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Mallinckrodt PLC

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Latest From Mallinckrodt PLC

Mallinckrodt’s Phase III Kidney Failure Trial Hits Primary Endpoint

The data position Mallinckrodt to file for US FDA approval of terlipressin early next year. Mallinckrodt thinks the drug could generate sales of $300m a year, helping it to mitigate its challenges.

Clinical Trials Companies

Deal Watch: Aevi Options AstraZeneca Antibody For Rare Disease

Aevi needs to raise funds first, but hopes to develop MEDI2338 for adult-onset Still’s disease. Also, Alnylam plans to leverage Ironwood’s GI expertise for givosiran in acute hepatic porphyria and Ultragenyx snags option to buy GeneTx.
Deals M & A

Opioid Blister Packs Need Study Before Mandate, Groups Urge

AAM, Upsher-Smith, APhA, and Cigna tell US FDA that packaging requirement will increase manufacturing and drug costs, create reimbursement hurdles and reduce access to medicines. Daiichi-Sankyo supports agency's proposal.

Drug Safety Neurology

Opioid Exposure Risk Intensifying For Generic Drug Makers

Business fundamentals took a back seat to opioid litigation in the second quarter for generic drug makers, including Teva, Mallinckrodt and Endo Pharmaceuticals.

Generic Drugs Legal Issues
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