FDA Final Guidance on Demonstrating Biosimilar Interchangeability
The FDA issued a final guidance on the pathway for interchangeable biosimilar drugs. The guidance is intended to assist sponsors…
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June 2019
McKesson Settles West Virginia Opioid Distribution Lawsuit, But the…
McKesson Corporation agreed to pay $37 million to settle a lawsuit by the state of West Virginia alleging that McKesson willfully…
Rockpointe Study Quantifies Impact of CME on AFib Treatment, Prompts New…
A recent study by Rockpointe demonstrated the value of CME to atrial fibrillation (AFib) patients and the physicians who treat…
Biopharma Executives Answer Senate Finance Committee Questions on Policies…
During the Senate Finance Committee hearing earlier this year addressing Drug Pricing in America, the committee posed questions to…
House E&C Panel Republicans Push Back on Drug Transparency Bills
The House Energy and Commerce Health Subcommittee held a hearing on improving drug pricing transparency and lowering prices for…
CMS Announces Medicare Part D Final Rule Maintaining Current Policy on Six…
The Centers for Medicare and Medicaid Services (“CMS”) announced a final rule maintaining the existing policy on coverage of drugs…
Minnesota Supreme Court Expands Medical Malpractice Liability Outside of…
The Minnesota Supreme Court issued an opinion in Warren v. Dinter. At issue was whether a physician-patient relationship is a…
ACCME Publishes Responses to Its January 2019 Call for Feedback
In January 2019, the Accreditation Council for Continuing Medical Education (ACCME) issued a call for feedback to review the rules…
CMS Announces Medicare Part B Final Rule Permitting Step Therapy on New…
The Centers for Medicare and Medicaid Services (“CMS”) announced a final rule permitting Medicare Part B plans, including those…
Open Payments Annual Report to Congress Shows Fourth Straight Year of $8…
The Centers for Medicare & Medicaid Services recently published its Annual Report to Congress on the Open Payments Program.…