerated approval in the USA for Padcev (enfortumab vedotin-ejfv), for certain people with bladder cancer. 19 December 2019
The US Food and Drug Administration has accepted US pharm giant Pfizer’s supplemental New Drug Application (sNDA) for Braftovi (encorafenib), in combination with Erbitux (cetuximab; Braftovi Doublet) based on the results from the Phase III BEACON CRC trial. 19 December 2019
European Commission has granted approval for Rinvoq (upadacitinib) for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). 19 December 2019
Parts of the UK and European pharma and biotech industry have spent significant periods of the last three and a half years preparing for possible Brexit outcomes. 18 December 2019
The European Federation of Pharmaceutical Industries and Associations (EFPIA), together with cancer patient groups, has called for a new European Cancer Plan to help tackle the burden of the disease. 18 December 2019
The US Food and Drug Administration’s (FDA) Janet Woodcock has delivered a statement on the impact of the agency’s proposals on bringing low-cost biosimilar and interchangeable protein products to market. 18 December 2019
Keytruda (pembrolizumab) looks set to become the first in its class to win approval for a hard-to-treat kind of bladder cancer, following a positive vote from the US regulator’s cancer advisory panel. 18 December 2019
Organized by Informa Markets, CPhi & P-MEC India 2019 recently closed its doors to over 45,000 visitors and 1,600+ exhibitors from 44 countries, making it the largest pharmaceutical trade show in South Asia. 18 December 2019
Denmark’s Bavarian Nordic yesterday announced that it has entered an agreement to sell its Priority Review Voucher (PRV) for a total cash consideration of $95 million. 18 December 2019
The US Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC) voted by a narrow margin of 7 to 5 in favor of recommending Lynparza (olaparib) as a first-line maintenance monotherapy for patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas, whose disease has not progressed following 1st-line platinum-based chemotherapy 18 December 2019
A report from the European Medicines Agency (EMA) on pharmacovigilance activities finds that the EU system is: “strong and adaptable,” creating: “a positive impact on public health.” 17 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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