Category: News & Comments

Regeneron: Improved Hearing to Normal Levels in a Child with Profound Genetic Deafness 

Regeneron in the NEWS Regeneron Pharmaceuticals (REGN) announced today that the investigational gene therapy DB-OTO improved hearing to normal levels in one child (dosed at 11 months of age) within 24 weeks, and initial hearing improvements were observed in a second child (dosed at 4 years of age) at a 6-week assessment. Both children were born with profound genetic deafness due to variants of the …

INmune Bio Inc. Update on Two Alzheimer Disease Patients Who Continued to Receive XPro Product

INmune Bio Press Release  INmune Bio (NASDAQ: INMB) is pleased to share an update on two patients from the Phase 1b trial completed in 2021 who have continued to receive XPro™ for treatment of Alzheimer’s Disease (AD) for more than three years under the Australian compassionate use program known as the Special Access Scheme (SAS).  Both patients, herein referred to as “Patient 1” and “Patient 2,” was …

Cerevel Therapeutics Announces Positive Results for Tavapadon in Phase 3 Adjunctive Trial for Parkinson’s Disease

Cerevel Therapeutics in the NEWS Cerevel Therapeutics (CERE) announced positive topline results from its pivotal Phase 3 TEMPO-3 trial for tavapadon, the first and only D1/D5 receptor partial agonist being studied as once a day treatment for Parkinson’s disease. The TEMPO-3 trial evaluated the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to levodopa  in adults. The trial met its primary endpoint. Patients …

Italfarmaco Received FDA Approval for Duvyzat™ for the Treatment of Duchenne Muscular Dystrophy

Italfarmaco in the NEWS  From Milan, Italy: Today, Italfarmaco announced that the U.S. Food and Drug Administration (FDA) has approved Duvyzat™ (givinostat) – a novel histone deacetylase (HDAC) inhibitor, for the treatment of patients 6 years or older with Duchenne muscular dystrophy (DMD) – a rare X-linked progressive and life-limiting neuromuscular condition with symptoms from early childhood. From Italfarmaco Paolo Bettica, MD, PhD, Chief Medical Officer …

Abbott Laboratories Launches a New PROTALITY™ Brand to Maintain the Muscle Mass of Adults Pursuing Weight Loss by Various Means

Abbott Laboratories New PROTALITY™ for Maintaining Muscle Mass During Weight Loss Abbott Laboratories (ABT) announced the launch of its new PROTALITY™ brand. The high-protein nutrition shake is the first product to support the adults interested in pursuing weight loss while maintaining muscle mass and good nutrition. Half of U.S. adults attempted to lose weight in the past year.  Whether pursuing weight loss by taking GLP-1 medications, …

Sanofi to Acquire Inhibrx, Inc.

Sanofi to Acquire Inhibrx Inc Paris, January 23, 2024, Sanofi (SNY) and Inhibrx, Inc. (INBX) entered into a definitive agreement under which Sanofi agreed to acquire Inhibrx following the spin-off of non-INBRX-101 assets into New Inhibrx. INBRX-101 is a human recombinant protein that holds the promise of allowing Alpha-1 Antitrypsin Deficiency (AATD) patients to achieve normalization of serum AAT levels with less frequent (monthly vs. …

Cognition Therapeutics CEO Issues Letter to Shareholders

Cognition Therapeutics CEO Letter to Shareholders Cognition Therapeutics (CGTX) today announced that CEO Lisa Ricciardi has issued a Letter to Shareholders to provide an update on recent pipeline developments and a preview of the company’s strategy in 2024. The full text of the letter: A MESSAGE FROM OUR CHIEF EXECUTIVE OFFICER To my fellow shareholders, The year ahead holds great promise for Cognition Therapeutics. We …

For Migraine Patients and People Interested in New Migraine Results, AbbVie Inc is Published in The Lancet.  

AbbVie Inc UBRELVY Results Published in The Lancet AbbVie Inc (ABBV) announced detailed results published in The Lancet evaluating the efficacy, safety, and tolerability of UBRELVY® (ubrogepant) 100 mg for the acute treatment of migraine when administered during the prodrome of a migraine attack. The Phase 3 study, PRODROME, showed that UBRELVY given during the prodrome (i.e., 1-6 hours before the predicted onset of headache pain) significantly reduced the …

Today at 2 PM, Akero Therapeutics Presented at the H.C. Wainwright 7th Annual NASH Virtual Investor Conference

Akero Therapeutics Presented at the H.C. Wainwright 7th Annual NASH Conference Indeed, today, Akero Therapeutics (AKRO) presented virtually at the H.C. Wainwright 7th Annual NASH Conference on Tuesday, October 24, 2023, at 12:00 p.m. E.T. A live webcast of the fireside chat will be available through the investor relations section of the Company’s website at www.akerotx.com In case you missed the live webcast, an archived …

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 …