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    Home > Medical News > Latest Medical News > 30 million euros commercially approved, Acacia Pharma drug injected with new drug remylinl is approved by the FDA

    30 million euros commercially approved, Acacia Pharma drug injected with new drug remylinl is approved by the FDA

    • Last Update: 2020-07-14
    • Source: Internet
    • Author: User
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    Read: BYFAVO is the second ACAcia Pharma pharmaceutical product approved by the FDA in 2020 and expands its new portfolio for anesthesiaBYFAVO is a very fast-acting/disordered IV benzodiazepine sedative for invasive medical procedures lasting 30 minutes or less, such as colonoscopy and bronchoscopy
    about 25 million such operations each year in the United States, about 90% of which use moderate sedation
    FAVO is the second ACAacia Pharma pharmaceutical product approved by the FDA in 2020, and expands its new drugportfolio Acacia Pharma Group plc ("Acacia Pharma" or the "Company") is a commercial biopharmaceutical company that develops and commercializes new products to improve its claims to ABC CareOn July 2, patients receiving severe medical treatment (e.g., surgery, invasive treatment, or chemotherapy) announced that the U.SFood and Drug Administration (FDA) has approved by BYFAVO ™ (remimazolam, Chinese name: remizolam) injections for inducing and maintaining the adult's procedural sedative effects or less during a 30-minute treatmentAcacia Pharma obtained a commercial license from Cosmo Pharmaceuticals NV in the United States in January 2020Remialen was developed by Paion AGinjection by BYFAVO (remimazolam) is a very fast starter/offset intravenous benzodiazepine sedative for invasive medical procedures such as colonoscopy and bronchoscopy in adult patients lasting 30 minutes or lessIn the United States, about 25 million such operations are performed each year, about 90 percent of which use moderate sedativesCosmo granted Paion AG access to BY FAVO in 2016 and they jointly registered the candidate productsBYFAVO is now approved in the United States and is used for adult induction and maintenance of procedure sedation for 30 minutes or lessit is understood that the approval of BYFAVO will help further strengthen Acacia Pharma's financial resources, which will now receive an additional 25 million euros in debt financing from CosmoUnder the approval, Acacia Pharma will pay COSMO 30 million euros of BYFAVO license, including 15 million euros in cash and 15 million euros of Acacia Pharma common stockAcacia Pharma will receive a net cash of 10 million euros to fund the launch of BYFAVO in the United StatesMike Bolinder, chief executive of acacia Pharma, , said: "We are pleased to announce that BYFAVO has been approved for routine sedation in adult patients in the United States "。" This marks the second FDA approval of Acacia Pharma products since the beginning of 2020 and another important milestone in our development to a comprehensive hospital pharmaceutical company with strong development and commercialization capabilities Adding BYFAVO to our portfolio enhances our products for anesthesiologists and allows us to further leverage our commercial infrastructure I want to thank our partners in Paion and Cosmo, as well as the Acacia Pharma team and stakeholders, who enabled us to bring this innovative and innovative therapy to market to meet the needs of millions of patients who need sedative procedures each year "。 Gerard A Silvestri, M.D., M.D., M.D., Professor of Medicine at The Medical University of South Carolina, and former President of the American College of Thoracic Physicians in Charleston, South Carolina, commented: "It's exciting to approve remimazolam (BYFAVO) Program experts, because the field has not seen the addition of new sedatives to our armory in decades The drug has performed well in clinical trials and has excellent sedative effects, successfully completing 80-90% of operations The state of the cardiac-respiratory system appears to be very encouraging, and patients quickly regain consciousness so that they can be discharged in time "
    " is pleased to see that our new strategy has been successfully implemented Integrating our products through equity acquisition, both the previously approved antimicrobial inhibitor, livermycin Aemcolo, and the approved BYFAVO have been given a stable and efficient marketing organization BYFAVO's approval is the third FDA-approved company product for our shareholding, following the approval of Red Hill Biopharma's Talicia and Acacia Pharma's BARHEMSYS Now, we look forward to Acacia Pharma turning BYFAVO into a great success Alessandro Della Ch, ceo of Cosmo Pharmaceuticals, said Dr Jim Phillips, CEO of PAION AG, , commented, "BYFAVO's marketing logo in the United States is the most important milestone in PAION's history, and I congratulate everyone who has played a role in this important achievement The U.S is the world's largest pharmaceutical market, and we're excited to see paiON's successful products available there to doctors We hope that Acacia will be a successful market in this important market, and we will support their commercialization efforts As we and our partners strive to get more marketing approvals, we also want remimazolam to be rolled out in other countries around the world Dr Gabriel Fox, chief medical officer of acacia Pharma, , said: "BYFAVO is an important addition to the limited selection of diagnostic sedatives that can be used in the program BYFAVO has demonstrated significant patient benefits in its extensive clinical trial program, providing very rapid efficacy and offsetting effects, and has seen heart breathing and other adverse reactions similar to those in the placebo group evaluated the safety of BYFAVO in three key studies of patients with 969 routine colonoscopy (two studies) or bronchoscopy (one study), 630 of whom received BYFAVO In these studies, the most common adverse reactions (incidence greater than 10%) after ADMINISTRATION were low blood pressure, high blood pressure, diastolic hypertension, systolic hypertension, hypoxia and diastolic hypotension Acacia Pharma's first product, BARHEMSYS (AmambriBili Injection) approved by the FDA on February 26, 2020 for treatment and prevention of postoperative heart and vomiting (PONV) in adult patients, and the company intends to launch BARHEMSYS and BYVOVO in the United States in the second half of 2020 it should be noted that BYFAVO may have to wait until the U.S Drug E.A has a schedule under the Controlled Substances Act, which is expected to take place in the coming months about Acacia Pharm
     Acacia Pharma is a hospital pharmaceutical company dedicated to the development and commercialization of new products aimed at improving the care of patients receiving critical treatments such as surgery, other invasive treatments or cancer treatments And the company has identified its portfolio to address the unmet needs that are important and commercially attractive in these areas Headquartered in Cambridge, Uk.s., Phasepharmaceutical sits in Indianapolis, Indiana, with its U.S operations The company is listed on the Euronext Brussels stock exchange
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