The National Academies of Sciences, Engineering, and Medicine recently released a discussion draft of a preliminary framework to assist policymakers in planning for equitable allocation of a COVID-19...
Today, CMS issued a proposed rule that would create a new, accelerated Medicare coverage process for innovative products that FDA deems “breakthrough,” including new implants or gene-based...
BioMarin Pharmaceuticals recently announced that FDA issued a complete response letter for the company’s biologics license application for a hemophilia A gene therapy.
In the complete response...
FDA announced yesterday that it issued an emergency use authorization (EUA) for investigational convalescent plasma as a COVID-19 treatment in hospitalized patients.
For more coronavirus updates,...
FDA recently approved Trevena Inc.’s Olinvyk (oliceridine), an opioid used to manage severe acute pain in adults who require an intravenous opioid and who have been unresponsive to alternative...
A bipartisan multistate coalition recently called on HHS, the National Institutes of Health (NIH), and FDA urging them to use their authority to increase the availability of remdesivir.
For more...
FDA recently announced that it is requiring label changes for opioid pain medicines and medicines used to treat opioid use disorder (OUD).
Updated labels for the prescription drugs will need to say,...
Among FDA approval packages for novel therapeutic agents from 2011 and 2015, disagreements were common over new drug approvals, populations indicated, and the specific parameters of the approval,...
Twenty-four members of Congress demand increased oversight and transparency of Operation Warp Speed vaccine development program in an official letter to HHS Secretary Alex Azar.
In the letter, the...
A coalition of 28 states and territories recently sued Mallinckrodt ARD LLC over accusations that the pharmaceutical company violated the False Claims Act and knowingly underpaid Medicaid drug rebates...
Pfizer and BioNTech were recently granted FDA Fast Track designation for two of the companies’ four investigational COVID-19 vaccine candidates from their BNT162 mRNA-based vaccine program,...
The German Pharmaceutical Market Restructuring Act (AMNOG) is an example of how a drug pricing strategy can be designed to better align prices with clinical benefit and is an approach the US can take...
The Justice Department announced that pharmaceutical company Novartis agreed to pay $642 million in two separate settlements to resolve healthcare fraud allegations involving False Claims Act (FCA)...
FDA recently issued guidance to assist sponsors with COVID-19 vaccine development development and licensure of their products. The guidance will be effective for the remainder of the public health...
Department of Justice (DOJ) recently charged Glenmark Pharmaceuticals Inc. for the it role in antitrust violations from May 2013 to December 2015.
The DOJ’s complaint alleged that the...
FDA is teaming up with the Critical Path Institute and National Center for Advancing Translational Sciences (NCATS) to launch the CURE Drug Repurposing Collaboratory (CDRC) to evaluate existing drugs...
A coalition of 51 attorney generals from around the US recently filed an antitrust complaint alleging that over two dozen drug manufacturers inflated the price of generic drugs illegally.
The...
Merck recently announced that the FDA approved a supplemental New Drug Application for Recarbrio, a drug targeting the source of some hospital-acquired infections.
Recarbrio is a combination of...
US taxpayers and the healthcare sector may save nearly $7 billion annually with a stronger, more competitive biosimilars market, which is a significant increase from the current annual cost-savings of...
The Department of Justice will soon decide whether to charge Teva Pharmaceuticals for an alleged healthcare fraud scheme to fix prices of certain generic medicines. But the company isn’t...
