Selecting and managing the right CRO or CMO partner can make or break an early-stage company’s path to market. Join us for a practical, insight-packed webinar exploring how to evaluate, engage, and grow with outsourcing partners that align with your technical needs, regulatory goals, and growth plans.Continue reading
Category Archives: AZBio News
Roche granted FDA Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancer
- The VENTANA TROP2 (EPR20043) RxDx Device is an immunohistochemistry (IHC) assay combined with a digital pathology algorithm to determine patient treatment.
- The device uses artificial intelligence-based image analysis with a level of diagnostic precision not possible with traditional manual scoring methods.
- This Breakthrough Device Designation (BDD) demonstrates Roche’s continued innovation in companion diagnostics and digital pathology to enable more precise diagnosis in oncology.
Genetic Factors May Influence Liver Fat Even in Healthy Weight People
TGen Study improves our understanding of steatotic liver disease in an understudied population
The Sun Devil who revolutionized kitty litter
A pioneering chemist and educator, Barbara Munk left an indelible mark on household products and science education. Continue reading
Health Innovation Leaders Respond to the Executive Order on Most Favored Nations Pricing
On May 12, 2025, President Donald J. Trump signed Executive Order DELIVERING MOST-FAVORED-NATION PRESCRIPTION DRUG
PRICING TO AMERICAN PATIENTS that establishes a requirement for Most Favored Nations Prescription Drug Pricing.
Section 5 of the EO states: “Within 30 days of the date of this order, the Secretary shall, in coordination with the Assistant to the President for Domestic Policy, the Administrator for the Centers for Medicare and Medicaid Services, and other relevant executive department and agency (agency) officials, communicate most-favored-nation price targets to pharmaceutical manufacturers to bring prices for American patients in line with comparably developed nations.”
The intent is to obtain the lowest prices offered by drug companies in other wealthy countries, known as “most-favored-nation” (MFN) pricing, and to take action if those prices aren’t extended to Americans. It also calls for direct-to-consumer programs, drug importation from countries with lower costs, and antitrust enforcement against companies that block price competition.Continue reading
Responses to The Administration’s Section 232 Inquiry into Pharmaceutical Imports
“The Trump administration’s Section 232 inquiry into pharmaceutical imports represents a pivotal moment for the sector. Leaders in pharmaceutical supply chains must adjust and create solutions to maintain access to essential medications while responding to the changing trade environment.” — Srihari Rangarajan, EY Americas Life Sciences Supply Chain LeaderContinue reading
Critical Path Institute Celebrates 20 Years of Advancing Drug Development through Innovation and Collaboration
TUCSON, Ariz., May 8, 2025 — The year 2025 marks a historic milestone for Critical Path Institute® (C-Path), as the organization celebrates 20 years of transforming the landscape of drug development through collaboration, regulatory science, and next-generation strategies. Continue reading
Castle Biosciences to Acquire Previse
Expected to complement Castle’s current gastroenterology franchise
Adds methylation technology developed at the Johns Hopkins University School of Medicine and additional technologies in developmentContinue reading
PREVAIL Act Reintroduced The PREVAIL Act to Address
The Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act supports American inventors, encourages investments in intellectual property, secures U.S. global technology leadership, and safeguards both economic and national security.
“The PREVAIL Act will empower startups and small businesses by realigning the Patent Trial and Appeals Board with Congress’s original intent,” — Dr. Hans Sauer, Deputy General Counsel and Vice President for Intellectual Property, Biotechnology Innovation Organization (BIO).
CND Life Sciences Closes $13.5M Series A Equity Round to Continue Growth and Innovation in Neurodiagnostics
Latest Series A3 financing includes Labcorp, along with new and longtime investorsContinue reading