New guidance from the UK regulator covers distribution and deployment of Pfizer/BioNTech's COVID-19 vaccine, which will be complex because of the temperature storage requirements and the large packs in which the vaccine doses will be delivered.

The UK’s rapid authorization of the Pfizer/BioNTech COVID-19 vaccine has sparked a public debate over regulatory processes at some of the world’s key regulatory bodies.

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

ClinROs, artificial intelligence-based algorithms will be included in approval pathway. FDA is taking a crash course on new techniques for trial assessment thanks to COVID.

In second letter this year targeting email communications, OPDP says that putting the methotrexate oral solution’s risk information below the signature block does not offer ‘prominence and readability’ comparable to the information on the drug’s effectiveness for the treatment of acute lymphoblastic leukemia that was in the body of the email.

Timeline is the most pessimistic public projection to date, but still incredibly fast. Clinical trial patients on placebo could be contacted and offered the vaccine after an EUA is granted.

The German pricing and reimbursement system has been successful in recognizing the value and uniqueness of orphan drugs.

CMS acknowledges stakeholders may need more details about the plan before it is finalized and a delay will give the agency more time to ‘consider the issue.’

Canada has announced new restrictions on exports to help mitigate the impact of measures in the US to lower medicine prices there.

As vaccines near availability, Moncef Slaoui says his full-time role at OWS may be ending. He has not met with the Biden Transition team, but notes that other Warp Speed officials have.

With its US/Mexico Phase III trial delayed due to manufacturing questions, Novavax has aligned its UK study with FDA guidance. It hopes for interim data from that study during Q1 2021.

Russia says it will make the first deliveries of its $10-per-dose Sputnik V vaccine in January, while international regulators say vaccine trials should continue for as long as possible to generate longer-term evidence on their benefits and risks. A UK research body has stressed that drugs repurposed for COVID-19 also need to undergo thorough safety and efficacy testing as reports suggest the UK regulator could approve a vaccine within days.

Given its ever-growing role as a critical component of the global biopharma industry, you can’t afford not to be up to speed on Asia. This biweekly selection of insights from our experienced on-the-ground team will help.

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.

The US FDA tells manufacturers in two recent warning letters to get to the root cause of contamination problems and take a more proactive approach to cleaning and equipment maintenance.

With its US/Mexico Phase III trial delayed due to manufacturing questions, Novavax has aligned its UK study with FDA guidance. It hopes for interim data from that study during Q1 2021.

Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.