Operation Expands Availability With More Arizonans Prioritized For VaccineContinue reading
Category Archives: AZBio News
Diary for Irritable Bowel Syndrome Symptoms-Constipation is the First Patient-Reported Outcome Consortium Measure Used to Support an FDA-approved Label Claim
TUCSON, Ariz., January 7, 2021 — Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium announces that clinical study results using the Consortium’s Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C) were recently included in the expanded label for the drug LINZESS® (linaclotide). The DIBSS-C was developed by the PRO Consortium’s Irritable Bowel Syndrome (IBS) Working Group to support the evaluation of both primary and key secondary endpoints related to improvements in IBS-C signs and symptoms within the context of clinical trials and is currently in FDA’s Clinical Outcome Assessment Qualification Program. Although the DIBSS-C was not specifically mentioned, results from its abdominal symptom scale were included in the updated label for LINZESS®. This is the first time a PRO Consortium measure has been used to support a label claim.
Economic Impact Payments on their way, visit IRS.gov instead of calling
Looking for your second round of Economic Impact Payment? Learn about eligibility, the process, and how to track your payment.Continue reading
I Peace, Inc. and Avery Therapeutics announce collaboration to bring iPSC derived cell therapy for heart failure to the clinic
I Peace’s GMP-grade iPSCs are key to manufacture Avery Therapeutics’ MyCardia™, a proprietary tissue-engineered heart graft developed to treat heart failureContinue reading
Connect2STEM 2021 Returns as Dynamic Virtual Experience on Saturday January 30
Live Kickoff Event Celebrates 10 Years of Arizona’s Statewide SciTech Festival Continue reading
Moderna Announces FDA Authorization of Moderna COVID-19 Vaccine in U.S.
- Total of 200 million doses ordered by the U.S government to date; U.S. government retains option to purchase up to an additional 300 million doses
- Approximately 20 million doses will be delivered by the end of December 2020
- Moderna intends to submit a Biologics License Application for full U.S. licensure in 2021
Payroll R&D Credit Five Years Later: Forging a New Path
By John Guy, Manager, Emerging Companies Policy at Biotechnology Innovation Organization
December 18, 2020: Five years ago today, the Protecting Americans from Tax Hikes (PATH) Act was signed into law. This important piece of legislation included several provisions helpful to start ups like small biotechs, including permanently extending both the R&D Credit and the Small Business Stock Gains Exclusion (Tax Code Section 1202), providing both investors and the companies they invest in security without worry of losing access to the critical incentive in the future.
HTG Announces First Collaborator in Early Access Program for its Prototype Whole Transcriptome Panel
TUCSON, Ariz., Dec. 18, 2020 (GLOBE NEWSWIRE) — HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, today announced that it has signed up the first collaborator in its recently announced Early Access Program for its prototype whole transcriptome panel.Continue reading
Ivy Brain Tumor Center Initiates Phase 0 Clinical Trial with BeiGene for Newly Diagnosed and Recurrent Glioblastoma
Trial Represents First-Ever Phase 0 for Newly Diagnosed Patients with Glioblastoma. The Ivy Brain Tumor Center’s Phase 0 clinical trials program is the largest of its kind in the world and enables personalized care in a fraction of the time and cost associated with traditional drug development.Continue reading
iMetabolic Biopharma Corporation Announces Expansion of its Strategic OmniAb Antibody Discovery Partnership with Ligand Pharmaceuticals Accelerating iMetabolic’s iPlatform™ Technology and Pipeline Development
TEMPE, Ariz.–(BUSINESS WIRE)–iMetabolic Biopharma Corporation (iMBP) announces expansion of its strategic partnership relationship with Ligand Pharmaceuticals, building on an earlier alliance agreement initiated in 2018, giving access to Ligand’s OmniAb platform. Continue reading