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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Alta Sciences

AUGUST 28, 2023

Additionally, Co-chief Operating Officer, Marie-Hélène Raigneau, said of the study: “Our goal at Altasciences is to help companies like Ischemix expedite the drug development process without compromising on quality or safety. Altasciences helps sponsors get better drugs to the people who need them, faster. About Ischemix, Inc.

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New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] However, development for these indications was discontinued. [2]

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Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

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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. On November 23, the FDA published a new, direct-to-final post-PHE version of the document.

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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. Children experience rapid growth and maturation in body size and composition as well as organ function, which in turn impacts drug disposition and response.

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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

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

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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Alta Sciences

FEBRUARY 19, 2025

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

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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. This week, CDER published its guidance agenda for 2024.

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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

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

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.

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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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Drug Target Review

JANUARY 20, 2025

The oncology drug development landscape is evolving rapidly, driven by the deployment of targeted therapies in precision medicine and regulatory initiatives like the FDAs Project Optimus. It also covers strategies for drug developers who have yet to identify a biomarker, helping them advance their programs effectively.

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Drug Target Review

NOVEMBER 27, 2024

Introduction Biomarkers are becoming increasingly essential in drug development and clinical practice, driving the need for more precise validation methods. 1 The journey to qualifying biomarkers for clinical and regulatory use is fraught with challenges, leading to a remarkably low success rate.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. On the other hand, CBER provided no additional guidance as to when a clinical endpoint would be appropriate as an intermediate clinical endpoint to support accelerated approval.

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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. Tags Clinical Trials Weight 15

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