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 …

GlaxoSmithKline and Vir Biotechnology Sotrovimab Retains In Vitro Activity Against Omicron GlaxoSmithKline plc (GSK) and Vir Biotechnology (

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 …

Ionis Pharmaceuticals Announced Pfizer Update of Vupanorsen Ionis Pharmaceuticals (IONS) announced that Pfizer's (

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. …

Bausch + Lomb and Clearside Biomedical Announce FDA Approval of XIPERE™ Bausch + Lomb, a leading global eye health business of Bausch Health Companies (BHC), and Clearside Biomedical (

Intellia Therapeutics Authorization of CTA for Phase 1/2 Study of NTLA-2002 Intellia Therapeutics (NTLA) announced the authorization of its Clinical Trial Application (CTA) by the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) to initiate a Phase 1/2 study evaluating NTLA-2002 for the treatment of adults with hereditary angioedema (HAE). About Hereditary . . . This content is for paid subscribers. Please click here to subscribe or …

Reata Pharmaceuticals to Submit Omaveloxolone for NDA in Early 2022 In a press release following the completion of pre-NDA meeting with the FDA, Reata Pharmaceuticals (RETA) stated that the purpose of the pre-NDA meeting was to discuss the content of Reata’s planned NDA submission. The firm plans to submit the NDA . . . This content is for paid subscribers. Please click here to subscribe or here to …

AstraZeneca Saphnelo Approved by Japanese Ministry of Health, Labor and Welfare Developed by AstraZeneca (AZN), Saphnelo is a first-in-class type I interferon receptor antibody shown to reduce overall disease activity in patients with systemic lupus erythematosus. The approval by the Japanese Ministry of Health, Labor and Welfare (MHLW) was based on efficacy and safety data from the Saphnelo clinical . . . This content is for paid subscribers. …

Cassava Sciences Announces Top-Line Clinical Data for Simulfilam Cassava Sciences Press Release Today Cassava Sciences (SAVA) announced top-line clinical data today from a pre-planned interim analysis of an on-going open-label study with its drug candidate simufilam in patients with mild-to-moderate Alzheimer’s disease. In a study funded by the National Institutes of Health (NIH), ADAS-Cog11 . . . This content is for paid subscribers. Please click here to subscribe …

Seagen and Genmab Granted FDA Accelerated Approval for TIVDAK™ The U.S. FDA granted accelerated approval to Seagen Inc (SGEN) and Genmab A/S (

Intellia Therapeutics IND Application of NTLA-5001 for AML is Accepted by the US FDA NTLA-5001 is Intellia Therapeutics (NTLA) first wholly-owned ex vivo CRISPR genome editing candidate for the treatment of cancer. It is an autologous T cell receptor (TCR)-T cell therapy engineered to target the Wilms’ Tumor (WT1) antigen for the treatment of all genetic subtypes . . . This content is for paid …

Regenxbio and AbbVie in the NEWS Regenxbio (RGNX) stock soared today. The Company, along with AbbVie (ABBV

IVERIC bio Stock Rally IVERIC bio (ISEE) stock rallied in early, premarket trading today as Stifel Nicolaus initiated a buy rating and a price target of $22. In premarket the stock was trading over $13.37, UP over $4 and still moving. Following the tumbling of the firm's stock . . . This content is for paid subscribers. Please click here to subscribe or here to log in.