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Rx Drugs

February 26, 2020 | Daily News

Senate appropriators on Tuesday (Feb. 25) grilled HHS Secretary Alex Azar on whether the White House’s $2.5 billion supplemental funding request is enough to respond to the coronavirus outbreak and to beef up the U.S. supply of masks, ventilators and other personal protective equipment given other cuts sought by the White House.

February 26, 2020 | Daily News

Sanofi’s plans to open up a new company in Europe focused on making and marketing active pharmaceutical ingredients to third-party drug manufacturers would be a boon to the pharmaceutical supply chain and make it less susceptible to region-specific challenges, according to Michael Ganio, director of pharmacy, practice and quality at the American Society of Health-System Pharmacists.

February 26, 2020 | Daily News

Days before HHS requested $2.5 billion from Congress to develop drugs and equipment for the coronavirus response, a group of 46 House Democrats cautioned the administration against awarding companies exclusive licenses for coronavirus drugs invented with taxpayer money, and they said the administration “must use every tool of the federal government to ensure a coronavirus vaccine is affordable and accessible.”  

February 24, 2020 | Daily News

Large employers continue to telegraph their frustration with drug and hospital prices in yet another report that shows an openness to price controls and government interventions that would have been anathema in previous years.

February 24, 2020 | Daily News

FDA on Friday (Feb. 21) sent a final competitive generic guidance to the White House budget office.

February 24, 2020 | Daily News

The White House budget office is reviewing a final FDA guidance that clarifies how the agency interprets a biosimilar law provision that deems certain biologics previously approved under drug law to be licensed at biologics starting on March 23.

February 24, 2020 | Daily News

The Center for Science in the Public Interest wants FDA and the Federal Trade Commission to “take swift enforcement action” against televangelist Jim Bakker, who on his show has promoted sales of a silver-based product and claimed it can prevent and treat myriad illnesses, including coronavirus.

February 24, 2020 | Daily News

Medicaid managed care plans negotiate prescription drug costs and encourage the use of generics more than traditional Medicaid, driving down net costs per prescription, according to a study by The Menges Group and that was put together for America’s Health Insurance Plans.

February 20, 2020 | Daily News

FDA on Thursday (Feb. 20) finalized its rule that brings the agency’s definition of a biological product in line with the definition under the Biologics Price Competition and Innovation Act, and that formally establishes the agency’s interpretation of what’s considered a protein.

February 20, 2020 | Daily News

For the first time in the history of Medicare Part D, generic drugs make up a bigger share of non-preferred formulary tiers where they cost more, which discourages consumers from choosing generics, according to a new analysis from Avalere.

February 20, 2020 | Daily News

A group of 20 organizations comprising pharmacists, health insurers and the biosimilars lobby group call on FDA to extend its streamlined approach on insulin interchangeability to other biosimilar and interchangeable products.

February 20, 2020 | Daily News

A U.S. district court judge will let drug maker Lannett intervene in Genus Lifesciences’ lawsuit against FDA in which the company argues the agency violated Hatch-Waxman by reviewing and approving Lannett’s cocaine hydrochloride nasal solution, Numbrino, even after Genus had obtained exclusivity on its own cocaine hydrochloride solution, Goprelto.

February 19, 2020 | Daily News

The White House budget office on Tuesday (Feb. 18) completed its review of FDA’s final rule that will bring the agency’s definition of a biologic in line with the definition under the Biologics Price Competition and Innovation Act.

February 18, 2020 | Daily News

Sen. Joni Ernst (IA) is the latest Republican to support bipartisan drug pricing legislation by fellow Iowan and Senate Finance Committee Chair Chuck Grassley (R), bringing the number of Senate Republicans who support the bill to 12.

February 18, 2020 | Daily News

FDA, the Government of India and U.S Customs and Border Protection stopped nearly 500 shipments of unapproved illicit drugs as part of a bilateral enforcement program known as Operation Broadsword.

February 14, 2020 | Daily News

Changes to the Senate Finance drug pricing bill already have been made and the Congressional Budget Office is estimating the revisions’ impact on the budget, but Senate Finance Committee Chair Chuck Grassley remained mum on those changes Thursday (Feb. 13).

February 13, 2020 | Daily News

Countering HHS Secretary Alex Azar’s statements Thursday (Feb. 13), a senior administration official insisted that the 2021 White House budget request does not endorse the Senate Finance Committee’s drug pricing bill.

February 13, 2020 | Daily News

The Center for American Progress is recommending several policies to help states cut drug costs, but it is not enthusiastic about drug imports.

February 13, 2020 | Daily News

In March, FDA’s newly established Controlled Substances Program will launch its Opioid Data Warehouse, which will allow the agency to integrate diverse data sources and enhance data analysis to pinpoint trends and new developments in the opioid crisis, FDA Deputy Center Director for Regulatory Programs Doug Throckmorton said Wednesday (Feb. 12).

February 12, 2020 | Daily News

If the coronavirus epidemic continues to spread in China, the United States will begin to see shortages of drugs and medical supplies, former FDA chief Scott Gottlieb warned lawmakers during a Senate Homeland Security and Governmental Affairs Committee roundtable meeting Wednesday (Feb. 12).

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