From time-to-time there are manufacturing woes at Indian biologics plants that grab headlines and set back development or production of a drug, but that has not stopped the country’s biologics market as a whole being set for robust growth this year. 17 April 2019
Biotech major Amgen on April 9 announced it had received US Food and Drug Administration approval for its osteoporosis treatment Evenity (romosozumab), nearly three months after the Japan approval. 17 April 2019
The Pharmaceutical Price Regulation Scheme (PPRS) is dead; long live the Voluntary Scheme for Branded Medicines Pricing and Access (Voluntary Scheme)! 16 April 2019
The European Medicines Agency has started a review of the multiple sclerosis medicine Lemtrada (alemtuzumab) following new reports of immune-mediated conditions (caused by the body’s defence system not working properly) and problems with the heart and blood vessels with the medicine, including fatal cases. 16 April 2019
Novartis has submitted for approval in the USA for brolucizumab, known internally as RTH258, for the treatment of wet age-related macular degeneration (AMD). 16 April 2019
The Janssen drug Balversa (erdafitnib) has become the first FGFR kinase inhibitor to receive US Food and Drug Administration (FDA) approval. 15 April 2019
USA-based liver specialist Intercept Pharmaceuticals has presented further Phase III data from the REGENERATE study of obeticholic acid (OCA) in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH). 11 April 2019
Regulators have a role to play in ensuring that there is a solid evidence base to support the assessment of added therapeutic benefit of novel treatments compared with existing and potentially cheaper therapies. 11 April 2019
If Amgen and UCB’s expectations for big sales for their partnered asset Evenity (romosozumab) in postmenopausal osteoporis had long since faded, then Tuesday’s approval will likely have further dampened their optimism. 10 April 2019
The European Commission has approved Lynparza (olaparib) as a monotherapy for the treatment of adult patients with germline BRCA1/2-mutations (gBRCAm), and who have human epidermal growth factor receptor 2 (HER2)-negative locally-advanced or metastatic breast cancer. 10 April 2019
Ned Sharpless, the man tasked with filling the shoes left by the departed US Food and Administration (FDA) Commissioner Scott Gottlieb, is just getting his feet under the desk. 10 April 2019
Daiichi Sankyo says that valemetostat (DS-3201), an investigational and potential first-in-class EZH1/2 dual inhibitor, has received Sakigake designation from the MHLW. 9 April 2019
Zogenix has disclosed that the US Food and Drug Administration has issued a Refusal to File (RTF) letter regarding its New Drug Application (NDA) for Fintepla (ZX008, fenfluramine hydrochloride) for the treatment of seizures associated with Dravet syndrome. 9 April 2019
Pharma needs to pay closer attention to ensuring the integrity of its third-party relationships, writes Kathy Johnson, vice president life sciences, LexisNexis Risk Solutions Health Care, in an Expert View piece. 9 April 2019
The US Food and Drug Administration on Monday approved the investigational two-drug single-tablet regimen (STR) Dovato (dolutegravir/lamivudine) for the treatment for HIV-1 infection in adults who have not previously been treated with antiretroviral drugs. 9 April 2019
Japanese pharma major Eisai says that its in-house discovered fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor E7090 has been granted the Sakigake designation by Japan’s Ministry of Health, Labor and Welfare for the treatment of unresectable biliary tract cancer with FGFR2 gene fusion. 8 April 2019
US biotech major Celgene and Acceleron Pharma today announced that Celgene has submitted a Biologics License Application (BLA) for luspatercept, 8 April 2019
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
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
Pharma giant Merck & Co has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 18 September 2024
AstraZeneca’s Fasenra (benralizumab) has been approved in the USA for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA, the UK pharma major announced today. 18 September 2024
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024
Bayer has submitted a Marketing Authorization Application (MAA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the investigational compound elinzanetant. 17 September 2024
The US Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), from Swiss pharma giant Roche. 16 September 2024
The Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) met on Friday to discuss Intercept Pharmaceuticals’ supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA). 16 September 2024
Oligonucleotide therapeutics are rapidly emerging as a promising class of drugs capable of addressing a variety of genetic and complex diseases by targeting RNA sequences.1 16 September 2024
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024