AstraZeneca: Tagrisso for Adult Patients with Early-Stage EGFRm NSCLC... AstraZeneca (AZN): Tagrisso (osimertinib) has been recommended for marketing authorization in the European Union for the adjuvant treatment of adult patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Sanofi and AstraZeneca MELODY Trial Results for Nirsevimab In March 2017, Sanofi (SNY) and AstraZeneca (

Vertex and CRISPR Granted PRIME Designation from the EMA for CTX001 Vertex Pharmaceuticals (VRTX) and CRISPR Therapeutics (

Gilead Sciences and Eisai Pharmaceutical Co Submitted an Application to Japan's PMDA for Filgotinib Galapagos NV (GLPG) announced that Gilead Sciences (

European Authorities Recommended Additional Approval of Bristol-Myers Squibb Product Onureg® for AML Bristol-Myers Squibb (BMY): The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Onureg® (azacitidine tablets; CC-486) as maintenance therapy in adult patients with acute myeloid leukemia (AML). The approval is for the AML . . . This content is for paid subscribers. Please click here …

Humanigen Product Lenzilumab Combination with CAR-T At the recommended Phase 2 dose, lenzilumab in combination with CAR-T demonstrated a 100% objective response rate and no severe cytokine release syndrome or severe neurotoxicity Lenzilumab reduced IL-6, CRP, ferritin, MCP-1, IL-8, and IP-10 (CXCL-10) among others Humanigen now plans to conduct a randomized, potentially registrational, Phase 2 study with lenzilumab combined with all commercially available CD19 CAR-T …

Cassava Sciences Guidance and Financial Results Cassava Sciences (SAVA) announced financial results for the first quarter ended March 31, 2021 as well as its guidance regarding the release of new clinical data with simufilam, the Company’s lead drug candidate to treat Alzheimer’s disease. Investors and shareholders of this firm are impatiently waiting for more news about the firm’s . . . This content is for …

Vir Biotechnology and GlaxoSmithKline in April 2020  In April 2020, Vir Biotechnology and GlaxoSmithKline entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2 (the virus that causes COVID-19). The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic …

Amylyx Pharmaceuticals Updated Plans to Advance AMX0035 Amylyx Pharmaceuticals, Inc. provided an update on its plans to advance AMX0035 through the clinical development process for the treatment of amyotrophic lateral sclerosis (ALS). The company intends to submit a Marketing Authorization Application (MAA) for AMX0035 to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) by the end of 2021. And, as …

Inovio Pharmaceuticals Promising Results for INO-4800 for COVID-19 Inovio Pharmaceuticals (INO) announces promising results of a study focusing on the human immune responses induced by Inovio DNA vaccine candidate, INO-4800, against COVID-19, and variants of concern. The results demonstrated that INO-4800 induced a robust T . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

FDA Grants Accelerated Approval for Gilead Sciences Trodelvy® The United States Food and Drug Administration (FDA) has granted accelerated approval of Gilead Sciences (GILD) product Trodelvy® (sacituzumab govitecan-hziy). The approval is for use of the product in adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 …

vTv Therapeutics Receives Breakthrough Therapy Designation for TTP399 vTv Therapeutics (VTVT) - a clinical-stage biopharmaceutical company focused on the development of oral treatments for type 1 diabetes, psoriasis, and other diseases, announced that the U.S. FDA has granted Breakthrough Therapy designation for TTP399 as adjunctive therapy to insulin for the treatment of type 1 diabetes. About vTv Therapeutics Product TTp399 . . . This content …

Gilead Sciences is Granted FDA Approval for Trodelvy® Gilead Sciences (GILD), a company that has been granted more approvals than many are aware of except for the short analysts and their followers, today announced that the U.S. FDA has granted full approval to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or . . . This content is for paid subscribers. Please click here …

Exelixis Latest News The latest news announced by Exelixis (EXEL) is the FDA acceptance of its New Drug Application (NDA) that evaluates the safety, tolerability, pharmacokinetics and preliminary antitumor activity of the firm’s investigational product XB002 in advanced solid tumors. XB002 is an antibody-drug conjugate (ADC) composed of a human monoclonal antibody against tissue factor. After binding to tissue factor on tumor cells, XB002 is …

Intellia Therapeutics NTLA-2001 for ATTR Granted Orphan Drug Designation by the EC Intellia Therapeutics (NTLA) announced that the European Commission (EC) has granted its product NTLA-2001 orphan drug designation. The investigational product is being developed as a treatment for transthyretin amyloidosis (ATTR), a rare condition that can impact a number of organs and tissues within the . . . This content is for paid subscribers. Please click here …

Exelixis Boxed in on Good News Exelixis (EXEL) is one of the firms boxed in by rule of thumb traders and short-sellers who put enormous pressure on biotech firms regardless of their good news. We sincerely believe that is what's happening to EXEL. We also believe that these firms, especially the achievers . . . This content is for paid subscribers. Please click here to subscribe …

Illumina Acquisition of GRAIL On September 21, 2020, Illumina and GRAIL Inc. announced that they entered into a definitive agreement under which Illumina will acquire GRAIL for cash and stock consideration of $8 billion, upon closing of the transaction. On March 31, 2021, Illumina announced that it disagrees with, and will oppose, the U.S. Federal Trade Commission's (FTC) challenge to its previously announced acquisition of GRAIL. Illumina …

Rubius Therapeutics Finding small development-stage biotech firms that contribute to biotechnology's limitless revolution of the biological sciences is difficult, but indispensable. Falling on firms that might have the science, the technological capability and the inspiration towards creating new diagnostics and treatments for severe diseases, is rewarding through improving lives.       Learning about Rubius Therapeutics (RUBY) has given us the impression . . . This content …

Current Presentations from Intellia Therapeutics  Intellia Therapeutics (NTLA) is presenting the first preclinical data set on its novel cytosine deaminase base editor technology at the seventh Cold Spring Harbor Laboratory (CSHL) virtual scientific meeting on Nucleic Acid Therapies. The data shows how the Company’s proprietary base editors can expand its genome editing capabilities by enabling the introduction of multiple gene knockouts simultaneously with no detectable increase in …

Novartis Positive Results for Radioligand Therapy, 177Lu-PSMA-617, for mCRPC Novartis (NVS) reported the first interpretable results of evaluating the efficacy and safety of 177Lu-PSMA-617, a targeted radioligand therapy, in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) compared to the best standard of care alone. The good news is that the trial has met both primary endpoints of overall survival (OS) and radiographic progression-free …