The Pharma Data

JANUARY 6, 2021

Process development and quality control will begin in 2021, and full manufacturing capabilities at the 88,000-square-foot facility will be available in 2023. In addition to its lead program, which began Phase I testing in 2020, the company expects to nominate three clinical candidates in 2021.

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The Pharma Data

MAY 13, 2021

Posted 13 May 2021 | By Michael Mezher . 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 ).

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EG Life Sciences

FEBRUARY 15, 2023

The US Food and Drug Administration (FDA) approved around 26 novel drugs in 2022. Approval processes were slow in comparison to 2020 and 2021, where 53 and 50 approvals were achieved respectively. Going into the third year of the pandemic, we know that the virus still impacts industry operations.

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The Pharma Data

APRIL 27, 2021

Paris, April 28, 2021. Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% Q1 2021 business EPS ( 1) growth at CER driven by efficiency and sales performance, supported by a one-time payment. Sanofi has become a member of the top five companies of the 2021 Access to Medicine index.

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The Pharma Data

DECEMBER 31, 2020

The messenger RNA (mRNA) vaccines encode a form of the spike (S) protein of SARS-CoV-2 virus. The vaccine teaches the cells to make a piece of the spike protein, which triggers an immune response to help prevent illness if later exposed to the virus. Orgovyx, from Myovant Sciences, is expected to be available in January 2021.

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The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope.

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The Pharma Data

JANUARY 6, 2021

6 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults. Posted: January 2021. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca.

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The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older. Posted: January 2021. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older. Posted: January 2021. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

NOVEMBER 17, 2021

The precise mechanism of the drug against SARS-CoV-2 is not yet known, but researchers have hypothesized that it may prevent the virus from taking hold by interfering with an enzyme it requires to replicate. If disulfiram’s effect against SARS-CoV-2 is confirmed, it could become a useful tool against the virus. A Pandemic Pivot.

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The Pharma Data

DECEMBER 15, 2020

” Last week, the FDA approved a different at-home test, but it requires samples to be mailed to a lab to get the results. The new Ellume COVID-19 Home Test approved Tuesday detects SARS-CoV-2 virus protein fragments on nasal swab samples from any person 2 years of age or older, according to the FDA.

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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). On August 13, 2021, the U.S. Food and Drug Administration (FDA) approved TicoVac™ for active immunization to prevent TBE in individuals 1 year of age and older. Global President, Vaccines, Pfizer.

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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

NOVEMBER 23, 2020

The Company is making rapid progress in manufacturing with a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body. AstraZeneca.

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The Pharma Data

DECEMBER 3, 2020

Clover intends to initiate a separate pivotal clinical trial of the S-Trimer vaccine candidate in combination with Dynavax’s advanced CpG 1018 adjuvant plus alum in the first half of 2021. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

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The Pharma Data

NOVEMBER 9, 2020

Depending on the overall COVID-19 attack rate, interim data in the UK trial, which is also event-driven, are expected as soon as early first quarter 2021. NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

NOVEMBER 20, 2020

In the first quarter of 2021, we expect to increase available global supply as we continue our collaboration with Roche.”. The casirivimab and imdevimab antibody cocktail is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus,” said George D. Yancopoulos, M.D.,

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The Pharma Data

DECEMBER 30, 2020

AstraZeneca is working with its global partners to continue building manufacturing capacity of up to three billion doses of the vaccine globally in 2021 on a rolling basis, pending regulatory approvals. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca. Posted: December 2020. Source link.

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The Pharma Data

DECEMBER 8, 2020

The Company is also making rapid progress in manufacturing with a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body. AstraZeneca.

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The Pharma Data

DECEMBER 23, 2020

It’s almost 2021, and the whole world just wants to move on from COVID-19. While the overall understanding of the condition is as novel as the virus that causes it, a recent survey from the U.K.’s While the overall understanding of the condition is as novel as the virus that causes it, a recent survey from the U.K.’s

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The Pharma Data

JANUARY 31, 2021

1, 2021 /PRNewswire/ — AIkido Pharma Inc. and the results are expected to be released in Q2 2021. If FDA approved, CONV 01-? would be the first antibody drug approved to direct a radioisotope into prostate cancer cells, and the first drug approved for the use of 225 Ac in cancer treatment. .

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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. ABOUT TAKEDA PHARMACEUTICAL COMPANY LIMITED.

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The Pharma Data

NOVEMBER 30, 2020

Interim data in this event-driven trial are expected as soon as early first quarter 2021, although the timing depends on the overall COVID-19 rate in the region. availability of efficacy data depends on the illness rate in South Africa and may be available as soon as the first quarter 2021. European Union and other countries.

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The Pharma Data

JANUARY 12, 2021

12, 2021 /PRNewswire/ — . Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. Casirivimab and imdevimab injection is not FDA approved for any use.

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The Pharma Data

JANUARY 6, 2021

6, 2021 /PRNewswire/ — FUJIFILM Corporation (President: Kenji Sukeno ) is making an investment of more than 200 Billion yen (2 Billion USD) to establish a new large-scale cell culture production site in the United States to accelerate the growth of its biopharmaceutical contract development and manufacturing business (CDMO).

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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. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021.

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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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NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

ACTIV-2 : A Phase 2/3 trial is enrolling adults with COVID-19 who are not hospitalized to evaluate the safety of multiple monoclonal antibodies (Lilly’s LY-CoV555, Brii Biosciences’s BRII-196 and BRII-198, and AstraZeneca’s AZD7442) used to block or neutralize the SARS-CoV-2 virus.

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The Pharma Data

APRIL 6, 2021

The FDA extended the action date to allow time to review additional data analyses submitted by Lilly in response to recent information requests from the FDA. The Prescription Drug User Fee Act (PDUFA) action date has been extended three months to early Q3 2021. OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S.

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Agency IQ

JANUARY 19, 2024

This most recent year saw 80 total opinions, compared to 92 in 2022 and 97 in 2021. The rate of negative opinions over the last three years has remained relatively stable, with three each in 2023 and 2022 and five in 2021. The EMA has now seen a three-year decline in new active substances, with 54 in 2021, 44 in 2022 and 39 in 2023.

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The Pharma Data

NOVEMBER 23, 2020

The next survival analysis is planned in first half of 2021. Food and Drug Administration (FDA) approved the combination of ipilimumab and nivolumab (Yervoy and Opdivo) for the first-line treatment of MPM based on mOS of 18.1 months (Baas 2020), and this is expected to serve as a benchmark for further approvals.

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The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. It is approved in the U.S.

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The Pharma Data

DECEMBER 29, 2020

The company expects to complete the manufacture of these doses on schedule in January 2021 and is in discussions with the U.S. Regeneron continues to increase in-house production of casirivimab and imdevimab, and the company has partnered with Roche to increase the global supply beginning in 2021. Under an agreement with the U.S.

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The Pharma Data

APRIL 3, 2021

Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for upadacitinib in the treatment of adults and adolescents with moderate to severe atopic dermatitis. The Prescription Drug User Fee Act (PDUFA) action date has been extended three months to early Q3 2021.

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The Pharma Data

JUNE 18, 2021

May 24, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced The Lancet published primary analysis results from the pivotal global Phase 3 clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating RINVOQ ® (upadacitinib) in adults and adolescents with moderate to severe atopic dermatitis who were candidates for systemic treatment.

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The Pharma Data

JULY 15, 2021

The Company announced topline preprint study results from this Phase 1/2a sub-study on July 1, 2021. Mature B-cells produce antibodies, which can help fight the virus that causes COVID-19. There is no FDA-approved vaccine to prevent COVID-19. Data from the study conducted in collaboration with Dan Barouch, M.D.,

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The Pharma Data

NOVEMBER 21, 2020

In the first quarter of 2021, we expect to increase available REGEN-COV2 global supply as we continue our collaboration with Roche.” ” “REGEN-COV2 is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus,” said George D. Yancopoulos , M.D.,

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