Amylyx Pharmaceuticals Announces Posting of Briefing Documents for Second FDA Advisory Committee Meeting on AMX0035

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) posted briefing documents for the reconvened Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) meeting to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) for … [Read more…]

For the Community: Mental Health Monday and Faith Fridays with UHSM

UHSM Shares Mental and Spiritual Wellness with Nationwide Audiences NORFOLK, Va.–(BUSINESS WIRE)–Unite Health Share Ministries™ (UHSM), a nonprofit, faith-based healthcare sharing ministry supporting a community of Christian believers through member-to-member healthcare sharing, introduced two initiatives meant to enhance and bring awareness to members’ wellness: #MentalHealthMonday and #FaithFridays. Partnering with mental health expert and advocate Brittney … [Read more…]

Know Labs Provides Update on IRB-Approved Internal Trial of Non-Invasive Glucose Monitoring Technology

SEATTLE–(BUSINESS WIRE)–Know Labs, Inc. (OTCQB: KNWN), an emerging developer of non-invasive medical diagnostic technology, today released a video update on the IRB-approved internal trial the Company has been conducting at its laboratory in Seattle. The video can be found here. The two-minute video breaks down the trial process, while Know Labs Chief Product Officer Steve … [Read more…]

CARsgen Releases the First Clinical Batch of CAR T Cells from its RTP GMP Manufacturing Facility in North Carolina

SHANGHAI–(BUSINESS WIRE)–CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the company’s Current Good Manufacturing Practice (CGMP) manufacturing facility located at the Research Triangle Park (RTP) in North Carolina, the United States of America (“The RTP GMP Manufacturing … [Read more…]

IQVIA CEO Ari Bousbib to Speak at Baird Global Healthcare Conference on September 14, 2022

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–IQVIA Holdings Inc. (“IQVIA”) (NYSE:IQV), announced today that Ari Bousbib, chairman and chief executive officer, will speak at the Baird 2022 Global Healthcare Conference in New York City on Wednesday, September 14, 2022 at 2:35 p.m. ET. A live audio webcast of the presentation will be available on the IQVIA Investor … [Read more…]

NCBiotech-Led Coalition Wins Phase 2 Build Back Better Regional Challenge Award

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–A statewide coalition of public and private partner organizations and institutions, led by the North Carolina Biotechnology Center (NCBiotech), has received a Phase 2 award totaling nearly $25 million from the U.S. Economic Development Administration’s (EDA) Build Back Better Regional Challenge. The NCBiotech-led consortium is one of only 21 projects chosen … [Read more…]

Astria Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

BOSTON–(BUSINESS WIRE)–Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company developing STAR-0215 for the treatment of hereditary angioedema and focused on life-changing therapies for rare and niche allergic and immunological diseases, granted stock options to purchase 5,500 shares of Astria’s common stock on September 1, 2022 under Astria’s 2022 Inducement Stock Incentive Plan. The 2022 Inducement Stock … [Read more…]

U.S. FDA approves first treatment option for generalized pustular psoriasis flares in adults

Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares After one week of treatment, more than half of patients treated with SPEVIGO® (spesolimab) intravenous injection showed no visible pustules in the EFFISAYIL® 1 trial The approval of SPEVIGO® in … [Read more…]

“Fixer Upper” stars, Magnolia media moguls Chip and Joanna Gaines become official ambassadors for St. Jude Children’s Research Hospital

Gaines family to support Childhood Cancer Awareness Month, St. Jude Thanks and Giving holiday campaign, share St. Jude mission year round MEMPHIS, Tenn.–(BUSINESS WIRE)–Today, on the first day of Childhood Cancer Awareness Month (CCAM), St. Jude Children’s Research Hospital® announced its newest ambassadors, Chip and Joanna Gaines, who have expanded their relationship with St. Jude, … [Read more…]

Bayer’s KERENDIA® (finerenone) Receives Updated Label to Include Findings From Phase III FIGARO-DKD Cardiovascular Outcomes Study in Patients With Chronic Kidney Disease and Type 2 Diabetes

  U.S. label now inclusive of data from comprehensive Phase III clinical trial program (FIGARO-DKD and FIDELIO-DKD) investigating kidney and cardiovascular (CV) outcomes in more than 13,000 patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D)1 FIGARO-DKD is the first contemporary Phase III CV outcomes trial with the majority of patients with … [Read more…]