Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.

Aurinia Presents Breadth of Data from AURORA Clinical Program Underscoring Value of LUPKYNISⓇ (voclosporin) for Patients with Lupus Nephritis at ACR 2023

Retrieved on: 
Tuesday, November 7, 2023
Biotechnology, Health, Science, Research, Clinical Trials, Patient, Lupus nephritis, Week, American College, CNI, EGFR, Human, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., TAC, AURORA, Safety, University of California, CSA, VCS, Lupus, Society, Mouse, Acute kidney injury, Ciclosporin, Division, Clinical trial, Efficacy, Physiology, Biopsy, MMF, University, Tacrolimus, Glucocorticoid, ACR, Conditional sentence, Proteinuria, Lithium toxicity, Pharmaceutical industry, Rheumatology, Black, ALMS, Aurinia, Medicine, UPCR, LN

Safety and efficacy outcomes for propensity-matched patients with active LN from the Aspreva Lupus Management Study (ALMS) and the AURORA 1 study were assessed at three and six months.

Key Points: 
  • Safety and efficacy outcomes for propensity-matched patients with active LN from the Aspreva Lupus Management Study (ALMS) and the AURORA 1 study were assessed at three and six months.
  • In AURORA 1, patients received LUPKYNIS® 23.7 mg BID in combination with MMF (target dose 2 g/day) and oral glucocorticoids (starting dose of 25 mg/day tapered to 2.5 mg/day by Week 16).
  • The data showed an improved safety profile over the first six months of treatment with LUPKYNIS® in combination with low-dose glucocorticoids and lower-dose MMF without compromising efficacy.
  • Additional data assessed the disposition of cyclosporine (CSA), tacrolimus (TAC), and voclosporin (VCS) in mouse kidneys relative to its systemic drug exposure.

Acadia Pharmaceuticals Reports Third Quarter 2023 Financial Results and Operating Overview

Retrieved on: 
Thursday, November 2, 2023
Mental Health, Health, Other Health, Clinical Trials, Research, Science, Pharmaceutical, Prader–Willi syndrome, PIN, ACAD, Senior, Polyphagia, Rett syndrome, Schizophrenia, Corporate communication, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Regulatory affairs, Pharmaceutical industry, Clothing, Cryptocurrency

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced its financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced its financial results for the third quarter ended September 30, 2023.
  • The Company plans to initiate a Phase 3 placebo-controlled study of ACP-101 for the treatment of hyperphagia in Prader-Willi syndrome in the fourth quarter of 2023.
  • The Company plans to initiate a Phase 2 study of ACP-204 as a potential treatment for Alzheimer’s disease psychosis in the fourth quarter of 2023.
  • Net product sales of DAYBUE were $66.9 million for the quarter ended September 30, 2023, the first full quarter of commercialization of DAYBUE following the April 17, 2023 launch.

Aurinia Presents Breadth of Data at ASN 2023 Demonstrating Clinical Importance of LUPKYNISⓇ for Managing Lupus Nephritis

Retrieved on: 
Thursday, November 2, 2023
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Patient, Lupus nephritis, National Institutes of Health, CNI, EGFR, Kidney failure, AURORA, Safety, Lupus, Kidney, ALMS, Society, Acute kidney injury, Clinical trial, ASN, MMF, NIH, Histology, Glucocorticoid, UPCR, Conditional sentence, Bangladesh Technical Education Board, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Ohio State University Wexner Medical Center, Proteinuria, Toxic leukoencephalopathy, Pharmaceutical industry, Black, Aurinia, LN

Results from an analysis of kidney biopsy samples collected from patients participating in the AURORA Clinical Program were presented in an oral session.

Key Points: 
  • Results from an analysis of kidney biopsy samples collected from patients participating in the AURORA Clinical Program were presented in an oral session.
  • Activity scores for both arms improved to a similar degree, while the chronicity scores remained stable in both arms.
  • “The results presented at ASN this week demonstrate important clinical and mechanistic findings associated with LUPKYNISⓇ treatment.
  • Following is the complete guide to Aurinia’s presentations at ASN 2023:
    Title: Comparison of dual-immunosuppressive therapy and a voclosporin-based, triple-immunosuppressive regimen for lupus nephritis: a propensity analysis of ALMS and AURORA 1 studies

Aurinia Pharmaceuticals Reports Third Quarter and Nine Months 2023 Financial and Operational Results

Retrieved on: 
Thursday, November 2, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Other Health, SLE, PSF, FDA, Insurance, American College, EGFR, U.S.–Canada Team Tournament (Go), Conversation, SG, EDGAR, SEDAR, American Society of Nephrology, AURORA, Nephrology, Lupus, Persistent environment, EC, Glomerular filtration rate, R, Society, Arthritis & Rheumatology, Bank statement, Growth, Risk, Marketing, Webcast, Analysis, Healthcare Improvement Scotland, American College of Rheumatology, Safety, LN, Investment, Management, Patient, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Rheumatology, Cryptocurrency, Pharmaceutical industry, Rare-earth element, Aurinia

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today issued its financial results for the three and nine months ended September 30, 2023.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today issued its financial results for the three and nine months ended September 30, 2023.
  • Total net revenue was $54.5 million for the three months ended September 30, 2023 and $55.8 million for the same period in 2022.
  • Financial Results for the Three and Nine Months Ended September 30, 2023
    Total net revenue was $54.5 million and $55.8 million for the three months ended September 30, 2023 and September 30, 2022, respectively.
  • Aurinia will host a conference call and webcast to discuss the quarter ended September 30, 2023 financial results today, Thursday, November 2, 2023 at 8:30 a.m.

Virpax Pharmaceuticals Announces that Envelta™ Remains on Track for Trial in Humans Following FDA Review

Retrieved on: 
Tuesday, October 31, 2023
Other Health, Research, General Health, Pharmaceutical, Medical Devices, Infectious Diseases, Science, Surgery, Biotechnology, FDA, Other Science, Health, Post-traumatic stress disorder, Rat, Analgesic, Nanotechnology, National Center for Advancing Translational Sciences, IND, Central nervous system disease, Food, NCATS, Chronic pain, Hematology, Mortality, Morphine, US Food Sovereignty Alliance, CNS, Nanoparticle, Administration, Human, Traffic barrier, Transitive dependency, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Completeness, DRF, Thermoregulation, Animal, Brain, NIH, CFA, Pain management, Drug tolerance, Dog, Pain, MET, Hypersensitivity, Bangladesh Technical Education Board, Coagulation, Central nervous system, Pharmaceutical industry

Envelta utilizes a novel and patented intranasal drug delivery system, Molecular Envelope Technology (MET) to bypass the blood-brain barrier.

Key Points: 
  • Envelta utilizes a novel and patented intranasal drug delivery system, Molecular Envelope Technology (MET) to bypass the blood-brain barrier.
  • The MET was developed by Nanomerics, Ltd. , a UK-based nanotechnology research and development company that has licensed its MET-LENK to Virpax.
  • The nose-to-brain MET platform protects molecules from biodegrading and enhances the bioavailability of product candidates on its transport to the brain.
  • “We are grateful to the FDA for the thorough and clear direction that was provided to us in our pre-IND meeting.

Aurinia Response in Support of 2023 Updated EULAR Recommendations for Management of Lupus and New Treatment Paradigm for Lupus Nephritis

Retrieved on: 
Thursday, October 26, 2023
Health, Other Science, Research, Pharmaceutical, Science, Biotechnology, EULAR, SLE, Steroid, European Alliance, Lupus nephritis, Patient, Glomerular filtration rate, Maintenance, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., EGFR, European Alliance of Associations for Rheumatology, Dietary supplement, Pharmaceutical industry, Rheumatology, Aurinia

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia welcomes the 2023 updated recommendations from The European Alliance of Associations for Rheumatology (EULAR) for the management of systemic lupus erythematosus (SLE) based on emerging new evidence, including a new treatment paradigm for lupus nephritis (LN).

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia welcomes the 2023 updated recommendations from The European Alliance of Associations for Rheumatology (EULAR) for the management of systemic lupus erythematosus (SLE) based on emerging new evidence, including a new treatment paradigm for lupus nephritis (LN).
  • The new recommendations suggest that in addition to traditional anchor drugs, therapies including LUPKYNIS® (voclosporin) should be considered for any active class of lupus nephritis.
  • “Aurinia appreciates EULAR’s thoughtful consideration for improving the management of lupus nephritis with recommendations that reflect therapeutic advancements in this underserved patient population.
  • The updated recommendations reflect the growing recognition of the clinical value that a therapy like voclosporin provides to people living with lupus nephritis.

Milestone Pharmaceuticals Announces Submission of New Drug Application to the U.S. FDA for Etripamil

Retrieved on: 
Tuesday, October 24, 2023
FDA, Food, Paroxysmal supraventricular tachycardia, Heart, Heart rate, Regulation of tobacco by the U.S. Food and Drug Administration, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., RAPID, Arrhythmia, NDA, Patient, PVST, Pharmaceutical industry, PSVT, Lancet

The primary analysis and supportive assessments from the pivotal RAPID Phase 3 clinical trial were recently published in The Lancet.

Key Points: 
  • The primary analysis and supportive assessments from the pivotal RAPID Phase 3 clinical trial were recently published in The Lancet.
  • The FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review.
  • If accepted, Milestone Pharmaceuticals expects a standard review of 10 months of the company's NDA.
  • Milestone continues to advance commercial preparations to support the anticipated launch of etripamil with the proposed trade name, CARDAMYST™.

Summit Therapeutics Appoints Proven Biotech Leader Manmeet S. Soni as Chief Operating Officer

Retrieved on: 
Monday, October 16, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Genentech, LLP, Drug development, Abstract, Harvard University, Pfizer, Data management, Drug, Pharmacyclics, Arena Pharmaceuticals, Therapy, SMMT, Quality of life, Lasso, PwC, Knowledge, Amgen, Biogen, AbbVie, Athenahealth, CFO, Stonehill College, Faculty, Risk, Jazz Pharmaceuticals, University, Cancer, Jazz, Trust, Nektar, Immunotherapy, CMO, Biostatistics, Information technology, Alnylam Pharmaceuticals, MD Anderson Cancer Center, Public health, Regulatory affairs, Nektar Therapeutics, Sale, Senior, Doctor of Philosophy, Licensed practical nurse, ARIAD Pharmaceuticals, Growth, Hematology, Patient, Management, Nursing, Pharmacovigilance, Robert Maki

Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that Manmeet S. Soni has been appointed as the Company’s Chief Operating Officer, effective immediately.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that Manmeet S. Soni has been appointed as the Company’s Chief Operating Officer, effective immediately.
  • “Manmeet Soni has few peers in this industry, and his track record speaks for itself,” stated Dr. Maky Zanganeh, Chief Executive Officer and President of Summit.
  • “Leveraging his leadership and wisdom on a daily basis is a powerful addition to the already formidable Team Summit.
  • I am grateful for the trust he has displayed in Maky, me, and our team in joining our mission full-time.”
    Mr. Soni has over 20 years of financial and operational leadership experience and joins Summit from Reata Pharmaceuticals, Inc., where he was President, Chief Operating Officer, & Chief Financial Officer.

Virpax Pharmaceuticals Announces Extension of CRADA with the U.S. Army Institute of Surgical Research

Retrieved on: 
Thursday, October 12, 2023
Veterans, Infectious Diseases, Military, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Defense, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Central nervous system, Pain management, Journal of Surgical Research, Bupivacaine, Trauma, U.S. Department of Defense Strategy for Operating in Cyberspace, Post-traumatic stress disorder, Walter Reed Army Institute of Research, CRADA, CNS, Research, Pharmaceutical industry

The USASIR is the U.S. Department of Defense’s primary laboratory for developing solutions for trauma and critical care challenges in combat casualties.

Key Points: 
  • The USASIR is the U.S. Department of Defense’s primary laboratory for developing solutions for trauma and critical care challenges in combat casualties.
  • The trial, which was expected to start earlier this year, was slightly delayed due to a change in leadership at USAISR.
  • Probudur is being developed to significantly reduce or eliminate the need for opioids after surgery in approved indications.
  • In pre-clinical trials, Probudur has shown long duration pain control for at least 96 hours.

Gerald W. Bruce Appointed President and CEO of Novvae™ Pharmaceuticals

Retrieved on: 
Monday, October 2, 2023
Other Health, Research, General Health, Pharmaceutical, Oncology, Medical Devices, Infectious Diseases, Science, Surgery, Biotechnology, Other Science, Health, Lincoln University, Central nervous system, Nitrome, Business, CNS, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Post-traumatic stress disorder, OTC, Pain management, Knowledge, BA, Pharmaceutical industry, Analgesic

Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and viral barrier indications, announced today that Gerald W. Bruce has been appointed as President and CEO of Novvae™ Pharmaceuticals , Virpax’s wholly-owned subsidiary focused solely on advancing the Company’s OTC pipeline.

Key Points: 
  • Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and viral barrier indications, announced today that Gerald W. Bruce has been appointed as President and CEO of Novvae™ Pharmaceuticals , Virpax’s wholly-owned subsidiary focused solely on advancing the Company’s OTC pipeline.
  • Mr. Bruce has spent over 30 years in the pharmaceutical and medical nutrition industries.
  • Most recently, he served as a Vice President of sales for Danone Specialized Nutrition North America, Danone’s medical nutrition division.
  • “Gerald, with his background in the pharma and medical nutrition industries, is uniquely positioned to lead Novvae.