A Biden Administration with near-term priorities other than drug pricing and a Republican-controlled Senate dedicated to blocking any legislation that would enact government price controls is a relatively positive outcome for industry.

Worst case scenario is civil unrest that might disrupt clinical trials and manufacturing. Under a more moderate scenario, companies must delay business planning because the US policy environment remains cloudy.

The global health crisis has presented a chance for the industry to improve its reputation by highlighting the value of its R&D engines. Pharma execs and observers talk to Scrip about why they are optimistic about industry’s chance to regain public trust.

Mylan’s proposed $12bn combination with Pfizer’s Upjohn unit is expected to close next month following a settlement agreement with the FTC, with a requirement to address competition concerns in ten markets. The FTC was however strongly divided on the deal, with dissenters labelling the directives of the Commission as “deeply flawed, favoring routine over rigor.”

The industry-backed investment fund to combat antimicrobial resistance hopes to be operational by end of year and begin assessing programs to invest in during the first quarter of 2021.

Trump receives Regeneron’s experimental antibody under FDA’s expanded access program, Gilead’s remdesivir and dexamethasone. The president’s treatment choices could influence clinical trials of all COVID-19 medicines and even trial recruitment for other diseases, experts said.

Bristol Myers Squibb confirmed that approval for lisocabtagene maraleucel (liso-cel) will be delayed by the US FDA’s COVID-19-related restrictions on travel for manufacturing facility inspectors.

Adamis got its second complete response letter for Zimhi. While not apparently related to the first, it may complicate the company's outlook following a lackluster quarter.

Worst case scenario is civil unrest that might disrupt clinical trials and manufacturing. Under a more moderate scenario, companies must delay business planning because the US policy environment remains cloudy.

From efficacy endpoints to patient warehousing, US FDA advisors weigh in on vaccine development and regulatory review.

Purdue pleads guilty to three felony charges over marketing of OxyContin under settlement that requires Purdue to be dissolved and transformed into an entity that provides addiction and overdose medicines. Twenty-five state AGs oppose creation of a PBC, arguing Purdue should be sold to another company.

The UK backs the world's first COVID-19 human challenge studies to accelerate research – though the first results will not be ready until mid-2021.