Market News & Trends
Zevra Therapeutics to Acquire Acer Therapeutics, Expanding its Rare Disease Portfolio & Adding Commercial Product
Proposed acquisition of Acer for $15M in Zevra stock plus Contingent Value Rights (CVRs) and Zevra’s purchase of Acer’s secured debt in capital efficient structure….
Zealand Pharma Announces Designation of Priority Review by the US FDA for Dasiglucagon in Congenital Hyperinsulinism
Zealand Pharma A/S recently announced that the US FDA has granted priority review designation for dasiglucagon for the prevention and treatment of hypoglycemia in pediatric…
OKYO Pharma Achieves 90% Enrollment in 240-Patient Phase 2 Clinical Trial of OK-101 to treat Dry Eye Disease
OKYO Pharma Limited recently announced it has enrolled and randomized 90% of the patients in its 240-patient Phase 2 multi-center, double-masked, placebo-controlled clinical trial of…
Denali Therapeutics Announces New Interim Data From Phase 1/2 Study of DNL310 in MPS II (Hunter Syndrome)
Denali Therapeutics Inc. recently announced new interim data from the ongoing open-label, single-arm Phase 1/2 study of DNL310 (ETV:IDS) in children with MPS II (Hunter…
Bio-Rad Launches First StarBright Red Dye & Extends Range of Antibody Markers Conjugated to StarBright Dyes to Enhance Multiplex Flow Cytometry & Research Capabilities
With 29 additional targets the range also includes dog, cow, and pig targets to support translational models in veterinary immunology research….
Biostax Signs Collaboration Agreement With Immgenuity to Pursue Remission in HIV
Immune Therapeutics, Inc. d/b/a Biostax Corp. recently announced the signing of a research collaboration agreement with Immgenuity, Inc. The joint research will focus on using…
Eagle Pharmaceuticals Announces Positive Type C Meeting With FDA for an Estrogen Receptor Antagonist Used in the Treatment of Metastatic Breast Cancer in Post-Menopausal Women
Eagle Pharmaceuticals, Inc. recently announced a positive Type C meeting with the US FDA. Eagle and the FDA agreed on a path forward to advance…
Ocean Biomedical Announces New Patent for Anti-Fibrosis Discovery With Allowance in Alcoholic Liver Disease & Multiple Fibrotic Conditions
Ocean Biomedical, Inc. recently announced the United States Patent and Trademark Office has issued a patent covering Ocean’s anti-Chitinase 1 small molecule candidate. Dr. Jack…
Certara Simcyp Group Awarded Two New Grants From US FDA
Programs focus on use of physiologically-based pharmacokinetic (PBPK) modeling for demonstrating virtual bioequivalence and predicting drug absorption of topical formulations…..
Cellares Announces Bristol Myers Squibb has Joined Technology Adoption Partnership Program to Evaluate Automated Manufacturing of CAR-T Cell Therapy on the Cell Shuttle Platform
Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, recently announced global biopharmaceutical company and cell therapy….
GeoVax Receives Notice of Allowance for Malaria Vaccine Patent
GeoVax Labs, Inc. recently announced the US Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/726,254 titled Compositions and…
Ascendia Named to 2023 Inc. 5000 List of America’s Fastest-Growing Private Companies for the Fourth Consecutive Year
Ascendia Pharmaceuticals®, a leading specialty pharmaceutical contract development and manufacturing organization (CDMO) in North America, proudly announces it has been named to the prestigious 2023…
Introducing BioReliance Analytical Development Services for mRNA-based Vaccines & Therapeutics
MilliporeSigma has launched its BioReliance mRNA Analytical Development Services. With their expertise and advanced capabilities, they are set to empower researchers and developers in unlocking…
Vaxxas Opens World-Class Manufacturing Facility to Produce Proprietary Needle-Free Vaccine Patch For Late-Stage Clinical Trials & First Commercial Products
Vaxxas recently announced the opening of its first, state-of-the-art manufacturing facility in Brisbane, Queensland. The custom-built 60,000-sq-ft Vaxxas Biomedical Facility will serve as….
NKGen Biotech Announces First Patient Dosed in Phase 1 Clinical Trial of Allogeneic NK Cell Therapy Product Candidate for the Treatment of Solid Tumors
NKGen Biotech, Inc. recently announced the first patient has been dosed in a Phase 1, multi-center, open-label, dose-escalation study evaluating its cryopreserved investigational allogeneic blood-derived…
US FDA Approves Orphan Drug Designation for NXC-201 as a Treatment for Multiple Myeloma
Nexcella, Inc. recently announced the US FDA has granted Orphan Drug Designation (ODD) designation for NXC-201 for the treatment of a life-threatening form of blood…
Revive Therapeutics Announces Initiation of Novel Bucillamine Formulation Development
Revive Therapeutics Ltd. recently announced it has initiated the development of a next-generation formulation of Bucillamine for the potential treatment of public health medical emergencies,…
Review of IND Application for IHL-42X by US FDA Completed; Clinical Trial for Patients With Obstructive Sleep Apnoea May Proceed
Incannex Healthcare Limited recently announce it has received approval from the US FDA to conduct the company’s Investigational New Drug (IND) opening pivotal IHL-42X Phase…
Foundery Launches Inaugural Biotech Venture Creation Fund to Accelerate the Development of Novel Immunotherapies
Foundery’s co-development venture studio model aligns first-in-class drug development opportunities with financing and experimental execution to catalyze university discoveries….
Phathom Pharmaceuticals Announces Submission of 6-Month Stability Data in Support of Erosive GERD NDA
Phathom Pharmaceuticals, Inc. recently announced it has submitted to the FDA 6-month stability data from its long-term and accelerated stability program for its reformulated vonoprazan…
