Agency IQ

JULY 13, 2023

Each of these re-authorizations, along with provisions in other, related legislative packages such as the 21 st Century Cures Act , sought to add to, tweak and/or amend the U.S. The House PAHPRA reauthorization package does include some interesting provisions. public health emergency preparedness and response infrastructure.

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The Pharma Data

DECEMBER 17, 2020

About casirivimab and imdevimab Casirivimab and imdevimab (formerly known as REGN-COV2 or REGEN-COV2) is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

DECEMBER 5, 2020

Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. (..)

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Agency IQ

JANUARY 12, 2024

FDA received its most recent statutory authority to collect fees through PDUFA VII on September 30, 2022, when it passed user fee reauthorization as part of the Continuing Resolution to fund the federal government. The PDUFA VII Commitment Letter describes the agreed-upon standard review times for most drug products.

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The Pharma Data

JANUARY 12, 2021

Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supply of the casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients to meet the federal government’s Operation Warp Speed goals. million doses. . We are pleased to work with the U.S.

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The Pharma Data

JANUARY 6, 2021

AstraZeneca has partnered with Serum Institute of India (SII), the world’s largest vaccine manufacturer, for the supply of the vaccine to the Indian Government but also to a large number of low and middle-income countries.

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The Pharma Data

NOVEMBER 20, 2020

Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure the casirivimab and imdevimab antibody cocktail is distributed fairly and equitably to the patients most in need. Yancopoulos, M.D., President and Chief Scientific Officer of Regeneron.

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The Pharma Data

AUGUST 7, 2020

Ministers say they were working with unions to ensure the “best possible” pay package for all health workers. “Each day I came home in tears, worrying I might bring the virus back home to my little girl. “So for the government to exclude us from a pay rise is awful – a real kick in the teeth.”

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The Pharma Data

MARCH 25, 2021

TAK-003 is Being Studied for the Prevention of Dengue Due to any Dengue Virus Serotype in Individuals Ages Four to 60. Dengue outbreaks, which result in half a million hospitalizations globally each year, can overwhelm communities and governments because of the broad impact on the health care system. About TAK-003.

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The Pharma Data

NOVEMBER 21, 2020

government allocation program. Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need. government and Regeneron signed an agreement for this initial supply of REGEN-COV2.

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The Pharma Data

JANUARY 16, 2021

Biden also vowed to make racial equity a priority in fighting a virus that has disproportionately infected and killed minorities. trillion pandemic “rescue” package that includes $20 billion for the vaccine effort. variant that has acquired three gene mutations not previously seen together in the virus.

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The Pharma Data

DECEMBER 29, 2020

government, Regeneron is producing approximately 300,000 doses (2,400 mg) for outpatient use under the EUA. government regarding additional doses. . Under an agreement with the U.S. The company expects to complete the manufacture of these doses on schedule in January 2021 and is in discussions with the U.S. In the U.S.

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The Pharma Data

NOVEMBER 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. government has agreed to provide up to $1.525 billion to purchase supply of mRNA-1273 under U.S. The Company expects that the U.S.

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The Pharma Data

NOVEMBER 5, 2020

“Last week, Regeneron achieved an important milestone in the fight against COVID-19 with prospective Phase 2/3 results showing REGN-COV2 significantly reduced virus levels and the need for further medical attention in non-hospitalized patients; we have shared these important data with regulatory authorities,” said Leonard S.

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Codon

JULY 27, 2023

government funded a massive effort: To sterilize millions of screwworms , initially with hospital x-ray machines, and air drop them over Florida, Texas, and elsewhere. government reared and sterilized some 50 million screwworms per week and swiftly eradicated the insects in Florida and in the southwest. In response, the U.S.

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Codon

JULY 27, 2023

government funded a massive effort: To sterilize millions of screwworms , initially with hospital x-ray machines, and air drop them over Florida, Texas, and elsewhere. government reared and sterilized some 50 million screwworms per week and swiftly eradicated the insects in Florida and in the southwest. In response, the U.S.

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Therapies RNA DNA Engineering 52

Agency IQ

OCTOBER 27, 2023

Government shutdown: At present, the U.S. federal government has appropriated funding through November 17. That means at 12:01 on November 18, the government will shut down unless Congress is able to pass either a full budget (unlikely) or a continuing resolution (more likely). the drug and device) of the combination product.

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Codon

MAY 2, 2023

Once the mosquito factory has made all these insects, they are packaged into boxes or cups and then released in “strategic” areas within a city, like near swampy water or in dengue-ridden neighborhoods. Mosquitoes infected with Wolbachia have a reduced ability to transmit viruses to people. At least, that’s the goal.

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Codon

MAY 2, 2023

Once the mosquito factory has made all these insects, they are packaged into boxes or cups and then released in “strategic” areas within a city, like near swampy water or in dengue-ridden neighborhoods. Mosquitoes infected with Wolbachia have a reduced ability to transmit viruses to people. At least, that’s the goal.

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Agency IQ

NOVEMBER 3, 2023

A non-paper drafted by the Belgian government in May 2023, obtained by POLITICO Pro EU, calls attention to the continuing issue of medicine supply shortages. Under the proposal, these elements would be addressed within the revised pharmaceutical regulation, thereby addressing drug shortages at a consistent, E.U.-wide wide level.

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Codon

JUNE 26, 2023

The speed at which glucose travels is governed by the equation v = sqrt(kT/mass). A phage is a virus that infects bacteria. For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) government, was one of three researchers who fell ill in the early days of the pandemic.

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Codon

JUNE 26, 2023

The speed at which glucose travels is governed by the equation v = sqrt(kT/mass). A phage is a virus that infects bacteria. For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) government, was one of three researchers who fell ill in the early days of the pandemic.

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The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg. Christoph D.

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The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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Agency IQ

NOVEMBER 3, 2023

Unfortunately, there is no regulatory body that governs the terminology used in this space, although there are definitions that are generally accepted by the scientific community. The term microbiome differs from “microbiota,” which describes the specific micro-organisms that are harbored by the human body.

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The Pharma Data

OCTOBER 14, 2020

. “Decades of investment in our VelociSuite® rapid response technologies, the dedication of world-class scientists, and the courageous contributions of healthcare providers and patients, together with remarkable cooperation between leading international health organizations and governments, have led to this important moment.

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The Pharma Data

FEBRUARY 22, 2021

RINVOQ (upadacitinib) [Package Insert]. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay. Some people have died from these infections. A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC).

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The Pharma Data

JUNE 18, 2021

RINVOQ ® (upadacitinib) [Package Insert]. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay. Some people have died from these infections. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-TAK). AbbVie Inc. .

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The Pharma Data

APRIL 27, 2021

We remain committed to moving as quickly and safely as possible to bring this vaccine to more people in Europe, as the deadly virus continues to wreak havoc across the continent.” This brings the total number of doses to be delivered to the EU to 600 million. “We said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “To

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The Pharma Data

DECEMBER 22, 2020

22, 2020 (Healthday News) — As Congress passed a $900 billion pandemic relief package on Monday, U.S. Instead, it may have been identified there first because the British government has a strong monitoring system that has tracked tens of thousands of genomic sequences of virus samples. TUESDAY, Dec.

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The Pharma Data

JANUARY 22, 2021

Additional directives will foster research into new treatments for COVID-19, strengthen the collection and analysis of data to shape the government’s pandemic strategy; and direct the federal occupational safety agency to release and enforce guidelines to protect workers from getting infected, the Post reported. .

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Codon

FEBRUARY 2, 2025

The 1964 report was not the first government report on smoking, but it was the first to authoritatively state that smoking causes lung cancer, bronchitis, and heart disease. In 1965, Congress mandated labeling on all cigarette packaging that warned consumers about the risks of smoking.

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The Pharma Data

JANUARY 21, 2021

Other orders will foster research into new treatments for COVID-19, strengthen the collection and analysis of data to shape the government’s pandemic strategy; and direct the federal occupational safety agency to release and enforce guidelines to protect workers from getting infected, the Post reported.

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Codon

FEBRUARY 23, 2025

government issued a limited waiver that let PEPFAR resume HIV treatments abroad, pending further guidance. At a time when government HIV initiatives look uncertain, lenacapavir could prove a much-needed failsafe. Healthcare workers who became exposed to the virus while treating patients in the 1980s took zidovudine as a prophylactic.

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Drug & Device Law

JULY 31, 2023

Since digital files were not “articles” under the statute, the government could not rely on this statute to prevent their importation. His claims about the content of the background investigation are appropriately governed by the [Fair Credit Reporting Act], not by product liability laws. 1145, 1165 n.135 at 1291-92. at 1293-94.

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