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Opioid Industry's 'Superstructure' Targeted By State Attorneys General

 
• By Brenda Sandburg

Janssen, Teva, Allergan, Endo, and Purdue – as well as several distributors – pursued in multistate investigation that follows individual AG inquiries and flurry of state, city, and county suits.

Hydrocodone prescription bottle. Hydrocodone is a generic medication name and label was created by photographer.

State attorneys general are expanding their investigation of opioid makers and distributors, intensifying the pressure on companies to change their sales and marketing practices.

At a Sept. 19 news conference, New York Attorney General Eric Schneiderman announced that a bipartisan coalition of 41 attorneys...

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Court Allows MSN Marketing Of Entresto Generic, But More Legal Issues Pending

 
• By Dean Rudge

Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.

Repurposed Generics For Rare Diseases: Janet Woodcock Proposes Shortcut

 
• By Grace Moser

A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.

‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents

 
• By Urtė Fultinavičiūtė

Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

The Politics Of Divisionals: How European Patentees Are Still Gaming The System

 
• By Dave Wallace

At Medicines for Europe’s legal affairs conference last month, divisional patents were once again a major subject of discussion. Attendees heard fresh details of how patentee games are preventing generics from hitting the market and restricting wider access to major medicines.

More from Pink Sheet

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

AI In Clinical Research: Benefits Across The Board, But ‘Nirvana’ Still Out Of Reach

 
• By Vibha Sharma

Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.

Japan Gives Global-First Recommendations To Taisho’s Vornorexant, Santen’s Sepetaprost

 
• By Lisa Takagi

Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.