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.

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.

China releases technical requirements for foreign drug makers to register their chemical drugs in the country, and issues patent linkage details, which a legal expert says needs to be closely examined.

The possibility, which seems driven by the culture of the times, may be legally possible, but experts raised many practical concerns.

The Canadian authorities have put in place an expedited pathway for authorizing new COVID-19 drugs and vaccines that offers a more agile approach to reviewing data than what was previously allowed.

The UK medicines regulator has a “unique opportunity” to evaluate the systems it operates and to “do things differently", according to its long-term interim head, June Raine.

In sign of how much has changed in four years, industry might be better off if Biden takes CAP’s advice and launches ‘march-in’ actions to address pricing of COVID products.

Center for American Progress suggests pricing reforms for the 'next Administration' in lieu of legislation.

While neither party is likely to make any big policy changes this year, the action from both sides of the aisle indicates politicians still see going after pharma as a winning issue with voters even as polls show voters are focused elsewhere. 

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.