While FDA chief Stephen Hahn scrambled to make the difficult case that the FDA will stay on the straight and narrow scientific path in reviewing vaccines for wide public use against the pandemic, President Trump has laid down his own timeline and issued marching orders the agency will be hard pressed to ignore.

And he’s clearly leaving the door open to a snap OK ahead of the election.

On Thursday night, Trump used his national speech accepting the Republican nomination for a second term to promise the American people a “safe and effective” vaccine within 4 months.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

Mark October 22 on your calendars if you want to watch the next big controversy over the rapid-fire development of Covid-19 vaccines play out at the FDA.

Embattled FDA commissioner Stephen Hahn was back on Twitter Wednesday, offering assurances and spotlighting the virtual session being planned by the vaccine advisory board, and he’s clearly ready to lay out all the Covid-19 data available — 12 days ahead of the election.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

Once the pandemic erupted in the US, Big Pharma enjoyed a brief period of detente — if not actually warm relations — with the Trump administration.

After years of criticizing high drug prices and threatening legislation that would curb the industry’s pricing freedom, the president warmly encouraged the industry’s commitment to a pell mell race to new vaccines and drugs to fight Covid-19 — often at speeds that would have been considered impossible back in January. And it raised the possibility that biopharma could finally find a way to achieve some kind of popularity after years of public toxicity.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

By all accounts, AbbVie holds the title as a master builder of patent walls. Its work on Humira has been both legendary and extraordinarily controversial, encircling a cash cow that can be milked without any generic rivals butting in until 2023 — as new and better drugs come along to outperform the copycats to come.

And now a group of patient advocates at I-MAK say AbbVie is deep into building its second high security patent perimeter around Imbruvica — the next Humira in the AbbVie portfolio.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN