After months of delay and suspense, in a Rose Garden ceremony, President Trump and HHS Secretary Alex Azar announced a comprehensive approach to prescription drugs, which they claimed would address major challenges.
The CEO of Ovid Therapeutics, Jeremy Levin, feels no time has ever been better for biopharma leaders to speak out as part of their commitment to this industry.
An in-depth look at J&J’s QuickFire Challenge program and how some of the winners have benefitted (and grown) beyond the cash grants.
Many private biotech companies have either initiated the process of going public or are at least contemplating it. But they should be aware of very significant pitfalls that lie in wait, regardless of how they approach the offering.
Results of a survey asking interviewees about their preferred category of CMO for a certain type of outsourced manufacturing work — full-service CDMOs with end-to-end capabilities or specialty contract manufacturers with expertise in particular areas of need.
Generation Bio made its official debut in January 2018 after operating under-the-radar for over one year with $25 million in Series A financing from Atlas Venture. While in stealth mode, the company conducted the proof-of-concept studies on its gene therapy approach that would attract $100 million in Series B financing from new investors.
Three biopharmaceutical key opinion leaders envision the future of manufacturing in 2028 and beyond.
George Yancopoulos, M.D., Ph.D., president and chief scientific officer at Regeneron Pharmaceuticals, shares thoughts on “blue sky” research, and the important role it plays in remaining a productive R&D innovation engine.
Three biopharmaceutical manufacturing executives provide perspective on what emerging innovations could impact manufacturing within the next few years.
Six biopharmaceutical industry key opinion leaders reveal what manufacturing trends they find most exciting and why.
Enforcement of failures in data integrity and data governance began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions. While the FDA is not the only health authority that identifies these issues in inspections and enforcement actions, its transparency ensures the data is available.
At the BIO-Europe Spring Conference in Amsterdam in March 2018, CRA hosted a special program where attendees from biotech, Big Pharma, healthcare provider/payer groups, and patient associations were asked to share their views on pricing strategies for innovative medicine, including cell and gene therapies. More than 60 attendees responded to a series of questions about drug pricing, with a focus on cell and gene therapies, and their responses were captured live through an instantaneous voting system during a panel session.
The industry will see a mixture of new emerging trends and an evolution of historical trends heavily influenced by technology innovation and AI. The next year promises to be an exciting one that will strengthen the position of some existing leaders and elevate some new companies focused on building forward-looking platforms that will deliver future innovation and growth.
This two-part article explores the use of various tools and the emergence of intelligent solutions in the industry.The first part provides an overview of how technological advancements and data analytics are critical in enabling regulators and the life sciences industry.
While hospital drug expenditures represent a substantial market for the pharmaceutical industry, manufacturers face an increasingly complicated market environment.
In my previous article, I argued that biosimilar companies must engage states as partners for successful U.S. market access. This article accepts that premise and also assumes interchangeability will occur at the federal level. My goal is to provide insights, along with several solutions for biosimilar companies to engage local politicians and patients in a manner that is mutually beneficial. This analysis is based on reading and assessing all 38 of the local statutes addressing biosimilars and my prior experience proposing statutes for local legislatures.
Lupus is a complicated imbalance of the immune system with a spectrum of manifestations that vary from patient to patient and may change in the same person over time. This complexity makes treatment development challenging.
The EU’s General Data Protection Regulation (GDPR) will go into full effect on May 25, 2018 — as will penalties for non-compliance. While most of the GDPR affects the back end of medical device data handling, the Cloud, Databases, and transportation of data, some of the GDPR affects software on medical devices themselves:
