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Rx Drugs

April 14, 2021 | Daily News

FDA, HHS and the American College of Obstetricians and Gynecologists on Tuesday (April 13) filed a joint motion with the U.S. Court of Appeals for the Fourth Circuit requesting the court put a hold on ACOG’s lawsuit against FDA in light of the agency’s recent decision to temporarily lift the in-person prescribing and dispensing requirements for abortion medication mifepristone.

April 13, 2021 | Daily News

All 50 states and several pharmacy retail chains have suspended use of Johnson & Johnson’s COVID-19 vaccine after FDA and the Centers for Disease Control and Prevention on Tuesday (April 13) recommended a pause after revealing that six women who received the shot experienced a rare blood clotting event known as cerebral venous sinus thrombosis (CVST).

April 13, 2021 | Daily News

Brand drug makers are now open to ending some patent-gaming industry practices, including “product hopping” and possibly “patent thicketing,” and rebating Medicare for Part B drugs, according to a legislative agenda released by the Pharmaceutical Research and Manufacturers of America Tuesday (April 13).

April 13, 2021 | Daily News

Brand drug makers are now open to ending some patent-gaming industry practices, including “product hopping” and possibly “patent thicketing,” and lowering Medicare reimbursement to doctors for administering drugs, according to a legislative agenda released by the Pharmaceutical Research and Manufacturers of America Tuesday (April 13).

April 13, 2021 | Daily News

Although the Congressional Progressive Caucus did not include extending the Affordable Care Act’s enhanced tax credits in its wish list for the next legislative package, a source familiar with the discussions says progressives do support making the American Rescue Package policies permanent -- but they want savings gleaned from drug-pricing reforms to go toward expanding public health programs and not just toward bolstering the ACA.

April 12, 2021 | Daily News

Acting FDA chief Janet Woodcock announced Monday (April 12) that Patrizia Cavazzoni will succeed her as permanent director of the agency’s drug center, leading some to speculate that Woodcock either expects to be nominated for the permanent FDA chief position or is contemplating retirement and wants to secure long-term leadership of the drug center.

April 12, 2021 | Daily News

A government-owned vaccine technology that could be used to develop universal flu vaccines is now available for licensing, the National Institutes of Health announced.

April 12, 2021 | Daily News

Researchers from academia and the federal government found a biochemical pathway they say might explain why COVID-19 is so difficult to treat, and they suggest that pairing antiviral drugs, such as remdesivir, with a Janus kinase inhibitor, such as ruxolitinib, might be more effective in treating the disease than monotherapy alone.

April 09, 2021 | Daily News

Pfizer and BioNTech on Friday (April 9) asked FDA to expand the emergency use authorization for their COVID-19 vaccine to include adolescents ages 12 to 15, coming a little more than a week after the companies announced that phase 3 data show the vaccine is 100% effective in preventing SARS-CoV-2 infection and induces a robust antibody response in that age group.

April 08, 2021 | Daily News

The Senate Finance Committee will hold confirmation hearings for CMS Administrator-nominee Chiquita Brooks-LaSure and Deputy HHS Secretary-nominee Andrea Palm on April 15, months after the Biden White House announced the appointments and as Democrats gear up for a potentially major health care overhaul.

April 08, 2021 | Daily News

In its latest guidance for the generic drug industry, FDA indicates that due to the backlog of onsite facility inspections, some generic drug makers might not be able to meet requirements for tentative approval for their drugs and as a result might not qualify for 180-day exclusivity, which raises questions about whether FDA will use its authority to disqualify companies from exclusivity, and if so, how the agency would decide which companies qualify and which don’t.

April 08, 2021 | Daily News

The American Hospital Association and the American Society of Health-System Pharmacists want to meet with FDA to make their case that insurer “white bagging” policies, which prevent hospitals from buying outpatient drugs from the specialty pharmacies of their choice, threaten supply chain security and pose safety risks to patients.

April 08, 2021 | Daily News

The National Pharmaceutical Council has named John O’Brien, a Trump-HHS point person on drug pricing, as its new president and CEO.

April 08, 2021 | Daily News

The Medicare Payment Advisory Commission unanimously voted in favor of draft recommendations to cover all preventive vaccines under Part B for free to beneficiaries.

April 08, 2021 | Daily News

The Government Accountability Office said the U.S. government doesn’t own patent rights to Gilead’s remdesivir, a coronavirus treatment for which HHS Secretary Xavier Becerra last year urged the government to break the patent when he was California attorney general.

April 06, 2021 | Daily News

The White House is expected to roll out the health care priorities for its two-part infrastructure package sometime this Spring, and the health piece potentially could move separately now that the Senate parliamentarian has agreed Democrats have another shot passing their priorities through a simple majority.

April 05, 2021 | Daily News

The global economic recovery will be aided by a stronger-than-expected rebound in global merchandise trade, the World Trade Organization said on Wednesday, but Director-General Ngozi Okonjo-Iweala warned the comeback remains uneven as vaccine distribution trails in significant swaths of the globe, urging countries to prioritize widespread vaccine access to ensure a strong, long-term recovery.

April 02, 2021 | Daily News

The U.S. Office of Special Counsel, an independent federal investigative agency, told President Joe Biden and key congressional committees that a credible whistleblower complaint shows FDA watered down troubling inspection findings in at least four instances at biologics plants in recent years, including at a Merck plant that now produces Johnson & Johnson vaccines.

April 02, 2021 | Daily News

FDA on Thursday (April 1) gave Moderna the greenlight to use a new multi-dose vial for its COVID-19 vaccine that can contain up to 15 doses. The agency also let health care providers know they can now extract up to 11 doses from currently available vials, an increase from the 10-dose limit.

April 01, 2021 | Daily News

HHS on Thursday (April 1) kicked off vaccine education and outreach efforts that include launching a Community Corps coalition comprising more than 275 community leaders and organizations nationwide that will work with the government to educate the public about vaccines, and running TV ads to encourage Americans to get vaccinated as soon as they’re eligible.

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