Advarra

AUGUST 2, 2022

The pandemic proved decentralized clinical trials (DCTs) can reduce patient burden while delivering quality data in a streamlined environment. Could our Trial Lend Itself Well to a DCT Model? Clinical trials are slow and costly, built around the research centers studying local participants.

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The Pharma Data

APRIL 19, 2022

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The median progression-free survival (PFS) was 8.2

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The Pharma Data

MAY 6, 2021

Denmark posts guidance on decentralizing clinical trials. New guidance on decentralized clinical trials from the Danish Medicines Agency (DKMA) is setting the stage for greater use of digital tools that reduce the need for participants to visit study centers. . Those measures are due to expire on 1 December.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. That did not happen.

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The Pharma Data

AUGUST 20, 2020

. “If you can get a CE mark [indicating compliance with the relevant legislation] for a bad test as there is no scrutiny on whether it works, it is just a marketing claim that is registered and we are left in a Wild West of antibody testing. “For drug licensing the onus is on the companies to go through clinical trials.

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The Pharma Data

SEPTEMBER 7, 2021

Bristol Myers Squibb has a global exclusive license to develop, manufacture and commercialize the Rockefeller University’s novel monoclonal antibody (“mAb”) duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19. Our Clinical Trials and Research. Contributions to Research, Life-Sciences Industry.

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The Pharma Data

DECEMBER 30, 2020

The proceeds from the Transaction would be primarily used to fund international multi-center trial for MVR-T3011-IT, IND filing and swift initiation of clinical trials for two additional pipeline candidates, as well as the discovery and validation of new product candidates developed on the OvPENS platform.

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The Premier Consulting Blog

JANUARY 17, 2023

How is PREA compliance handled in this case? However, it is important to remember that, according to the FDA’s current thinking, children should only participate in clinical trials when their participation is needed to further the scientific understanding of a product’s use in children.

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The Pharma Data

JANUARY 3, 2021

and in Asia and for our R&D pipeline, including the Phase 1 trial of EYP-1901 in wet age-related macular degeneration that is expected to commence in the coming months.”. “We We are excited about the significant potential of these products in both the U.S.

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Agency IQ

JANUARY 4, 2024

Part of the strategic priorities are to increase supervisory and surveillance activities , so the regulator is increasing inspections of clinical trials, hospitals and other economic operators in the devices sector. It is also increasing economic operator inspections. It is also increasing economic operator inspections.

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The Premier Consulting Blog

NOVEMBER 8, 2022

prefilled syringe) A drug used with a specified device in clinical trials — but that may be used with other devices once marketed (e.g., Determining if you have a combination product The high-level definition of combination product seems straightforward: a product with at least two constituent parts, such as: Drug/biologic (e.g.,

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The Pharma Data

DECEMBER 23, 2020

Algernon is a drug re-purposing company that investigates safe, already approved drugs for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. About Algernon Pharmaceuticals Inc. .

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Agency IQ

JUNE 2, 2023

The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

MAY 3, 2024

The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

JANUARY 27, 2021

We look forward to working with Eurofins Discovery to bring this treatment to patients as quickly as possible as we prepare for our IND and trials,” said BetterLife’s Chief Executive Officer, Dr. Ahmad Doroudian.

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The Pharma Data

NOVEMBER 15, 2020

a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004. Before joining Acorda, Ms.

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The Pharma Data

DECEMBER 20, 2020

Transcend is a research focused biotechnology company creating and clinically validating an evolving IP portfolio of novel molecules and drug delivery mechanisms for clinical trials and commercialization. No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release.

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The Pharma Data

OCTOBER 18, 2020

AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF mAb) in head and neck cancer, acute myeloid leukemia and pancreatic cancer and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab in head and neck cancer.

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Agency IQ

JUNE 29, 2023

AgencyIQ’s guidance agenda tracker FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

SEPTEMBER 16, 2020

About CodeBreaK The CodeBreaK clinical trial program for Amgen’s investigational drug sotorasib is designed to treat patients with multiple KRAS G12C -mutant solid tumors and address the longstanding unmet medical need for these cancers. The Phase 2 CRC trial is expected to have a data readout in early 2021.

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Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

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Molecule Blog

MARCH 17, 2023

The university then licenses the IP to an existing pharmaceutical company or a biotech startup, which takes on Investigational New Drug (IND) enabling studies. Data federation has compelling benefits, especially in areas like clinical trial recruitment.

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The Pharma Data

OCTOBER 29, 2020

In the third quarter, we further progressed our LEAD-EXPAND-DIVERSIFY strategy with multiple regulatory approvals, the initiation of new Phase 3 trials and the integration of the Portola team,” said Ludwig Hantson , Ph.D., Chief Executive Officer of Alexion. ” Third Quarter 2020 Financial Highlights.

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The Pharma Data

JULY 27, 2021

The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected.

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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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The Pharma Data

SEPTEMBER 20, 2020

About CodeBreaK The CodeBreaK clinical trial program for Amgen ‘s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. The Phase 2 CRC trial is expected to have a data readout in 2021.

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The Pharma Data

AUGUST 6, 2020

announced that the companies submitted the Biologics License Application (BLA) to the U.S. In June, the company announced results from True North, a pivotal Phase 3 trial evaluating oral Zeposia as an induction and maintenance therapy for adult patients with moderate to severe ulcerative colitis. Regulatory.

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Agency IQ

MAY 10, 2024

Similarly, while the agency’s guidance on the conduct of decentralized trials doesn’t “endorse any specific method” for remotely confirming patient/participant identify digitally, it does point sponsors to NIST’s Digital Identity Guidelines. health and tech), or delays while the FDA works to establish its own systems.

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Agency IQ

SEPTEMBER 1, 2023

In medical product research, RWD is considered any data captured outside of the confines of a clinical trial, such as claims or electronic health record (EHR) data or records from clinical registries, while RWE is evidence generated from analyzing those data.

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The Pharma Data

DECEMBER 23, 2020

based Avacta Group entered into a license agreement with Astrea Bioseparations that allows that company to use Avacta’s Affimer platform in affinity purification applications. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020.

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The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

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The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

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The Pharma Data

JANUARY 9, 2021

Pipeline progress is expected across the vaccines, therapeutics, and devices portfolios, anticipating at least one Phase 3 launch and one Biologics License Application (BLA)/Emergency Use Authorization (EUA) filing. FOOTNOTES. (1)

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The Pharma Data

APRIL 27, 2021

reflecting increased competition partially offset by demand growth partly related to clinical trial supply and price upside in Europe. reflecting lower treatment compliance during the COVID-19 pandemic. The second pivotal trial to study itepekimab in chronic obstructive pulmonary disease (COPD) (AERIFY-2) enrolled its first patient.

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The Pharma Data

AUGUST 3, 2021

The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer’s disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. Numbers may not add due to rounding.

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The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. We believe this collaboration will create opportunity to more broadly distribute vaccine doses to people in harder-to-reach communities, especially those on the African continent.”. myocarditis and pericarditis.

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The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. 8) There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial.(8)

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