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. …

Cassava Sciences Released a Statement  Cassava Sciences, Inc. (SAVA) – a biotechnology company focused on Alzheimer’s disease, today released a statement regarding plasma p-tau analysis from a previously disclosed randomized, controlled Phase 2b clinical study in patients with Alzheimer’s disease. For this study, Cassava Sciences contracted with Quanterix Corp., a highly regarded, independent laboratory, to perform sample testing on blinded samples. The Phase 2b clinical …

Agenus Good News for Balstilimab Monotherapy Agenus (AGEN) announced that results from a global Phase 2 clinical study of balstilimab monotherapy in recurrent/metastatic cervical cancer were published online in the international peer-reviewed journal Gynecologic Oncology. From the CMO of Agenus Steven O’Day, MD, Chief Medical Officer of Agenus, said, “Publication of these data marks another significant achievement toward our objective to provide effective therapeutic options to …

Cassava Sciences Responds to Misleading Posts Cassava Sciences (SAVA) today issued a response to claims that were posted online yesterday after market hours. Cassava Sciences believes the claims made in this post regarding scientific integrity are false and misleading. The Company stands behind its science, its scientists, and its scientific collaborators; it is responding to ensure the facts are known and respected . . . …

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 …

Axsome Therapeutics Inc and Major Depressive Disorder In a teleconference on August 20, 2021, the U.S. Food and Drug Administration (FDA) informed Axsome Therapeutics (AXSM) that its review of the new drug application (NDA) for AXS-05, for the treatment of major depressive disorder, would not be completed by the Prescription Drug User Fee Act (PDUFA

Sutro Biopharma Inc Granted Fast Track Designation for STRO-002 by the US FDA Sutro Biopharma Inc (STRO) announced that the U.S. FDA granted Fast Track designation for its STRO-002 – a folate receptor alpha (FolRα)-targeting antibody-drug conjugate (ADC), for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior lines of systemic therapy. From …

Virpax Pharmaceuticals  Virpax Pharmaceuticals (VRPX) - a company specializing in developing product candidates for pain management, CNS and anti-viral indications, announced the receipt of a written pre-investigational new drug (pre-IND) response from the U.S. Food and Drug Administration (FDA) for MMS019, its patented and proprietary high-density molecular masking spray under development for use . . . This content is for paid subscribers. Please click here to subscribe …

BeiGene Ltd and EUSA Pharma Receive Approval from China NMPA for QARZIBA®  BeiGene Ltd (BGNE) and EUSA Pharma announced that China National Medical Products Administration (NMPA) has granted QARZIBA® (dinutuximab beta) conditional approval for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response followed by myeloablative therapy and stem cell …

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 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 …

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  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 …

Agenus Inc News and Q2 Results for 201 Agenus (AGEN) announced results with better than usual news including the following:  $200 million received from BMS for anti-TIGIT bispecific antibody collaboration FDA cleared IND for AGEN1777 clinical enrollment AGEN1181 rapidly advancing in the clinic - data to be presented in 2H 2021 Cell therapy . . . This content is for paid subscribers. Please click here to …

Prohost Letter #446 A Reevaluation of Prohost Biotech’s Picked Firms We have already pinpointed some of the devastating and life-threatening diseases that have yet to find treatment. Prohost’s plans are about discovering small &/or large biotech or biopharma firms that demonstrate scientific capability for treating or curing these diseases. Most of the firms that we picked for investment in yesteryears had solid scientific and managerial …

Exelixis sNDA Accepted by the US FDA for CABOMETYX® The U.S. Food and Drug Administration (FDA) accepted Exelixis (EXEL) supplemental New Drug Application (sNDA) for CABOMETYX ® (cabozantinib) as a treatment for patients 12 years and older with differentiated thyroid cancer (DTC) who have progressed following prior therapy and are radioactive iodine-refractory (if radioactive . . . This content is for paid subscribers. Please click here …

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. …

Sanofi Will Acquire Translate Bio Sanofi (SNY) will acquire all the outstanding shares of Translate Bio (

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 …