Expert Advice 15 Mar 2024
Is biotechnology a good career? Here are the pros and cons
Find out about the pros and cons of pursuing a career in biotechnology, from competitive salaries to dealing with regulatory hurdles.
Regulatory approval
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News and Trends 28 Jul 2023
FDA grants breakthrough therapy designation to Duchenne muscular dystrophy treatment
The U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy Designation to NS Pharma Inc.’s NS-089/NCNP-02, an investigational candidate for patients with Duchenne muscular dystrophy amenable to exon 44 skipping therapy. The breakthrough designation is based on results from a first-in-human, investigator-initiated clinical trial conducted in Japan. In June 2023, NS-089/NCNP-02 was granted Rare […]
Expert Advice 28 Jul 2023
What you need to know about the EU HTA regulation before deadline
By Anke van Engen, senior principal, EMEA value & payer evidence, IQVIA, and Dima Samaha, senior principal, EMEA value & payer evidence, IQVIA The European Union (EU) comprises 27 member states (MS) with varying laws, processes and regulatory standards. This variation has led to a complex data landscape for health technologies and drug therapeutics developers, […]
News and Trends 20 Jul 2023
Endometrial cancer drug receives breakthrough therapy designation in China
HUTCHMED (China) Limited has announced that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to the combination of fruquintinib and sintilimab (a PD-1 antibody) for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed at least one line of platinum-based […]
News and Trends 18 Jul 2023
FDA approves Beyfortus ahead of 2023-24 RSV season
The U.S. Food and Drug Administration (FDA) has approved Sanofi and AstraZeneca’s Beyfortus (nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. The approval also covers children up to 24 months of age who remain vulnerable to severe […]
News and Trends 7 Jul 2023
FDA approves Alzheimer’s treatment
Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI (lecanemab-irmb) 100 mg/mL injection for intravenous use. The decision makes LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression […]
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News and Trends 5 Jul 2023
Narcolepsy drug gets Chinese approval
RareStone Group, a rare disease-focused company aiming to establish the first rare disease ecosystem in China, has announced that the Chinese National Medical Products Administration (NMPA) has approved pitolisant (Wakix) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. In China, pitolisant is the first approved innovative drug for […]
News and Trends 4 Jul 2023
Innovent and IASO Bio obtain approval for CAR-T multiple myeloma treatment
Innovent Biologics, Inc. and IASO Biotechnology have announced that China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for FUCASO (Equecabtagene Autoleucel). FUCASO is the first fully-human BCMA-directed chimeric antigen receptor (CAR) T-cell therapy for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior […]
News and Trends 30 Jun 2023
FDA approves BioMarin gene therapy for hemophilia A
BioMarin Pharmaceutical Inc. has announced that the United States Food and Drug Administration (FDA) has approved ROCTAVIAN (valoctocogene roxaparvovec-rvox) gene therapy for the treatment of adults with severe hemophilia A (congenital factor VIII (FVIII) deficiency with FVIII activity < 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test. The […]
News and Trends 29 Jun 2023
FDA gives Orphan Drug Designation to CellCentric multiple myeloma drug
CellCentric, a UK-based biotechnology company, has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for inobrodib in the treatment of multiple myeloma. Delivered as an oral capsule, inobrodib can be used at home without requiring intensive monitoring. It is a first-in-class drug, with a new mechanism of action. It […]
News and Trends 27 Jun 2023
UCB myasthenia gravis drug given FDA approval
UCB has announced RYSTIGGO (rozanolixizumab-noli) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. Rozanolixizumab-noli injection for subcutaneous infusion is a humanized IgG4 monoclonal antibody that binds to the neonatal […]
News and Trends 26 Jun 2023
AbbVie takes step forward in Europe with migraine drug
AbbVie says the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CMHP) has adopted a positive opinion recommending the approval of atogepant for the prophylaxis of migraine in adults who have four or more migraine days per month. If approved, AbbVie will be the only company to offer a once daily oral […]
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