Takeda Pharmaceutical Granted FDA Approval for LIVTENCITY for Post-Transplant Cytomegalovirus On November 23, 2021 Takeda Pharmaceutical Co Ltd (TAK) announced that the U.S. FDA has approved LIVTENCITY™ (maribavir) for adults and pediatric patients (12 years of age or older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or …

Intellia Therapeutics to Present at ASH Intellia Therapeutics (NTLA) announced the presentation of data from its ex vivo research and development efforts in two poster presentations at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition taking place in Atlanta, GA, as well as virtually, December 11-14, 2021. From the CSO at Intellia Therapeutics Laura Sepp-Lorenzino, Ph.D., Chief Scientific Officer, Intellia Therapeutics, said, “As we continue to …

Cassava Science: Journal of Neuroscience Review Shows No Evidence of Data Manipulation Cassava Sciences (SAVA) has been informed by the Journal of Neuroscience that there is no evidence of data manipulation in an article it published in July 2012 describing a new approach to treating Alzheimer’s disease. The peer-reviewed article was co-authored by scientists and academic collaborators for Cassava Sciences and is foundational to simufilam, the Company’s …

Gilead Sciences and Merck Collaboration to Develop Long-Acting HIV Treatment  Gilead Sciences (GILD) and Merck (MRK) announced the start of a Phase 2 clinical study evaluating an investigational, once-weekly oral combination treatment regimen of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy. From Gilead Sciences and Merck Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences, …

Reata Pharmaceuticals Announcements Reata Pharmaceuticals (RETA) announced that the abstracts highlighting clinical data for bardoxolone methyl (“bardoxolone”) and disease education data on Alport syndrome will be presented at the American Society of Nephrology Kidney Week 2021 being held virtually from November 4 – 7, 2021. The abstracts for the oral and poster presentations are listed below and are available on the conference website at https://www.asn-online.org/education/kidneyweek/.  Oral …

Oyster Point Pharma, Inc.  The U.S. Food and Drug Administration (FDA) has approved the Oyster Point Pharma Inc (OYST) product TYRVAYA™ (varenicline solution) Nasal Spray 0.03 mg for the treatment of signs and symptoms of dry eye disease. TYRVAYA™ Nasal Spray TYRVAYA Nasal Spray is the first and only nasal spray approved for the treatment of dry eye disease. TYRVAYA Nasal Spray is believed to bind to cholinergic …

Don’t Miss Enanta Pharmaceuticals Virtual Conference Enanta Pharmaceuticals (ENTA) – a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced that new preclinical data for EDP-235 – its lead oral protease inhibitor, which is specifically designed for the treatment of COVID-19, will be presented at the International Society for Influenza and Other Respiratory Virus Diseases (ISIRV)-World Health …

Excision BioTherapeutics, Inc. IND Application for EBT-101 for HIV Accepted by the US FDA Excision BioTherapeutics, Inc., which focuses on developing CRISPR-based therapies intended to cure viral infectious diseases, announced that the U.S. FDA has accepted the firm’s Investigational New Drug (IND) application for EBT-101 – a CRISPR-based therapeutic candidate in development as a potential functional cure for chronic HIV. The IND clearance enables Excision …

Can-Fite Biopharma Good News We learned, from Petach Tikva, Israel, that Can-Fite Biopharma (CANF) – a biotechnology company advancing its pipeline of small molecule drugs that address inflammatory, cancer and liver diseases, announced its completion of enrollment of all patients (>400) planned for its Phase 3 Comfort™ study with the firm’s product Piclidenoson in patients with moderate to severe plaque psoriasis.  Piclidenoson is a novel, …

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 …

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 …

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 …

Cassava Sciences Inc Press Release Related to Positive Biomarker Data  Cassava Sciences Inc (SAVA) announced today, in a press release, positive biomarker data from an open-label study of simufilam, the Company’s investigational drug for the treatment of Alzheimer’s disease. In a clinical study funded by the National Institutes of Health (NIH), simufilam significantly improved all measured biomarkers in patients with Alzheimer’s disease following 6 months of open-label …

Cassava Sciences: Positive Clinical Data with SavaDX Cassava Sciences (SAVA) today announced positive clinical data with SavaDx, an investigational diagnostic/biomarker to detect Alzheimer’s disease with a simple blood test. SavaDx was used to measure plasma levels of altered filamin A before and after simufilam treatment in patients with Alzheimer’s disease. In this Phase 2b randomized, controlled trial sponsored by the National Institutes of Health (NIH), simufilam significantly reduced …

Immunome Inc: Neutralizing SARS-C0V-2 Delta Variant Immunome Inc (IMNM) is a small biotech firm whose stock soared after announcing today that its three-antibody cocktail (IMM-BCP-01) demonstrated potent neutralizing activity against the SARS-CoV-2 (the virus that cause COVID-19) Delta variant in pre-clinical pseudovirus testing. The IMM-BCP-01 cocktail demonstrated in-vitro activity via non-neutralizing mechanisms, such as complement fixation, which Immunome expects will enable viral clearance. From the …

Celldex Therapeutics is Soaring Celldex Therapeutics (CLDX) stock soared following the firm’s announcement of updated data from its ongoing, open-label Phase 1b clinical trial of CDX-0159 in patients with antihistamine refractory cold urticaria and symptomatic dermographism, which are the two most common forms of chronic inducible urticaria. CDX-0159 is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and …

TRxADE HEALTH Inc TRxADE HEALTH Inc (MEDS) is a health service IT company focused on digitalizing the retail pharmacy experience by optimizing drug procurement, the prescription journey, and patient engagement in the U.S.. The firm operates the TRxADE drug procurement marketplace serving a total of 12,100+ members nationwide, fostering price transparency. Under the Bonum Health brand, the firm offers patient-centric telehealth services. For more information, please visit …

Prilenia Therapeutics Prilenia Therapeutics is a clinical-stage biotech company. The firm’s leader, Michael Hayden, MD, PhD., is a world-renowned scientist in Huntington’s Disease (HD) research. Dr. Hayden was the President of Global R&D and Chief Scientific Officer at Teva Pharmaceuticals, where he led the development of 35 new products towards approval in several major markets, predominantly in the central nervous system (CNS). Michael Hayden and …

Reata Pharmaceuticals Good News Reata Pharmaceuticals (RETA) announced it received a communication from the Division of Neurology Products of the U.S. FDA stating, that after a preliminary review of briefing materials for an upcoming Type C meeting, a pre-NDA meeting is the most appropriate format for a discussion of the development program for omaveloxolone in Friedreich’s ataxia The Division suggested that the Company withdraw the …