Blog
RSS FeedPosted by Michael Wonder on 09 Jan 2024
Orphan drug label expansions: analysis of subsequent rare and common indication approvals
8 January 2024 - We found that 491 novel orphan drugs were approved between 1990 and 2022. ...
Posted by Michael Wonder on 08 Jan 2024
Novel drug approvals for 2023
8 January 2024 - Innovative drugs often mean new treatment options for patients and advances in health care for the American ...
Posted by Michael Wonder on 04 Jan 2024
2023 FDA approvals
2 January 2024 - The FDA’s Center for Drug Evaluation and Research approved 55 new drugs in 2023, as the small ...
Posted by Michael Wonder on 12 Dec 2023
FDA creates new advisory committee for evaluation of genetic metabolic disease treatments
12 December 2023 - Today, the US FDA announced it is creating a new advisory committee related to potential treatments for ...
Posted by Michael Wonder on 08 Dec 2023
Statement from President Joe Biden on FDA approval of gene therapies to treat sickle cell disease
8 December 2023 - As we’ve seen throughout our history, when the US Government invests in innovation, we can achieve breakthroughs ...
Posted by Michael Wonder on 07 Dec 2023
‘Learning each other’s language’: FDA, patent office seek to work together to lower drug prices
7 December 2023 - In 1997, Celgene obtained a key patent for what would become a blockbuster blood cancer treatment, ...
Posted by Michael Wonder on 20 Nov 2023
The FDA is at a crossroads on cell and gene therapies
20 November 2023 - Cell and gene therapies are the next frontier in medicine and promise long-sought hope for people ...
Posted by Michael Wonder on 16 Nov 2023
Data sharing a a new era for research funded by the US Government
15 November 2023 - In January 2023, the NIH implemented its new Data Management and Sharing Policy. ...
Posted by Michael Wonder on 15 Nov 2023
To get things done fast at FDA: ‘don’t tell anybody,’ cancer chief says
15 November 2023 - The FDA’s top cancer drug regulator doesn’t always ask for permission before taking on big initiatives. ...
Posted by Michael Wonder on 14 Nov 2023
Inequitable conduct and invalidation of patents related to FDA regulated products
13 November 2023 - Median brand name drug launch prices increased from $2,115 in 2008 to $180,007 in 2021. ...
Posted by Michael Wonder on 14 Nov 2023
Ancillary product patents to extend biologic patent life
13 November 2023 - In 2021, 46% ($260 billion) of all gross prescription drug spending in the US was on biologic ...
Posted by Michael Wonder on 09 Nov 2023
FDA’s Califf wants to get the public as excited about life expectancy as cures
8 November 2023 - It’s easy to get people worked up about cures, but they don’t seem to be bothered ...
Posted by Michael Wonder on 08 Nov 2023
FDA finalises guidance on real-time review of oncology drugs
7 November 2023 - The US FDA has finalised its guidance that outlines the eligibility and submission requirements for applicants interested ...
Posted by Michael Wonder on 04 Nov 2023
How should the FDA evaluate psychedelic medicine?
4 November 2023 - Drug companies are spending millions of dollars to incorporate psychedelic agents into health care. Working with ...
Posted by Michael Wonder on 02 Nov 2023
The FDA and Moderna’s cosy relationship: how lax rules enable a revolving door culture
1 November 2023 - After holding oversight roles for covid vaccines, two regulators from the US FDA went to work for ...