Codon

AUGUST 26, 2024

After the outbreak ended, it took another three years for the first Ebola vaccine by Merck to be approved. When COVID-19 emerged in 2019, by contrast, mRNA vaccines developed by Pfizer and Moderna took just 326 days from the initial sequencing of the virus to gaining approval for emergency use.

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The Pharma Data

MAY 13, 2021

Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection ( FDA ). J&J Vision sets sights on childhood myopia with new FDA contact lens clearance ( Fierce ). Government, Regulatory & Legal.

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The Pharma Data

JANUARY 6, 2021

The approval in India is an important milestone as it will enable to supply India but also a large number of countries around the world. We hope this effective, well-tolerated and simple-to-administer vaccine will now begin to have a real impact on this deadly virus. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

JANUARY 29, 2021

AstraZeneca continues to engage with governments, international organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca . Posted: January 2021. Source link.

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The Pharma Data

JANUARY 29, 2021

AstraZeneca continues to engage with governments, international organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca. Posted: January 2021. Source link.

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The Pharma Data

DECEMBER 30, 2020

The Company aims to supply millions of doses in the first quarter as part of an agreement with the government to supply up to 100 million doses in total. We would like to thank our many colleagues at AstraZeneca, Oxford University, the UK government and the tens of thousands of clinical trial participants.”. Source: AstraZeneca.

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The Pharma Data

OCTOBER 28, 2020

In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

FEBRUARY 23, 2022

For laboratory workers: TBE vaccination is recommended for those with a potential exposure to the TBE virus (TBEV). Food and Drug Administration (FDA) approved TicoVac™ for active immunization to prevent TBE in individuals 1 year of age and older. 1 TicoVac™ is the only FDA-approved vaccine to help protect U.S.

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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

NOVEMBER 23, 2020

AstraZeneca continues to engage with governments, multilateral organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. AstraZeneca. Source: AstraZeneca. Posted: November 2020.

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The Pharma Data

NOVEMBER 9, 2020

NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. government.

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The Pharma Data

OCTOBER 24, 2020

That’s just not possible when the virus is surging everywhere,” Eleanor Murray, an epidemiologist at Boston University, told the Post. The winter’s cold, dry air will also help the virus stay stable longer, just as people start to spend more time indoors where ventilation may be poor.

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The Pharma Data

OCTOBER 23, 2020

Remdesivir gets full FDA approval to treat COVID. Remdesivir’s full approval Thursday by the FDA comes after the agency granted it emergency use authorization last spring. For patients younger than 12, the FDA will still allow the drug’s use in certain cases under its previous emergency authorization.

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The Pharma Data

DECEMBER 8, 2020

AstraZeneca continues to engage with governments, multilateral organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. AstraZeneca. Source: AstraZeneca. Posted: December 2020.

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The Pharma Data

OCTOBER 30, 2020

About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) 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 8, 2020

During the call, Takeda provided a deep dive into TAK-721, which has the potential to be the first FDA-approved agent for the treatment of eosinophilic esophagitis (EoE), and TAK-003, which is a live attenuated tetravalent vaccine for prevention of dengue disease.

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The Pharma Data

NOVEMBER 30, 2020

Therefore, the Company has been working closely with the FDA to complete trial-initiation gating activities related to its commercial-scale production at FUJIFILM Diosynth Biotechnologies in Research Triangle Park, North Carolina. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History. Novavax was awarded $1.6 Source link.

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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

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

DECEMBER 29, 2020

government, Regeneron is producing approximately 300,000 doses (2,400 mg) for outpatient use under the EUA. government regarding additional doses. . Casirivimab and imdevimab injection is not FDA approved for any use. Under an agreement with the U.S. In the U.S.

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The Pharma Data

JULY 29, 2021

HCV product sales increased 23% to $549 million for the second quarter 2021 compared to the same period in 2020, driven primarily by improved market starts in the United States and Europe as well as an unfavorable change in estimate of government rebates in the second quarter 2020. Total second quarter 2021 revenue of $6.2

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The Pharma Data

MAY 4, 2021

Direct Relief will allocate donations of baricitinib to low- and lower-middle-income countries (based on World Bank classification) for the treatment of hospitalized COVID-19 patients requiring supplemental oxygen, based on requests from these governments to Direct Relief. It is approved in the U.S.

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The Pharma Data

DECEMBER 11, 2020

Operation Warp Speed, the White House-led initiative to develop and distribute vaccines, has already said it plans to begin shipping the vaccine to all 50 states within 24 hours of an FDA approval. Initially, a shipment of 2.9 million doses will leave warehouses and be sent across the country, the Times reported. and Troy, Mich. —

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The Pharma Data

NOVEMBER 16, 2020

Since early January, we have chased this virus with the intent to protect as many people around the world as possible. I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. 75A50120C00034.

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The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic.

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The Pharma Data

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus. government. Regeneron Pharmaceuticals, Inc. Schleifer , M.D.,

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The Pharma Data

DECEMBER 5, 2020

Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

JANUARY 29, 2021

The Phase 3 ENSEMBLE trial is being conducted at the height of the COVID-19 pandemic in eight countries and three regions, at a time when disease spread has accelerated throughout the world resulting in people having increased exposure to the virus. COV2-S (SARS-CoV-2 vaccine) FDA Approval History. i] [link] [ii] The B.1.351

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Agency IQ

NOVEMBER 3, 2023

So what about all of the “biotic” terms that pop up in the news, on products labels and even in FDA warning letters? 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.

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The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.

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The Pharma Data

APRIL 27, 2021

In Japan, sales were €59 million (up 53.7%), where strong demand was moderated by the government price decrease implemented in April 2020. Dupixent ® was approved in China for the treatment of adults with moderate-to-severe AD in June 2020 and is listed on the NRDL (National Reimbursement Drug List) as of March 2021. Change at CER.

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Agency IQ

OCTOBER 27, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Government shutdown: At present, the U.S. federal government has appropriated funding through November 17. the drug and device) of the combination product.

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Agency IQ

SEPTEMBER 29, 2023

What we expect to be talking about in October: Government shutdown: The odds of a government shutdown happening in October are, we think, rather high absent a last-minute breakthrough in Congressional negotiations. That means that thousands of FDA staff are likely to be furloughed in early October, and potentially for weeks.

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The Pharma Data

OCTOBER 29, 2020

We are also focused on minimizing potential interactions that could contribute to the spread of the virus and put additional strain on healthcare systems through the use of innovative virtual means where possible. FDA approved the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS.

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Drug Target Review

FEBRUARY 15, 2024

To survive this era, governments, multi-lateral organisations, foundations, and industry will need to work collectively on researching and developing new drugs that can prevent or treat a broad range of epidemic-prone pathogens, some of which have not yet been identified. The reasons for this are sound. The scientific challenges are enormous.

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The Pharma Data

DECEMBER 12, 2020

. “More than 100,000 in long-term care have died from this virus in the U.S. and our nursing homes are now experiencing the worst outbreak of new cases since last spring, with more than 2,000 residents succumbing to this virus each week.” When you don’t have that capacity, that means people will die.”

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The Pharma Data

MAY 7, 2021

Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the rigorous FDA review process. “We Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We For more than 170 years, we have worked to make a difference for all who rely on us.

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