FDA Law Blog

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials.

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Worldwide Clinical Trials

JUNE 15, 2022

To discuss your study and how to reduce the chances of receiving a clinical hold, talk with us. . The pandemic has had a lasting impact on the ability of sites to participate in trials, particularly in the US. It really is—there has been a 10x increase in cell and gene therapies in the clinical development pipeline since 2012.

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pharmaphorum

SEPTEMBER 21, 2020

COMP360 is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. MindMed has a combination of the MDMA and LSD in a phase 1 clinical trial scheduled to start this year, to see if the drugs can be used to aid a psychedelic-assisted therapy session.

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Delveinsight

JULY 27, 2021

Remarkable drop was observed in altered filamin A plasma levels after treatment with simufilam in Phase 2b trials. a biotechnology (clinical stage immuno-oncology) company from California publicized the design of its new XPro therapy in Phase 2 clinical trials. P-tau 181 plasma levels were also reduced in a good amount.

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Disclaimer. About Sandoz.

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Pharmaceutical Technology

FEBRUARY 27, 2023

Hydrocortisone is under clinical development by Antares Pharma and currently in Phase I for Adrenal Insufficiency. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Metastatic Adenocarcinoma of The Pancreas. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Gastric Cancer. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Adenocarcinoma Of The Gastroesophageal Junction. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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pharmaphorum

MARCH 29, 2022

Less than six months after the late-stage failure of tofersen, Biogen and Ionis have suffered further disappointment in the amyotrophic lateral sclerosis (ALS) pipeline after BIIB078 (IONIS-C9Rx) failed to demonstrate clinical benefit in a Phase 1 trial. This is the latest in a string of setbacks for both companies in recent months.

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pharmaphorum

MAY 4, 2022

In testing new treatments, what is promising in animal models may not transfer particularly well to humans, which helps to explain why there is a 90% failure rate during clinical development. Once selected, Quris can in-license them, progress them through to phase 1 trials and, those that succeed, can be licensed to pharma companies.

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pharmaphorum

OCTOBER 2, 2020

COMP360 is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5 million with its IPO shortly after the announcement.

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The Pharma Data

JANUARY 10, 2021

Each of the first three dose cohorts contain up to six patients on ASLAN004 and two patients on placebo, and the expansion cohort will contain at least 12 patients on ASLAN004 and at least six patients on placebo. This release contains forward-looking statements. For additional information please visit www.aslanpharma.com.

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The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Disclaimer. About Sandoz.

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pharmaphorum

SEPTEMBER 9, 2020

It’s a bleak day in the fight against COVID-19, after the UK banned social gatherings of more than six people to contain growing numbers of new cases and the lead vaccine trial from AstraZeneca was halted because of a safety concern.

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The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company. “We

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The Pharma Data

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

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Advarra

FEBRUARY 24, 2023

In most cases, the results you are really looking for and trying to prove in a trial can be complex. One area receiving increased focus from the Food and Drug Administration (FDA) are trial designs incorporating multiple endpoints to support efficacy. All key questions to consider and address before the therapy even leaves the lab.

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The Pharma Data

AUGUST 31, 2021

In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy.

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pharmaphorum

APRIL 6, 2022

The ‘ gamification ’ of website design, app development, investment platforms, or just about any activity that exists on the internet, will contain examples of how this strategy maintains user engagement. Clinical development is no game.

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XTalks

DECEMBER 5, 2023

Augtyro, a tyrosine kinase inhibitor (TKI), is available as oral capsules, each containing 40 mg of repotrectinib. The drug’s efficacy and safety were evaluated in the TRIDENT-1 study, an open-label, single-arm Phase I/II trial, focusing on both TKI-naïve and TKI-pretreated patients. percent (95 percent CI: 46.2 percent, 79.2

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The Pharma Data

JANUARY 17, 2021

The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA. The trial consisted of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part with dosing up to 1600mg/day.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has cleared Armata’s IND to initiate a clinical trial of its lead therapeutic candidate, AP-PA02, in Pseudomonas aeruginosa infections. . “Results from this study, which we are calling SWARM- P.a. The SWARM- P.a. About Armata Pharmaceuticals, Inc.

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The Pharma Data

JANUARY 13, 2021

PITTSBURGH–( BUSINESS WIRE )– Knopp Biosciences LLC today announced positive top-line results in a Phase 2 dose-ranging trial of the novel oral drug dexpramipexole in patients with moderate-to-severe eosinophilic asthma. The trial was conducted at 28 U.S. 14, 2021 11:00 UTC. study centers. ABOUT THE EXHALE STUDY.

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XTalks

OCTOBER 29, 2024

Protocols drive every clinical study, guiding research teams from early inception through planning and into the trial’s execution. Clinical trial protocols are also very complex, with detailed schedules of assessments, inclusion/exclusion criteria and scientific reasoning all captured into a single written document.

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The Pharma Data

JANUARY 13, 2021

Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. About the Phase 1/2 Trial for HPN217. HPN217 is covered by a global development and option agreement with AbbVie Inc. NYSE: ABBV). About Harpoon Therapeutics.

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The Pharma Data

OCTOBER 26, 2020

Forward-Looking Statements This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Synlogic anticipates that subsequent events and developments will cause its views to change.

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The Pharma Data

JANUARY 10, 2021

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development.

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The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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XTalks

JUNE 14, 2023

The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. The solution of Vevye does not contain water, anti-microbial preservatives, oils or surfactants.

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The Pharma Data

DECEMBER 21, 2020

Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). ALLSCHWIL, Switzerland, Dec.

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The Pharma Data

DECEMBER 10, 2020

“We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. Safe Harbor Statement.

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Pfizer

SEPTEMBER 28, 2022

This study is consistent with regulatory guidance and follows the design of the previous Phase 1/2/3 trial to evaluate further options for protection in this age group. . Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus .

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The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. On Thursday, October 22, Moderna completed enrollment of the Phase 3 COVE study. About Moderna. Forward-Looking Statements.

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The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics.

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