News and Trends 4 Jan 2023 Infex’s novel AMR drug candidate MET-X receives FDA QIDP designation Infex Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has granted qualified infectious disease product (QIDP) designation to MET-X, the company’s broad spectrum metallo-beta-lactamase (MBL) inhibitor. Infex Therapeutics’ MET-X is a resistance bypass treatment that targets Gram-negative Enterobacterales. These pathogens produce MBL enzymes to deactivate beta-lactam antibiotics and evade antibiotic clearance of […] January 4, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 3 Jan 2023 Legend Biotech new drug application approved in China Legend Biotech Corporation has announced that China’s National Medical Products Administration (NMPA) has formally accepted its new drug application (NDA) for ciltacabtagene autoleucel (cilta-cel). This submission is based on data from the confirmatory phase 2 clinical study CARTIFAN-1, conducted in China, which evaluated the efficacy and safety of cilta-cel in adult patients with relapsed or […] January 3, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
In Depth 20 Dec 2022 Ebvallo approval ushers in off-the-shelf T-cell immunotherapies Patient-derived CAR-T immunotherapies have dominated the cancer immunotherapy space over the last decade. The EU approval of Atara Biotherapeutics’ Ebvallo marks the first immunotherapy based on T cells sourced from healthy donors. Since the approvals of Kymriah and Yescarta in 2017, CAR-T immunotherapies have changed the way we treat rare forms of blood cancer. In […] December 20, 2022 - 6 minutesmins - By Jonathan Smith Share WhatsApp Twitter Linkedin Email
News and Trends 20 Dec 2022 F2G looks for FDA new drug application approval for invasive fungal infections treatment F2G Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its new drug application (NDA) for olorofim for the treatment of invasive fungal infections in patients who have limited or no treatment options. F2G has requested approval of the NDA under the Limited Population Pathway for Antibacterial and Antifungal […] December 20, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 19 Dec 2022 Jacobio’s cancer treatment given breakthrough therapy designations by China CDE Jacobio Pharma’s in-house KRAS G12C inhibitor JAB-21822 has been granted breakthrough therapy designations in China. The designations are for the second line and above treatment of advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS G12C mutation. The designations were granted by the Center for Drug Evaluation (CDE) of the National Medical Products […] December 19, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 16 Dec 2022 CSL closer to gene therapy treatments for hemophilia B patients in Europe CSL says the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization (CMA) of etranacogene dezaparvovec. Etranacogene dezaparvovec is a one-time gene therapy for the treatment of appropriate adults with hemophilia B that reduces the rate of annual bleeds with a single infusion. […] December 16, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
In Depth 15 Dec 2022 To avoid stagnation, the EU must refine its ATMP regulation Over the decades, the EU has spearheaded the adoption of advanced therapy medicinal products (ATMPs) such as cell and gene therapies. However, changes are needed to ATMP regulations to keep Europe competitive with the rest of the world. The EU has a rich resource base in terms of biotech innovation. Over the last decades, this […] December 15, 2022 - 8 minutesmins - By Jonathan Smith Share WhatsApp Twitter Linkedin Email
News and Trends 15 Dec 2022 European Commission approves Dupixent as first and only targeted prurigo nodularis medicine The European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials […] December 15, 2022 - 5 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 15 Dec 2022 EMA gives Myrtelle’s Canavan disease gene therapy candidate OD designation Myrtelle Inc., a clinical stage gene therapy company, has announced that the European Medicines Agency (EMA) has granted orphan drug (OD) designation for rAAV-Olig001-ASPA, the company’s lead gene therapy product candidate for the treatment of Canavan disease (CD). EMA OD designation’s aim is to encourage the development of treatments for life-threatening rare conditions by providing […] December 15, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 9 Dec 2022 Visiox Pharma announces FDA acceptance of glaucoma new drug application Visiox Pharma, LLC has received notification from the U.S. Food and Drug Administration (FDA) that the agency has completed its filing review and accepted for filing the New Drug Application (NDA) for PDP-716 (0.35% brimonidine tartrate) for the treatment of glaucoma. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date […] December 9, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 29 Nov 2022 Biocomposites antibiotic carrier, STIMULAN, receives approval for use in Mexico UK-based medical devices company, Biocomposites Ltd., has announced that antibiotic carrier STIMULAN has received a new broad-based approval for use in bone and soft tissue in Mexico. The approval, granted by COFEPRIS, the Mexican Regulatory Authority, authorizes the use of STIMULAN as a carrier of substances such as antibiotics that are chosen by the surgeon […] November 29, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 24 Nov 2022 Gene therapy approval “game changer” in hemophilia B treatment The approval of CSL’s gene therapy Hemgenix has ushered in a new era for hemophilia B treatment. With the addition of other approvals like Rocktavian and Upstaza, 2022 could be a turning point for the broader gene therapy field. Earlier this week, etranacogene dezaparvovec (Hemgenix) made history as the first gene therapy approved by the […] November 24, 2022 - 7 minutesmins - By Jonathan Smith Share WhatsApp Twitter Linkedin Email