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
The UK subsidiary of Japan’s Astellas Pharma revealed yesterday that National Institute for Health and Care Excellence (NICE) has recommended Xospata (gilteritinib) in its Final Appraisal Document (FAD) for adult patients with relapsed or refractory (resistant to existing treatment) FLT3 mutation-positive acute myeloid leukemia (AML). 17 July 2020
US biotech Tricida opened more than a third lower on Thursday after announcing a setback relating to veverimer, the company’s orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD). 16 July 2020
Guangzhou, China-based LintonPharm is launching a Phase III trial program for catumaxomab in peritoneal carcinomatosis, a form of advanced gastric cancer. 16 July 2020
The European Commission has approved an additional indication for nintedanib in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype beyond idiopathic pulmonary fibrosis (IPF). 16 July 2020
Good news on the regulatory progress of its terlipressin pushed shares of Mallinckrodt up 12.7% by close of trading on Wednesday, plus a further 5.8% to $3.28 in after-hours trading. 16 July 2020
A US Food and Drug Administration (FDA) advisory committee has voted in favor of the demonstrated benefit of treatment with belantamab mafodotin outweighing the risks for relapsed or refractory multiple myeloma patients, who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. 15 July 2020
On Tuesday, the European Council adopted, by written procedure, a regulation which aims to speed up the development and the deployment of a vaccine against COVID-19 in the European Union. 15 July 2020
In the USA, Senate Minority Leader Charles Schumer (Democrat: New York) and Senator Patty Murray (Democrat: Washington), the top Democrat on the Senate Health Committee, released a white paper on Monday saying the Trump Administration needs to do more to ensure safe and effective vaccines for the fight against the novel coronavirus pandemic sweeping the country. 15 July 2020
Johnson & Johnson’s Janssen unit has announced that the US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA). 14 July 2020
US tumor drug resistance specialist Deciphera Pharmaceuticals today announced that the Australian Therapeutics Goods Administration (TGA) has approved Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. 14 July 2020
Washington, USA-based biotech has received a Refusal to File letter for leronlimab, causing shares in the company to fall more than a fifth. 14 July 2020
US pharma giant Pfizer has announced the registration of Bisponsa (inotuzumab ozogamycin), which is an innovative drug, designed for the treatment of acute lymphoblastic leukemia (ALL), in Russia. 14 July 2020
Anglo-Swedish drugmaker AstraZeneca has announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Brilinta (ticagrelor) for the reduction of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack (TIA). 13 July 2020
The US Food and Drug Administration (FDA) has granted Fast Track designation to two vaccine candidates from the Pfizer and BioNTech BNT162 mRNA-based vaccine program. 13 July 2020
US RNAi therapy specialist Alnylam Pharmaceuticals says that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted lumasiran, an investigational RNAi therapeutic in development for the treatment of primary hyperoxaluria type 1 (PH1), a positive scientific opinion through the Early Access to Medicines Scheme (EAMS). 13 July 2020
Clocking up another approval for the repurposed anti-viral, Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to US biotech major Gilead Sciences’ Veklury (remdesivir) as the first treatment option for COVID-19 in the country. 13 July 2020
Biocon has received the Drugs Controller General of India’s (DCGI) approval to market Alzumab (itolizumab) injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome (CRS) in moderate to severe ARDS (acute respiratory distress syndrome) patients due to COVID-19. 13 July 2020
The German federal government took over the European Union Council Presidency on July 1, 2020. It is therefore a moderator in the European debate until the end of the year. 13 July 2020