The CMS rule the establishes a new coverage pathway – MCIT – for breakthrough medical technologies.
Category Archives: AZBio News
Regenesis Biomedical Names Tom Eisiminger, Jr., Chief Executive Officer
Former Vice President of Sales to focus on key value driversContinue reading
Roche launches two digital pathology image analysis algorithms for precision patient diagnosis in breast cancer
- uPath HER2 (4B5) image analysis and uPath Dual ISH image analysis aid pathologists in providing faster, more accurate patient diagnoses in breast cancer
- In combination with the VENTANA DP 200 slide scanner and Roche uPath enterprise software, the new algorithms provide innovative digital pathology solutions to advance personalised healthcare
- Nearly 2.1 million new cases of breast cancer are diagnosed worldwide each year.1 About 15 to 20 percent of women diagnosed with breast cancer are HER2 positive.2
State, Partners Opening 24/7 COVID-19 Vaccination Site At State Farm Stadium
Operation Expands Availability With More Arizonans Prioritized For VaccineContinue reading
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.