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, …

Bausch + Lomb and Clearside Biomedical Announce FDA Approval of XIPERE™ Bausch + Lomb, a leading global eye health business of Bausch Health Companies (BHC), and Clearside Biomedical (

Agenus to Withdraw BLA for Balstilimab Agenus (AGEN) announced a strategic decision to withdraw its Biologics License Application (BLA) for balstilimab, its PD-1 inhibitor. The firm stated that its decision will not change the development plans for balstilimab with regard to its combination with AGEN1181, which will . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Intellia Therapeutics Granted Orphan Drug Designation for NTLA-2001 Intellia Therapeutics (NTLA) announced that the U.S. FDA has granted orphan drug designation to NTLA-2001 for the treatment of transthyretin (ATTR) amyloidosis. This investigational therapy is the first CRISPR therapy to be administered systemically to edit a disease-causing gene inside the human body. NTLA-2001 has the potential to be the first single-dose treatment for ATTR amyloidosis as it …

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 …

Rocket Pharmaceuticals Inc Announces Successful Results at the ESGCT Gene therapy and gene editing plus other gene and genome-based therapeutics are the only treatments expected to lead to  miraculous cures. While genetic manipulation for the treatment of severe life-threatening diseases is still moving towards perfection, gene therapy and gene editing are accomplishing miraculous long-term effective treatments, saving thousands of lives where there are no currently …

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 …

Intellia Therapeutics and SparingVision Collaboration Intellia Therapeutics (NTLA) and SparingVision - a genomic medicine company developing vision saving treatments for ocular diseases, announced a strategic collaboration to develop novel genomic medicines utilizing CRISPR/Cas9 technology for the treatment of ocular diseases. Intellia Therapeutics is to grant SparingVision exclusive rights to Intellia . . . This content is for paid subscribers. Please click here to subscribe or here to …

Regenxbio Announced Data from Phase 2 ALTITUDE Trial of RGX-314 for DR Regenxbio (RGNX) announced initial data from the ongoing Phase 2 ALTITUDE™ trial of RGX-314 for the treatment of diabetic retinopathy (DR) without center-involved diabetic macular edema (CI-DME) using in-office suprachoroidal delivery. Regenxbio is a clinical-stage biotechnology company seeking to improve lives . . . This content is for paid subscribers. Please click here to …

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 …

Denali Therapeutics News Denali Therapeutics (DNLI) -  a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases.  Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the BBB and guiding development through biomarkers that demonstrate target and pathway engagement. Denali is based in South San . . . This content is for …

Intellia Therapeutics Authorization of CTA for Phase 1/2 Study of NTLA-2002 Intellia Therapeutics (NTLA) announced the authorization of its Clinical Trial Application (CTA) by the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) to initiate a Phase 1/2 study evaluating NTLA-2002 for the treatment of adults with hereditary angioedema (HAE). About Hereditary . . . This content is for paid subscribers. Please click here to subscribe or …

Two Clinical-Stage Firms Rallied Yesterday On a day when the Stock Market was crushed, taking down with it shareholders’ money for no reason other than the self-serving untouchable agendas, two small biotechnology companies staged rallies. Atea Pharmaceuticals and Xenon Pharmaceuticals deserved the boosting of their stocks.   Atea Pharmaceuticals Atea Pharmaceuticals (AVIR) - a clinical-stage biopharmaceutical company, reported for the first time . . . …

Merck and Ridgeback Biotherapeutics COVID-19 News  Merck (MRK) and Ridgeback Biotherapeutics today announced that molnupiravir (MK-4482, EIDD-2801) - an investigational oral antiviral medicine, has significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Valneva SE and Pfizer Inc Announced More Positive Trial Results of VLA15 for Lyme Disease What is Lyme Disease? What is the vaccine? What is the importance of the vaccine and the company that created it?    Lyme disease is an infection caused by Borrelia burgdorferi bacteria transmitted to humans by infected Ixodes ticks. Lyme disease is considered the most common vector- borne illness in the Northern Hemisphere. The U.S. …

Reata Pharmaceuticals to Submit Omaveloxolone for NDA in Early 2022 In a press release following the completion of pre-NDA meeting with the FDA, Reata Pharmaceuticals (RETA) stated that the purpose of the pre-NDA meeting was to discuss the content of Reata’s planned NDA submission. The firm plans to submit the NDA . . . This content is for paid subscribers. Please click here to subscribe or here to …

AstraZeneca Saphnelo Approved by Japanese Ministry of Health, Labor and Welfare Developed by AstraZeneca (AZN), Saphnelo is a first-in-class type I interferon receptor antibody shown to reduce overall disease activity in patients with systemic lupus erythematosus. The approval by the Japanese Ministry of Health, Labor and Welfare (MHLW) was based on efficacy and safety data from the Saphnelo clinical . . . This content is for paid subscribers. …

Mirum Pharmaceuticals Inc Mirum Pharmaceuticals Inc (MIRM) is a clinical-stage biopharmaceutical company focused on the development and commercialization of a late-stage pipeline of novel therapies for debilitating liver diseases. Maralixibat, is Mirum Pharmaceuticals lead product candidate. The product is an investigational oral drug in development for the following conditions:   Alagille syndrome (ALGS) Progressive familial intrahepatic . . . This content is for paid subscribers. …

Regeneron Welcomes the World Health Organization's Recommendation for Use of REGEN- COVTM to Treat COVID-19 The World Health Organization (WHO) updated its Therapeutics and COVID-19: living guideline to include the casirivimab and imdevimab monoclonal antibody cocktail, known as REGEN-COVTM in the U.S. and Ronapreve® in other countries. The guideline conditionally recommends REGEN-COV to treat high-risk non-hospitalized patients with non-severe COVID-19 and seronegative (no measurable . …

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 …