Drug Target Review

FEBRUARY 1, 2024

In other cases, well-established biomarker profiles enable patient enrichment strategies in early-stage clinical development. Provided that existing clinical data are compelling, the disease areas we can consider are unlimited. The organizing principle is the data package. Is the mechanistic rationale bona fide?

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FDA Law Blog: Drug Discovery

SEPTEMBER 27, 2023

The meeting package for Type D meetings should be included with the meeting request. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. The goal for meeting minutes is the same as all other meeting types – 30 days after the meeting.

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The Pharma Data

NOVEMBER 18, 2021

Gilead has been encouraged by early clinical data generated for each of the three programs. By concluding in early to all three programs now, Gilead and Arcus are suitable to accelerate the clinical development and advancement of these clinical- stage motes and grease the disquisition of treatment combinations across the portfolios.

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The Premier Consulting Blog

JULY 31, 2024

A key difference is that the Sponsor of a 505(b)(1) NDA owns or has right of reference to the safety and effectiveness information versus the Sponsor of a 505(b)(2) NDA leverages information from other drug approval packages and/or published information they do not own or have right of reference to.

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The Pharma Data

MAY 2, 2022

Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package. Food & Drug Administration.

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PPD

SEPTEMBER 6, 2023

It’s an effective way to manage capacity and labor uncertainty and provides drug developers the option to retain knowledgeable, proven personnel. Through rebadging, sponsors can maintain continuity on key development programs while avoiding costly severance packages and payouts.

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The Premier Consulting Blog

OCTOBER 11, 2022

However, acceptance of that data depends on a sponsor’s understanding of the FDA criteria for historical control groups, study data standards, and clinical meaningfulness. In this article, we review two case studies involving the successful use of RWD or RWE in advancing the clinical development of treatments for rare diseases.

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The Pharma Data

NOVEMBER 4, 2020

In addition, clinical biomarker data confirm proof of mechanism in patients. “The solid clinical package from Phase I and the new favorable benchmark data to our key competitors further strengthen our belief in mitazalimab as a potent immunotherapy agent. and AC101 in clinical development by Shanghai Henlius Biotech Inc.).

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The Pharma Data

JANUARY 31, 2021

Metrion Biosciences’ ion channel expertise includes an industry leading panel of in vitro cardiac ion channel safety assays, translational native cell and phenotypic assays for neurological and cardiotoxicity testing, and a range of other ion channel screening services such as cell line development and optimization.

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The Pharma Data

DECEMBER 8, 2020

Now poised to advance a robust therapeutics pipeline to clinical development, Nuance will use the funds for ongoing R&D of existing products and business development of potential new assets. Already having been in clinical studies at Roche, all four candidates have strong clinical and preclinical safety packages.

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

These meetings have a question-and-answer format to provide clarity to sponsors about the particular topics at hand.

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LifeSciVC

AUGUST 21, 2024

I am fortunate to have a great Tech Ops team at Lifordi who is on top of managing all the moving parts across the globe for making tox and clinical supply for us. We will have to support an evolving clinical development plan and to keep manufacturing off the critical path.

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The Premier Consulting Blog

MARCH 7, 2024

The analytical package, consisting of release, stability, and characterization tests, includes data generated throughout the product development and manufacturing process. For example, analytical procedures may be used to test raw materials or starting materials for purity, identity, and safety.

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The Pharma Data

JANUARY 13, 2021

.” MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare.

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Drug Target Review

SEPTEMBER 10, 2024

However, developing an accelerated IND application requires that good laboratory practice (GLP) toxicological data must be generated, collected, interpreted and integrated in the IND-enabling data package.

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Advarra

JUNE 6, 2022

A: If the GCLP term referenced is interpreted as a combination of good laboratory practice (GLP) and good clinical practice (GCP), then the roadmap needs to include processes covering pre-clinical and clinical development stages.

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The Pharma Data

JUNE 28, 2021

Lilly intends to submit the full registration package to regulatory authorities by the end of 2021. The SURPASS phase 3 global clinical development program for tirzepatide has enrolled more than 19,000 people with type 2 diabetes across 10 clinical trials, five of which are global registration studies.

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The Pharma Data

OCTOBER 30, 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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Cytel

DECEMBER 27, 2023

Perspectives covers a wide range of topics related to data submission and data integration, from ISS and ISE best practices to leveraging automation to the use of Define-XML 2.1, and much more. Here are some of the top topics covered this year:

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The Pharma Data

OCTOBER 14, 2020

Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration (..)

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Vaccine Pharmaceuticals Small Molecule Virus 40

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” “The investigational cocktail is now available to indicated high-risk U.S.

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The Pharma Data

JUNE 28, 2021

Lilly intends to submit the full registration package to regulatory authorities by the end of 2021. The SURPASS phase 3 global clinical development program for tirzepatide has enrolled more than 19,000 people with type 2 diabetes across 10 clinical trials, five of which are global registration studies. mg, 5 mg and 7.5

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The Pharma Data

DECEMBER 5, 2020

REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.

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The Pharma Data

OCTOBER 28, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. . “We will submit detailed results from this trial for publication in order to share insights with the public health and medical communities,” said David Weinreich, M.D.,

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Agency IQ

APRIL 12, 2024

Similarly, ARM suggested that the term “candidate potency-related quality attribute” be used in the early stages of clinical development to discuss product attributes that are thought to be linked to potency, but where the “criticality (mechanistic relationship) of the attributes” to product potency has not yet been established.

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Drug Target Review

MAY 22, 2024

There are siRNAs in clinical development for liver-associated AATD, but there are no approved therapeutics available and presently the only treatment option is liver transplantation. We are now running follow-up experiments to track the advantage long-term. We are also exploring other vector formats, delivery strategies and payloads.

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The Pharma Data

AUGUST 30, 2021

“We are pleased to offer two potential new treatment options with KEYTRUDA for patients in Japan based on compelling data from our clinical trial program,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. months (95% CI, 7.6-11.3)

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LifeSciVC

APRIL 27, 2023

By the time Chapter 1 was nearing its end, Project Troubled Water, then Nimbus Discovery, became Nimbus Therapeutics as we took a further step to forward integrate into clinical development. Our long-time clinical development lead, Bhaskar Srivastava, an M.D. dermatologist, could not contain his excitement.

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The Pharma Data

NOVEMBER 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. The Company expects that the U.S.

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The Pharma Data

DECEMBER 29, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. . “We appreciate the continued support of patients and investigators around the world who are working to advance Regeneron’s antibody cocktail trials under very challenging circumstances,” said David Weinreich , M.D.,

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The Pharma Data

NOVEMBER 5, 2020

Key Pipeline Progress Regeneron has more than 20 product candidates in clinical development, including five marketed products for which it is investigating additional indications. Updates from the clinical pipeline include: Dupixent ® (dupilumab). Non-GAAP net income per share – diluted (1). $. Business Highlights.

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Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. The real cost is clinical development.

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The Pharma Data

JULY 6, 2021

At its Investor Update, GSK announced a package of new financial outlooks and ambitions. This business has benefited from operational integration with pharmaceuticals in key areas for many years, notably commercial operations and clinical development; but is also operationally independent where it is optimal, for example in manufacturing.

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The Pharma Data

MARCH 29, 2022

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 2 subvariant, now the dominant strain in Europe. 1-3 Evusheld was generally well-tolerated in the trial.

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Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

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The Pharma Data

DECEMBER 14, 2020

The filing of an IND will enable participation of US medical centers in future clinical studies of Rabeximod in Covid-19, rheumatoid arthritis and potential other indications. The IND package is based upon the favorable safety profile of Rabeximod shown in previous Phase 1 and Phase 2a studies.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

The draft guidance recommends that no more than 15 questions are included in the briefing package. CBER will not commit to reviewing packages greater than 250 pages. All the while, this efficiency in clinical development requires accelerating CMC by having early-stage studies serve as large stage studies.

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