Biden Administration seeks to put its stamp on a new phase of the US government’s collaboration with the pharma industry against COVID-19.

The CDC panel’s mandate is to make recommendations for each specific vaccine brought forward, not ‘comparing two, three or four vaccines, and coming up with specific recommendations for each one independent of the other,’ chairman Jose Romero says as ACIP recommends use of Janssen’s COVID-19 vaccine under EUA.

A strong year is predicted for biopharma business with investment and deal making set to continue apace. Executives across industry share their forecasts for the year ahead.

Executives share their expectations and hopes around the multi-faceted topic of patient access to medicines. From health inequities to value assessment and reimbursement trends, expectations for change abound.

Daily round-up from the virtual J.P. Morgan Healthcare Conference: Novartis explains its PD-1 deal; Biogen partners with Apple; Sanofi and Merck discuss business development priorities; and why AbbVie is confident it can grow without relying on deals. 

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.

The FDA’s rejection of Acadia’s label expansion into a broader patient population for its only approved drug resulted in an aggrieved reaction. Better disclosure from both sides would have helped.

The long-running Mediator saga reached a conclusion of sorts on 29 March when fines and sentences were handed out to those involved in delaying the withdrawal of a fenfluramine derivative that is thought to have caused many thousands of serious cardiac side-effects.

The expansion of upadacitinib for a new indication in psoriatic arthritis has been pushed out three months to late in the second quarter.

Antitrust regulators in the US, Europe and elsewhere say they will now collaborate on how to best assess pharmaceutical mergers, in a move that could restrict deals on grounds they excessively raise prices paid by consumers or dampen medical innovation. 

The US FDA has asked Soleno to conduct another Phase III Study evaluating its chief asset in Prader-Willi syndrome patients prior to any NDA submission, rattling investors and clouding the company’s prospects.

A round up of COVID-19 developments, including the CDC advising that it is "prudent" to start testing variant vaccines in case the South African B.1.351 strain gains a foothold in the US.