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Advocates Stand Up Against AstraZeneca to Save Drug Discount Program for Vulnerable Populations

Wilmington Protest, Wed., Oct. 14th – 12 noon – 1:00 pm ET

Dozens of concerned healthcare advocates from across the northeast region protest AstraZeneca, one of five U.S. based pharmaceutical companies that have cut back on the number of drugs they provide through the 340B federal drug discount program

Please replace the release with the following updated version due to multiple revisions.

The updated release reads:

DELAWARE PROTEST: ADVOCATES STAND UP AGAINST ASTRAZENECA TO SAVE DRUG DISCOUNT PROGRAM FOR VULNERABLE POPULATIONS

Wilmington Protest, Wed., Oct. 14th – 12 noon – 1:00 pm ET

Dozens of concerned healthcare advocates from across the northeast region protest AstraZeneca, one of five U.S. based pharmaceutical companies that have cut back on the number of drugs they provide through the 340B federal drug discount program.

Healthcare advocates from across the northeast region will protest the recent actions of AstraZeneca, in cutting back the number of critical life-saving drugs provided at discounted rates to non-profit healthcare providers, through the federal 340B drug discount program.

WHAT:

Protest against AstraZeneca

 

 

WHERE:

AstraZeneca’s Corporate Office

 

1800 Concord Pike, Wilmington, DE 19803

 

NOTE: The protest will take place at the intersection of Powder Mill Road & Route 22

 

 

WHEN:

Tomorrow, Wednesday, October 14, 2020

 

12noon – 1pm (EDT)

 

 

WHO:

Healthcare advocates from across the Northeast Region

The federal 340B Drug Discount Program is a lifeline that allows safety net providers, including HIV/AIDS clinics receiving funding through the Ryan White program, to obtain prescription drugs at below-retail prices. The program was established with bipartisan support as part of the Veterans Health Care Act of 1992. With 340B savings, Ryan White clinics are able to stretch their grant funds, offer a wider range of services, and improve the quality of care persons living with HIV/AIDS receive. The program also benefits qualified 340B covered entities such as non-profit rural health facilities, community clinics and children’s hospitals that serve vulnerable populations.

Tomorrow’s protest, led by healthcare advocates from AIDS Healthcare Foundation (AHF), follows a lawsuit filed by Ryan White Clinics for 340B Access (RWC-340B) against the U.S. Department of Health and Human Services (HHS), in U.S. District Court for the District of Columbia, to require the HHS secretary to take action against AstraZeneca and three other pharmaceutical companies, including Eli Lilly, Novartis and the U.S. division of Sanofi-Aventis which are illegally withholding drugs they are required to sell through the 340B program. With tomorrow’s protest, AHF is demanding that these greedy pharmaceutical companies stop their bullying tactics that will have a devastating impact on the healthcare and well-being of our most vulnerable populations (see LITIGATION PRESS RELEASE). RWC340B also recently released a study on the potential adverse impact of policies reducing resources to Ryan White clinics, see WHITE PAPER, PRESS RELEASE, and FACT SHEET.

“AstraZeneca has launched an assault on a federal drug discount program essential to the safety net of our nation’s health care,” stated John Hassell, AHF’s national director of advocacy. “They are messing with the numerous health care centers

U.S. signs agreement with AstraZeneca to develop, supply COVID-19 antibody treatment

(Reuters) – The U.S. government on Friday signed an agreement with AstraZeneca Plc <AZN.L> worth $486 million to develop and secure supplies of up to 100,000 doses of COVID-19 antibody treatment, a similar class of drugs that was used to treat President Donald Trump.

The U.S. health agency will provide the funding to AstraZeneca for two Phase 3 clinical trials under operation Warp Speed, which is aimed at speeding up treatments and vaccines for COVID-19.

One trial will evaluate the safety and efficacy of the experimental treatment to prevent infection for up to 12 months, in about 5,000 participants, while the second trial will evaluate post-exposure preventative and pre-emptive treatment in roughly 1,100 participants.

AstraZeneca said it plans to supply up to 100,000 doses starting towards the end of 2020 and the US Government can acquire up to an additional one million doses in 2021 under a separate agreement.

In a video posted on Twitter on Wednesday, Trump credited Regeneron Pharmaceuticals Inc’s <REGN.O> therapeutic for his recovery. Trump received Regeneron’s treatment last week after he was diagnosed with COVID-19.

(Reporting by Ankur Banerjee in Bengaluru; Editing by Anil D’Silva)

Source Article

U.S. Signs Agreement With AstraZeneca to Develop, Supply COVID-19 Antibody Treatment | Top News

(Reuters) – The U.S. government on Friday signed an agreement with AstraZeneca Plc

worth $486 million to develop and secure supplies of up to 100,000 doses of COVID-19 antibody treatment, a similar class of drugs that was used to treat President Donald Trump.

The U.S. health agency will provide the funding to AstraZeneca for two Phase 3 clinical trials under operation Warp Speed, which is aimed at speeding up treatments and vaccines for COVID-19.

One trial will evaluate the safety and efficacy of the experimental treatment to prevent infection for up to 12 months, in about 5,000 participants, while the second trial will evaluate post-exposure preventative and pre-emptive treatment in roughly 1,100 participants.

AstraZeneca said it plans to supply up to 100,000 doses starting towards the end of 2020 and the US Government can acquire up to an additional one million doses in 2021 under a separate agreement.

In a video posted on Twitter on Wednesday, Trump credited Regeneron Pharmaceuticals Inc’s

therapeutic for his recovery. Trump received Regeneron’s treatment last week after he was diagnosed with COVID-19.

(Reporting by Ankur Banerjee in Bengaluru; Editing by Anil D’Silva)

Copyright 2020 Thomson Reuters.

Source Article

U.S., AstraZeneca strike deal for COVID-19 antibody treatment touted by Trump

(Reuters) – The U.S. government has awarded $486 million to AstraZeneca Plc to develop and secure supplies of up to 100,000 doses of COVID-19 antibody treatment, a similar class of drug that was used in treating President Donald Trump.

The agreement, under the Trump administration’s Operation Warp Speed, is for developing a monoclonal antibody cocktail that can prevent COVID-19, especially in high-risk population like those over 80 years old, the U.S. Department of Health and Human Services said.

The treatment has come under the spotlight after Trump was treated with Regeneron Pharmaceuticals’ antibody drug last week. The president has also released a video on Twitter touting its benefits.

In a call earlier on Friday, a top U.S. health official said the government was expecting to provide more than 1 million free doses of antibody treatments to COVID-19 patients, similar to the one that was administered to Trump.

Regeneron and Eli Lilly have both applied to the U.S. Food and Drug Administration for emergency use authorizations of their antibody treatments.

AstraZeneca said it was planning to supply up to 100,000 doses starting toward the end of 2020 and that the U.S. government could acquire up to an additional one million doses in 2021 under a separate agreement.

Regeneron signed a $450 million deal in July to sell Operation Warp Speed enough doses of its antibody treatment, REGN-COV2, to treat around 300,000 people.

Eli Lilly said on Friday it had not signed an agreement with Operation Warp Speed.

AstraZeneca plans to evaluate the treatment, AZD7442, which is a cocktail of two monoclonal antibodies, in two studies.

One trial will evaluate the safety and efficacy of the experimental treatment to prevent infection for up to 12 months in about 5,000 participants, while the second will evaluate post-exposure preventative and pre-emptive treatment in roughly 1,100 participants.

(Reporting by Ankur Banerjee in Bengaluru; Editing by Anil D’Silva)

Source Article

FDA broadens probe into serious illness in AstraZeneca coronavirus vaccine study: report

The Food and Drug Administration (FDA) has reportedly broadened its investigation into a serious illness suffered by a patient participating in AstraZeneca’s COVID-19 vaccine testing trials.

Reuters reported Thursday that FDA officials will seek data from Oxford University, AstraZeneca’s testing partner, regarding trials of vaccines for other diseases unrelated to COVID-19 in the hopes of determining whether patients in those trials developed similar side effects.

The move comes after the AstraZeneca/Oxford project was put on hold in early September due to one British trial participant falling ill with what was believed to be the rare spinal condition transverse myelitis.

“It just shows that the FDA is being thorough,” one source familiar with the probe said to Reuters.

The widened scope of the probe reportedly does not indicate a view by the FDA that AstraZeneca’s trials are unsafe or that other vaccines used in trials by Oxford were unsafe either, according to the sources, who noted that some delays have occurred due to Oxford’s data being presented in a different format from what the FDA has requested.

The FDA declined to comment to Reuters, while AstraZeneca pledged to continue working with the agency to deliver a COVID-19 vaccine.

“We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the US trial,” said a company spokesperson.

A number of private companies are pursuing COVID-19 vaccines in various stages of clinical trials, including drugmakers Pfizer and Moderna; AstraZeneca is also conducting clinical trials in other countries besides the U.S., including the U.K. and India.

Source Article

EXCLUSIVE-FDA widens U.S. safety inquiry into AstraZeneca coronavirus vaccine -sources

By Marisa Taylor and Dan Levine

WASHINGTON, Sept 30 (Reuters) – The U.S. Food and Drug Administration has broadened its investigation of a serious illness in AstraZeneca Plc’s COVID-19 vaccine study and will look at data from earlier trials of similar vaccines developed by the same scientists, three sources familiar with the details told Reuters.

AstraZeneca’s large, late-stage U.S. trial has remained on hold since Sept. 6, after a study participant in Britain fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis.

The widened scope of the FDA probe raises the likelihood of additional delays for what has been one of the most advanced COVID-19 vaccine candidates in development. The requested data was expected to arrive this week, after which the FDA would need time to analyze it, two of the sources said.

Effective vaccines are seen as essential to help end a pandemic that has killed more than one million people worldwide.

The administration of President Donald Trump has pledged $1.2 billion to support development of the AstraZeneca vaccine and secure 300 million doses for the United States. Other leading companies in the U.S. vaccine race include Pfizer Inc , Moderna Inc and Johnson & Johnson.

Regulators in the UK, Brazil, India and South Africa have allowed AstraZeneca to resume its clinical trials there.

The FDA, however, wants to determine whether similar side effects emerged in trials of other vaccines designed by AstraZeneca’s coronavirus vaccine partner, researchers at Oxford University, the sources said. That does not mean the agency believes there were safety issues associated with any of these vaccines, they added.

“It just shows that the FDA is being thorough,” said one of the sources.

Further complicating the situation is that the data requested by FDA is in a different format than what the U.S. regulator requires, two of the sources said.

The FDA declined to comment on discussions involving an experimental product. Oxford did not respond to requests for comment. AstraZeneca, in a statement, said: “We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the US trial.”

VIRAL VECTOR

All of the vaccines it wants to review use a modified adenovirus as vectors to safely deliver genetic material from the target illnesses – flu, Middle East Respiratory Syndrome, and other diseases – into the body to stimulate an immune system response to fight future infection.

While other vaccine developers have used human adenoviruses for such vaccines, the Oxford researchers chose an adenovirus found in chimpanzees. They felt this would reduce the likelihood that an individual’s immune system would attack the vector virus due to prior exposure rather than the intended target.

Reuters reviewed six research papers that detailed safety data of vaccines using the engineered chimpanzee adenovirus called ChAdOx1 for diseases including tuberculosis, prostate cancer and influenza.

In one of those trials, one serious adverse event cited by researchers was deemed unrelated to the vaccine.

The

Exclusive: FDA widens U.S. safety inquiry into AstraZeneca coronavirus vaccine – sources

WASHINGTON (Reuters) – The U.S. Food and Drug Administration has broadened its investigation of a serious illness in AstraZeneca Plc’s COVID-19 vaccine study and will look at data from earlier trials of similar vaccines developed by the same scientists, three sources familiar with the details told Reuters.

FILE PHOTO: A test tube labelled with the Vaccine is seen in front of AstraZeneca logo in this illustration taken, September 9, 2020. REUTERS/Dado Ruvic

AstraZeneca’s large, late-stage U.S. trial has remained on hold since Sept. 6, after a study participant in Britain fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis.

The widened scope of the FDA probe raises the likelihood of additional delays for what has been one of the most advanced COVID-19 vaccine candidates in development. The requested data was expected to arrive this week, after which the FDA would need time to analyze it, two of the sources said.

Effective vaccines are seen as essential to help end a pandemic that has killed more than one million people worldwide.

The administration of President Donald Trump has pledged $1.2 billion to support development of the AstraZeneca vaccine and secure 300 million doses for the United States. Other leading companies in the U.S. vaccine race include Pfizer Inc, Moderna Inc and Johnson & Johnson.

Regulators in the UK, Brazil, India and South Africa have allowed AstraZeneca to resume its clinical trials there.

The FDA, however, wants to determine whether similar side effects emerged in trials of other vaccines designed by AstraZeneca’s coronavirus vaccine partner, researchers at Oxford University, the sources said. That does not mean the agency believes there were safety issues associated with any of these vaccines, they added.

“It just shows that the FDA is being thorough,” said one of the sources.

Further complicating the situation is that the data requested by FDA is in a different format than what the U.S. regulator requires, two of the sources said.

The FDA declined to comment on discussions involving an experimental product. Oxford did not respond to requests for comment. AstraZeneca, in a statement, said: “We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the US trial.”

VIRAL VECTOR

All of the vaccines it wants to review use a modified adenovirus as vectors to safely deliver genetic material from the target illnesses – flu, Middle East Respiratory Syndrome, and other diseases – into the body to stimulate an immune system response to fight future infection.

While other vaccine developers have used human adenoviruses for such vaccines, the Oxford researchers chose an adenovirus found in chimpanzees. They felt this would reduce the likelihood that an individual’s immune system would attack the vector virus due to prior exposure rather than the intended target.

Reuters reviewed six research papers that detailed safety data of vaccines using the engineered chimpanzee adenovirus called ChAdOx1 for diseases including tuberculosis, prostate cancer and