Updated COVID-19 shots expected to enter the market this fall should be priced at a reasonable rate, the U.S. Department of Health and Human services said on Thursday, in a letter addressed to COVID vaccine manufacturers
https://finance.yahoo.com/news/hhs-says-updated-covid-shots-131804363.html
Quest Diagnostics (NYSE: DGX), the leading provider of diagnostic information services, today announced the launch of a novel prostate cancer biomarker test through its subspecialty pathology business, AmeriPath, in collaboration with Envision Sciences. Envision Sciences Pty Ltd. is an Australian-based clinical diagnostics company developing a pipeline of biomarker-based cancer diagnostic and prognostic tests in tissue and blood.
The new, tissue-based test service is intended to address the pressing clinical need for tests to help identify and differentiate potentially aggressive cases of prostate cancer in men. Physicians in the United States, with the exception of New York, may order the test starting today.
Quest developed and validated the laboratory test under an intellectual property license agreement with Envision for use of Envision's proprietary biomarker and immunohistochemistry technology, which includes Envision's unique staining technology and novel biomarkers (named EV1, EV2 and EV3).Recently published data in Pathology shows that 22% of tissue specimens examined with a panel based on the three Envision biomarkers and technology were upgraded, and 20% were downgraded, as compared to the conventional assessment of pathologic evaluation based on hematoxylin and eosin-stained tissue alone
Data published in peer-reviewed British Journal of Cancer Research
No evidence of cardiotoxicity in any subject treated in this study, including up to 16 subjects whose cumulative anthracycline dose (Annamycin included) exceeded the lifetime cumulative doxorubicin (or equivalent) dose of > 450 mg/m2
After experiencing an 80%/60% ORR/CRi rates in last single agent cohort, Annamycin is currently being evaluated in a Phase 1b/2 study in combination with Cytarabine for the treatment of AML
First Wave BioPharma, Inc., (NASDAQ:FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced the Company has received topline results from the Company’s Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF). Initial data from the study indicate the enhanced adrulipase formulation was safe and well tolerated and demonstrated an improvement over prior formulations of adrulipase. However, the preliminary data also indicate that it is likely the primary efficacy endpoint was not achieved. First Wave BioPharma is continuing to assess the data and expects to report additional findings on primary and secondary endpoints in approximately eight weeks.
https://finance.yahoo.com/news/first-wave-biopharma-announces-initial-110000695.html
Platform Enables Customers to Manufacture mRNA with Substantial Reduction in dsRNA and Manufacturing Complexities; Integrable into Current mRNA Workflows -
- Platform Currently Available Under Early Access Program -
Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today announced that it has acquired Spindle Biotech Inc. ("Spindle"), an early-stage, private biotech company developing next-generation RNA manufacturing technologies. The acquisition uniquely leverages the Company's LinearDNA™ platform that enables the efficient chemical modification of DNA templates and the high binding affinity of Spindle's proprietary, high-performance RNA polymerase (RNAP) for chemically modified DNA templates to deliver multiple advantages over conventional plasmid DNA-based mRNA production, including 1) the prevention or reduction of double-stranded RNA (dsRNA) contamination resulting in higher target mRNA yields; 2) delivery of IVT templates in as little as 14 days for milligram scale and 30 days for gram scale; and 3) reduced mRNA manufacturing complexities.
The acquisition combines the Company's linearDNA™ IVT templates and Spindle's RNA polymerase into an integrated offering branded as the LineaIVT™ platform. With this integrated offering, Applied DNA expands its access to the mRNA value chain severalfold to what it estimates is over 20%1 of mRNA manufacturing costs of goods.
Terms of the Stock Purchase Agreement
Under the terms of the stock purchase agreement entered into among Applied DNA, Spindle, and the former shareholders of Spindle, Applied DNA acquired all outstanding shares in Toronto-based Spindle for an upfront purchase consideration of $625,000 cash, as adjusted for debt and transaction expenses, and 750,000 restricted shares of Company common stock, in addition to future contingent consideration of up to 1.0 million shares of Company common stock upon the satisfaction of certain commercialization and revenue milestones. The SPA also provides for a 10-year revenue share based on the net sales generated by the LineaIVT platform. Aaron Chung, co-founder and CEO of Spindle, joins the Company as Director of Nucleic Acid Platforms.
Phase 2 Bryostatin-1 Severe Cohort secondary and exploratory endpoint data selected by independent committee for presentation
Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the "Company"), an emerging biopharmaceutical company developing regenerative therapeutics for neurodegenerative disorders, today announced that an abstract featuring secondary endpoint data of its National Institutes of Health (NIH) sponsored Phase 2 Bryostatin-1 trial was accepted for presentation at the 11th International Brain Research Organization (IBRO) World Congress of Neuroscience to be held in September 2023 in Spain.
In the recently completed Phase 2 clinical trial of Bryostatin-1, two cohorts were studied: a Moderate Cohort, with MMSE* scores of 15-18, and a Severe Cohort, with MMSE scores of 10-14. All patients were randomized with respect to treatment groups, with safety checked by an independent Data Safety Monitoring Board (DSMB). While Moderate Cohort patients showed no significant benefit, for patients of the Severe Cohort, representing the patient population with the most advanced Alzheimer's disease (AD), nearly all pre-specified secondary endpoints were achieved with statistical significance. Data also showed statistical significance in exploratory secondary endpoints for this Severe Cohort (MMSE 10-14 stratum), and post hoc analysis was positive. Statistical significance in these analyses was measured by patients' Severe Impairment Battery* (SIB) changes from baseline for the Bryostatin-1 treatment group compared with the placebo group patients.
https://finance.yahoo.com/news/synaptogenix-abstract-highlighting-bryostatin-1-130000474.html
