FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ). 21 U.S.C. § 355(i)(1)(A).

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Drug Discovery World

AUGUST 3, 2023

For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1. There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol).

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New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] Food and Drug Administration (FDA). 1] It is taken by mouth. [1]

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The Pharma Data

NOVEMBER 6, 2020

We appreciated the opportunity to share our data with the Advisory Committee, and we will continue to work with the FDA as it completes its review of our application.”. FDA Advisory Committees provide non-binding recommendations for consideration by the FDA. CAMBRIDGE, Mass. and TOKYO, Nov. About Aducanumab’s Clinical Program.

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Drug Discovery World

SEPTEMBER 26, 2022

To do this, the Drug Repurposing Hub has developed an open-access library of over 6,000 compounds, which are being tested against disease models in an effort to find new treatments using small molecules – many of which have already been approved by the FDA. . Diving into data . Volume 23 – Issue 4, Fall 2022. References .

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Sygnature Discovery

NOVEMBER 29, 2023

This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage. 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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Sygnature Discovery

NOVEMBER 29, 2023

This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage. 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

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 months (95 percent CI, 6.9 – NE). [7]. About RYBREVANT TM.

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The Pharma Data

JANUARY 3, 2021

Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application and that the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has authorized its Clinical Trial Application (CTA) for a Phase 1/2 clinical trial evaluating INZ-701 in adults with ENPP1 deficiency.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration (FDA) had granted Breakthrough Therapy designation for donanemab based on the Phase 2 data. Additionally, pharmacokinetic/pharmacodynamic modeling showed that greater relative amyloid plaque clearance was correlated with greater clinical benefit. In June 2021, Lilly announced the U.S.

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The Pharma Data

MAY 4, 2021

Baricitinib has not been approved for the treatment of COVID-19, but has been authorized for emergency use by the FDA. See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. It is approved in the U.S.

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The Pharma Data

APRIL 16, 2021

Food and Drug Administration (FDA) revoke the Emergency Use Authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg alone. for the treatment of COVID-19 – as planned with the FDA – follows the modification of contracts with the U.S. Bamlanivimab and etesevimab together have not been approved by the FDA for any use.

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The Pharma Data

APRIL 14, 2021

Bamlanivimab and etesevimab together and bamlanivimab alone have not been approved by the FDA for any use. Please see the FDA Letter of Authorization , Fact Sheet for Healthcare Providers , and Fact Sheet for Patients, Parents and Caregivers ( English ) ( Spanish ) for bamlanivimab and etesevimab together.

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The Pharma Data

JULY 23, 2021

The US EUA is temporary and does not take the place of the formal biologics license application (BLA) submission, review and approval process. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a high-volume molecular test to detect the virus. The antibody combination was authorised by the United States (U.S.)

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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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Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., License and research and development revenue. .

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Drug Discovery World

FEBRUARY 20, 2023

AstraZeneca’s Evusheld became the first antibody combination for pre-exposure prophylaxis (PrEP) against Covid-19 licensed in the UK. Prostate cancer A new metastatic prostate cancer drug was approved by the FDA in March, followed by the European Commission in December.

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The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences.

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Agency IQ

FEBRUARY 15, 2024

166 guidance documents the FDA is actively working on in 2024 (and beyond) The FDA is set to be very, very busy in 2024. For now, we haven’t included all documents previously released by the FDA in draft form unless specifically included on the agency’s draft agendas. New on CDRH’s guidance agenda. Priority A List.

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LifeSciVC

APRIL 24, 2024

In the absence of a clinical trial result or FDA label to point to, how does one create the case and target product profile (TPP) around a new target? Alternatively, are there potential existing assets that may be available for in-licensing, especially if the potential licensor has pivoted strategic directions (i.e.,

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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. TITUSVILLE, N.J. , Read full announcement here: [link].

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The Pharma Data

MARCH 26, 2021

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation.

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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Codon

APRIL 2, 2023

Read Safety and pharmacokinetics of escalating doses of neutralising monoclonal antibody CAP256V2LS administered with and without VRC07-523LS in HIV-negative women in South Africa (CAPRISA 012B): a phase 1, dose-escalation, randomised controlled trial. Ricciardi M.J. Science Translational Medicine. Will Bedingfield. ” Emma Marris.

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The Pharma Data

JANUARY 26, 2021

BLAZE-4 Additionally, initial results from the ongoing BLAZE-4 trial provide viral load and pharmacodynamic/pharmacokinetic data which demonstrated lower doses, including bamlanivimab 700 mg and etesevimab 1400 mg together, are similar to bamlanivimab 2800 mg and etesevimab 2800 mg together. It remains under review by the FDA.

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The Pharma Data

NOVEMBER 11, 2020

Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study. SLV213 was developed based on research from UC San Diego and the university exclusively licensed it to Selva Therapeutics.

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Agency IQ

FEBRUARY 12, 2024

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” This list is known as the FDA’s “guidance agenda.”

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The Pharma Data

DECEMBER 23, 2020

Food and Drug Administration (FDA), and further regulatory applications have been submitted and are being reviewed by other regulatory bodies worldwide, the company said. FRANKD is CE IVD-approved and FDA EUA-applied. Peijia received an exclusive license regarding certain proprietary TMVR products currently in development by HighLife.

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The Pharma Data

NOVEMBER 26, 2020

Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. Protalix has licensed to Pfizer Inc.

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The Pharma Data

DECEMBER 15, 2020

In late October, SetPoint Medical received Breakthrough Device Designation from the FDA for the use of its novel bioelectronic device by patients with rheumatoid arthritis (RA) who have incomplete response to, or are intolerant to multiple biologic drugs. The secondary outcome involves pharmacokinetic endpoints. Bioelectronic Platform.

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The Pharma Data

JANUARY 10, 2021

. TransCon hGH (lonapegsomatropin) : Lonapegsomatropin is an investigational long-acting prodrug of somatropin (human growth hormone or hGH) currently under review for use in pediatric growth hormone deficiency (GHD) by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA): .

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The Pharma Data

SEPTEMBER 15, 2020

Submission of an amended protocol to the FDA for the Phase 3 pivotal trial to expand recruitment to approximately 44,000 participants that allows for the enrollment of new populations. Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1.

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FDA Law Blog: Biosimilars

MAY 21, 2024

The State of Current Scientific Knowledge Regarding Marijuana HHS found that marijuana’s pharmacokinetic profile varies depending on the route of administration. Basis at 18; NPRM at 44,605. Basis at 24. Basis at 63; NPRM at 44,617. Basis at 63-64.

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The Pharma Data

DECEMBER 29, 2020

” In May 2020 , Protalix and Chiesi Global Rare Diseases announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease via the FDA’s Accelerated Approval pathway.

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The Pharma Data

MARCH 11, 2021

Food and Drug Administration (FDA) and a positive scientific opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Bamlanivimab and etesevimab together and bamlanivimab alone have not been approved by the FDA for any use.

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The Pharma Data

MARCH 5, 2021

Bamlanivimab and etesevimab together and bamlanivimab alone have not been approved by the FDA for any use. Please see the FDA Letter of Authorization , Fact Sheet for Healthcare Providers , and Fact Sheet for Patients, Parents and Caregivers ( English ) ( Spanish ) for bamlanivimab and etesevimab together.

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