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Judge Jackson’s Patent, FDA Rulings Show She Is ‘Super Smart’ And Would Be Beneficial For Pharma

 
• By Brenda Sandburg

Supreme Court nominee issued three decisions on Hatch-Waxman regime as district court judge, including case in which she ruled against the FDA’s denial of orphan drug designation and another in which she deferred to the agency’s view on exclusivity. Her analysis of facts may play a role if the court takes up a case on administrative agency deference.

Ketanji Brown Jackson
Supreme Court nominee Ketanji Brown Jackson has track record deciding patent cases • Source: Alamy

While pharmaceutical-related cases that go before the US Supreme Court do not fall along the ideological divide, there is one issue on which Ketanji Brown Jackson’s appointment to the court may be a factor: whether administrative agencies should be given deference when laws are ambiguous.

As US District Judge on the US District Court for the District of Columbia, Jackson issued two decisions in cases that challenged the US Food and Drug Administration’s interpretation of the statute governing eligibility for market exclusivity

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HHS Secretary Kennedy Says Trump Will Make Final Decision On Mifepristone Policy

 
• By Derrick Gingery

With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.

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• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

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EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

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Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
• By Eliza Slawther

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
• By Sue Sutter and Derrick Gingery

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