"Survodutide Phase 2 Trial Results"
Drug Updates

Zealand Pharma announces Boehringer Ingelheim survodutide Phase 2 trial shows 83% of adults treated achieved groundbreaking results in liver disease due to MASH, with significant improvements in fibrosis

Zealand Pharma A/S (Nasdaq: ZEAL) today announced that Boehringer Ingelheim has reported that up to 83.0% of adults treated with survodutide (BI 456906) achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%) in a Phase 2 trial [response difference: 64.8% (CI 51.1% – 78.6%), p-value (p<0.0001)]. The trial met its primary […]

Beyond Celiac Investments Launch
Hospital Updates

Beyond Celiac Launches First Investment Program for Celiac Disease Therapeutics

Beyond Celiac, the leading catalyst for a cure for celiac disease, today announces the creation of Beyond Celiac Investments (BCI), an investment program to accelerate the development of treatments and a cure for celiac disease by leveraging the speed and scale of venture capital and capital markets. BCI launches with an initial funding of $2 million and […]

"Research Collaboration Image"
Drug Updates

Numab Therapeutics and Ono Pharmaceutical Announce an Option and Collaboration Agreement to Develop Multi-specific Antibody NM49 for Treatment of Cancer

Numab Therapeutics AG (“Numab”) and Ono Pharmaceutical Co., Ltd. (“Ono”) today announced a global research, development and commercialization collaboration for NM49, a multi-specific antibody designed to activate tumor associated macrophage phagocytosis for the treatment of cancers and identified through Numab’s proprietary discovery and engineering technology platform. Under the terms of the agreement, Ono has obtained an […]

"Sana Biotechnology's HIP-modified Pancreatic Islet Cells"
Digital Health News

Sana Biotechnology Announces Publication of Preclinical Diabetes Data in Cell Stem Cell Demonstrating Insulin Independence Following Transplantation of Hypoimmune Allogeneic Primary Islet Cells Without Immunosuppression in a Diabetic NHP

Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced that Cell Stem Cell has published a paper titled “Hypoimmune islets achieve insulin independence after allogeneic transplantation in a fully immunocompetent non-human primate.” The paper evaluated a transplant of Sana’s engineered allogeneic, hypoimmune (HIP)-modified pancreatic islet cells into […]

Abbott TriClip FDA Advisory Committee Approval
Device Digest

FDA Advisory Committee Votes in Favor of Abbott’s First-of-Its-Kind TriClip™ System to Treat People With a Leaky Tricuspid Heart Valve

Abbott (NYSE: ABT) today announced that the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the U.S. Food and Drug Administration (FDA) confirmed 13 to 1, with 0 abstention that the benefits of Abbott’s TriClip™ transcatheter edge-to-edge repair (TEER) system outweighed the risks for the treatment of people with tricuspid regurgitation (TR). The […]

"FDA Approval for Onivyde NALIRIFOX Regimen"
Drug Updates

Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA  

Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC). This is the second approval for an Onivyde regimen in mPDAC, […]

"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 […]

MDMA-Assisted Therapy for PTSD
Drug Updates

Lykos Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for MDMA-Assisted Therapy for PTSD

Lykos Therapeutics (formerly MAPS Public Benefit Corporation) (“Lykos”), a company dedicated to transforming mental healthcare, announced that the U.S. Food and Drug Administration (“FDA”) has accepted its new drug application (“NDA”) for midomafetamine capsules (“MDMA”) used in combination with psychological intervention, which includes psychotherapy (talk therapy) and other supportive services provided by a qualified healthcare provider […]

HMB-001 Phase 1 Results Presentation
Drug Updates

Hemab Therapeutics Presents Positive Phase 1 Results for HMB-001 in Glanzmann Thrombasthenia at 2024 EAHAD Annual Congress

Hemab Therapeutics, a clinical-stage biotechnology company developing novel prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders, today presented initial results from Phase 1 of its ongoing evaluation of HMB-001. A novel bispecific antibody, HMB-001 is in development as a prophylactic treatment for the bleeding disorder Glanzmann Thrombasthenia (Glanzmann). The data were presented as one of […]

NRx Bipolar Depression Trial Completion
Mental Wellness

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Reports Comments by Strategic Partner Lotus Pharmaceutical Co. Ltd. (1975.TW) in Recent Financial Report

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”, the “Company”), a clinical-stage biopharmaceutical company, today announced that its Asia Pacific strategic partner Lotus Pharmaceutical Co. Ltd (1975.TW) identified enrollment completion of the NRx clinical trial in bipolar depression as a material event in is February 7 financial filing.[1]  Lotus provides the Asia Pacific component of NRx’s global partnership with Alvogen, Inc. Lotus reported […]