Agency IQ

JANUARY 26, 2024

More recently – in 2019 – researchers from Germany published a sweeping review of the available literature on drug stability beyond the labeled expiration date. What happens when a drug is not stored in its original container or within a licensed facility? Enter the beyond-use date.

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OCTOBER 27, 2020

patients during the review of the NexoBrid Biologics License Application (BLA). Vericel holds an exclusive license for North American commercial rights to NexoBrid. In January 2019, MediWound announced positive top-line results from the acute phase of the pivotal Phase 3 U.S.

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The Pharma Data

APRIL 27, 2021

the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorisation by the European Medicines Agency to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. AUTHORIZED USE IN THE EU: COMIRNATY® ?

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The Pharma Data

JANUARY 9, 2021

. Revenue Metrics Total revenues for 2020 are expected to be in the range of $1,545 and $1,555 million, an increase at the midpoint of $444 million or 40% as compared to 2019. 2019 (Actual). 2019 (Actual). 2019 (Actual). FOOTNOTES.

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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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Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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OCTOBER 14, 2020

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. 1 Noyce RS, et al. 2018) PLoS One. 13(1):e0188453. About Tonix Pharmaceuticals Holding Corp.

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Codon

JULY 27, 2023

A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). In 2019, about 4,000 Americans were waiting for a heart at any given time.) ” (Here is a good talk at the F.D.A. No longer.

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Codon

JULY 27, 2023

A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). In 2019, about 4,000 Americans were waiting for a heart at any given time.) ” (Here is a good talk at the F.D.A. No longer.

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The Pharma Data

OCTOBER 30, 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 June 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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Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources. and the E.C.

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Codon

JANUARY 21, 2024

We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. 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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NOVEMBER 20, 2020

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

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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DECEMBER 29, 2020

The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational. Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized.

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The Pharma Data

OCTOBER 28, 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 June 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

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

NOVEMBER 21, 2020

The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. 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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JANUARY 12, 2021

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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AUGUST 3, 2021

Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. While disease progression is slower in patients with later-onset SMA, there are significant unmet needs. “We

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The Pharma Data

JANUARY 21, 2021

CABENUVA, a co-packaged kit with two injectable medicines, offers people living with HIV a new approach for maintaining viral suppression. Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). Global Head, Janssen Research & Development, Johnson & Johnson.

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Agency IQ

JUNE 16, 2023

The agency’s Reporting Requirements for Emissions From Animal Waste Under the Emergency Planning and Community Right-to-Know Act states that the agency is considering to rescind a 2019 final rule that exempted air emissions from animal waste under the Emergency Planning and Community Right-to-Know Act (EPCRA).

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The Pharma Data

MAY 13, 2021

in the year 2019…. While in a major 2019 review published in Clinical Nutrition looked at 12 trials on cinnamon that included 786 human subjects…. So go ahead and choose your discounted package of HB5 right now…. And the answer is to simply click on one of the packages you see below right now…. Have a thriving career….

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Agency IQ

DECEMBER 1, 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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Agency IQ

JULY 12, 2024

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). and the E.C.

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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. 2019; 381(24):2293-2303. 1Mulangu, S, Dodd, LE, Davey, RT, et al. New England Journal of Medicine.

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Agency IQ

JANUARY 12, 2024

On July 31, 2019, the Department of Health and Human Services (HHS), in conjunction with the FDA, announced the release of a Safe Importation Action Plan which provided two potential pathways for the importation of certain drugs originally intended for foreign markets, including one focused on states importing drugs from Canada.

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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. . . 2018), cert.

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