Seladelpar medication for primary biliary cholangitis
Drug Updates

The New England Journal of Medicine Publishes Positive Phase 3 RESPONSE Data of CymaBay’s Seladelpar in Primary Biliary Cholangitis

CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that The New England Journal of Medicine (NEJM) has published detailed results from the RESPONSE Phase 3 trial evaluating seladelpar, an investigational agent, and the only potent, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist or delpar, […]

"PharmaTher Phase 1 Clinical Study"
Drug Updates

PharmaTher’s Sairiyo Therapeutics Inc. Advances Clinical Development of Patented Reformulated Cepharanthine for Phase 1 Study in Australia

PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, announced today Sairiyo Therapeutics Inc. (“Sairiyo”), a company that is forty-nine percent (49%) owned by PharmaTher and fifty-one percent (51%) owned by PharmaDrug Inc. (CSE: PHRX) (OTC Pink: LMLLF) (“PharmaDrug”), has initiated its regulatory and clinical development plan to evaluate […]

"Illustration of Heart Surgery"
Drug Updates

United States Food & Drug Administration (FDA) Grants Mesoblast Orphan-Drug Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease

Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted its allogeneic cell therapy Revascor® (rexlemestrocel-L) an Orphan-Drug Designation (ODD) following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome (HLHS), a potentially life […]

Brii Biosciences and VBI Vaccines agreements
Drug Updates

Brii Biosciences Announces Agreement to Acquire VBI’s IP Rights in BRII-179 (VBI-2601) and Plans to Initiate Technology Transfer to Expand Clinical and Commercial Supplies

Brii Biosciences Limited (“Brii Bio,” “we,” or the “Company”, stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet needs, today announced that it has entered into agreements with VBI Vaccines, Inc. (“VBI”, NASDAQ: VBIV), ensuring expansion and control of future clinical and commercial supplies of BRII-179, a late-stage […]

"BioXcel Therapeutics Fast Track Designation"
Digital Health News

BioXcel Therapeutics Receives FDA Fast Track Designation for BXCL701 for Treatment of Small Cell Neuroendocrine Prostate Cancer (SCNC)

BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of BXCL701 in combination with a CPI for the treatment of patients with metastatic small cell […]

"Nipocalimab Breakthrough Therapy Designation"
Digital Health News

Johnson & Johnson’s nipocalimab granted U.S. FDA Breakthrough Therapy Designation for the treatment of individuals at high risk for severe hemolytic disease of the fetus and newborn (HDFN)

Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for nipocalimab for the treatment of alloimmunizeda pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN). Nipocalimab is currently the only therapy reported to be in clinical development for the treatment […]

"Human Acellular Vessel (HAV)"
Digital Health News

Human Acellular Vessel™ (HAV™) Biologics License Application Granted Priority Review by U.S. FDA for the Treatment of Vascular Trauma

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to Humacyte’s Biologics License Application (BLA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular […]

"IPX203 Parkinson's Treatment"
Drug Updates

Amneal Announces Complete Response Resubmission for IPX203 New Drug Application

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced that it has provided a Complete Response resubmission to the U.S. Food and Drug Administration (FDA) for IPX203, a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for the treatment of Parkinson’s disease (PD). The original NDA for IPX203 resulted in a Complete Response […]

"Yiviva AstraZeneca R&D Collaboration"
Digital Health News

Yiviva Announces Memorandum of Understanding with AstraZeneca to Develop Platforms, Technologies, and Innovative Therapeutics through a Systems Biology Approach

Yiviva, a clinical-stage, platform biotechnology company developing systems biology medicines to treat aging-related diseases, signed a memorandum of understanding (MOU) with AstraZeneca China to establish a research and development collaboration at AstraZeneca’s Innovation Campus (iCampus) in Chengdu, China. The signing ceremony took place at the 2023 China International Import Expo (CIIE) at the National Exhibition […]

Digital Health News

Surgical Information Sciences Initiates VISION Study to Support Deep Brain Stimulation for Parkinson’s Disease Patients

Surgical Information Sciences, a medical device company focused on improved visualization of brain structures for deep brain stimulation (DBS) surgery, announced the commencement of its post-market study, the Visualization of the STN and GPi for DBS Surgery in Patients with Parkinson’s Disease (VISION Study). This study aims to evaluate the potential of SIS technology in […]