Policy
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
FEATURED STORIES
The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
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Although there is some slowdown as the FDA moves into the holiday season in late November and into December, there are still upcoming target action dates. Here’s a look at this week’s PDUFA dates.
It was 36 years ago when Food and Drug Administration (FDA) approved Eli Lilly and Company’s Humulin, the first human Recombinant insulin for diabetes treatment.
MAPS is testing MDMA in a Phase III trial and hopes to seek regulatory approval by 2021.
Alkermes now faces a difficult uphill battle to gain regulatory approval for ALKS-5461 as a treatment for MDD.
The U.S. Food and Drug Administration issued a voluntary recall of a medication to treat high blood pressure due to trace amounts of a carcinogen being found within some lots of the drug.
The U.S. Food and Drug Administration (FDA) gave the green light to Hyrimoz, a biosimilar to AbbVie’s blockbuster drug Humira, five years ahead of the time it can be launched in U.S. markets.
The U.S. Food and Drug Administration (FDA) and Department of Homeland Security (DHS) are celebrating National Cybersecurity Awareness Month by announcing a strengthened partnership to buff up medical device cybersecurity, increasing communication and coordination between the two agencies.
Noting advances in genetic manipulation and gene editing, the Food and Drug Administration announced a new Plant and Animal Biotechnology Innovation Action Plan.
To suggest that the pharma industry is a reluctant partner in President Donald Trump’s attempts to decrease drug prices is to overstate the fact. But now the industry appears to be pushing back, at least a little bit.
One of the drugs being discussed this week by a U.S. Food and Drug Administration advisory committee is Waltham, Mass.-based Alkermes’ ALKS-5461. The drug itself has some controversy.