Category: Impacting News

BioMarin Pharmaceutical Inc Product VOXZOGO® is the First to Prevent Dwarfism in Europe

The most important news in biological sciences is the high degree of success the biological revolution can reach. We can feel the great value every time an untreatable, devastating condition is successfully treated thanks to discoveries made possible through the information brought in by the unparalleled revolution that allows for a better understanding of the living body mechanisms of actions in health and in diseases. …

Cara Therapeutics and Vifor Pharma Announced the U.S. FDA Approval of KORSUVA™

Cara Therapeutics and Vifor Pharma Granted US FDA Approval of KORSUVA™ Indeed, the U.S. Food and Drug Administration (FDA) approved Cara Therapeutics (CARA) and Vifor Pharma injectable product KORSUVA™ (difelikefalin) - a first-in-class kappa opioid receptor (KOR) agonist that targets the body’s peripheral nervous system, for moderate-to-severe pruritus associated with chronic kidney . . . This content is for paid subscribers. Please click here to subscribe or here to …

Travere Therapeutics: Positive Trial Results of its Product Sparsentan in Treating IgA Nephropathy

Travere Therapeutics Sparsentan for IgAN Positive Results Phase 3 PROTECT Study of Travere Therapeutics (TVTX) product sparsentan for the treatment of IgA nephropathy (IgAN) demonstrated positive topline interim results. The PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater than a threefold reduction of proteinuria from baseline after 36 weeks of treatment . . . This content is for paid …

Akero Therapeutics Inc Q2 Business Updates and Financial Results

Akero Therapeutics Inc Akero Therapeutics Inc (AKRO) is a clinical-stage cardio-metabolic company developing transformational treatments for non-alcoholic steatohepatitis (NASH), a disease without any approved therapies. Akero’s investigational drug product candidate, efruxifermin (EFX), is a differentiated Fc-FGF21 fusion protein engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates . . . This content is for paid subscribers. Please click here …

A Biotechnology Company to Remember and Appreciate

Vir Biotechnology: What We've Learned from Dr. George Scangos George Scangos, PhD. is the chief executive officer of Vir Biotechnology (VIR), we don't know if you remember him from our previous postings, so we will remind that Dr. Scangos has said that Vir Biotechnology made strong progress across its extensive infectious disease portfolio, the most notable of which . . . This content is for …

Reata Pharmaceuticals Two Stories: Updated News of its Clinical Programs and Finances

Reata Pharmaceuticals Two Stories  Omaveloxolone in Patients with Friedreich’s Ataxia  Several communications between Reata Pharmaceuticals (RETA) and the FDA have taken place in the past regarding omaveloxolone for Friedreich’s Ataxia (FA) without reaching clear results that could satisfy either the Firm or the FDA. However, recent communication by the FDA seems to have finally satisfied both.  Following . . . This content is for paid …

Novartis Announces Lift of Partial Clinical Trial Hold. See Also: Plans to Initiate a New SMA Study

Novartis Partial Clinical Trial Hold for OAV-101 IT for SMA Lifted Novartis (NVS) announced that the U.S. FDA has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. The decision to lift the hold was based on data from . . . This content is for paid subscribers. …

AstraZeneca: Big Step Towards Improving the Lives of SLE Patients and More on Cassava Sciences

Cassava Sciences There is no doubt in our minds that Cassava Sciences’ (SAVA) product simufilam will play a major role in the treatment of Alzheimer’s disease. We have no doubt that simufilam has improved cognition in patients with mild to moderate Alzheimer’s disease. The cognition gained 3.0 Points on ADAS-Cog in 9 months. The Alzheimer’s patients’ disordered . . . This content is for paid …

Cassava Sciences Good News and an Unwarranted Sell-Off. A New Drug Approval for Bristol-Myers Squibb and ImmunoGen Quarterly Results

Cassava Sciences Inc Following Cassava Sciences Inc successful and promising presentations, all the titles of the news and articles written by fair professionals have been as follows: “Cassava Sciences announces positive biomarkers’ data and positive Cognition Data following the treatment with Simufilam” These titles never moved from the Internet even after a huge sell-off occurred.  Indeed, the improvement in cognition demonstrated by the data was …

Cassava Sciences Stock Soared. See Also: The Resurrection of Sunesis Pharmaceuticals

Cassava Sciences Soared Cassava Sciences (SAVA) stock soared today. The firm announced that it will present two new clinical datasets for its product candidates at the 2021 Alzheimer’s Association International Conference (AAIC), which will be held virtually in Denver, CO from July 26th through July 30th. Cassava Sciences’ investigational product candidates include simufilam treatment . . . This content is for paid subscribers. Please click here to subscribe or …

Important News and Results from Two Companies in the Prohost Portfolio

Important News and Results from Akero Therapeutics Akero Therapeutics (AKRO) announced that full results of the main portion of its Phase 2a BALANCED trial in biopsy-confirmed NASH patients with F1-F3 fibrosis have been published in Nature Medicine. The study shows investigational NASH Drug Efruxifermin (EFX) reduced liver fat to normal levels and reversed fibrosis after 16 weeks . . . This content is for paid subscribers. …

Auris Medical Holding Ltd has Encouraging Results Addressing the Unmet Needs of ATLL

Auris Medical Holding Ltd OligoPhoreTM Technology for ATLL Auris Medical Holding Ltd. (EARS) is a company focusing on addressing unmet medical needs through RNA therapeutics for allergies, viral infection protection and inner ear therapeutics. The firm has published results from an in vivo study demonstrating significant inhibition of tumor growth. The inhibition of tumor growth occurred by siRNA knock-down of . . . This content …

An FDA Approval for Blueprint Medicines. See Also: An Important Presentation from IVERIC Bio

Inferior ways used to evaluate clinical-stage biotech firms are those that ignore the sciences, the technologies and the promising results from the products in clinical trials. It reached a stage where assessors are even ignoring the value of the approval of biotech firms’ products that succeeded in treating diseases that are yet to find treatments. We have Superior News from Blueprint Medicines The U.S. Food …

Gilead Sciences CAR-T Cell Yescarta Became the First and Only FDA Approved Treatment for Patients with Relapsed or Refractory Indolent Follicular Lymphoma

Gilead Sciences Yescarta for Relapsed or Refractory Indolent Follicula Lymphoma If Kite Pharma - a Gilead Sciences (GILD) company, had been acquired by any firm other than Gilead the stock would have gained at least 20% because of the news announced a few days ago. Kite Pharma announced outstanding Yescarta® (axicabtagene ciloleucel) results from the pivotal ZUMA-5 trial. At a minimum follow . . . This …

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 …