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. …
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 …
Some Gains in Biotech Stocks During the War in Europe On Tuesday, Mar 8,2022 the United States’ government decided to ban the importation of Russian oil, liquefied natural gas and coal. This decision was made to further deprive Russia from the resources that enable it to continue with the unwarranted war against Ukraine. This resolution has come at a time when the price of oil …
The Stock Market Today Before the end of 2021 we recognized that investors were not going to swallow what was reiterated about the strong economy. The fact was there were no criteria for a strong economy. Instead, the unparalleled inflation problem was confirmed, which, normally, is expected to negatively impact most of the criteria of a strong economy. The stock market looked to be outperforming …
We Are Back! Thanks to God. Hello to all our subscribers. Our sickness was unanticipated, making our year start in February rather than January. We will tackle the sickness later in another article. Now it is time to appreciate and offer our love and thanks from the bottom of our hearts for those who wished us well, prayed for our recovery and made it happen. …
Sutro Biopharma Inc and Tasly Biopharmaceuticals Exclusive Licensing Agreement for STRO-002 In a press release from today, December 27, 2021, we learned that Sutro Biopharma Inc (
Gilead Sciences and Arcus Biosciences Gilead Sciences (GILD) and Arcus Biosciences (RCUS) announced the closing of Gilead . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Arcturus Therapeutics Holdings Arcturus Therapeutics Holdings (ARCT) is a clinical-stage mRNA medicines company of enabling technologies with an interesting pipeline of treatments and vaccines as well as other products for diseases that have yet to find treatments. Arcturus Therapeutics’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense . . . This …
AstraZeneca Long Acting Antibody Granted FDA EUA for COVID-19 Prevention AstraZeneca (AZN) product Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody (LAAB) combination received emergency use authorization (EUA) in the US for the pre-exposure prophylaxis (prevention) of COVID-19, with the first doses expected to become available very soon. The EUA for Evusheld was granted for . . . This content is for paid subscribers. Please click here …
Celldex Therapeutics Dosed the First Patient with CDX-0159 for Prurigo Nodularis Celldex Therapeutics (CLDX) announced that the first patient in a Phase 1 study of CDX-0159 for prurigo nodularis (PN) has been already dosed. From Celldex Therapeutics Diane C. Young, MD, Senior Vice President and Chief Medical Officer of . . . This content is for paid subscribers. Please click here to subscribe or here to log …
Vertex Pharmaceuticals Phase 2 Results of VX-147 Vertex Pharmaceuticals (VRTX) announced today that, in a Phase 2 proof-of-concept (POC) study in patients with APOL1-mediated focal segmental glomerulosclerosis (FSGS), VX-147, on top of standard of care, achieved a statistically significant, substantial and clinically meaningful . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
The Bizarre Assessment of Biotech Firms in the Stock Market The Clinical-Stage Biotechnology Firms We are witnessing inexplicable evaluations of clinical-stage biotechnology companies. Bizarre is the best description of this group’s assessment which is based on incomes that do not exist in biotech firms that are yet to have approved and marketed products anywhere in the world. Unfortunately, the most impacted firms by the bizarre …
GlaxoSmithKline and Vir Biotechnology Announces US Gov't Contracts to Purchase Sotrovimab for COVID-19 GlaxoSmithKline plc (GSK) and Vir Biotechnology (
Crispr Therapeutics and ViaCyte Inc to Start Trial of First Gene-Edited Cell Replacement Therapy CRISPR Therapeutics (CRSP) and ViaCyte, Inc., announced that Health Canada approved their Clinical Trial Application (CTA) for the product VCTX210, an allogeneic, gene-edited, immune-evasive, stem cell-derived therapy, for the treatment of type 1 diabetes (T1D). The Initiation of patient . . . This content is for paid subscribers. Please click here to …
U.S. Government to Purchase More of Merck and Ridgeback Biotherapeutics Molnupiravir for COVID-19 Merck (MRK) and Ridgeback Biotherapeutics announced that the United States government will exercise two of its options to purchase a total of 1.4 million additional courses of molnupiravir - an investigational oral antiviral medicine, if the medicine is granted Emergency Use Authorization (EUA) or . . . This content is for paid …
Reata Pharmaceuticals Business Operations and Clinical Development Updates Reata Pharmaceuticals (RETA) – a clinical-stage biopharmaceutical company announced financial results for the quarter ended September 30, 2021, and provided an update on the Company’s business operations and clinical development programs. Recent Highlights Bardoxolone in Patients with Chronic Kidney Disease (CKD) Caused by Alport Syndrome The New Drug Application (NDA
Reata Pharmaceuticals MAA Submission for Bardoxolone Methyl Reata Pharmaceuticals (RETA) announced the submission of a Marketing Authorization Application (MAA) for bardoxolone methyl to the European Medicines Agency (EMA) for chronic kidney disease (CKD) caused by Alport syndrome. The MAA submission is based on the efficacy and safety data from the CARDINAL Phase 3 clinical trial. This . . . This content is for paid subscribers. …
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.
