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 higher number of people are currently being diagnosed with cancer in Europe than at any point since 1995, yet fewer of these people are dying of the disease, according to a new study. 16 January 2020
A list of approved biologics that are set to go from being regarded as New Drug Applications (NDAs) to Biologics License Applications (BLAs) has been updated. 16 January 2020
The evolution in the regulation of prescription medicines from the 1980s to 2018, and trends in drug approvals, come under the microscope in an analysis published in JAMA this week. 16 January 2020
A document from the National Institute for Health and Care Excellent (NICE) has not recommended Keytruda (pembrolizumab) for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumors express PD-L1 with a combined positive score of one or more. 15 January 2020
The US Food and Drug Administration (FDA) has issued an alert over the results from a clinical trial showing a possible increased risk of cancer with the weight management drug Belviq/Belviq XR (lorcaserin). 15 January 2020
ViiV Healthcare says it has obtained approval of Dovato (dolutegravir 50mg/lamivudine 300mg) from the Japan Ministry of Health, Labor and Welfare. 15 January 2020
Tuesday’s meeting of the Food and Drug Administration's (FDA's) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) to discuss the New Drug Application (NDA) for oxycodegol (formerly NKTR-181) did not recommend approval of oxycodegol, by a vote of 27 to 0. 15 January 2020
US biotech firm Celgene, now a subsidiary of Bristol-Myers Squibb, plans to pursue a New Drug Application (NDA) in first-quarter 2020 for its formulation of oral azacitidine (CC-486) after data from the Phase III QUAZAR AML-001 trial showed that maintenance therapy can prolong the overall survival (OS) of acute myeloid leukemia (AML) patients compared with placebo 15 January 2020
French oncology-focussed Innate Pharma late yesterday announced that the French National Agency for Medicines and Health Product Safety (ANSM) has agreed that the lacutamab (IPH4102) TELLOMAK Phase II trial can resume recruitment of new patients with relapsed/refractory Sézary syndrome and mycosis fungoides (MF) who have received at least two lines of prior systemic therapy. 14 January 2020
Eli Lilly has introduced two more insulins to a program that offers the treatments to US diabetics at reduced prices to the branded versions. 14 January 2020
The Canadian business of Japanese drugmaker Astellas Pharma has won approval for the oral once-daily therapy Xospata (gilteritinib), for relapsed or refractory acute myeloid leukemia (AML). 14 January 2020
Swiss pharma giant Novartis has announced a deal with the National Health Service (NHS) that will bring English patients with atherosclerotic cardiovascular disease (ASCVD) access to inclisiran. 14 January 2020
The impact of durable and potentially curative cell and gene therapies on health system costs has been assessed in a report published by the Alliance for Regenerative Medicine (ARM). 13 January 2020
US gene therapy company bluebird bio has announced the first launch anywhere of Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene). 13 January 2020
The US Food and Drug Administration (FDA) doesn’t always get it right and often comes under much public criticism, especially in recent years. It is important for the federal agency to learn from its mistakes and make positive changes moving forward if they are to restore the public’s trust and confidence in them. Dr Nicola Davies explores some of the recent criticism faced by the FDA and discusses some of the changes they might choose to implement going forwards in 2020. 13 January 2020
A group of three new treatments for acute migraine have been assessed by the Institute for Clinical and Economic Review (ICER) to deem what a fair US price for these yet-to-be-launched medicines might look like. 13 January 2020
AstraZeneca and partner Merck & Co today announced that a supplemental New Drug Application for Lynparza (olaparib) in combination with bevacizumab has been accepted and granted Priority Review in the USA for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy with bevacizumab. 13 January 2020
Clinical-stage USA-based biotech Aruvant Sciences says that the US Food and Drug Administration has granted Rare Pediatric Disease designation to ARU-1801, Aruvant’s investigational therapy for the treatment of sickle cell disease, an inherited blood disorder. 13 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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