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Rx Drugs

July 13, 2020 | Daily News

Operation Warp Speed and the National Institutes of Health have developed two master protocols for COVID-19 monoclonal antibody clinical trials, FDA drug center director Janet Woodcock told reporters on a press call Monday (July 13).

July 13, 2020 | Daily News

A Maryland federal court on Monday (July 13) temporarily prohibited FDA from enforcing certain in-person prescribing and dispensing requirements for the abortion drug mifepristone.

July 10, 2020 | Daily News

HHS Secretary Alex Azar on Thursday (July 9) said the United States wants to make sure any vaccines it has invested in will be manufactured and distributed domestically to avoid relying on other countries.

July 10, 2020 | Daily News

Former FDA chief Margaret Hamburg on Thursday (July 9) cautioned against allowing political pressure and wishful thinking to stand in the way of answering critical questions about whether COVID-19 vaccines and therapies are actually effective and safe.

July 09, 2020 | Daily News

Big brand-drug executives announced Thursday (July 9) that they’ve created a $1 billion fund to help small- to mid-sized companies develop breakthrough antibiotics because, they said, the market is broken and resistance to existing antibiotics is growing.

July 09, 2020 | Daily News

FDA biologics center director Peter Marks said the agency hasn’t ruled out letting sponsors conduct human challenge trials for COVID-19 vaccines.

July 09, 2020 | Daily News

Regulatory experts say drug and medical device makers want more clarification about FDA’s view on decentralized clinical trials and how new flexible trial policies, including options for remote visits and monitoring, will be applied beyond the COVID-19 pandemic.

July 09, 2020 | Daily News

The National Institute of Allergy and Infectious Diseases has merged four NIAID-funded clinical trial networks to create a new trial network that will recruit thousands of patients into large-scale clinical trials for investigational COVID-19 vaccines and monoclonal antibody therapies.

July 08, 2020 | Daily News

Stakeholders are closely watching to see whether FDA will cave to pressure from the White House and doctors and reinstate emergency use authorization for the anti-malarial drug hydroxychloroquine.

July 08, 2020 | Daily News

Joe Biden would direct Medicare to negotiate prices of drugs that face little competition, using international prices as a reference, and the negotiated prices would be available to public and private insurers, according to the presumptive Democratic presidential nominee’s platform.

July 08, 2020 | Daily News

As White House officials tease a buy-American executive order, Joe Biden this week issued his plan for bringing pharmaceutical manufacturing back to the United States, and some of the general principles of the two plans overlap.

July 08, 2020 | Daily News

Republican lawmakers on the House Ways & Means Committee will soon introduce four bills aimed at providing additional incentives and tax benefits for pre-revenue companies, start-up businesses and partnerships that are focused on infectious disease drug development, committee staff members told reporters on a press call Wednesday (July 8).

July 08, 2020 | Daily News

The American Civil Liberties Union says the Supreme Court’s recent 5­-4 decision to strike down Louisiana abortion restrictions boosts abortion care providers’ calls for FDA to remove prescribing and dispensing restrictions on the abortion pill mifepristone and shuts down the agency’s arguments that clinicians have no standing to assert patients’ rights to access the drug.

July 08, 2020 | Daily News

The White House Office of Management and Budget last week completed its review of FDA’s draft guidance on quality considerations for clinical research on cannabis.

July 07, 2020 | Daily News

Novavax will receive $1.6 billion from HHS to make its COVID-19 vaccine candidate, and Regeneron Pharmaceuticals will receive $450 million to scale up production of its antibody candidate, HHS announced on Tuesday (June 7).

July 06, 2020 | Daily News

Trump administration officials told a Senate Appropriations panel that reported moves by several COVID-19 vaccine and drug developers to eliminate “march-in” language from their contracts with HHS should not lead to price gouging.

July 06, 2020 | Daily News

FDA on Monday (July 6) announced its plans to launch a two-phase study assessing how consumer and health care provider perceptions of a prescription drug are affected by certain disclosures in promotional materials, including information about a product’s biosimilar status and whether a drug may have additional clinical benefit based on secondary endpoints.

July 02, 2020 | Daily News

Senate Finance Committee Chair Chuck Grassley on Thursday (July 2) re-introduced drug pricing legislation that is structurally unchanged from the version passed by Finance last summer, but none of the Democrats who previously voted for it are co-sponsors.

July 02, 2020 | Daily News

HHS officials told senators on Thursday (July 2) that clinical trial data from diverse populations, including racial and ethnic minorities, pregnant and lactating women, and children, will help inform the government’s COVID-19 vaccine distribution plan and ensure the vaccine is appropriately distributed among those in need.

July 02, 2020 | Daily News

A bipartisan group of senators on Thursday (July 2) introduced legislation to waive eligibility requirements next year for any previously eligible hospital in the 340B program, citing challenges faced by these hospitals during the COVID-19 pandemic that might make them ineligible moving forward.

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