/PRNewswire/ Alkermes plc (Nasdaq: ALKS) today reported financial results for the first quarter of 2021. "Our first quarter results reflect solid execution.
ClearCam Success in First 100 Human Trials with Kelling™ Device
The Windshield Wiper for A Laparoscope design meets expectations
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AUSTIN, Texas, April 28, 2021 /PRNewswire/ Despite the trials and upsets of the pandemic, ClearCam blazed a trail to maximize surgical vision and skill with over 100 human trials for its laparoscopic lens cleaning Kelling™ device. ClearCam completed its clinical pilot of the groundbreaking tool in March. The Kelling device allows a surgeon to clean the scope of fat, condensation, blood, and other surgical debris, without removing it from the patient s body, to maintain a perfectly clear optical visual field.
Protalix BioTherapeutics and Chiesi Global Rare Diseases Receive Complete Response Letter for Pegunigalsidase Alfa from FDA
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CARMIEL, Israel and BOSTON, April 28, 2021 /PRNewswire/ Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx
® plant cell-based protein expression system, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), today announced that they received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX‑102) for the proposed treatment of adult patients with Fabry disease.
Amgen Provides Updated Information On LUMAKRAS™ (Sotorasib)¹ Dose Comparison Study
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THOUSAND OAKS, Calif., April 28, 2021 /PRNewswire/ Amgen (NASDAQ:AMGN) today announced that it agreed last night with the FDA s proposed post-marketing requirement to conduct, as part of the ongoing development program, a multi-center randomized clinical trial to compare the safety and efficacy of LUMAKRAS™ at 960 mg once daily versus a lower daily dose of the drug. Based on the preclinical, pharmacokinetic, and clinical data, Amgen intends to proceed with the previously disclosed study comparing 960 mg once daily to a 240 mg once daily dose.