Alta Sciences

OCTOBER 31, 2023

Whether as a standalone bioanalytical service or as part of an integrated program, Altasciences provides top-quality data for TK, PK, and PD determinations to support preclinical and clinical studies.

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Laboratories Clinical Pharmacology Cell Based Assays Drug Development 52

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

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.

Clinical Pharmacology 40

Clinical Pharmacology Drug Development Science Clinical Research 40

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.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Clinical Development 52

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.

Clinical Trials 40

Clinical Trials Trials Clinical Pharmacology Drug Development 40

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.

Clinical Pharmacology 40

Clinical Pharmacology Drug Development Science Clinical Trials 40

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.

Trials 40

Trials Treatment Clinical Pharmacology Pharmacokinetics 40

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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Virus Clinical Pharmacology Drugs FDA Approval 40

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.

Compounding Pharmacies 40

Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply 40

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.

Pharmaceuticals 52

Pharmaceuticals Clinical Pharmacology Medical Schools Therapies 52

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

Clinical Pharmacology Production FDA Packaging 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 (..)

FDA 40

FDA Science Regulations Clinical Trials 40

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]

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

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.

Science 40

Science FDA Trials Clinical Pharmacology 40

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 (..)

FDA 40

FDA Science Regulations Production 40

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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FDA Science Regulations Production 40

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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FDA Science Regulations Production 40

The Pharma Data

NOVEMBER 9, 2020

. “Our initial focus is to develop standardized drug formulations with precise, predictable and efficient API delivery for clinical study and therapeutic use.” ” Prof. About XPhyto Therapeutics Corp. XPhyto Therapeutics Corp.

Drug Development 40

Drug Development Drugs Clinical Pharmacology Pharmaceuticals 40

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 (..)

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

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.

Science 52

Science Clinical Trials Pharmacokinetics Clinical Pharmacology 52

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.

FDA 40

FDA Science Clinical Trials Regulations 40

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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FDA Science Biosimilars Clinical Trials 40

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.

FDA 40

FDA Science Regulations Production 40

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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FDA Science Clinical Trials Regulations 40

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.

Clinical Trials 52

Clinical Trials Trials Drugs Drug Development 52

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.

Drug Development 52

Drug Development Regulations Laboratories FDA 52

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, (..)

Production 64

Production FDA Therapies Clinical Pharmacology 64