News and Trends 10 Feb 2023 Europe approves childhood epilepsy treatment UCB’s FINTEPLA (fenfluramine) oral solution has been approved in the European Union (EU) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) as an add-on therapy to other anti-epileptic medicines for patients two years of age and older. The approval by the European Commission (EC) was based on safety and efficacy data from a […] February 10, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 7 Feb 2023 Endogena Therapeutics retinitis pigmentosa treatment gets FDA fast track designation The US Food and Drug Administration (FDA) has designated the investigation of Endogena Therapeutics’ EA-2353 for the treatment of retinitis pigmentosa (RP) as a fast track development program. Fast track is a process designed to enable patients to benefit earlier from new drugs for serious conditions. Endogena Therapeutics’ EA-2353 takes a novel, small-molecule approach and […] February 7, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 3 Feb 2023 UK approval for AbbVie Crohn’s disease drug AbbVie has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved RINVOQ (upadacitinib), a janus kinase (JAK) inhibitor, for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biological agent. […] February 3, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 3 Feb 2023 Genoscience Pharma receives orphan drug designation for hepatocellular carcinoma drug Genoscience Pharma has announced that its lead candidate, ezurpimtrostat, a PPT-1 (Palmitoyl Protein Thioesterase-1) inhibitor, has been granted orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for the treatment of hepatocellular carcinoma (HCC). ODD qualifies ezurpimtrostat for a potential seven years of market exclusivity after approval. The FDA’s ODD program provides […] February 3, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 31 Jan 2023 Stemline Therapeutics’ breast cancer treatment approved The Menarini Group, an Italian pharmaceutical and diagnostics company, says that the U.S. Food and Drug Administration (FDA) has approved ORSERDU for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Stemline Therapeutics, a wholly-owned subsidiary […] January 31, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 31 Jan 2023 Stargardt disease treatment gets FDA fast track Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation (FTD) for MCO-010. MCO-010 is an ambient-light activatable multi-characteristic opsin (MCO) optogenetic monotherapy to restore vision in blind patients, for the treatment of Stargardt disease to […] January 31, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 31 Jan 2023 Abbisko Therapeutics receives breakthrough therapy designation for CSF-1R inhibitor Abbisko Therapeutics Co., Ltd. has announced that its CSF-1R inhibitor Pimicotinib has been granted the breakthrough therapy designation from the FDA for the treatment of tenosynovial giant cell tumor (TGCT) patients that are not amenable to surgery. The designation approval is based on results from the phase Ib clinical trial of TGCT cohort for Pimicotinib. […] January 31, 2023 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 27 Jan 2023 EMA accepts Marketing Authorization Application for lecanemab to treat early Alzheimer’s disease BioArctic AB’s partner Eisai says the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab. Lecanemab, known as LEQEMBI in the U.S., is an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed […] January 27, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 27 Jan 2023 Dupixent gets EU nod for children with severe atopic dermatitis The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent (dupilumab), recommending expanded approval in the European Union (EU) to treat severe atopic dermatitis in children six months to five years old who are candidates for systemic therapy. The European Commission is expected to announce a final […] January 27, 2023 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 26 Jan 2023 Milestone for gene-edited therapy for sickle cell disease Vertex Pharmaceuticals (Europe) and CRISPR Therapeutics have announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application of exa-cel for the treatment of sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). The submission is supported by two global phase 3 studies investigating exa-cel as a potential one-time therapy for people with […] January 26, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
Best in Biotech 12 Jan 2023 The biggest biotech trends that will shape 2023 2023 has begun at full throttle. We have collected seven major biotech trends that industry experts are keeping an eye on over the next 12 months. Just like that, another year has begun. 2023 has already launched with announcements of big pharma acquisitions and the approval of Eisai and Biogen’s Alzheimer’s drug lecanemab by the […] January 12, 2023 - 9 minutesmins - By Jonathan Smith Share WhatsApp Twitter Linkedin Email
News and Trends 11 Jan 2023 AstraZeneca’s Airsupra gets US approval as new rescue treatment for asthma Avillion LLP says the US Food and Drug Administration (FDA) has approved AstraZeneca’s Airsupra for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. Airsupra, (albuterol/budesonide, formerly known as PT027) is a first-in-class, pressurized metered-dose inhaler (pMDI), fixed-dose combination rescue medication […] January 11, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email