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.

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Agency IQ

JANUARY 19, 2024

Prevention of viral contamination is especially important as it may not be apparent that cells have been contaminated with a virus using conventional detection methods. These and other points were summarized in the 2019 Final Concept Paper developed to guide the revisions.

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The Pharma Data

SEPTEMBER 1, 2020

This can help healthcare professionals identify a SARS-CoV-2 infection in people suspected to carry the virus with results typically ready in 15 minutes. The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7

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The Pharma Data

OCTOBER 14, 2020

The research is part of an ongoing collaboration between Columbia University and Tonix that focuses on T cell and antibody responses to SARS-CoV-2 (CoV-2), the virus that causes COVID-19. The research encompasses two projects. The study led by Dr. Ilya Trakht, Ph.D., About TNX-1800.

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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. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S.

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Agency IQ

JANUARY 19, 2024

When compared to the year immediately prior to the pandemic, however, 2023 actually marks an increase in volume, with only 70 opinions issued in 2019. This approval type has always been uncommon – before the pandemic, this pathway was used just eight times between 2015 and 2019. [ for the years 2020 to 2022.

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Codon

JULY 27, 2023

In 2019, about 4,000 Americans were waiting for a heart at any given time.) 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.” No longer.

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Codon

JULY 27, 2023

In 2019, about 4,000 Americans were waiting for a heart at any given time.) 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.” No longer.

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The Pharma Data

NOVEMBER 5, 2020

billion versus third quarter 2019 (4). billion versus third quarter 2019. billion versus third quarter 2019. REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus. Total revenues increased by 32% to $2.294 billion in the third quarter of 2020, compared to $1.744 billion in the third quarter of 2019.

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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.,

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Codon

JANUARY 21, 2024

2 AP: A news story in Nature about your organization, 1Day Sooner, discussed some recent challenge trials involving the hepatitis C virus. With hepatitis C, what changed within the last 10 years was the development of direct-acting antivirals , or DAAs, which are packaged into pills that you can take once a day for a few months.

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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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The Pharma Data

NOVEMBER 5, 2020

Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended September 30, 2020. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S.

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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

FEBRUARY 22, 2021

3 In August 2019 , RINVOQ received U.S. EULAR 2019; THU0167. 2019 ACR/ARP Annual Meeting; 2728. Discovered and developed by AbbVie scientists, RINVOQ is an oral, once daily, selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases. Some people have died from these infections. Mease P.J.,

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The Pharma Data

APRIL 27, 2021

We remain committed to moving as quickly and safely as possible to bring this vaccine to more people in Europe, as the deadly virus continues to wreak havoc across the continent.” This brings the total number of doses to be delivered to the EU to 600 million. “We said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “To

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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. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended September 30, 2020.

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The Pharma Data

DECEMBER 29, 2020

About Regeneron Antibody Cocktail Casirivimab and imdevimab 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

JUNE 18, 2021

14 In August 2019 , RINVOQ received U.S. RINVOQ ® (upadacitinib) [Package Insert]. Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Some people have died from these infections. ClinicalTrials.gov. North Chicago, Ill.

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The Pharma Data

DECEMBER 5, 2020

Securities and Exchange Commission , including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended September 30, 2020. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S.

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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. ” Bacteriophages infect a bacterium. Paper by Sha G. in Nature.

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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. ” Bacteriophages infect a bacterium. Paper by Sha G. in Nature.

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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.

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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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Agency IQ

NOVEMBER 3, 2023

Shortages increased by 60% between 2017 and 2019 in select European countries, the U.S., 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

OCTOBER 14, 2020

In 2019, as reported in the New England Journal of Medicine, the PALM Trial was stopped early following a pre-specified interim analysis that showed superiority of Inmazeb to ZMapp and remdesivir with respect to mortality. A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics. 2019; 381(24):2293-2303.

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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. Malaria mortality from 2000 (left) to 2019 (right). If you want to edit a gene inside of a neuron, what do you do? Green dots indicate neurons.

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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. Malaria mortality from 2000 (left) to 2019 (right). If you want to edit a gene inside of a neuron, what do you do? Green dots indicate neurons.

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Vaccine DNA Virus Engineering 52

Agency IQ

JULY 13, 2023

PAHPA has been reauthorized several times since its original passage, including as the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) and the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA). The House PAHPRA reauthorization package does include some interesting provisions.

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Drug & Device Law

JULY 31, 2023

2019 WL 4751807, at *8 (D. 30, 2019) (“a patent application is not a tangible good. . . 2019), precluded assertion of strict liability in litigation over a bank loan. 2019), similarly held that a website designer owed no duty under California negligence, because the defendant’s “content-neutral functions. . .

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Drug & Device Law

DECEMBER 19, 2022

2019), it simply misconstrued the FDA’s rather (that’s an understatement) complicated supplemental application/changes being effected regulation, 21 C.F.R. one HDPE resin to another HDPE resin) of a packaging component that may affect the impurity profile of the drug product. Albrecht , 139 S. 2022 WL 16729466, at *3.

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