Category: Impacting News

Why Merck KGaA, Darmstadt, Germany Paid Sutro Biopharma. See Also: BMY Approval of Zeposia for UC

Sutro Biopharma Receives Milestone Payment from Merck KGaA, Darmstadt, Germany Sutro Biopharma (STRO) announced that it has received a milestone payment under its collaboration and license agreement with the healthcare division of Merck KGaA, Darmstadt,Germany. The payment is related to a patient enrollment achievement in the Phase 1 dose-escalation and expansion study of M1231 in adult patients . . . This content is for paid …

Amgen: FDA Approves LUMAKRAS™, the First and Only Targeted Treatment for Patients with KRAS G12C-Mutated Locally Advanced or Metastatic NSCLC

Amgen Announced FDA Approval of LUMAKRAS™  Amgen (AMGN) announced the news about the FDA approval of LUMAKRAS™ (sotorasib) on May 28, 2021. The firm indicated that the FDA granted approval is for adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. LUMAKRAS received . . . This content is for paid subscribers. Please …

Aptevo Therapeutics Inc Product APVO436 Improves the Treatment of Resistant AML and MDS

Aptevo Therapeutics Inc in the News Aptevo Therapeutics Inc (APVO) has positive results from the Phase 1 dose-escalation trial evaluating its lead ADAPTIR candidate product APVO436 for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). APVO436 APVO436 - Aptevo's bispecific ADAPTIR that targets CD123 x CD3, is designed to redirect the immune system . . . This content is for paid subscribers. …

Recursion Pharmaceuticals: A Step Forward Towards Improving C. Difficile Treatment

Recursion Pharmaceuticals Product REC-163964 Recursion Pharmaceuticals Inc (RXRX) announced the initiation of an investigational new drug (IND)-enabling studies for REC-163964, a first-in-class, small molecule toxin inhibitor for possible prevention of recurrent Clostridium difficile (C. difficile) infections and potential prophylactic use in high-risk patients. REC-163964 is a new chemical entity and the first to be . . . This content is for paid subscribers. Please click here …

Cassava Sciences Awarded NIH Grant. See Also: Intellia Therapeutics Presentations at the 24th ASGCT Meeting

Cassava Sciences Awarded NIH Research Grant for Simufilam Cassava Sciences (SAVA) announced that it has been awarded a new $2.7 million research grant from the National Institutes of Health (NIH). The grant was awarded following a peer review of clinical and scientific data for simufilam, its drug candidate for Alzheimer's disease, and is intended to fund clinical readiness activities . . . This content is …

Sutro Biopharma: First Quarter Financial Results, Business Highlights and More

Sutro Biopharma Inc Sutro Biopharma (STRO) is a clinical-stage drug discovery, development and manufacturing company. Its expertise is in the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics. Sutro Biopharma reported its financial results for the first quarter of 2021 and its recent business highlights, in addition to providing a preview of anticipated selected . . . This content …

Gilead Sciences Conference Call Information. See Also: Compugen Announcements

Gilead Sciences First-Quarter 2021 Financial Results Conference Call Info Gilead Sciences (GILD) management will host a conference call to discuss the company’s first-quarter 2021 financial results and will provide a business update today, Thursday, April 29, at 4:30 p.m. EST.  Investors can dial 1-877-359-9508 (U.S.) or 1-224-357-2393 (international) to reach . . . This content is for paid subscribers. Please click here to subscribe or here to …

AstraZeneca: Tagrisso Recommended for Marketing Authorization in the EU for Early Stage EGFRm NSCLC

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.

Humanigen Inc Product Lenzilumab Combination with CAR T in DLBCL Protects from Severe Cytokine Syndrome

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 …

Vir Biotechnology and GlaxoSmithKline: The European Medicines Agency Started a Review of VIR-7831 for COVID-19

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 …

Intellia Therapeutics Announces More Good News

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 CABOMETYX: Now Approved in Europe for First-Line Treatment of Renal Cell Carcinoma

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 …

A Biotech Firm We Love to Discover

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 …

The FDA Approved KemPharm Inc’s AZSTARYS™ for ADHD

KemPharm Inc KemPharm Inc (KMPH) - a specialty pharmaceutical focused on the discovery and development of proprietary prodrugs, announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for AZSTARYS™, a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in . . . This content is for paid subscribers. Please click here to subscribe or here to log …