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California Gov. Jerry Brown (D) signed into law a bill that would allow companies, nonprofits and government agencies to purchase and maintain Mylan’s EpiPen for emergency use, while criticizing the company for the hiking the price of the allergy treatment. Read More
If Mylan wants to improve access to its emergency allergy treatment EpiPen, then the company should lower the price of the drug, instead of marketing a generic version, members of the House Committee on Oversight and Government Reform said Wednesday. Read More
The National Institutes of Health published a summary of the 240 comments received on a rule mandating that researchers post the results of their clinical trials on a public website. Read More
The Senate Finance Committee and West Virginia’s attorney general are requesting information on the rebates Mylan paid to Medicaid for its allergy treatment EpiPen, a day ahead of a hearing on the price of the combination product. Read More
Hebei Yuxing Bio-Engineering, a Chinese producer of active pharmaceutical ingredients, received a warning letter from the FDA citing significant cGMP and data integrity issues discovered at its manufacturing plant. Read More
Option Care Enterprises received a warning letter from the FDA due to deficiencies in the production of sterile drugs and infusion products at its facility in Everett, Wash. Read More
Several senators expressed doubts that the FDA should take on the regulation of tens of thousands of laboratory-developed tests currently being used across the country, during a committee hearing on the future of regulation in an age of precision medicine. Read More