Amgen Repatha Studies Repatha is the Longest Studied PCSK9i Amgen (AMGN) announced top-line results from two Repatha® (evolocumab) open label extension (OLE) studies to the Phase 3 FOURIER cardiovascular outcomes trial. The studies were designed to assess the long-term safety and tolerability of Repatha over five years in adults with clinically evident atherosclerotic cardiovascular disease. The FOURIER-OLE (Further . . . This content is for paid …

Gilead Sciences Receives sNDA from the FDA for Remdesivir for Pediatric Patients with COVID-19 Gilead Sciences (GILD) announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Veklury®, aka remdesivir, for the treatment of pediatric patients who are older than 28 days, weighing at least 3 kg, and . . . This content is for paid subscribers. …

Arcturus Therapeutics Holdings News Arcturus Therapeutics Holdings (ARCT) shared topline data from an ongoing Phase 1/2/3 trial evaluating ARCT-154, Arcturus’ self-amplifying mRNA vaccine candidate against COVID-19. The ongoing Phase 1/2/3 registrational study, sponsored by Arcturus’ collaborator Vinbiocare Biotechnology Joint Stock Company – a member of Vingroup Joint Stock Company, enrolled over . . . This content is for paid subscribers. Please click here to subscribe or here to log …

FDA Lifts Partial Clinical Hold on Gilead Sciences Studies of Magrolimab On April 12, 2022, Gilead Sciences (GILD) announced that the U.S. FDA lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with azacitidine. The FDA removed the partial hold after reviewing the comprehensive safety data from each trial. Enrollment in the U.S. can resume . . . This …

The Clinical Stage Biotech Firms   We have reasons to believe that some clinical-stage biotechnology firms, which have yet to generate revenues, have solid scientific fundamentals, breakthrough technologies and extremely promising  products that will generate billions of dollars in future years. These solid firms’ shareholders are currently experiencing selloffs of their stocks. Short-sellers, and the followers who are encouraging the ridding of these stocks, explain …

Jazz Pharmaceuticals and Werewolf Therapeutics Agreement Jazz Pharmaceuticals (JAZZ) and Werewolf Therapeutics (HOWL)

Sunshine Biopharma mRNA Therapeutics Effective at Destroying Cancer Cells Sunshine Biopharma, Inc. (SBFM) –  a pharmaceutical company focused on research, development and commercialization of oncology and antiviral drugs, announced that two of its newly designed mRNA molecules are effective at destroying cancer cells grown in culture. The cytotoxicity tests were performed on a variety of cancer cells including the following cancers: Multidrug resistant breast cancer …

Gilead Sciences' Product Yescarta Kite - a Gilead Sciences (GILD) Company, announced the U.S. FDA has approved Yescarta® (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma (LBCL) refractory to first-line chemo-immunotherapy or that which relapses within 12 months of first-line chemo-immunotherapy. Yescarta demonstrated a clinically meaningful and statistically significant . . . This content is for paid subscribers. Please click here to subscribe or …

Reata Pharmaceuticals Completed Rolling NDA Submission for Omaveloxolone for Friedreich’s Ataxia Reata Pharmaceuticals (RETA) announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. FDA for omaveloxolone’s treatment of Friedreich’s ataxia (FA). The NDA is supported by the efficacy and safety data from the MOXIe Part 1, Part 2 and MOXIe Extension studies. The FDA has granted Fast Track …