Category: News & Comments

An Important Reminder from Vir Biotechnology

Vir Biotechnology  Vir Biotechnology (VIR) is a commercial-stage immunology firm focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir assembled four technology platforms that stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Vir’s current pipeline consists of product candidates targeting COVID-19, hepatitis B and hepatitis D viruses, influenza A and human immunodeficiency virus. …

Eisai and Biogen: Lecanemab for the Treament of Early Alzheimer’s DIisease

Eisai and Biogen Inc: Lecanemab Eisai and Biogen Inc. (BIIB) announced that Eisai has completed the rolling submission to the U.S. FDA of a Biologics License Application (BLA) under the accelerated approval pathway for the investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (BAN2401). The  product is for mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence …

Sunshine Biopharma’s New mRNA Therapeutics Killed Cancer Cells with Little or No Adverse Effects

Sunshine Biopharma mRNA Therapeutics Effective at Destroying Cancer Cells Sunshine Biopharma, Inc. (SBFM) –  a pharmaceutical company focused on research, development and commercialization of oncology and antiviral drugs, announced that two of its newly designed mRNA molecules are effective at destroying cancer cells grown in culture. The cytotoxicity tests were performed on a variety of cancer cells including the following cancers: Multidrug resistant breast cancer …

Reata Pharmaceuticals Completed Rolling NDA Submission of Omaveloxolone for Friedreich’s Ataxia

Reata Pharmaceuticals Completed Rolling NDA Submission for Omaveloxolone for Friedreich’s Ataxia Reata Pharmaceuticals (RETA) announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. FDA for omaveloxolone’s treatment of Friedreich’s ataxia (FA). The NDA is supported by the efficacy and safety data from the MOXIe Part 1, Part 2 and MOXIe Extension studies. The FDA has granted Fast Track …

Intellia Therapeutics Statement on Recent U.S. Patent and Trademark Office Decision

Intellia Therapeutics Statement on Recent U.S. Patent and Trademark Office Decision – In May 2012, the Regents of University of California, University of Vienna, and Emmanuelle Charpentier (collectively, “CVC”) filed a patent application for their CRISPR/Cas9 genome editing technology. The CVC team led by Drs. Jennifer Doudna and Emmanuelle Charpentier promptly brought these discoveries to the public, and in June 2012 published a seminal paper …

These Dangerous World Circumstances and the Prohost Portfolio

The circumstances that we find the world in today are abnormal. They are extremely intense and dangerous. We are living  an unprecedented, unexpected and inexplicable  war in Europe, which nobody seems to know how it would end up.  When it comes to the  Market, the degree of chaos, mysteries and destruction have far exceeded our ability to fairly evaluate our selected  biotech picked firms. We …

The FDA Authorized Emergency Use of Pfizer Paxlovid Pills Against COVID-19

Pfizer Received Emergency Use Authorization from the FDA for Paxlovid Pills for COVID-19 Good news for Pfizer (PFE), the U.S. FDA announced it has authorized the emergency use of PAXLOVID™ for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 (the virus that cause COVID-19) viral testing …

The FDA Cleared the IND for Erasca Inc Product ERAS-801 for Recurrent Glioblastoma

Erasca Inc Product ERAS-801 IND Cleared by FDA Erasca Inc (ERAS) announced that the United States Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for ERAS-801, an orally available small molecule epidermal growth factor receptor (EGFR) inhibitor specifically designed to have high central nervous system (CNS) penetration for the treatment of recurrent glioblastoma multiforme (rGBM). In the meantime, the company entered into …

Takeda Pharmaceutical Product LIVTENCITY Granted Approval by the FDA

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 Highlight Ex Vivo Genome Editing and CRISPR/Cas9 Manufacturing Advances at ASH

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 …

No Evidence of Data Manipulation in Technical Paper Foundational to Cassava Sciences Lead Drug Candidate

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 Initiate Phase 2 Study Evaluating Lenacapavir and Islatravir for HIV-1

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 Announces Presentations Highlighting Clinical Data for Bardoxolone and Disease Education Data on Alport syndrome

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 …

The U.S. FDA Approved Oyster Point Pharma Inc Product TYRVAYA™ to Treat Dry Eye Disease

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 the Enanta Pharmaceuticals Virtual Conference on October 19th – October 21st

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 …

Can Excision BioTherapeutics Inc Cure HIV?!

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 Has Encouraging News but Will It Enthuse Investors?

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 Statement Regarding Plasma p-tau Analysis from a Previously Disclosed Phase 2b Study in Alzheimer’s Patients

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: Balstilimab Monotherapy Data Published in Gynecologic Oncology

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 …

The US FDA Granted Fast Track Designation for Sutro Biopharma Product STRO-002

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 …