Gilead Sciences Good News for Breast Cancer Gilead Sciences' (GILD) product Trodelvy® has significantly improved the Overall Survival (OS) in Pre-Treated HR+/HER2- metastatic breast cancer patients in the TROPiCS-02 study. Today, Gilead Sciences' (

On September 7th the FDA Will Review Amylyx Pharmaceuticals NDA for ALS Treatment Amylyx Pharmaceuticals (AMLX) announced that the U.S. FDA Peripheral and Central Nervous System Advisory Committee (PCNSDAC) will reconvene to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol known also as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS

Hutchmed: Treating Advanced Refractory Metastatic Colorectal Cancer On August 8, 2022, Hutchmed (HCM) announced that pivotal global Phase 3 FRESCO-2 trial evaluating the investigational use of fruquintinib met its primary endpoint of overall survival (OS) in patients with advanced, refractory metastatic colorectal cancer (CRC). The FRESCO-2 Study A multi-regional clinical trial conducted in the U.S., Europe, Japan and Australia demonstrates that investigated fruquintinib plus best supportive …

Reata Pharmaceuticals in the NEWS Reata Pharmaceuticals (RETA) on August 8, 2022, after the U.S. financial markets closed, received a communication from the U.S. Food and Drug Administration (FDA) informing us that they have extended the review timeline for the New Drug Application (NDA) for omaveloxolone for the treatment of Friedreich’s ataxia by three . . . This content is for paid subscribers. Please click here …

Gilead Sciences to Acquire MiroBio At $405 Million Gilead Sciences (GILD) and MiroBio - a privately held U.K based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, announced that they entered into a definitive agreement pursuant to which Gilead will acquire MiroBio for approximately $405 million in . . . This content is for paid subscribers. Please click here to subscribe …

Regenxbio in the NEWS  Regenxbio (RGNX) announced, on August 3, 2022, its intention to file a Biologics License Application (BLA) in 2024 using the FDA's accelerated approval pathway for RGX-121 for the treatment of Mucopolysaccharidosis Type II (MPS II), also known as Hunter Syndrome.   The Company has also announced that a pivotal program for RGX-121 is . . . This content is for paid …

Offsetting the Biotech Firms' Good News There is no doubt that good news is filling the media about outperformances of both development-stage small biotech firms and revenues-generating firms. This good news has been offset by inflation, hiked interest rates, that aimed at bringing down the inflation, the continued presence of COVID-19 and an unwarranted European  war, which has only demonstrated the terrible impact on the …

Seagen, Astellas Pharma & Merck Collaboration Seagen (SGEN) and Astellas Pharma (ALPMY) have entered a clinical collaboration . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Rhythm Pharmaceuticals is Rebounding Rhythm Pharmaceuticals (RYTM) announced yesterday, July 20, 2022, that the French National Agency for Medicines and Health Products Safety (ANSM) and Haute Autorité de santé (HAS) have granted pre-marketing authorization AP1 (autorisation d’accès précoce - early access authorization), for IMCIVREE® (setmelanotide), an MC4R agonist, for patients with genetically-confirmed Bardet-Biedl syndrome . . . This content is for paid subscribers. Please click here …

Incyte Announces FDA Approval of Opzelura Cream for Vitiligo Incyte (INCY) announced today, July 19, 2022, that the United States Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream 1.5% for the topical treatment of nonsegmental vitiligo in 12 years old patients and older. Opzelura is the first and only FDA-approved treatment for . . . This content is for paid subscribers. Please click here …

Avista Therapeutics Avista Therapeutics’ mission is to develop innovative gene therapies for retinal diseases, including rare ophthalmic conditions that have a profound impact on patients’ quality of life. Avista leverages its computationally guided single-cell adeno-associated virus engineering (scAAVengr) platform to generate and validate a toolkit of proprietary AAV vectors that target specific cell types using minimally invasive intravitreal delivery with reduced dosages. Avista’s quantitative, in …

The clinical-stage Clene Nanomedicine Firm Reported Significantly Decreased Mortality in Amyotrophic Lateral Sclerosis (ALS) CNM-Au8® treatment resulted in a significant survival benefit (5 CNM-Au8 deaths vs 14 placebo deaths CNM-Au8 treatment was well-tolerated, with no significant safety findings  during this trial Clene Inc in the NEWS Clene Inc (CLNN), along with its subsidiaries, “Clene”, and its wholly owned . . . This content is for paid …

CytomX Therapeutics Update CytomX Therapeutics (CTMX) announced plans to focus on its emerging preclinical and early clinical pipeline and realign its capital resources to drive these efforts. Sean McCarthy, D.Phil. Chief Executive Officer and Chairman, CytomX Therapeutics, said, “With the Probody® therapeutic platform, CytomX has pioneered a new and strategic field of biologics drug discovery and development. Our leadership position will continue as we incorporate …

Vertex Pharmaceuticals and ViaCyte Inc are in the NEWS Vertex Pharmaceuticals (VRTX) entered into a definitive agreement under which it will acquire ViaCyte, a private biotechnology company focused on delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D), for $320 million in cash. From Vertex Pharmaceuticals and ViaCyte Inc Reshma Kewalramani, M . . . This content is for paid subscribers. …

Is Merck to Acquire Seagen? The Wall Street Journal reported that Merck is in advanced talks to buy Seagen in a deal that could be worth $40 billion or more. The report, cited by people familiar with the matter, said that the companies are discussing a price above $200 a share for SGEN. It is said that the acquisition will help Merck boost its products …

Insilico Medicine Insilico Medicine is a clinical stage end-to-end artificial intelligence (AI)-driven drug discovery company, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques to discover novel targets and to design novel molecular structures with desired properties. Insilico Medicine is delivering breakthrough …

Vertex Pharmaceuticals VX-880 for Type 1 Diabetes Vertex Pharmaceuticals (VRTX) announced that the FDA has lifted the clinical hold placed on the Phase 1/2 clinical trial of VX-880. VX-880 is an investigational allogeneic stem cell-derived, fully differentiated pancreatic islet cell replacement therapy for people with type 1 diabetes (T1D) with impaired hypoglycemic awareness and severe hypoglycemia . . . This content is for paid subscribers. …

CureVac N.V. Files Lawsuit Against BioNTech for Infringement  CureVac N.V. (CVAC), a company that develops therapeutics based on messenger ribonucleic acid (mRNA), has moved to assert its intellectual property rights that have been accumulated over more than two decades of pioneering work in mRNA technology. Technology that contributed to COVID-19 vaccine development. The Company acknowledged filing a lawsuit . . . This content is for …

Celldex Therapeutics Interim Trial Data for Barzolvolimab Interim data from Celldex Therapeutics (CLDX) Phase 1b clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines demonstrate meaningful symptom improvements. The results showed that multiple doses of barzolvolimab resulted in dose-dependent decreases in itch and hives, as measured through the urticaria activity score over . . . This content …

Kite Pharma - A Gilead Company In The NEWS Gilead Sciences' (GILD) firm Kite Pharma, announced that the European Commission (EC) has approved its CAR T-cell therapy Yescarta® (axicabtagene ciloleucel) for adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy. Yescarta maintained its orphan medicinal product designation in this indication. From . . . This content is for …