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Crestor Generics To Launch After 12-Day Delay

 
• By Brenda Sandburg

AstraZeneca's legal gambit results in almost two more weeks of sales for the statin even though the court ultimately agreed with FDA on labeling carve-out for orphan indication.

court house

AstraZeneca Pharmaceuticals LP struck out in its attempt to use a new pediatric orphan indication for Crestor (rosuvastatin) to block generic competition for seven more years. But the company was able to delay the launch of generic versions of the cholesterol-lowering blockbuster for 12 days, garnering it tens of millions of dollars in revenue.

On July 19, Judge Randolph Moss, of the U.S. District Court for the District of Columbia, denied AstraZeneca's motion for...

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EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.

Aurobindo, MSN Fail To Beat US Nuplazid Patent Expiring In August 2038

 
• By Dean Rudge

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.

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• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
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Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.

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Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

Infographic: Leqembi – A Geographical Comparison

 
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EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.