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Shorla Oncology Announces US Acquisition of Jylamvo, an Oncology and Autoimmune Drug from Therakind

Retrieved on: 
Tuesday, October 31, 2023

Shorla Oncology (‘Shorla’), a US-Ireland specialty pharmaceutical company, and Therakind Ltd (‘Therakind’), a UK-based specialty pharmaceutical company have entered into an agreement under which Shorla has agreed to acquire Jylamvo, an oncology and autoimmune drug, for the US market.

Key Points: 
  • Shorla Oncology (‘Shorla’), a US-Ireland specialty pharmaceutical company, and Therakind Ltd (‘Therakind’), a UK-based specialty pharmaceutical company have entered into an agreement under which Shorla has agreed to acquire Jylamvo, an oncology and autoimmune drug, for the US market.
  • Jylamvo is an easy-to-administer, sweet tasting oral methotrexate solution that eliminates the need for crushing or splitting pills, or compounding into a liquid formulation.
  • “We are delighted to acquire Jylamvo to provide an alternative solution for patients who may have difficulty swallowing pills,” said Sharon Cunningham, chief executive officer of Shorla Oncology.
  • “This acquisition will provide a much-needed treatment to patients in need,” said Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology.

Dr. Reddy’s Q2 FY24 Financial Results

Retrieved on: 
Friday, October 27, 2023

Q2 FY24 revenue at Rs.

Key Points: 
  • Q2 FY24 revenue at Rs.
  • Q2 FY24 revenue at Rs.
  • Q2 FY24 revenue at Rs.
  • Net Finance income for Q2 FY24 at Rs.1.2 billion compared to net finance expense of Rs.

Empatica's Platform Receives New FDA Clearance for Cardiac Digital Biomarkers

Retrieved on: 
Thursday, November 2, 2023

BOSTON, Nov. 2, 2023 /PRNewswire/ -- Empatica, a digital health and AI company developing medical-grade wearables and digital biomarkers for health monitoring and diagnostics, today announced US Food and Drug Administration (FDA) 510(k) clearance for two new digital biomarkers for its Empatica Health Monitoring Platform: pulse and respiratory rate.

Key Points: 
  • BOSTON, Nov. 2, 2023 /PRNewswire/ -- Empatica, a digital health and AI company developing medical-grade wearables and digital biomarkers for health monitoring and diagnostics, today announced US Food and Drug Administration (FDA) 510(k) clearance for two new digital biomarkers for its Empatica Health Monitoring Platform: pulse and respiratory rate.
  • With the addition of pulse and respiratory rate, the Empatica Health Monitoring Platform now includes six FDA-cleared digital biomarkers, among the most offered for use in clinical trials.
  • In addition to the EmbracePlus wearable, the Empatica Health Monitoring Platform also includes Empatica's proprietary Care software suite, secure cloud infrastructure, and clinically validated digital biomarkers.
  • The Empatica Health Monitoring Platform received its initial FDA clearance in November 2022.

Empatica's Platform Receives New FDA Clearance for Cardiac Digital Biomarkers

Retrieved on: 
Thursday, November 2, 2023

BOSTON, Nov. 2, 2023 /PRNewswire/ -- Empatica, a digital health and AI company developing medical-grade wearables and digital biomarkers for health monitoring and diagnostics, today announced US Food and Drug Administration (FDA) 510(k) clearance for two new digital biomarkers for its Empatica Health Monitoring Platform: pulse and respiratory rate.

Key Points: 
  • BOSTON, Nov. 2, 2023 /PRNewswire/ -- Empatica, a digital health and AI company developing medical-grade wearables and digital biomarkers for health monitoring and diagnostics, today announced US Food and Drug Administration (FDA) 510(k) clearance for two new digital biomarkers for its Empatica Health Monitoring Platform: pulse and respiratory rate.
  • With the addition of pulse and respiratory rate, the Empatica Health Monitoring Platform now includes six FDA-cleared digital biomarkers, among the most offered for use in clinical trials.
  • In addition to the EmbracePlus wearable, the Empatica Health Monitoring Platform also includes Empatica's proprietary Care software suite, secure cloud infrastructure, and clinically validated digital biomarkers.
  • The Empatica Health Monitoring Platform received its initial FDA clearance in November 2022.

ImmunoGen Announces European Medicines Agency Acceptance of Marketing Authorization Application for Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer

Retrieved on: 
Friday, October 27, 2023

ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for mirvetuximab soravtansine (ELAHERE®) for the treatment of patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Key Points: 
  • ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for mirvetuximab soravtansine (ELAHERE®) for the treatment of patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • We look forward to working closely with the EMA throughout the review process and to potentially bring this novel ADC to Europe as early as 2024."
  • In the MIRASOL trial, ELAHERE demonstrated statistically significant and clinically meaningful improvements in progression-free survival, objective response rate, and overall survival compared to investigator's choice (IC) of single-agent chemotherapy.
  • ELAHERE demonstrated a tolerable safety profile compared to IC chemotherapy consisting predominantly of low-grade ocular and gastrointestinal events.

EOSolutions Corp receives FDA clearance for the Thinline Introducer Sheath, to enhance the utility of the Dr. Banner Balloon Guide Catheter

Retrieved on: 
Thursday, October 26, 2023

Banner Balloon Guide Catheter, offering an innovative solution to the challenges associated with large-bore Balloon Guide Catheters.

Key Points: 
  • Banner Balloon Guide Catheter, offering an innovative solution to the challenges associated with large-bore Balloon Guide Catheters.
  • Anthony Parise, General Manager of EOSolutions, expressed his excitement, saying, "We are delighted to receive FDA clearance for the EOSolutions Thinline Introducer Sheath.
  • Banner Balloon Guide Catheter and expanding the possibilities for physicians with our innovative offerings."
  • Banner Balloon Guide Catheter sets a new standard in the industry with its impressive 0.091-inch Inner Diameter, providing the largest balloon guide catheter lumen available.

Pioneers and Innovators in Psilocybin Treatments and How Big Pharma Wants in on the Game

Retrieved on: 
Thursday, October 19, 2023

As psilocybin and other alternative health innovators try to shape the future of mental health, Pharma and traditional healthcare investors are watching and waiting to get their share.

Key Points: 
  • As psilocybin and other alternative health innovators try to shape the future of mental health, Pharma and traditional healthcare investors are watching and waiting to get their share.
  • (OTCQB: KAYS) is the only U.S. public company engaged in securing an Oregon Health Authority ("OHA") license to open a psilocybin treatment center.
  • Kaya Holdings just announced that it has closed an additional round of bridge financing targeted to complete KAYS' planned psilocybin treatment center in Portland, Oregon.
  • Reporting on the Mindset Pharma deal, Psychedelicspotlight.com said , "Big Pharma has certainly taken note of the potential therapeutic benefits of psychedelics.

EQS-News: Galimedix Appoints Dr. Luciana Summo as Vice President, R&D Operations

Retrieved on: 
Thursday, October 26, 2023

Galimedix Appoints Dr. Luciana Summo as Vice President, R&D Operations (news with additional features)

Key Points: 
  • Galimedix Appoints Dr. Luciana Summo as Vice President, R&D Operations (news with additional features)
    The issuer is solely responsible for the content of this announcement.
  • In this newly created position, she will oversee all activities related to R&D operations, with an emphasis on clinical development and operations.
  • “We are delighted to welcome Luciana to Galimedix,” said Alexander Gebauer, MD, PhD, Co-founder and Executive Chairman.
  • Luciana Summo, PhD, Vice President, R&D Operations, added: “I am truly excited to be joining Galimedix at this important point in the Company’s growth.

Basilea announces acquisition of novel clinical-stage antifungal for treatment of Aspergillus mold infections

Retrieved on: 
Thursday, October 19, 2023

David Veitch, Chief Executive Officer of Basilea, stated: “This is the first transaction in the implementation of our strategy to expand our clinical-stage anti-infectives pipeline and to complement our portfolio of marketed products, Cresemba and Zevtera.

Key Points: 
  • David Veitch, Chief Executive Officer of Basilea, stated: “This is the first transaction in the implementation of our strategy to expand our clinical-stage anti-infectives pipeline and to complement our portfolio of marketed products, Cresemba and Zevtera.
  • Based on its novel mechanism of action which results in rapid fungicidal activity in vitro, BAL2062 could become a valuable treatment option against difficult-to-treat invasive mold infections.
  • To define the optimal positioning and the most efficient clinical development path, we will initiate a focused preclinical profiling program.
  • In addition, Basilea will pay tiered royalties on sales starting in the low single-digit percentage range, going to the mid-single-digit percentage range.

Muscular Dystrophy Association Celebrates FDA Approval of ZILBRYSQ® zilucoplan for the Treatment of Generalized Myasthenia Gravis (gMG) in Adult Patients

Retrieved on: 
Wednesday, October 18, 2023

New York, Oct. 18, 2023 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) celebrates the US Food and Drug Administration (FDA) approval of ZILBRYSQ® zilucoplan for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive.

Key Points: 
  • New York, Oct. 18, 2023 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) celebrates the US Food and Drug Administration (FDA) approval of ZILBRYSQ® zilucoplan for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive.
  • Zilucoplan is the first once-daily subcutaneous, targeted C5 complement inhibitor for gMG, and it is the only once-daily gMG-target therapy for self-administration.
  • "The recent approval of zilucoplan is great news for people living with gMG,” said Sharon Hesterlee, Ph.D., Chief Research Officer, MDA.
  • “This is the second gMG therapy out of UCB that has achieved FDA approval this year, providing patients and physicians with important options.