Category: News & Comments

The U.S. FDA Approved Johnson & Johnson AKEEGA™ for BRCA-Positive Metastatic Castration-Resistant Prostate Cancer

Johnson & Johnson’s Janssen Pharmaceutical AKEEGA Johnson & Johnson (JNJ) owned Janssen Pharmaceutical announced that the U.S. FDA has approved AKEEGA™ (niraparib and abiraterone acetate), the first-and-only dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone for adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC), which no longer responds to androgen deprivation therapy and has spread to other …

The U.S.FDA Granted CellTrans Inc., Approval of its Product Lantidra for the Treatment of Type 1 Diabetes

CellTrans Inc FDA Approval for Lantidra for Type 1 Diabetes The U.S. Food and Drug Administration (FDA) approved CellTrans Inc treatment Lantidra, the first allogeneic pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of adults having type 1 diabetes. The approval is for people who are unable to approach target glycated hemoglobin (average blood glucose levels) because of current repeated episodes …

Bayer & BlueRock Therapeutics: A First Neuronal Stem Cell Therapy to Show Positive Results in Phase I Clinical Study for Parkinson’s Disease    

Bayer and BlueRock Therapeutics Berlin, Germany and Cambridge, M.A., U.S.A., June 28, 2023 – Bayer AG (BAYRY) and its subsidiary firm BlueRock Therapeutics LP announced positive top-line results from a Phase I clinical trial of the investigational drug bemdaneprocel (BRT-DA01), a potential first-in-class cell therapy for Parkinson’s disease. Bemdaneprocel was well-tolerated in all 12 patients in the study to date with no major safety events.    Secondary …

Celmatix Inc: Revolutionizing Fertility Treatments

Celmatix Inc. Celmatix Inc., announced the identification of promising early leads in its latest drug program, aimed at developing the world’s first oral FSH receptor (FSHR) agonist drug. The innovative investigational product has the potential to revolutionize fertility treatments. The announcement coincides with the annual meeting of the European Society of Human Reproduction and Embryology (ESHRE), currently underway in Copenhagen, Denmark. From Celmatix Inc Dr. …

Intercept Pharmaceuticals Stock is Halted Today as the FDA Advisory Committee is Reviewing Obeticholic Acid as a Treatment of NASH Precirrhotic Fibrosis

Intercept Pharmaceuticals  Intercept Pharmaceuticals Inc (ICPT) is a biopharmaceutical company focused on the development and commercialization of novel therapeutics aimed at treating progressive non-viral liver diseases, including primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH) and severe alcohol-associated hepatitis (sAH). On May 19, 2023, Intercept Pharmaceuticals, announced that NASDAQ has halted trading of the company’s common stock. Today’s Meeting Today, the U.S. FDA Gastrointestinal Drugs Advisory …

Longeveron has Encouraging Trial Results for Hypoplastic Left Heart Syndrome

Longeveron in the NEWS On May 9, 2023, Longeveron (LGVN) announced new long-term follow-up data from the Company’s ELPIS I trial of Lomecel-BTM for patients with hypoplastic left heart syndrome (HLHS). What is Hypoplastic Left Heart Syndrome HLHS is a rare and life-threatening congenital heart defect affecting approximately 1,000 babies per year. Infants born with HLHS have an underdeveloped or absent left ventricle. Current standard-of-care is …
Intellia Therapeutics Releases 2023 Corporate Responsibility Report Highlighting the Advancement of its Environmental, Social & Governance (ESG) Priorities

Intellia Therapeutics Releases 2023 Corporate Responsibility Report Highlighting the Advancement of its Environmental, Social & Governance (ESG) Priorities

May 01, 2023 (GLOBE NEWSWIRE) –Today, Intellia Therapeutics (NTLA) released its 2023 Corporate Responsibility report. The report provides a comprehensive update of the Company’s performance and progress across key Environmental, Social and Governance (ESG) areas of focus. John Leonard, M.D., Intellia President and Chief Executive Officer said, “As the leaders in a new era of medicine, we believe ESG principles support long-term value creation for …

New Study from Neuvivo’s NP001: First to Link Regulation of the Innate Immune System with Respiratory Function in ALS

New Study from Neuvivo On March 30, 2023, Neuvivo – a private Company, announced the publication of a peer-reviewed paper in ‘Cells‘ titled: “Regulation of the Innate Immune System as a Therapeutic Approach to Supporting Respiratory Function in ALS”.   The biomarker study used vital capacity (VC), a quantitative test for respiratory function, to highlight the relationship between a compromised innate immune system and ALS disease activity.  …

23andMe Teams Up with Novartis on Lipoprotein(a) Education for its Customers

23andMe Aims To Raise Awareness of Lipoprotein(a), a Little-Known Genetic Risk Factor for Cardiovascular Disease March 24, 2023 (GLOBE NEWSWIRE) — In support of Lipoprotein(a) Awareness Day, 23andMe Holding Co. (ME) announced a collaboration with Novartis Pharmaceuticals Corporation (NVS) to increase awareness for Lipoprotein(a) (Lp(a)). The Information to Learn High levels of Lp(a) are associated with increased risk of heart attack, stroke and other life …

As Expected, Seagen Was Taken Over, the Buyer is Pfizer.

Pfizer to Acquire Seagen Pfizer (PFE) is to acquire Seagen (SGEN) for $229 per share in cash, for a total enterprise value of approximately $43 billion Dr. Albert Bourla, Pfizer Chairman and Chief Executive Officer, said, “Pfizer is deploying its financial resources to advance the battle against cancer, a leading cause of death worldwide with a significant impact on public health. Together, Pfizer and Seagen …

XyloCor Therapeutics Reported Positive Safety and Efficacy Results of XC001 Novel Gene Therapy for Refractory Angina

XyloCor Therapeutics Announced Positive Results for XC001 XyloCor Therapeutics announced the completion of the Phase 2 portion of its Phase 1/2 clinical trial (EXACT) designed to assess the safety and preliminary evidence of efficacy of lead gene therapy candidate XC001 (encoberminogene rezmadenovec) in patients with refractory angina. The EXACT clinical trial met both safety and efficacy objectives. There were no safety issues related to drug product or …

From bluebird bio: FDA Accelerated Approval for SKYSONA® Gene Therapy for Early, Active Cerebral Adrenoleukodystrophy

FDA Approves bluebird bio Product Skysona for Early, Active CALD SKYSONA is the first FDA approved therapy shown to slow the progression of neurologic dysfunction in boys with this devastating and fatal neurodegenerative disease. The U.S. FDA has granted Accelerated Approval of bluebird bio’s (BLUE) SKYSONA® (elivaldogene autotemcel), also known as eli-cel. SKYSONA® is indicated to slow the progression of neurologic dysfunction in boys 4-17 …

Intellia Therapeutics to Present Data from Clinical Trial of NTLA-2002 Aimed at Treating Hereditary Angioedema

Intellia Therapeutics to Present Interim Clinical Data from NTLA-2002 Trial for Hereditary Angioedema An abstract featuring interim clinical data from the Phase 1/2 study of Intellia Therapeutics’ (NTLA) product NTLA-2002 has been selected for an oral presentation at the 2022 Bradykinin Symposium, taking place September 15-16 in Berlin, Germany. NTLA-2002 NTLA-2002 is an investigational in vivo CRISPR/Cas9 therapy in development as a single-dose treatment to prevent …

Hutchmed: Treating Advanced Metastatic Colorectal Cancer and Other Treatment Resistant Cancers

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 …

Avista Therapeutics Partners with Roche to Develop Advanced AAV Gene Therapy Vectors for Ocular Diseases

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 …

CytomX Therapeutics Provided an Important Strategic Update

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 …

Insilico Medicine: Identifying Multiple Novel Therapeutic Targets for ALS AI-driven Target Discovery Engine

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 and Type 1 Diabetes

Vertex Pharmaceuticals to Announce New Data on VX-880 Clinical Trial Vertex Pharmaceuticals (VRTX) announced three abstracts, including two oral presentations and one poster, detailing data on type 1 diabetes (T1D) and its Phase 1/2 trial of VX-880, a stem cell-derived, fully differentiated pancreatic islet cell replacement therapy. The Abstracts have been accepted for presentation during the American Diabetes Association 82nd Annual Scientific Sessions Conference held …

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 …