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

AUGUST 16, 2021

Still, with the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. We continuously strive to stay at least one step ahead of the virus. In the U.S.,

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The Pharma Data

MAY 4, 2021

Posted 04 May 2021 | By Michael Mezher . Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month ( CNBC ). The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week. © 2021 Regulatory Affairs Professionals Society.

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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

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

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 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

JANUARY 6, 2021

6, 2021– Moderna, Inc. The authorization is based upon the recommendation of the European Medicines Agency (EMA) for use of the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older. “I Posted: January 2021. CAMBRIDGE, Mass.–(BUSINESS

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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

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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The Pharma Data

JANUARY 12, 2021

12, 2021– Moderna, Inc. The authorization is given according to the ordinary approvals procedure and is based on a rolling submission of data and the totality of scientific evidence shared by the Company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30. Posted: January 2021.

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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

JANUARY 18, 2021

Napoleone Ferrara, a member of OKYO’s Scientific Advisory Board, will be spearheading this effort at OKYO to advance chemerin and its associated analogues for the treatment of patients with SARS-CoV-2 virus and ARDS. LONDON and BOSTON, Jan. LONDON and BOSTON, Jan.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Ayushi Jain and Khalid Mumtaz, 2022.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Ayushi Jain and Khalid Mumtaz, 2022.

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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. Source link.

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The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021. immediately, with delivery fulfillment expected to be completed in 2021.

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The Pharma Data

DECEMBER 15, 2020

Also in September, the FDA accepted a new drug application ( NDA ) from ChemoCentryx seeking approval for its investigational candidate, avacopan, for treating anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-associated vasculitis), a rare autoimmune disease. The FDA has set an action date of July 7, 2021.

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The Pharma Data

DECEMBER 5, 2020

We are also expanding our odronextamab program with multiple pivotal trials in 2021.” We are currently enrolling patients in a potentially registrational Phase 2 portion of this REGN5458 trial. Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

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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. Alexion plans to initiate a Phase 3 study of SOLIRIS in GBS in Japan in 2021, pending regulatory feedback.

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The Pharma Data

JULY 29, 2021

econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Nasdaq: GILD) announced today its results of operations for the second quarter 2021. “We Second Quarter 2021 Financial Results. Total second quarter 2021 revenue of $6.2 As of June 30, 2021, Gilead had $7.4

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The Pharma Data

JANUARY 21, 2021

21, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. “With the approval of CABENUVA, we’re proud to bring a new treatment option to people living with HIV that removes the burden of taking a daily pill,” said Paul Stoffels , M.D., TITUSVILLE, N.J. ,

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company’s first FDA approval. PALO ALTO, Calif.,

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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 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

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

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). Regulatory submissions in the United States and European Union (EU) are planned by the first quarter of 2021. Schleifer , M.D.,

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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 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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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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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

DECEMBER 10, 2020

The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Secondary endpoints include prevention of severe COVID-19 in those groups. About Pfizer: Breakthroughs That Change Patients’ Lives. Source: Pfizer Inc. . Posted: December 2020.

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