They may have a good shot at passage given recent actions by President Biden and the Federal Trade Commission, and bipartisan interest in drug pricing. 

As Democrats in the US Congress work to move legislation empowering the Health and Human Services Department to negotiate drug prices directly with manufacturers, the Center For American Progress releases an analysis on which drugs would be targeted by House bill HR 3 and how much prices could be reduced.

Reimbursement, health policy and medical experts predicted a slow rollout ahead for Biogen's new Alzheimer's treatment at a public meeting sponsored by ICER.

The policies have long been Democratic priorities, but of the three, the order’s implicit support for march-in rights might lead to the biggest change.

South Korea is stepping on the gas to develop its own mRNA COVID-19 vaccine and eventually next generation mRNA platform technology for use in other diseases, to meet its goal of becoming a global vaccine hub.

NIH director Francis Collins and former FDA commissioner Margaret Hamburg outline learnings from the COVID-19 pandemic and what needs to be done next amid concerns around the dangerous Delta and also Lambda variants. They also discuss the role of the WHO, which has “many masters to try and satisfy.”

Biocon is awaiting a scheduled FDA pre-approval inspection for insulin aspart at its facility in Malaysia, amid concerns that the surge in COVID-19 cases in the Southeast Asian nation may cloud timelines. The Indian firm is also pursuing a mutual recognition agreement route with the agency for a generic product approval.

Comirnaty and Spikevax to get EU label update on cardiac safety, Japanese filing for REGEN-COV, plus vaccine progress for ReiThera and Genexine.

US regulators indicate that authorizing booster shots is not a priority - but Pfizer still plans to seek an EUA in the fall.

While Opdivo’s first-line approval has altered the treatment landscape, Keytruda may expand its presence there in the next few years with new indications.

This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.

Lilly said it will seek accelerated approval in the US based on Phase II data for its amyloid-clearing antibody, potentially narrowing Biogen/Eisai’s newly approved therapy Aduhelm’s time on the market as the only disease-modifying Alzheimer’s drug.