Pivotal data from a Phase II study of the FGFR inhibitor pemigatinib will be used to support a US filing later in the year, says Incyte chief executive Hervé Hoppenot. 27 September 2019
German pharma and sciences firm Merck KGaA says that Erbitux (cetuximab) has been granted approval by China’s National Medical Products Administration (NMPA) for the first-line treatment for patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC) in combination with FOLFOX or FOLFIRI, or in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy. 27 September 2019
The US. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) yesterday announced that the reorganization of the Office of New Drugs (OND) with corresponding changes to the Office of Translational Sciences (OTS) and the Office of Pharmaceutical Quality (OPQ) has been approved 27 September 2019
Insights from a Clarivate Analytics report "2019 Centre for Medicines Research (CMR) International Pharmaceutical R&D Factbook" show there are two main factors in the pharmaceutical industry that are causing the increase in drug approvals and subsequently the decrease in cost per new molecular entity (NME). 26 September 2019
With nitrosamines impurities now identified in ranitidine and ‘sartan’ medicines, the European Medicines Agency’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorization holders for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines and test all products at risk. 26 September 2019
US biotech Omeros Corp has announced study results showing that inhibition of mannan-binding lectin-associated serine protease-2 (MASP-2) protects against renal injury caused by proteinuria (ie, high levels of plasma proteins in the urine) and inflammation. 26 September 2019
The US Food and Drug Administration (FDA) has accepted UK-based Acacia Pharma resubmitted New Drug Application (NDA) for Barhemsys (amisulpride injection). 26 September 2019
The US Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc, used to decrease the amount of acid created by the stomach. 25 September 2019
Swiss pharma giant Novartis has responded to the US Food and Drug Administration’s (FDA) issuing of a Form 483 relating to allegations of data manipulation on Zolgensma (onasemnogene abeparvovec-xioi). 25 September 2019
The US Food and Drug Administration yesterday announced the approval of Jynneos smallpox and monkeypox vaccine, live, on-replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. 25 September 2019
Shares of clinical-stage US biotech Provention Bio rose 6% in pre-market trading in reaction to reiteration of its registration plan for its Breakthrough Therapy-designated teplizumab (PRV-031) for the prevention or delay of clinical type 1 diabetes in at-risk people 24 September 2019
The Chinese business of Japanese drugmaker Mitsubishi Tanabe Pharma has filed for approval to market Tenelia (teneligliptin) for type 2 diabetes. 24 September 2019
The European Commission has approved the marketing authorization for marijuana-based Epidyolex (cannabidiol) for use as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients aged two years and older. 23 September 2019
China-based biotech CARsgen Therapeutics has been granted PRIority MEdicines (PRIME) eligibility to its investigational CAR-T cell therapy fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cells (ct053) for the treatment of relapsed or refractory multiple myeloma, by the European Medicines Agency 23 September 2019
The US Food and Drug Administration has issued an update on efforts to increase the availability of all forms of naloxone products, with the aim of combating the opioid crisis. 23 September 2019
Merck & Co says that the US Food and Drug Administration approved supplemental New Drug Applications (sNDAs) for Pifeltro (in combination with other antiretroviral agents) and Delstrigo (as a complete regimen) that expand their indications to include adult patients with HIV-1 infection who are virologically suppressed . 23 September 2019
As well as recommending approval of four novel medicines and three generic medicines at its September 2019 meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced positive opinions for a number of label extensions, as follows: 23 September 2019
Novo Nordisk late Friday day announced the much awaited US Food and Drug Administration approval of its first-of-a-kind oral diabetes drug Rybelsus (semaglutide), as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, with the news sending the Danish diabetes giant’s shares up 2.59% to 350.50 Danish kroner in late trading. 22 September 2019
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
The US Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC) injection for patients in the USA, Swiss pharma giant Roche subsidiary Genentech announced yesterday. 13 September 2024