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
Shares of AstraZeneca were up 1.55% at £88.05 by late morning, after it revealed that its Bevespi Aerosphere (glycopyrronium/formoterol fumarate) has been approved in China as a maintenance treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. 18 May 2020
Daiichi Sankyo and partner AstraZeneca today announced that their Enhertu (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy designation (BTD) in the USA for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 mutation and with disease progression on or after platinum-based therapy. 18 May 2020
Global specialist HIV company ViiV Healthcare, majority-owned by GlaxoSmithKline, has announced positive results from an interim analysis of the HIV Prevention Trials Network (HPTN) 083 study. 18 May 2020
On Friday, US President Donald Trump announced the addition of two of the most highly respected and skilled professionals to the White House new initiative, dubbed Operation Warp Speed, the objective of which is to finish developing and then to manufacture and distribute a proven coronavirus vaccine as fast as possible. 16 May 2020
The US Food and Drug Administration approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST), a type of tumor that originates in the gastrointestinal tract. 16 May 2020
On Friday, the US Food and Drug Administration granted accelerated approval to Rubraca (rucaparib) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. 16 May 2020
The US Food and Drug Administration on Friday expanded the indication of already-marketed Pomalyst (pomalidomide) to include treating adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy and Kaposi sarcoma in adult patients who are HIV-negative. 16 May 2020
The US Food and Drug Administration has issued a complete response letter (CRL) for the new drug application of avapritinib for the treatment of adults with unresectable or metastatic fourth-line gastrointestinal stromal tumor (GIST). 15 May 2020
Paris-based Sanofi has been forced to walk back claims that the USA would be entitled to the largest order of its investigational COVID-19 vaccine, should it be successfully developed. 15 May 2020
Privately-held USA-based Pharmazz on Thursday announced receipt of a marketing authorization of centhaquine, trade name Lyfaquin, a first-in-class drug, to manage patients with hypovolemic shock from the Indian regulatory agency. 15 May 2020
The global coronavirus pandemic has placed an unprecedented strain on the pharmaceutical industry, with the enforcement of strict lockdown measures disrupting enrolment onto clinical trials and delaying decisions on drugs nearing approval. 14 May 2020
The European Commission (EC) has extended the current conditional marketing authorization of Adcetris (brentuximab vedotin) to include adults with previously untreated systemic anaplastic large cell lymphoma (sALCL), in combination with cyclophosphamide, doxorubicin, prednisone (CDP). 14 May 2020
The Chinese regulator has approved a submission from Novocure and Shanghai’s Zai Lab for Optune (tumor treating fields), a novel electric field-based therapy. 14 May 2020
Shares in bluebird bio were hit and those in Bristol-Myers Squibb were holding up after the news that they received a Refusal to File letter from the US Food and Drug Administration (FDA) relating to their CAR-T therapy, idecabtagene vicleucel (ide-cel; bb2121). 13 May 2020
The European Medicines Agency’s Committee for Medical Products for Human Use (CHMP) has recommended expanding the compassionate use of Gilead Sciences’ remdesivir so that more patients with severe COVID 19 can be treated. 13 May 2020
UK cell and gene therapy developer Oxford Biomedica today announced the successful outcome of its recent UK Medicines & Healthcare products Regulatory Agency (MHRA) inspection, resulting in the issue of a Certificate of GMP compliance for the first two GMP manufacturing suites and supporting area such as warehouse, cold chain facilities and QC laboratories, in its new Oxbox manufacturing facility. 13 May 2020
Cancer drugs from Pfizer and Roche have won recommendations from the National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales. 13 May 2020
During 2019 – before COVID-19 could offer an explanation for reduced routine regulatory activity – US Food and Drug Administration (FDA) approvals were down by 16% compared to 2018. 12 May 2020
The Russian government plans to provide support to producers of cheap drugs, with the aim to prevent their disappearance from the domestic market, according to recent statements by representatives of some senior state officials and industry’s analysts, reports The Pharma Letter’s local correspondent. 12 May 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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