FDA Law Blog: Biosimilars

MARCH 4, 2024

For purposes of these notification requirements, finished products are prescription drugs and biological products that are (1) life supporting, life sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, and (2) not radiopharmaceutical drug products or any other products specifically designated by FDA.

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The Pharma Data

JANUARY 13, 2021

Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA. . NEW YORK , Jan. MindMed Co-CEO J.R. MindMed trades on the Canadian exchange NEO under the symbol MMED.

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The Pharma Data

NOVEMBER 20, 2020

Importantly, we continue to advance our rigorous clinical trial program evaluating the safety and efficacy of the antibody cocktail for both the treatment and prevention of COVID-19, and we will share new results as available.”. Food and Drug Administration (FDA). Department of Health and Human Services.

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The Pharma Data

OCTOBER 30, 2020

NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc.

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The Pharma Data

DECEMBER 29, 2020

The benefit was driven by results starting one week post-treatment, when the risk of death or receiving mechanical ventilation was reduced by approximately half with antibody cocktail treatment, based on a post-hoc analysis. The results passed the futility analysis (p<0.3 Under an agreement with the U.S.

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The Pharma Data

DECEMBER 17, 2020

These follow-on data provided the first definitive prospective evidence demonstrating anti-viral activity for a treatment regimen now available for COVID-19, and also further documented the ability of this treatment to decrease the need for further medical attention,” said George D. Yancopoulos , M.D.,

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The Pharma Data

NOVEMBER 5, 2020

These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron’s and its collaborators’ ability to continue (..)

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FDA Law Blog: Biosimilars

JUNE 2, 2023

Stacking” refers to aggregating discounts provided by a manufacturer to different customers on the same unit of drug – for example a discount to a pharmacy and a rebate to a third-party payor – when determining best price. Allergan Sales , which affirmed a lower court decision in a Federal False Claims case involving best price stacking.

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The Pharma Data

JANUARY 12, 2021

Patients, caregivers and healthcare providers can find sites with COVID-19 antibody treatments through these links to the HHS or National Infusion Center Association locator tools. . Regeneron is responsible for development and distribution of the treatment in the U.S. , .” The U.S. In the U.S.

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The Pharma Data

DECEMBER 5, 2020

Among all patients responding to treatment, 95% experienced a very good partial response or better; among responding patients with ?6 “As these data continue to mature, we look forward to assessing whether responses will further deepen and remain durable with ongoing REGN5458 treatment.” TARRYTOWN, N.Y. ,

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The Pharma Data

OCTOBER 28, 2020

Food and Drug Administration as part of its review of our Emergency Use Authorization submission, and we continue to focus on completing our ongoing trials evaluating REGN-COV2 for the treatment and prevention of COVID-19.” Serious adverse events were numerically more frequent with placebo than REGN-COV2 treatment (0.8%

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The Pharma Data

NOVEMBER 21, 2020

21, 2020 /PRNewswire/ — First treatment of any kind to have prospectively confirmed and statistically significant anti-viral activity against SARS-CoV-2. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. TARRYTOWN, N.Y. ,

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The Pharma Data

OCTOBER 27, 2020

License-related fees (5). License-related fees (5). The BREEZE study (NCT03950739) seeks to evaluate 45 patients on a stable dose of Tyvaso after switching to our new dry powder inhaler (DPI) form of treprostinil, which we licensed from MannKind Corporation. .

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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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Agency IQ

SEPTEMBER 29, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

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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. No new safety signals potentially related to the use of baricitinib were identified. Wesley Ely, M.D.,

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Policy Prescription

MARCH 11, 2022

It’s important because this case was wrongly used as a pretext to oppose safe personal drug importation and international online pharmacies, which help Americans afford prescription drugs. The Winnipeg Free Press has an excellent story on that. Kris Thorkelson never pled guilty to selling counterfeit drugs. supply chain.

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Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. Following on from their exclusive license agreement with UCL in January 2022, subsequent preclinical and clinical development was undertaken by Qualigen Therapeutics Inc.

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Agency IQ

AUGUST 16, 2024

Many commenters took issue with the guidance’s statement that, “The contribution of the psychotherapy component to any efficacy observed with psychedelic treatment has not been characterized. In the clinical studies, this consisted of a four-month course of treatment with three doses of MDMA administered in supervised therapy sessions.

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The Pharma Data

JANUARY 24, 2021

Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases. Food and Drug Administration (“FDA”) approval. billion during 2019-2023 (Technavio 2019).

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Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. Following on from their exclusive license agreement with UCL in January 2022, subsequent preclinical and clinical development was undertaken by Qualigen Therapeutics Inc.

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The Pharma Data

NOVEMBER 5, 2020

Lastly, we are proud that our novel antibody cocktail REGN-EB3 recently became the first FDA-approved treatment for Ebola, underscoring the potential of antibody therapies to address deadly infectious diseases.” ” “We continue to invest in our promising pipeline while delivering meaningful revenue and earnings growth.

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Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

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Agency IQ

FEBRUARY 15, 2024

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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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3202 Orphan Drug Program : FDA will convene a public meeting (or several) to solicit input from stakeholders regarding rare disease patient burdens, treatment options, side effects of treatments, etc. The following PDUFA dates were obtained from publicly available sources.

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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

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. About Inmazeb. HHSO100201700016C and HHSO100201500013C. . 5 x ULN).

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Drug Target Review

MARCH 13, 2025

The development of targeted drugs for genetically defined patient subgroups has significantly improved the efficacy of treatments, while reducing the risks of adverse effects. He also develops and presents customised training programmes (both live and virtual) for companies seeking to improve their in- and out-licensing processes.

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Drug Target Review

FEBRUARY 11, 2025

These hurdles not only delay patient access to innovative treatments but also threaten the economic sustainability of research and development (R&D) and the advancement of medical innovation. These failures not only increase overall costs, but also slow down scientific progress, delaying potential treatments for patients.

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FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

All DEA-registered practitioners may continue to prescribe via audio-visual telemedicine encounters schedule II-V controlled substances, and schedule III-narcotic controlled substances that are FDA-approved for opioid use disorder management and treatment.

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Drug & Device Law

JANUARY 4, 2024

Alabama State Board of Pharmacy , 61 F.4th by] authoriz[ing] the [HHS] Secretary to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines. . . . Okuley’s Pharmacy & Home Medical , N.E.3d 247d-6d(b)(8). “To 4th 902, 905 (11th Cir.

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Drug & Device Law

DECEMBER 29, 2023

Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence. They had no warning causation case, either, because their own experts had testified that, at the blood levels they exhibited, no doctor would change their treatment.

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Drug & Device Law

MAY 19, 2023

at *1, by threatening to revoke the license, and jail for at least three years, any West Virginia physician so bold as to prescribe the plaintiff’s FDA-approved drug for its FDA-approved use. Sorsaia , 2023 WL 3211847, at *2. Its] FDA approval allows it to sell mifepristone nationwide. . . . [T]he T]he growing market for mifepristone. . .

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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. 247d-6d(b). 2023 WL 3135662, at *3-5 (detailed PREP Act discussion). pharmacist. . . That was it.

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Drug & Device Law

FEBRUARY 20, 2023

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. In at least the short term, a popular pain reliever would have to be removed from pharmacies. Wyeth Laboratories, Inc. ,

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