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FDA Issues New Approvals For Leukemia, Ovarian Cancer Medicines

KHN Morning Briefing

The Food and Drug Administration approves a new Pfizer drug to treat a rare, fast-progressing form of leukemia. The agency also expands the use Lynparza, sold by AstraZeneca and Merck & Co, to treat recurrent ovarian cancer. In other pharmaceutical news, changes to 340B program are delayed and a biopharma executive encounters challenges when trying to fund his own project.

Settlement Finalized Between Mylan, Feds Over Epipen Overcharges To Medicaid

KHN Morning Briefing

The $465 million settlement announced Thursday by the Department of Justice resolves claims that Mylan avoided paying rebates to the government by improperly classifying the EpiPen as a generic drug. Mylan and its auto-injector product have been at the center of the national debate over prescription drug costs.

House Democrats Push Pharmaceutical Companies To Explain High Costs Of MS Drugs

KHN Morning Briefing

Two Democratic lawmakers, Rep. Elijah Cummings of Maryland and Rep. Peter Welch of Vermont, are pressing Bayer, Biogen, EMD Serono, Novartis, Sanofi, Teva, and Roche Pharmaceuticals for an explanation of the pricing strategies and whether companies were increasing prices as part of a coordinated effort.

House Expected To Hold Hearings On ‘Right-To-Try’ Bill That Senator Tied To FDA Funding

KHN Morning Briefing

The Senate quickly passed the bill that would allow dying patients access to experimental drugs after Sen. Ron Johnson (R-Wis.) had threatened to slow down consideration of a separate bill to renew the FDA’s fee-collection authority. In other drug industry news, the FDA is implementing new rules about hiring foreign scientists, industry tightens controls to keep out counterfeit drugs, cancer trials are low on patients and costs of old drugs rising quickly for Medicaid.