Companies are being encouraged to become “early adopters” of the EU Clinical Trials Information System when it goes live in December 2021.

With coronavirus cases again on the rise in many European countries, members of two EU parliamentary committees asked industry representatives to explain why details of COVID-19 vaccine supply agreements are being kept under wraps.

Industry access to real world data for regulatory and market access purposes in Asia Pacific compares poorly with the US.

The UK regulator wants to be a “catalyst for change” in reducing regulatory burdens, saying that better regulation based on science is in everyone’s interest.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Congress should give FDA more flexibility to administer orphan designations, such as the ability to revoke designations later if the disease prevalence grows beyond the rare disease threshold.

Governor Cuomo will establish two panels, one examining safety and efficacy and another considering distribution and pricing, to advise the state on how to approach use of coronavirus vaccines once one is approved.

Letter from department’s general counsel responds to request from the company for a pre-enforcement advisory opinion. Despite the letter, Lilly maintains its ‘limited distribution program is fully consistent with applicable laws and regulations.’

Industry access to real world data for regulatory and market access purposes in Asia Pacific compares poorly with the US.

Effectiveness can be evaluated more quickly because researchers won’t have to wait for the second dose, company executive notes during briefing on the launch of the Phase III study.

Acquisition is based on the prospects for Immunomedics’ Trodelvy, but regulatory changes, manufacturing challenges, and research dynamics could upset even the best-laid plans.

InflaRx and Relief Therapeutics/NeuroRx are investigating potential new treatments for COVID-19-induced pneumonia and for coronavirus-related ARDS.

Acquisition is based on the prospects for Immunomedics’ Trodelvy, but regulatory changes, manufacturing challenges, and research dynamics could upset even the best-laid plans.

As CEO Erck touts that its COVID vaccine has the 'best data,' Novavax prepares to enter Phase III trials and inks deal with Serum Institute to boost production even as its 'almost a perfect flu vaccine' remains on hold.

Join Anju Ghangurde and Vibha Ravi in this recorded session from Informa Pharma Intelligence's recent 24-hour webinar series on COVID-19: Lessons Learned And A Path Forward.

US HHS turns to COVID-19 vaccine distributor to assemble vaccine administration kits, citing revised vaccine delivery schedule.

Officials from the US Food and Drug Administration cited their reasons for refusing to review new applications for companies with unresolved data integrity failures.

Stand-alone bill headed for Senate, where it fared poorly in coronavirus response legislative packages.