Regulation

COVID vaccine booster decision hinges on sense of urgency

The outcome of Friday’s advisory committee meeting on Pfizer’s application for approval of a booster dose of its Comirnaty COVID-19 vaccine is likely to turn on the committee’s confidence in observational data from Israel, as...

Moderna argues for boosters while protection from severe disease is high

Moderna waded into the booster debate Wednesday, with new data from its Phase III COVE study showing increasing breakthrough infections with time from vaccination. However, given that protection against severe disease remained high, others might...

U.K. takes stepwise approach to COVID boosters

Preliminary data are guiding the U.K. to provide COVID-19 booster shots for the most vulnerable segment of the population first, while it waits for more data to decide on boosters for younger, healthier individuals. On...

Four lenses on accelerated approvals over time: Data Byte

FDA accelerated approvals are on the rise, in large part due to biomarker-defined drug development and strategic moves into new indications for cancer therapies.  And though most accelerated approvals...

Cancer leads way to routine use of accelerated approval: Data Byte

Accelerated approval is becoming the de facto route for approvals of new molecular entities in cancer. In three of the past five years, the number of new cancer drugs granted accelerated approval by FDA has outnumbered...

Most accelerated approvals gain full approval within five years: Data Byte

Contrary to the view that companies often do not attend to their postmarket commitments in a timely manner after an accelerated approval, an analysis published as part of BioCentury’s annual Back to School project found...

FDA turning conditional approvals to full faster than EMA: Data Byte

One of the major differences between FDA’s accelerated approval pathway and EMA’s conditional marketing authorization is that the latter requires annual reviews of companies’ progress on postmarketing commitments. While this suggests EMA’s system could do...

Spotlight on Back to School & FDA: a BioCentury podcast

On the latest BioCentury This Week podcast, BioCentury’s editors focus on the key takeaways from the 2021 Back to School package and discuss why they believe accelerated approval is poised for change. The editors also...

Stretching the vision of accelerated approval

There are two co-existing views of FDA’s accelerated approval pathway. It has been a grand success for cancer treatment, an area it has revolutionized. It has also been an underperformer, doing little...

Modifying access for accelerated approvals: a BioCentury Back to School podcast

The principle of accelerated approval hinges on the third part of the expedited pathway, where regulators, payers, companies and patients act on the evidence that’s generated in confirmatory trials. On...

China and Japan raise the bar on expedited approvals, adding time limits

China and Japan have taken the expedited drug approval pathways in the U.S. and Europe, and tightened one of the loosest provisions: the time taken to deliver data from the postmarket confirmatory trials....

MHRA seizes opportunity to reshape expedited approval

The U.K.’s exit from the EU has afforded its MHRA a fresh start in creating an expedited approval pathway that goes beyond what FDA or EMA can offer: integrating market access, clinical trial and...

Pricing the uncertainty in expedited therapies

Payment systems developed in an age dominated by small molecules for common chronic diseases are not up to the challenge of 21st century medicine. Drugs are increasingly being approved based on new mechanistic understanding of...

Regulatory rheostats key to meeting promise of expedited approvals

Mounting frustration with the accelerated approval process, brought to the public’s attention by the controversial decision on Biogen’s Aduhelm, is sparking debates inside and outside FDA about ways to...

Delivering the evidence for accelerated approval: a BioCentury Back to School podcast

Postmarket trials to support a therapy’s accelerated approval could become a launchpad for innovation rather than a rote exercise. In the third of four podcasts discussing this year’s Back to School package,...