The Pharma Data

MARCH 25, 2021

European Medicines Agency to Conduct First-Ever Parallel Assessment of a Medicinal Product, Takeda’s Dengue Vaccine Candidate (TAK-003), for use in the EU; Countries Outside of the EU through the EU-M4all (Previously Article 58) Procedure. About TAK-003. 4,5 Efficacy varied by serotype.

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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. Promising new malaria vaccine for kids approved in Ghana. If you want to edit a gene inside of a neuron, what do you do? From Stahl E.C. in bioRxiv.

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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. Promising new malaria vaccine for kids approved in Ghana. If you want to edit a gene inside of a neuron, what do you do? From Stahl E.C. in bioRxiv.

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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

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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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.

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Drug Target Review

MAY 22, 2024

In parallel, we are exploring the technical performance of circVec in other viral vectors, as well as non-viral approaches which we expect will surpass virus-based vector-format as the state-of-the-art solutions for gene therapy in the future. We are now running follow-up experiments to track the advantage long-term.

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

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Agency IQ

JANUARY 19, 2024

Though some biological products may be developed using PCCs, such as viral vaccines, these cultures are also commonly used for in vitro experiments that seek to mimic in vivo conditions as closely as possible (e.g., for renal function studies ). Secondly, their use minimizes both the risk and the impact of viral contamination.

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The Pharma Data

OCTOBER 26, 2020

For 20 years, Novasep has acquired experience in developing and manufacturing a wide range of viral vectors through its sites in Belgium: AAV, Adenovirus, Lentivirus, HSV, VEEV, VSV…, for cell & gene therapy, immunotherapy, vaccination and other therapies from process development to cGMP production.

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Codon

APRIL 2, 2023

Read Inhalable nanoparticles, packaged with mRNA or CRISPR systems, efficiently edit lung cells. mRNA vaccines and hybrid immunity use different B cell germlines against Omicron BA.4 Therapeutic neutralizing monoclonal antibody administration protects against lethal yellow fever virus infection. Nature Biotechnology. Andreano E.

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

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The Pharma Data

JANUARY 6, 2021

End-to-End Single-Site Solution from Drug Substances to Fill-Finish & Packaging. In addition to drug substance manufacture, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services. Packaging line?. TOKYO , Jan. 8 x 20,000L bioreactors for mammalian cells.

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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.

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Agency IQ

JANUARY 19, 2024

The clinical package, safety and label were not affected. Although the number of products holding the PRIME (priority medicines) designation declined, this is likely due to product development timelines. According to comments from Eli Lilly – which holds the U.S.

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Agency IQ

NOVEMBER 3, 2023

Changes that could be implemented rapidly include using different sources of raw materials and/or finished product, packaging, or changes to batch sizes, manufacturing sites, and equipment.

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The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg. Christoph D.

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The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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The Pharma Data

DECEMBER 21, 2020

military scientists to determine if it might be resistant to vaccines. 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. Flu Rates Seen as Pandemic Rages.

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BioPharma Drive: Drug Pricing

JUNE 23, 2025

Published June 23, 2025 Delilah Alvarado Staff Reporter post share post print email license A micrograph image of influenza A virus. Influenza A virus" [Micrograph]. Study success could open the door to an alternative to seasonal influenza vaccines, which some Wall Street analysts view as a multibillion-dollar sales opportunity.

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Codon

NOVEMBER 1, 2024

Such models will, in turn, make it much easier to invent the sorts of platform tools that Amodei asserts “drive >50% of progress in biology,” such as CRISPR and mRNA vaccines, because the creation of these tools ultimately derive from a deeper understanding of how cells work.

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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. As the name suggests, a synbiotic is a product that seeks “synergy” from its contents. To do this, it provides both a probiotic and a prebiotic.

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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. Inmazeb may reduce the efficacy of live vaccine therefore, avoid the concurrent administration of a live vaccine during treatment with Inmazeb.

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The Pharma Data

FEBRUARY 22, 2021

Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines. 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. Are pregnant or plan to become pregnant.

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The Pharma Data

JUNE 18, 2021

Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines. 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. Are pregnant or plan to become pregnant.

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Codon

MAY 30, 2023

This means that IscB base editors might be easier to package inside of AAVs, which can only store 4,700 bases of DNA for gene therapies. Read *An engineered influenza virus to deliver antigens for lung cancer vaccination. Read Meningococcal ACWYX conjugate vaccine in 2-to-29-year-olds in Mali and Gambia. Only about 1.5

DNA 52

DNA RNA Engineering Vaccine 52

Codon

MAY 30, 2023

This means that IscB base editors might be easier to package inside of AAVs, which can only store 4,700 bases of DNA for gene therapies. Read *An engineered influenza virus to deliver antigens for lung cancer vaccination. Read Meningococcal ACWYX conjugate vaccine in 2-to-29-year-olds in Mali and Gambia. Only about 1.5

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DNA RNA Engineering Vaccine 52

Codon

JANUARY 21, 2024

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October.

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The Pharma Data

APRIL 27, 2021

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021. As with any vaccine, vaccination with COMIRNATY® may not protect all vaccine recipients.

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The Pharma Data

OCTOBER 19, 2020

The assay targets on coronavirus-specific nanobodies and tests affinity and efficacy to prevent the virus infection. . Testing Therapies, Antivirals and Vaccines. There has been some discussion of running challenge trials for COVID-19 vaccines. There has been some discussion of running challenge trials for COVID-19 vaccines.

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SugarCone Biotech

APRIL 8, 2025

That said, interest and opportunity in advanced therapeutic modalities for oncology cell therapy, bispecific antibodies, antibody drug conjugates, vaccine strategies remains high. Thats enough size to encode an expression construct containing a chimeric antigen receptor (CAR), perhaps along with an enhancement or 2, eg.

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The Pharma Data

DECEMBER 22, 2020

22, 2020 (Healthday News) — As Congress passed a $900 billion pandemic relief package on Monday, U.S. Seeking to reassure a troubled nation, President-Elect Joe Biden received the first dose of the two-dose Pfizer COVID-19 vaccine on Monday. “The vaccine is a pretty thorough thing,” Hanage explained.

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The Pharma Data

JANUARY 22, 2021

Next on the agenda: speeding up the nation’s vaccine rollout. To help do so, he’s directed the Federal Emergency Management Agency to begin constructing federally supported community vaccination centers, with the goal of having 100 centers in operation within the next month, The New York Times reported.

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The Pharma Data

JANUARY 20, 2021

vaccine rollout seeks to gather steam amid the discovery of new COVID-19 variants that might eventually threaten the efficacy of those vaccines. A new lab study suggests someone might be able to get infected with the South African variant even if they’ve had COVID-19 before or have been vaccinated.

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Codon

FEBRUARY 2, 2025

Polio, largely transmitted via aerosols and droplets, had a vaccine by 1955; in 1961, there were only 161 reported cases. Measles (1963), mumps (1967), and rubella (1969) were all vaccine-preventable by 1970 (and targeted by a single vaccine in 1971). This included the most rudimentary of ventilation tools: windows.

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The Pharma Data

JANUARY 19, 2021

At the same time, the national vaccination rollout has been slow and chaotic. Adding to these issues, a more contagious virus variant that first surfaced in Britain has now been detected in at least 20 U.S. But the virus must be grown in a lab and tested more fully before any conclusions can be drawn, he added. 14 and Jan.

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The Pharma Data

JANUARY 21, 2021

He’ll also issue executive orders that aim to ramp up the production and distribution of COVID-19 tests and vaccines, make schools and travel safer, and help states fight the spread of coronavirus. The new plan also steers more money to states, which have complained they need more funding to test and vaccinate residents.

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