Albireo Submits Bylvay® Alagille Syndrome Regulatory Filings to FDA and EMA
- Gold standard Phase 3 ASSERT study supports supplementary filings in the U.S. and EU - ASSERT study demonstrated efficacy...
COVID-19
Fortress Biotech Appoints Lucy Lu, M.D., to its Board of Directors
MIAMI, Dec. 19, 2022 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on efficiently...
scPharmaceuticals Inc. Announces Appointment of Rachael Nokes as Chief Financial Officer
Appointment brings more than 20 years of life sciences finance leadership experience to the CFO roleBURLINGTON, Mass., Dec. 19, 2022...
Assembly Biosciences Announces Promising Interim Results from Two Clinical Trials Evaluating Highly Potent Next-Generation Core Inhibitor Candidates ABI-H3733 and ABI-4334
In initial ABI-H3733 cohort of 50 mg in 28-day Phase 1b study, six of eight HBV patients on treatment reached...
Oncotelic Presents Clinical Data of Confirming TGF-β2 as the appropriate target for gliomas at JCA-AACR Meeting 2022
-Reduced TGF-β2, but not TGF-β1 nor TGF-β3, is associated with improved OS. AGOURA HILLS, Calif., Dec. 19, 2022 (GLOBE NEWSWIRE)...
ProSomnus® Enrolls First Participant in Study Evaluating Safety and Efficacy of ProSomnus EVO™ in Treating Severe Obstructive Sleep Apnea
SAN FRANCISCO, Dec. 19, 2022 (GLOBE NEWSWIRE) -- ProSomnus, Inc. (“the Company”) (NASDAQ: OSA), a pioneer in precision medical devices...
Cocrystal Pharma Reports Highly Favorable Safety and Tolerability Results from a Phase 1 Study with its Oral Antiviral CC-42344 for the Treatment of Pandemic and Seasonal Influenza A
BOTHELL, Wash., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) announces highly favorable safety and tolerability results...
Wave Life Sciences Provides Positive Update on Proof-of-Concept Study for WVE-N531 in Duchenne Muscular Dystrophy
53% mean exon skipping and <1% (BLQ) mean dystrophin expression six weeks after initiating biweekly multidosing PN chemistry improved pharmacology...
Biogen Reaches Agreement with Genentech to Receive Royalties on the Potential Commercialization of a Late-Stage Bispecific Antibody as Part of Anti-CD20 Collaboration
Glofitamab is an investigational T-cell engaging bispecific antibody targeting CD20 and CD3 in development for B-cell non-Hodgkin’s lymphoma and other...
Pfizer Opts In to LianBio Rights to Respiratory Syncytial Virus Therapeutic Candidate Sisunatovir in Mainland China, Hong Kong, Macau, and Singapore
Pfizer will now lead all development and commercialization activities in Mainland China, Hong Kong, Macau, and Singapore LianBio will receive...
Tonix Pharmaceuticals Achieves Enrollment of First 50 Percent of Participants in the RESILIENT Study, a Potentially Pivotal Confirmatory Phase 3 Study of TNX-102 SL for the Management of Fibromyalgia
Results from Planned Interim Analysis of First 50 Percent of Participants Expected Second Quarter 2023 Topline Results Expected Fourth Quarter...
COMP Adopts Positive Opinion on Orphan Designation for Mycapssa® for the Treatment of Carcinoid Syndrome Associated with Neuroendocrine Tumors
COMP Adopts Positive Opinion on Orphan Designation for Mycapssa® for the Treatment of Carcinoid Syndrome Associated with Neuroendocrine Tumors DUBLIN,...
Invivyd Presented Joint Industry Rationale on Potential Expedited Development Pathways for Monoclonal Antibodies at FDA-EMA Workshop
WALTHAM, Mass., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to...
Madrigal Announces Positive Topline Results from the Pivotal Phase 3 MAESTRO-NASH Clinical Trial of Resmetirom for the Treatment of NASH and Liver Fibrosis
In MAESTRO-NASH, a 52-week serial liver biopsy Phase 3 study in more than 950 patients, resmetirom achieved both primary endpoints...
Revolution Medicines Announces Publication Describing Design and Synthesis of RMC-5552, a First-in-Class, Bi-Steric mTORC1-Selective Inhibitor
Findings Published in the Journal of Medicinal Chemistry Demonstrate Compound’s Exceptional Selectivity for mTORC1 over mTORC2 Tumor Regressions Observed During...
XORTX Announces Completion of Dosing in XRX-OXY-101 Clinical Study
CALGARY, Alberta, Dec. 19, 2022 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX...
atai Life Sciences Initiates Phase 2b proof-of-concept trial of RL-007 for Cognitive Impairment Associated with Schizophrenia
The phase 2b proof-of-concept trial will evaluate the novel compound, RL-007, for pro-cognitive effects in patients with Cognitive Impairment Associated...
Taysha Gene Therapies Announces Executive Leadership Changes
Chair of the Board of Directors, Sean P. Nolan, appointed Chief Executive Officer Board Director, Sukumar Nagendran, M.D., appointed President...
Wesana Health Announces Receipt of Short-Term Loan
CHICAGO and TORONTO, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Wesana Health Holdings Inc. (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF),...
Panbela Receives Positive EMA Opinion on Orphan Designation for Ivospemin (SBP-101) in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Metastatic Pancreatic Ductal Adenocarcinoma
MINNEAPOLIS, Dec. 14, 2022 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the...