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The Issue with Reissue: PTE Edition

The FDA Law Blog

Merck applied for a patent term extension on the reissued patent, claiming the start of the regulatory review period as April 2004 and termination at the approval of the BRIDION NDA in December 2015. With this long regulatory review period, the PTO granted the statutory-maximum five-year patent term extension. The plain text of 35 U.S.C.

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HHS' health IT office makeover may tip the scales in historic funding battle

Fierce Healthcare

The Department of Health and Human Services’ (HHS') technology office is poised to bring significant technological expertise to the department, which the Office of the National Coordinato | HHS tech policy office failed to receive consistent funding bumps from Congress since 2004. The recent revamp could change that.

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People with MND in England and Wales fear losing access to life-extending drug

The Guardian - Pharmaceutical Industry

Exclusive: NHS cost threshold has not been raised by National Institute for Health and Care Excellence since 2004 People with motor neurone disease have spoken of their devastation at a likely loss of access to a life-extending drug due to an NHS cost threshold that has not been raised since 2004.

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STAT+: Insitro, biotech AI’s quiet unicorn, unveils efforts in ALS, liver disease, and cancer at JPM

STAT

Insitro, a South San Francisco firm, was founded in 2018 by Daphne Koller, who had previously been a Stanford professor, a 2004 MacArthur “genius” grant recipient, and the co-founder and co-CEO of the online course company Coursera. But in biotech, one of the most well-funded AI players has been quiet.

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STAT+: U.K. pharma increasingly violates voluntary industry marketing codes, and probes are taking longer

STAT

Between 2004 to 2021, the Prescription Medicines Code of Practice Authority, a self-regulatory body overseen by the Association of the British Pharmaceutical Industry, ruled on more than 1,100 cases involving nearly 160 companies where there was a breach of the industry code. Moreover, such instances have occurred more frequently.

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Opinion: Long waits to see a doctor are a public health crisis

STAT

In 2004, the physician search firm Merritt Hawkins first issued their Survey of Physician Appointment Wait Times. That year, the national average wait to get in to see a new physician was 21 days, an unacceptable amount of time to wait to access care. But that number has only gotten worse.

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STAT+: Gilead gets a boost from California court in a case over slow-walking an HIV drug

STAT

Back in 2004, Gilead explained its decision by maintaining the medicines were not sufficiently different, but internal documents produced in court suggested the company made this move in order to maximize profits.