Blogs

A new report from the EMA and EUnetHTA shows a shift towards a more efficient form of collaboration.

Biopharma companies’ efforts to promote “vaccine equity” and “dose sharing” also aim to limit challenges to international patent protections.

FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle.

Conclusions from the Global Health Summit provide plenty of support for research, innovation, investment, and incentivization.

A major international collaboration within ICH features big hitters from across the world's major regulatory authorities and drug firms

FDA has responded to pressures for quick and reliable processes with multiple guidance documents and policy initiatives for updating the clinical research process.

FDA expects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel imposed by the COVID-19 pandemic.

The drive for “vaccine equity” around the world is bolstering efforts to limit patent protections on innovative medicines and vaccines to combat the global pandemic.

The EU Cancer Research Summit sparked powerful support for personalized and precision medicine across three specific areas of research: translational, clinical, and outcomes.

To derive the greatest benefits from eCOA technology, several elements must work together to create a strong foundation for sponsor success.

Bari Kowal, Senior Vice President, Head Development Operations & Portfolio Management at Regeneron, discusses her experiences about how Regeneron rapidly and successfully developed a therapy to treat COVID-19.

Pressure mounts in Brussels as calls for new ways to debate pharma policies come from all directions.

Sponsors ignoring FDA requirements will now face stricter penalties.

White House’s summary of “topline” funding requests this month continues efforts to combat coronavirus pandemic and to restore the nation’s economic health.

FDA officials have taken the unusual step of issuing the closeout report (form 483) on its just-completed re-inspection of Emergent BioSolutions’ Baltimore manufacturing facility.

Just two weeks after instructing Johnson & Johnson to take over operations at Emergent BioSolution’s noncompliant Baltimore manufacturing operation, FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant.

Parliament's health committee is answering calls for a firmer grip on policies affecting the well-being of its 450 million citizens.

FDA is halting enforcement of a policy that limits prescribing and dispensing of Mifeprex (mifepristone), a widely used drug to induce a medical abortion in the very early stages of pregnancy.

European Group on Ethics in Science and New Technologies issues cautious opinion on the use of gene editing amidst COVID vaccination controversy.

FDA acting commissioner Janet Woodcock announced that Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research (CDER), shifting from her role as acting director since last spring.

A picture of wide manufacturing violations appears in a recently disclosed FDA form 483 report on a site visit to Emergent’s Baltimore vaccine plant.

Updated programs supporting the development and review of prescription medicines are being readied for approval by federal agencies and ultimately by Congress

A look at the issues in Europe affecting ongoing trials including data management, measures being taken by sponsors, and more.

New American Jobs Plan set to be funded by corporate taxes will affect biopharma industry.

Lan Fong, Founder and Principal Consultant at Avery Biopharma Consulting and Venture Partner at Congress Avenue Ventures, discusses her perspective on how the pandemic is shifting the clinical trials industry.

Rate of adoption in Europe for advanced diagnostics is falling behind that of others' globally.