Alta Sciences

OCTOBER 29, 2024

PBSS - San Francisco Bay—Clinical Pharmacology Studies on Hepatic and Renal Impairments for NDA Filing iianiro Tue, 10/29/2024 - 16:53 Image gettyimages-1330763893-640x640.jpg jpg Synopsis Foster City, CA URL [link] Event End Date Fri, 11/01/2024 - 12:00 Event Start Date Fri, 11/01/2024 - 12:00 Weight 1

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Alta Sciences

MAY 28, 2024

Altasciences Receives 2024 CRO Leadership Award for Capabilities aasimakopoulos Wed, 05/29/2024 - 17:54 Laval, Québec, May 29, 2024 – Altasciences announced today that it has been recognized for excellence in contract research with a 2024 CRO Leadership Award for Capabilities.

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Alta Sciences

JULY 25, 2024

Top 10 Life Science Resources for Summer 2024 pmjackson Thu, 07/25/2024 - 14:44 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for your convenience. Catch up on what you might have missed below!

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FDA Law Blog: Drug Discovery

JULY 17, 2024

Earlier this month the FDA announced the first meeting of the GeMDAC will be held on August 2, 2024 to discuss a novel treatment for Niemann-Pick disease type C (and Frank and James are looking forward to being there!). clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

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Alta Sciences

JANUARY 23, 2024

Altasciences Appoints New General Manager, Clinical Operations pmjackson Tue, 01/23/2024 - 19:52 Laval, Québec, Monday, January 29, 2024 — Altasciences announced the appointment of James Brazeal as General Manager, Clinical Operations, at its clinical facility in Kansas City.

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Alta Sciences

FEBRUARY 8, 2024

Utilizing 10 state-of-the-art simulators available in-house at our Montréal clinical facility (with the capacity for more than 20), we are equipped to measure a range of studies; from impairment in cognition and comparing compounds to assessing the impact on new formulations have on impairment.

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Alta Sciences

NOVEMBER 20, 2024

Altasciences Supports Metsera in Their Early-Stage Clinical Trials for Obesity pmjackson Wed, 11/20/2024 - 17:04 Laval, Québec, November 21, 2024 — Altasciences is proud to have supported Metsera, Inc. , Altasciences helps sponsors get better drugs to the people who need them, faster.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. We’re about to find out.

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Alta Sciences

OCTOBER 9, 2024

Altasciences’ Chief Scientific Officer Named a PharmaVoice 100 Honoree pmjackson Wed, 10/09/2024 - 17:59 Greater Montréal, Québec, October 9, 2024 — Altasciences is proud to announce that Dr. Beatrice Setnik, PhD, has been honored as a PharmaVoice 100 winner. These honorees are inspirations.

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New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]

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Agency IQ

SEPTEMBER 15, 2023

FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. First, Cathy Gelotte, a clinical pharmacology consultant, made the case that low bioavailability does not necessarily indicate a lack of efficacy. Read AgencyIQ analysis here. ].

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Agency IQ

FEBRUARY 23, 2024

On the first day, discussants looked at how to tackle first-in human trials, weighed the importance of the maximum tolerated dose, and looked at the evolving concept of the clinical utility index. Key Documents and Dates FDA-AACR Public Workshop: Optimizing Dosages for Oncology Drug Products , February 16-17, 2024

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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. We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below.

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Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. Read Agency IQ’s breakdown of the 2024 CDRH guidance agenda here].

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Alta Sciences

AUGUST 28, 2023

Ischemix expects to complete all of the work required for a Phase II trial of CMX-2043 in acute TBI by the end of 2023, and plans to request a pre-IND meeting with FDA for early Q1 2024. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions.

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Agency IQ

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. The anticipated date of publication is June 2023, meaning we should see this regulation imminently. fit in this definition.

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Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.

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Agency IQ

DECEMBER 11, 2023

What to look for in 2024: This year, OCE amassed a significant volume of feedback from its advisory committee members and from stakeholders via the rulemaking process on trial design. What to expect in 2024? As AgencyIQ stated previously , this point is well-aligned with the goal of OCE’s Project FrontRunner.

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Agency IQ

OCTOBER 27, 2023

The date on which the FDA would no longer have Congressionally-appropriated funding with which to continue its operations POLITICO / AgencyIQ November 27 DSCSA Technically goes into full effect While the FDA has technically extended enforcement of certain provisions under the Drug Supply Chain Security Act until November 2024, certain provisions of (..)

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Agency IQ

JUNE 2, 2023

OIG claims a review will be complete in 2024. FDA pushes to bring dietary supplements into regulatory compliance with a 180-day amnesty period FDA asked the HHS Office of the Inspector General to review FDA’s Accelerated Approval pathway following the approval of Biogen’s Aduhelm (aducanumab).

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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

SEPTEMBER 29, 2023

AgencyIQ November 27 DSCSA Technically goes into full effect While the FDA has technically extended enforcement of certain provisions under the Drug Supply Chain Security Act until November 2024, certain provisions of the law are still due to come into effect in late November. Review to take place within 21 days.

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Agency IQ

DECEMBER 1, 2023

Now, the FDA has issued its first post-PHE version of this guidance Although the previous version of the guidance was revised to remain in effect until March 7, 2024, it has now been replaced. In addition, the guidance suggested that sponsors conduct antibody testing throughout the study to identify asymptomatic cases.

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Agency IQ

DECEMBER 1, 2023

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. Morgan Chase 42 nd Annual J.P. The report must be published within 120 days of each new fiscal year.

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Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. The latest update, announced this week, is known as the Spring 2024 Unified Agenda.

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Drug Target Review

JANUARY 20, 2025

Adaptive Clinical Trial Design in Oncology: An Overview. Clinical Pharmacology & Therapeutics, 86 (1), 97100. She eventually progressed to the role of Senior Medical Director and was appointed Vice President of Medical & Scientific Services at Simbec-Orion in 2024. Food and Drug Administration. FDA.gov biotx.ai

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New Drug Approvals

APRIL 18, 2025

1] [2] [3] Iomeprol was approved for medical use in the United States in November 2024. [1] 1] [2] [3] Iomeprol was approved for medical use in the United States in November 2024. [1] 6] Legal status Iomeprol was approved for medical use in the United States in November 2024. [1] 1 October 2024. January 2025.

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Drug Target Review

NOVEMBER 27, 2024

2023 [cited 2024 Oct 22]. Clinical Pharmacology & Therapeutics. Outsourcing Biomarkers in Clinical Trials: Advantages and Disadvantages. Why your new cancer biomarker may never work: recurrent patterns and remarkable diversity in biomarker failures. Cancer research. 2012 Dec 1;72(23):6097-101. Pacific BioLabs.

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New Drug Approvals

APRIL 21, 2025

6] Acoramidis was approved for medical use in the United States in November 2024, [6] [7] [8] [9] and in the European Union in February 2025. [2] 6] Acoramidis was approved for medical use in the United States in November 2024, [6] [7] [8] [9] and in the European Union in February 2025. [2] 26 November 2024. 26 November 2024.

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