Schiff Hardin LLP advised Moleculin Biotech, Inc. in connection with its public offering of 16,414,736 shares of common stock for gross proceeds of approximately $78 million.
On December 23, 2020, Judge Catherine Blake of the US District Court for the District of Maryland put in place a 14-day restraining order while she considers whether to issue a preliminary injunction. She plans to consider whether the Centers for Medicare & Medicaid Services rulemaking was adequate
The White House released three Executive Orders on July 24, 2020 setting forth policies that the Administration believes will “deliver lower prescription drug prices to American patients.”
Join Jeff Blake, Managing Partner of Federal Compliance Solutions, and Stephanie Trunk, Health Care Partner at Arent Fox, for a Government Pricing & Pharmaceutical Reimbursement Office Hour.
A HHS Final Rule for Exchange plans states that coupons and copay cards offered directly by drug manufacturers can be counted towards a patient’s annual cost-sharing limit.
On May 12, the California Department of Consumer Affairs (DCA) issued an Order Waiving Restrictions on Pharmacists Ordering and Collecting Specimens for COVID-19 Tests, under the authority of California Governor Newsom’s March 30 Executive Order.
Stephanie Trunk will present during the ABA International Law Section’s 2020 virtual annual meeting. She will discuss how different jurisdictions address consumers’ demand for affordability of prescription drug and medical devices.
The U.S. Food and Drug Administration (FDA) issued a guidance document today outlining its procedures for conducting clinical trials of investigational products in view of the worldwide COVID-19 outbreak.
As the spread of COVID-19 accelerates across the United States, hospitals, health systems, and other providers face unique challenges. Arent Fox’s Health Care Group analyzes what you need to know about regulatory changes and guidance from the federal government.
The Centers for Medicare & Medicaid Services (CMS) announced a voluntary model within the Medicare Part D program that would allow certain Part D plans to cap Medicare beneficiaries’ out-of-pocket costs for insulin.
The First Circuit handed the generic pharmaceutical industry an early Valentine’s Day treat earlier this month by resuscitating an antitrust suit against Sanofi by direct purchasers of insulin glargine.
CMS issued an Interim Final Rule with comment period that further delays the inclusion of the US territories in the definitions of “States” and “United States” for purposes of the Medicaid Drug Rebate Program from April 1, 2020 until April 1, 2022.
Late Friday, September 27, 2019, President Trump signed the Fair and Accurate Medicaid Pricing Act into law as part of the Continuing Appropriations Act.