Drug Target Review

AUGUST 7, 2024

The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. However, making informed labelling decisions during preclinical stages is complex and requires expertise in a variety of areas, including clinical pharmacology, toxicology, regulatory affairs and medical writing.

Drug Development

Alta Sciences

FEBRUARY 8, 2024

In this on-demand webinar, Ingrid Holmes , Vice President of Global Clinical Operations at Altasciences, and Dr. Gary G. President of Cognitive Research Corporation , examine simple and cognitive domains in clinical and pharmacology studies, including analysis of driving impairment.

Clinical Trials

Alta Sciences

APRIL 10, 2025

Altasciences is committed to using cutting-edge technology to support its ocular research. From comprehensive ocular assessments to complex surgical interventions, Altasciences is equipped to handle the full spectrum of ophthalmic research needs. What advanced instruments does Altasciences utilize to conduct these ocular studies?

Clinical Pharmacology

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.

Clinical Pharmacology

Alta Sciences

SEPTEMBER 22, 2023

You can expect a robust program suited to your unique needs to support your IND submission and minimize potential risks, so you can transition smoothly from preclinical to clinical pharmacology. png Tags Preclinical Research Weight 10

Clinical Pharmacology

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.

Virus

Alta Sciences

DECEMBER 14, 2023

Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Clinical Supply Manufacturing Integration with our manufacturing team, ensuring flexibility and adaptability to meet the evolving needs of your studies throughout your drug development program or study.

Compounding Pharmacies

The Pharma Data

NOVEMBER 8, 2020

HK) (“Pharmaron”), a fully integrated contract research and manufacturing organization offering laboratory, CMC and clinical development services for the life science industry, announced today that it has acquired 100% of the equity of Absorption Systems for up to US$137.5 BEIJING–( BUSINESS WIRE )– Pharmaron Beijing Co.,

Clinical Pharmacology

Alta Sciences

OCTOBER 30, 2023

Discover the considerations and assessments necessary for performing preclinical research for ophthalmic therapies in this new eBook, that covers everything you need to know, from species selection and routes of administration, to preparing for first-in-human trials. Read or listen now. Listen here.

Science

The Pharma Data

NOVEMBER 9, 2020

Dr. Löbenberg holds Health Canada licences for research and analytical testing of a wide range of psychedelic compounds under the Controlled Drugs and Substance Act and research and analytical testing licences for cannabis under the Cannabis Act. DMT (N,N-dimethyltryptamine). Prof. About XPhyto Therapeutics Corp.

Drug Development

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] As of July 2022, it is in phase 3 clinical trials for major depressive disorder.

Treatment

The Pharma Data

DECEMBER 17, 2020

The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021. Patient enrollment of EXCELLENCE pivotal trial reaches 98%. SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec.

Clinical Trials

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

Agency IQ

JULY 8, 2024

and the E.C.

FDA

Alta Sciences

AUGUST 28, 2023

We wish the team at Ischemix continued success on the next Phase of clinical research.” That is incredibly rewarding,” stated Dr. Morelli, MD, Chief Medical Officer and Principal Investigator for Altasciences. “We

Trials

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.

Biosimilars

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. Enriching Possibilities for Rare Disease Patients Drug discovery and research starts with in vivo and in vitro models to select drug candidates.

Drug Development

Agency IQ

OCTOBER 6, 2023

BY AMANDA CONTI | OCT 4, 2023 10:40 PM CDT A quick note: How AgencyIQ gathers data on drug approvals AgencyIQ reviews drug approvals from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). Featuring previous research by Kedest Tadesse, Kari Oakes and Alec Gaffney.

FDA

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.

Pharma Companies

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

FDA

Agency IQ

JUNE 16, 2023

Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation. 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.

Regulations

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 (..)

FDA

The Pharma Data

OCTOBER 15, 2020

formed a Partnership Advisory Committee comprised of former multi-national pharmaceutical veterans and industry leaders. Prior to joining Inozyme, Sabbagh served as the head of rare renal and musculoskeletal diseases research at Sanofi. Processa Pharmaceuticals – Michael Floyd was named COO of Processa. Katherine S.

Pharmaceuticals

The Anticancer Fund

JUNE 7, 2022

Our intention is to help bring these findings to the attention of the broader cancer research community. All articles need to be critically assessed and viewed in their broader research context. Please get in touch if you’re interested in discussing research based on the findings presented below ( info@anticancerfund.org ).

Drugs

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

Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

FDA

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

Agency IQ

FEBRUARY 2, 2024

But there are some potential hints, such as an upcoming Friends of Cancer Research event at which several of FDA’s top officials will be speaking on the “implementation of diversity plans.” The documents describe all the guidance documents that are under development and that may be published in a given year.

FDA

The Pharma Data

FEBRUARY 8, 2021

Vice President, Late Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. “In In our commitment to advance the science and treatment of prostate cancer, these findings will help inform our research efforts in developing novel approaches and combinatory regimens to improve outcomes for these patients.”.

Pharmaceutical Companies

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

Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

FDA

Agency IQ

JULY 12, 2024

and the E.C.

Regulations

Alta Sciences

MARCH 27, 2025

"This recognition reflects our CDMO teams unwavering dedication and expertise of our CDMO team, as well as our unrelenting commitment to advancing drug development in collaboration with leading pharmaceutical and biotech innovators, says Marie-Hlne Raigneau, Co-Chief Operating Officer at Altasciences.

Small Molecule

Drug Target Review

JANUARY 20, 2025

These advances are reshaping how pharmaceutical and biotechnology companies approach clinical trial design, with a focus on patient-centric dosing strategies. This article explores how innovations in precision medicine are reshaping clinical trials, followed by a discussion on Project Optimus and its impact on dose optimisation.

Clinical Trials

Drug Target Review

NOVEMBER 27, 2024

Advanced techniques like liquid chromatography tandem mass spectrometry (LC-MS/MS) and Meso Scale Discovery (MSD) provide the kind of comprehensive and reliable data increasingly favoured by regulators, yet many researchers continue to rely exclusively on enzyme-linked immunosorbent assay (ELISA). Cancer research. per sample.

Drug Development