The Pharma Data

MARCH 22, 2022

Additionally, Pfizer has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for its oral treatment to help expand access, pending country regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population.

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The Pharma Data

JULY 23, 2021

Ronapreve is a combination of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19. The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process.

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The Pharma Data

FEBRUARY 12, 2022

Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories. Pseudovirus and authentic virus testing demonstrate that bebtelovimab retains full neutralizing activity against Omicron – currently the predominant variant in the U.S. About BLAZE-4.

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The Pharma Data

OCTOBER 26, 2020

Demand for our products remains robust, and production, supply and distribution of our medicines, vaccines and animal health products are moving forward with minimal disruption,” said Kenneth C. billion related to certain license and collaboration agreements, and certain other items. Non-GAAP EPS of $1.74 COVID-19 Research Highlights.

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The Pharma Data

JANUARY 13, 2021

said, “Nearly 30 years ago my laboratory at Columbia University generated the first anti-CD40-ligand mAb (5c8), discovered and characterized human CD40-ligand and elucidated the molecular basis of T cell helper function 1. ; Enbrel®, Prolia® and Xgeva® are trademarks of Amgen Inc. Tonix Pharmaceuticals Holding Corp.

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The Pharma Data

APRIL 6, 2021

Ongoing research for baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, in adult and pediatric AD, alopecia areata (AA), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), COVID-19 and for its approved indication for rheumatoid arthritis (RA) continues.

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The Pharma Data

MAY 4, 2021

” “Even as the world makes progress on vaccine roll-outs, it remains vital for treatments to be available that can make a meaningful difference for those fighting COVID-19,” said David A. Abnormal Laboratory Values: Evaluate at baseline and thereafter according to local patient management practice.

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Broad Institute

MAY 14, 2024

William Studier for development of widely used protein- and RNA-production platform The $400,000 award recognizes the far-reaching medical impacts of Studier’s development, in the 1980s, of an efficient and scalable technology to produce mass amounts of RNA and proteins in laboratories that is widely used today all over the world.

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The Pharma Data

MARCH 22, 2021

Casirivimab and imdevimab is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed by Regeneron scientists to block infectivity of SARS-CoV-2, the virus that causes COVID-19. As soon as the novel SARS-CoV-2 virus was sequenced in early 2020, we got to work.

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The Pharma Data

APRIL 16, 2021

1.429 California strain that currently accounts for 50 percent of the virus in California and over 10 percent across a number of additional states. Lilly’s chief scientific officer and president of Lilly Research Laboratories. Lilly’s chief scientific officer and president of Lilly Research Laboratories. In the U.S.,

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The Pharma Data

JANUARY 12, 2021

“Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics. “Additionally, as expected, the virus continues to mutate, with the possibility of developing resistance to any one antibody. . Schleifer , M.D., President and Chief Executive Officer of Regeneron.

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Drug Discovery World

OCTOBER 28, 2022

A panel of investigational monoclonal antibodies (mAbs) targeting different sites of the Epstein-Barr virus (EBV) have been shown to block infection when tested in human cells in a laboratory setting. . There is no licensed vaccine to protect against the virus. . EBV is one of the most common human viruses.

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The Pharma Data

OCTOBER 29, 2020

Baricitinib, an oral JAK1/JAK2 inhibitor discovered by Incyte, is developed by Lilly under license from Incyte. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant.

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The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. based Mogrify Limited expanded its research collaboration with MRC Laboratory of Molecular Biology.

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Agency IQ

FEBRUARY 2, 2024

The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

NOVEMBER 3, 2023

Although this guidance document is mostly focused on chemistry, manufacturing and control (CMC) information, it clarifies that LBPs are considered biologics, and will thus need to utilize the Biologics License Application (BLA) pathway.

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The Pharma Data

MARCH 16, 2021

Pascal Soriot, Chief Executive Officer, said: “The long-acting antibody combination has the potential to offer almost immediate protection to those who are not able to be vaccinated, to both prevent infection or treat the disease in patients already infected with the virus. Financial considerations.

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The Pharma Data

MARCH 11, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program.

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Drug Discovery World

SEPTEMBER 16, 2022

In particular these SMEs wanted affordable workspace; better provision of wet laboratory and clean room space in London, available at higher specification but not necessarily at great scale; universities and hospitals to make their equipment and facilities more usefully available; and more endeavour to grow skills and talent,” Patel said. . “The

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Codon

APRIL 2, 2023

A giant dataset about the rat brain, and how neurons connect to each other, was collected and pooled together from 20 different research laboratories. mRNA vaccines and hybrid immunity use different B cell germlines against Omicron BA.4 Nature Neuroscience. Read You love to see it! Andreano E. Nature Communications. Ricciardi M.J.

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The Pharma Data

JUNE 25, 2021

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. The PROVENT trial will give us more clarity in this patient population.

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The Pharma Data

NOVEMBER 9, 2020

TScan Therapeutics announced the signing of a research license and option agreement with QIAGEN to develop T cell-based laboratory tests for detecting prior exposure to the novel coronavirus, SARS-CoV-2, using discoveries from TScan’s high-throughput TCR/Target discovery platform. Testing Therapies, Antivirals and Vaccines.

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The Pharma Data

NOVEMBER 30, 2020

(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.

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The Pharma Data

NOVEMBER 20, 2020

“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. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process.

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The Pharma Data

NOVEMBER 21, 2020

.” “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. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. Yancopoulos , M.D.,

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The Pharma Data

JUNE 30, 2021

Food and Drug Administration, European Medicines Agency and other global health authorities regarding submission of a supplemental Biologics License Application later this year to expand the currently approved indications for Yescarta. The most common non-laboratory adverse reactions (incidence ?20%)

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The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. Hepatotoxicity: Hepatic adverse events were reported.

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The Pharma Data

MARCH 4, 2021

” Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant.

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The Pharma Data

JANUARY 26, 2021

Lilly’s chief scientific officer and president of Lilly Research Laboratories. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. “The death toll from COVID-19 continues to rise around the world and hospitalizations, particularly in the U.S.,

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The Pharma Data

NOVEMBER 9, 2020

. “The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus,” said Daniel Skovronsky, M.D.,

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Agency IQ

SEPTEMBER 29, 2023

July 2023 (Under OIRA Review) Medical Devices; Laboratory Developed Tests (Proposed Rule) This proposed rule would propose to amend the Food and Drug Administration’s regulations to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act.

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The Pharma Data

NOVEMBER 22, 2020

Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. In 2012, Merck licensed islatravir (4’-ethynyl-2-fluoro-2’-deoxyadenosine or EFdA) from the Yamasa Corporation based in Choshi, Japan. Merck’s Commitment to HIV. About Merck.

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The Pharma Data

MARCH 11, 2021

Lilly’s chief scientific officer and president of Lilly Research Laboratories. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

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The Pharma Data

OCTOBER 14, 2020

The three antibodies help neutralize the Ebola virus by blocking its ability to invade patients’ and/or enlisting other immune cells to target infected cells and remove them from the body. Selected grade 3 and 4 laboratory abnormalities for Inmazeb included high sodium (? mmol/L), low potassium (< 2.5 About Regeneron.

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Codon

APRIL 16, 2023

These microbes were engineered to express tumor antigens that could “elicit T cells that were licensed by the commensal immune program but specific for a tumor,” including both CD4+ and CD8+ T cells, according to the study. Read An RNA-based system to study hepatitis B virus replication and evaluate antivirals. Arieta C.M.

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