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.

Hospitals 52

Hospitals Virus Production Clinical Trials 52

Agency IQ

JULY 13, 2023

Each of these re-authorizations, along with provisions in other, related legislative packages such as the 21 st Century Cures Act , sought to add to, tweak and/or amend the U.S. The House PAHPRA reauthorization package does include some interesting provisions. public health emergency preparedness and response infrastructure.

FDA 40

FDA Packaging Laboratories Testimonials 40

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.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

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.

Production 40

Production Trials Treatment Disease 40

Codon

JUNE 5, 2025

If the same virus invades the cell a second time, the gRNA’s spacer sequence will bind to the matching viral DNA sequence, then be cut by the Cas protein. pyogenes protein — whose compactness makes them far easier to package into viral vectors and deliver into the human body.

DNA 78

DNA RNA Clinical Trials Engineering 78

Broad Institute

JUNE 27, 2024

They used an engineered adeno-associated virus (AAV) that crosses the blood-brain barrier after intravenous administration. The first problem they had to tackle was the editor’s size, because the editor needs to be small enough to be packaged and delivered to specific cells in the body.

Disease 142

Disease Therapies Clinical Trials Engineering 142

The Pharma Data

JANUARY 12, 2021

. “Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D. Yancopoulos , M.D.,

Government 52

Government Hospitals Virus Clinical Trials 52

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.

FDA Approval 52

FDA Approval Treatment RNA FDA 52

The Pharma Data

MARCH 25, 2021

TAK-003 is Being Studied for the Prevention of Dengue Due to any Dengue Virus Serotype in Individuals Ages Four to 60. Takeda’s tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four vaccine viruses. About TAK-003.

Vaccine 52

Vaccine Virus Trials Hospitals 52

Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. If you want to edit a gene inside of a neuron, what do you do? These viruses enter the brain and deliver the gene-editing ingredients into neurons.

Vaccine 52

Vaccine DNA Virus Engineering 52

Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. If you want to edit a gene inside of a neuron, what do you do? These viruses enter the brain and deliver the gene-editing ingredients into neurons.

Vaccine 52

Vaccine DNA Virus Engineering 52

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. Yancopoulos, M.D., President and Chief Scientific Officer of Regeneron.

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

Agency IQ

JANUARY 19, 2024

While some biologic developers may choose to develop new cell lines in-house, given the extensive resources required to do so, it is common for researchers and/or sponsors to acquire cell seeds from outside laboratories or cell banks. First, viral contaminants may be introduced from starting materials.

Virus 40

Virus Science Production FDA 40

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. Read Inhalable nanoparticles, packaged with mRNA or CRISPR systems, efficiently edit lung cells. Nature Neuroscience. Read You love to see it! Nature Biotechnology. Ricciardi M.J.

DNA 52

DNA RNA Engineering Licensing 52

Agency IQ

AUGUST 2, 2024

Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed. Positive August 2024 Balversa (erdafitinib) Janssen-Cilag International N.V.

Regulations 40

Regulations Clinical Trials Production Trials 40

Codon

JULY 27, 2023

A new paper from Michael Elowitz’s group at Caltech reports engineered RNA exporters that “efficiently and specifically package and secrete target RNA molecules from mammalian cells within protective nanoparticles.” A YouTuber, The Thought Emporium , is growing rat neurons in the laboratory. No longer. mycoides cell.

Therapies 52

Therapies RNA DNA Engineering 52

Codon

JULY 27, 2023

A new paper from Michael Elowitz’s group at Caltech reports engineered RNA exporters that “efficiently and specifically package and secrete target RNA molecules from mammalian cells within protective nanoparticles.” A YouTuber, The Thought Emporium , is growing rat neurons in the laboratory. No longer. mycoides cell.

Therapies 52

Therapies RNA DNA Engineering 52

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. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.

FDA 40

FDA Clinical Trials Hospitals Production 40

The Pharma Data

DECEMBER 29, 2020

All patients entering the trial were hospitalized with laboratory-confirmed COVID-19 requiring low-flow oxygen, and all received other background standard-of-care as required. Patients were randomized 1:1:1 to receive a one-time infusion of 8,000 mg of the antibody cocktail (high dose), 2,400 mg of the antibody cocktail (low dose) or placebo.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

NOVEMBER 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. The Company expects that the U.S. on October 22, including those at high risk of severe complications of COVID-19 disease.

Vaccine 52

Vaccine FDA Clinical Trials Disease 52

The Pharma Data

NOVEMBER 5, 2020

“Last week, Regeneron achieved an important milestone in the fight against COVID-19 with prospective Phase 2/3 results showing REGN-COV2 significantly reduced virus levels and the need for further medical attention in non-hospitalized patients; we have shared these important data with regulatory authorities,” said Leonard S.

Production 40

Production FDA Trials FDA Approval 40

Agency IQ

OCTOBER 27, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

FDA 40

FDA Science Regulations Production 40

Codon

JUNE 26, 2023

This reminds me of the Chemputer , “an autonomous compiler and robotic laboratory platform to synthesize organic compounds on the basis of standardized methods descriptions,” that was reported back in 2019. A phage is a virus that infects bacteria. It was used to make catalysts, a dye, and an insect repellant. in Nature.

DNA 52

DNA Therapies Engineering Clinical Trials 52

Codon

JUNE 26, 2023

This reminds me of the Chemputer , “an autonomous compiler and robotic laboratory platform to synthesize organic compounds on the basis of standardized methods descriptions,” that was reported back in 2019. A phage is a virus that infects bacteria. It was used to make catalysts, a dye, and an insect repellant. in Nature.

DNA 52

DNA Therapies Engineering Clinical Trials 52

Codon

NOVEMBER 1, 2024

” Nobody really knows without trying it out in the laboratory. For one, life itself grows and develops slowly, and the many steps required to “do” biological research in the laboratory are often tedious and manual. Even in vitro experiments — or those done in the laboratory — are relatively slow because E.

DNA 130

DNA RNA Molecular Biology Laboratories 130

The Pharma Data

DECEMBER 21, 2020

The team at the Walter Reed Army Institute of Research is checking genetic sequences of the mutated virus variant posted online by British researchers, CNN reported. Congress Strikes Deal on Economic Relief Package. A deal on a $900 billion COVID-19 economic relief package was reached Sunday by the U.S.

Vaccine 52

Vaccine Packaging Laboratories Virus 52

Agency IQ

NOVEMBER 3, 2023

The prebiotic may either feed the probiotic that it is packaged with, or it may feed another beneficial microbe that is intended to complement the activity of the probiotic. And last week, the FDA released a warning letter sent to Abbott Laboratories for marketing its Similac Probiotic Tri-Blend for premature infants.

Therapies 40

Therapies Science FDA Production 40

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

FDA Approval 52

FDA Approval FDA Production Treatment 52

The Pharma Data

FEBRUARY 22, 2021

Tears in the stomach or intestines and changes in certain laboratory tests can happen. RINVOQ (upadacitinib) [Package Insert]. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay. Some people have died from these infections. ClinicalTrials.gov. AbbVie Inc.

Disease 52

Disease Treatment Therapies Trials 52

The Pharma Data

JUNE 18, 2021

Tears in the stomach or intestines and changes in certain laboratory tests can happen. RINVOQ ® (upadacitinib) [Package Insert]. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay. Some people have died from these infections. ClinicalTrials.gov. AbbVie Inc.

Treatment 40

Treatment Disease FDA Therapies 40

Codon

FEBRUARY 23, 2025

Experimenting with a retrovirus called murine leukemia virus , he found that zidovudine did, in fact, obstruct retrovirus replication by inhibiting reverse transcriptase. Healthcare workers who became exposed to the virus while treating patients in the 1980s took zidovudine as a prophylactic. Subscribe to Asimov Press! Always free.

Clinical Trials 76

Clinical Trials Virus Vaccine DNA 76

Drug & Device Law

JULY 31, 2023

Smith rejected plaintiff’s analogy between books and drug package inserts. May 13, 2015) (contract involving multiple, identical “software package[s]” governed by UCC). From these exercises we concluded that a 50-state survey on intangibles as “products” for product liability purposes would be both doable and useful. 1145, 1165 n.135

Production 52

Production Trials International Government 52