Alta Sciences

JANUARY 23, 2024

“James’ proven leadership skills, and deep knowledge of all phases of clinical research, will be invaluable in delivering expert guidance for our clients along their early-phase clinical journey,” said Ingrid Holmes, Vice President, Clinical Operations, Altasciences.

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Alta Sciences

APRIL 10, 2025

Simone Iwabe, DVM, PhD, DACVO and Randy Wheeland, BS pmjackson Thu, 04/10/2025 - 19:59 As a leading partner in ocular therapy, Altasciences has been at the forefront of ophthalmic drug development for over 30 years, having completed more than 100 ocular studies to assess the safety of new drug products intended for human use.

Clinical Pharmacology 52

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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

In addition to clinical conduct, Altasciences supported Metsera with its proactive drug development solution , including nonclinical, bioanalysis, CRO and program management services for several additional therapeutic candidates. This work enabled Metsera to recently initiate a randomized 16-week Phase II trial of MET-097i.

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Alta Sciences

OCTOBER 9, 2024

Dr. Setnik made the list of 100 honorees for her hands-on leadership and nearly 20 years of experience in clinical drug development, with a focus on abuse potential studies. Each winner represents the transformative impact of the pharmaceutical industry in their own unique way.

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Alta Sciences

MAY 28, 2024

This marks the ninth year that Altasciences, a fully integrated drug development solution company, has been deemed a top performer. Clinical Leader and Life Science Leader teamed up with ISR Reports to assess 42 CROs on more than 20 performance metrics in ISR’s annual CRO Quality Benchmarking survey.

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Alta Sciences

SEPTEMBER 20, 2023

Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses pmjackson Wed, 09/20/2023 - 13:48 Laval, Québec, September 21, 2023 - Altasciences is pleased to have been chosen by Virpax Pharmaceuticals, Inc.

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Alta Sciences

DECEMBER 14, 2023

Regulatory Excellence - Licenses for Schedule I through IV drug substances. Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Our CDMO team offers formulation development and manufacturing of your API, from discovery through commercialization.

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Alta Sciences

OCTOBER 30, 2023

Find out what the key factors are when developing nonclinical cell and gene therapies, including expert approaches to vindicating complex challenges, making your studies more efficient, and maximizing translational opportunities to first-in-human (FIH) trials. Read or listen now. Watch the video. Listen here. The Altascientist : Issue No.

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The Premier Consulting Blog

NOVEMBER 4, 2023

For the drug product, the critical review items during the IND review revolve around the dose uniformity, stability, and the amount of active pharmaceutical ingredient (API) released from the dosage form. The justification is suitable for discussion at the pre-IND meeting. What About Combination Products?

Clinical Pharmacology 52

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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] Drug Discovery. 2] Aticaprant is taken by mouth. [1]

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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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The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.

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Alta Sciences

AUGUST 28, 2023

“We wish the team at Ischemix continued success on the next Phase of clinical research.” 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. Ischemix Inc.

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Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

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Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Agency IQ

JUNE 2, 2023

Title Type Comments Close Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act Guidance June 5 Patient Preference Information—Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in (..)

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Agency IQ

OCTOBER 27, 2023

Date What’s Happening Explanation Source October 31 FDA deadline on Florida drug importation plan The FDA has said in court filings that it plans to make a ruling on Florida’s prescription drug importation plan by October 31. The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

OCTOBER 15, 2020

The award honors McHutchison’s work in developing life-changing and curative therapies for patients with the hepatitis C virus. formed a Partnership Advisory Committee comprised of former multi-national pharmaceutical veterans and industry leaders. Processa Pharmaceuticals – Michael Floyd was named COO of Processa.

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Pharmaceuticals Clinical Pharmacology Medical Schools Vaccine 52

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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Agency IQ

SEPTEMBER 29, 2023

October 2023 Amendments to the Final Rule Regarding the List of Bulk Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Proposed Rule) FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound (..)

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Agency IQ

MARCH 1, 2024

EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 5 Lawsuit (Vanda vs. FDA) FDA required to have resolved dispute with Vanda Pharmaceuticals or hold a hearing. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

FEBRUARY 2, 2024

Legal Deadline March 7 Considerations for the Development of CAR T Cell Products FDA CBER March 15 Patient Listening Session: Patients with ADHD FDA March 22 Patient Listening Session: Patients with ADHD FDA March 25 Deadline to participate in the Quality Management Maturity Program Pilot. and the E.C.

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Agency IQ

DECEMBER 1, 2023

The guidance will include FDORA, Section recommendations FDORA, Section on the inclusion of the “the longest feasible expiration date supported by such data” in a drug’s label. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

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Alta Sciences

MARCH 27, 2025

Altasciences CDMO site supports drug development with formulation, manufacturing, and analytical testingfrom discovery to commercialization. Altasciences CDMO facility supports all stages of drug development, from early-phase formulation to late-phase scale-up and commercial manufacturing.

Small Molecule 40

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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

OCTOBER 28, 2024

Additional product-specific considerations include clinical pharmacology considerations, such as whether the product is thought to penetrate the CNS; clinical experience with the product in other populations; the route of administration (such as the impact of pain from repeated injections on neurodevelopment); and the nature of product components, (..)

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Production FDA Therapies Clinical Pharmacology 64

New Drug Approvals

APRIL 21, 2025

under reduced pressure to afford a solid residue of Formula IX.Example 7Preparation of a Pharmaceutically Acceptable Salt of Formula I The solid residue of Formula IX was dissolved in water (57 mL) and stirred for 10 min and cooled to 05 C. The aqueous solution was acidified with conc. 25 November 2024. Retrieved 25 November 2024. ^

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