In the first of a two-part article on transparency provisions for the new EU clinical trial portal, the Pink Sheet reports on aspects that sponsors must consider to protect commercially confidential information in their clinical trial applications. The second article will look at the approach taken by Merck and discuss outstanding hot topics in relation to transparency and CTIS.

EU and UK regulators are vying for vaccine filings, and the EMA will consider changing the terms of the marketing authorization for remdesivir after a WHO panel advised against its use in COVID-19. An Austrian biotech firm is investigating the prophylactic potential of a carrageenan-based spray.

Former acting Commissioner Josh Sharfstein argues that while agency officials have done a commendable job in overall communication on COVID vaccine development, more information is needed on the clinical holds.

Pfizer’s abrocitinib and Biogen/Eisai’s aducanumab are among a host of new investigational products that are under review by the European Medicines Agency.

Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.

Assurances from HHS Secretary Azar that rule will not significantly raise premiums and federal spending amount to a request to ‘just trust me.’

First group to receive vaccine would comprise health care personnel and residents of long-term care facilities; next in line are non-health care essential workers, who would take priority over adults with high-risk medical conditions and those ages 65 years and older, according to the CDC advisory committee’s proposed allocation framework.

Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated.

Increasingly looking to China to commercialize their latest therapies, multinationals may be leaping into unknown waters to navigate an intellectual property judiciary and administrative maze, in a country where some copy drugs have been approved before patent expiry. With a government trying to balance innovation and access, two recent rulings involving AstraZeneca shed rare light onto China’s protections for innovation, with advisors pointing to challenges and success factors.

Incoming US President may be wise to up government investment in COVID-19 therapeutics, including both research and manufacturing, experts say. Additional government funding should target a larger variety of treatment types and prioritize better study designs.

Strengthening regulatory partnerships and being ready to support the translation of disruptive innovations into the treatments of tomorrow are on the to-do list of incoming European Medicines Agency chief Emer Cooke.

Russia seeks WHO endorsement of its Sputnik V vaccine, a UK BioIndustry Association taskforce identifies potential new antibody cocktails, and the European Centre for Disease Prevention and Control considers the best strategies for targeted vaccination programs.

The price of the antibody monotherapy for COVID-19 will be $1,250 per vial for wealthy countries. CEO David Ricks outlined the company's guidelines for pricing and distributing a limited supply.

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.

Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated.

Perrigo, Pfizer want the US FDA to postpone its March 1 deadline for conducting nitrosamine risk assessments. Generics exec cites“serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.

Accelerated development of COVID-19 products prompts World Health Organization to revise a guideline on good manufacturing practices for investigational drugs and propose a new guideline applying GMP principles to R&D facilities.