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Galectin’s NASH Phase III Trial Will Use Surrogate Measures Of Esophageal Varices

Other NASH registration trails have targeted fibrosis, but Galectin's mostly-resolved discussions with US FDA will allow the belapectin program to focus of signs and symptoms of the disease.

Liver & Hepatic Drug Approval Standards

Vaccine Development Challenges Include Extensive Quality Control, Sanofi's Loew Notes

Sanofi spends 70% of vaccine production on quality control, Sanofi Pasteur exec VP David Loew tells the Pink Sheet; company is working on next generation flu vaccines that may provide greater efficacy.

Vaccines Research & Development

Will Purdue Bankruptcy Filing Resolve 'Unrelenting Chaos' Of Opioid Litigation?

Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.

Legal Issues Policy

Purdue Nears Settlement Of Opioid Multidistrict Litigation, But State AGs Vow To Press On

Lead plaintiffs counsel have accepted Purdue's proposed settlement offer to resolve more than 2,000 opioid suits, but more than half of state attorneys general reject the proposal.

Legal Issues Policy

Novartis’ “Living Drugs”: Kymriah, Zolgensma – And Diovan?

Novartis is pioneering the new “living drugs” model. But its present financial performance benefits from regulatory problems that have beset generic competitors to a franchise written off for dead: the antihypertensive brand Diovan (valsartan).

Commercial Manufacturing

Sunset Begins For Roche's Herceptin As Amgen/Allergan Biosimilar Launches

Amgen and Allergan launched the first US biosimilar for Roche's Herceptinand the Swiss pharma's Avastin – at a 15% discount to the brand-name products' list prices. Infographic reviews Herceptin's past and its future competitors.

Biosimilars Launches
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