The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron. Regeneron has shared these results with the U.S.

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The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. As part of Operation Warp Speed, in July the U.S.

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The Pharma Data

NOVEMBER 21, 2020

government allocation program. The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

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The Pharma Data

DECEMBER 29, 2020

The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., government, Regeneron is producing approximately 300,000 doses (2,400 mg) for outpatient use under the EUA. government regarding additional doses. . futility analysis). . In the U.S.

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The Pharma Data

DECEMBER 10, 2020

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Germany, Turkey, South Africa, Brazil and Argentina. Source: Pfizer Inc. .

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The Pharma Data

OCTOBER 14, 2020

Additionally, immunogenicity, duration of immune response and occurrence of symptomatic COVID-19 will be measured. The agreement also details the structure of shared governance of the joint collaboration. The study’s primary objective is to examine the safety and reactogenicity of two-doses of the vaccine.

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The Pharma Data

JANUARY 29, 2021

The Company’s anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations. COV2-S (SARS-CoV-2 vaccine) FDA Approval History. Janssen’s COVID-19 vaccine program has been designed to be thorough and driven by science. i] [link] [ii] The B.1.351

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The Pharma Data

AUGUST 11, 2020

We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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The Pharma Data

AUGUST 11, 2020

We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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The Pharma Data

OCTOBER 26, 2020

In addition, the observed median PFS shows that the regimen can induce a sustained and durable response, which is also shown consistently by the induction of a specific immune response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

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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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The Pharma Data

JANUARY 10, 2021

Multiple COVID-19 vaccine developers are expected to file for regulatory approval in the coming months as the global pandemic continues its relentless advance. The European Commission, which will receive the same data, is not expected to approve the AZ/Oxford University vaccine until February or later ( DID , Dec. 30, 2020 ).

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