The Pharma Data

JANUARY 13, 2021

14, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company today announced the addition of Robert Barrow , an accomplished pharmaceutical executive, as Chief Development Officer. We are excited to attract such top tier talent from the psychedelic drug development community.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir. Under the EUA, inpatient pharmacies in the U.S. Adverse Reactions. BC HCP EUA ISI 28JUL2021.

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The Pharma Data

NOVEMBER 5, 2020

Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021. Department of Health and Human Services under OT number: HHSO100201700020C. If REGN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S.

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The Pharma Data

OCTOBER 30, 2020

Food and Drug Administration , which is currently evaluating REGN-COV2 for a potential Emergency Use Authorization in mild-to-moderate outpatients at high risk for poor outcomes. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021. Regeneron is also informing the U.S.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Conditions for Coverage after January 1, 2025: Any manufacturer that wishes to have its applicable drugs covered under Medicare Part D after January 1, 2025 (“participating manufacturers”) must execute a Discount Program agreement with CMS by March 1, 2024. Non-applicable drugs (e.g.,

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The Pharma Data

OCTOBER 27, 2020

INCREASE sNDA under FDA review with April 2021 action date; Remunity launch preparations continue. License-related fees (5). License-related fees (5). In August 2020 , the FDA accepted the sNDA for review, which we expect will be complete in April 2021.

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The Pharma Data

NOVEMBER 20, 2020

Food and Drug Administration (FDA) has approved Zokinvy (lonafarnib) for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies (PL). . Eiger licensed exclusive worldwide rights to lonafarnib from Merck, known as MSD outside of the United States and Canada.

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The Pharma Data

DECEMBER 29, 2020

Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. 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. In the U.S.

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The Pharma Data

NOVEMBER 5, 2020

In 2021, we look forward to important potential launches including for our PD-1 inhibitor Libtayo in non-small cell lung cancer and advanced basal cell carcinoma. Regulatory submissions in the United States and European Union (EU) are planned by the first quarter of 2021. Oncology Program. Evinacumab , an antibody to ANGPTL3.

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The Pharma Data

DECEMBER 17, 2020

Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in patients 12 years of age and older and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

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The Pharma Data

JANUARY 12, 2021

12, 2021 /PRNewswire/ — . Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021 , up to 1.25 None of the SAEs were considered to be related to study drug. TARRYTOWN, N.Y. , New agreement covers 1.25 supply to over 1.5

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The Pharma Data

DECEMBER 5, 2020

We are also expanding our odronextamab program with multiple pivotal trials in 2021.” We are currently enrolling patients in a potentially registrational Phase 2 portion of this REGN5458 trial.

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The Pharma Data

OCTOBER 28, 2020

“The first job of an antiviral therapeutic drug is to lower the viral load, and our initial data in 275 patients strongly suggested that the REGN-COV2 antibody cocktail could lower viral load and thereby potentially improve clinical outcomes. . Regeneron has shared these results with the U.S.

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Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products.

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Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

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Agency IQ

JUNE 16, 2023

Perhaps the most important addition to FDA’s agenda is a proposed rule intended to clarify that Laboratory Developed Tests (LDTs) are to be regulated as medical devices under the Federal Food, Drug and Cosmetic Act (FD&C Act). Read our analysis of that rule here and here. ]

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Agency IQ

SEPTEMBER 29, 2023

Many of those activities are tied to various user fee program commitments; a few others are related to other major pieces of legislation like last year’s Food and Drug Omnibus Reform Act (FDORA). We’re expecting to get a better sense in October about which of these bills might eventually start to move forward and potentially become law.

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Agency IQ

DECEMBER 1, 2023

December also has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may soon receive greater clarity about the FDA’s thinking about prescription drug importation plans. December also typically brings end-of-year perspectives on the agency’s accomplishments.

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The Pharma Data

NOVEMBER 20, 2020

Food and Drug Administration (FDA). In the first quarter of 2021, we expect to increase available global supply as we continue our collaboration with Roche.”. 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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Agency IQ

OCTOBER 27, 2023

December has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may start the month of November with greater clarity about the FDA’s thinking about prescription drug importation plans.

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The Pharma Data

NOVEMBER 21, 2020

Food and Drug Administration (FDA). In the first quarter of 2021, we expect to increase available REGEN-COV2 global supply as we continue our collaboration with Roche.” 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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Agency IQ

FEBRUARY 15, 2024

Priority A List. CDRH FY2024 Guidance Agenda Device software Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers CDRH Final By 10/1/24 Priority B List CDRH FY2024 Guidance Agenda Post-approval reporting 3D Printing Medical Devices at the Point of Care CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority B List.

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Policy Prescription

APRIL 1, 2022

Department of Justice, according to Seeking Alpha , is investigating the sale and distribution of counterfeit drugs in the U.S. drug supply chain consisting of $250 million in counterfeit HIV drugs that were sold throughout the U.S. from licensed pharmacies to American patients.

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Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. United States Department of Health and Human Services , 58 F.4th 4th 696 (3d.

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Drug & Device Law

JANUARY 4, 2024

To the contrary, the COVID-19 vaccine in question was fully approved by the FDA as safe and effective on August 23, 2021, and has remained so (or updated versions have) ever since. Alabama State Board of Pharmacy , 61 F.4th Okuley’s Pharmacy & Home Medical , N.E.3d The FDA, however, did not and does not share that belief.

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Drug & Device Law

FEBRUARY 20, 2023

Drug manufacturers often could trade a little less efficacy for a little more safety, but the safest design is not always the best one. Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations.

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Drug & Device Law

MAY 15, 2023

The relevant facts were quite concisely stated: In the fall of 2021, [plaintiff’s] 15-year-old [daughter] visited [defendant’s] pharmacy seeking to be vaccinated for COVID-19 without parental consent. includ[es] retail pharmacies. 2021); Texas Health Huguley, Inc. 2021); Frey v. 10, 2021); DeMarco v.

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