BioPharma Drive: Drug Pricing

FEBRUARY 20, 2024

Why clinical pharmacology is critical to accelerating drug development, and how it can help drive value in a complex and rapidly evolving landscape.

Clinical Pharmacology 141

Clinical Pharmacology Drug Development Drugs 141

Fierce BioTech

OCTOBER 26, 2023

Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval? Eva Gil Berglund, PhD Justin Hay, PhD Paola Coppola, MSc Duration 60 Minutes Clinical pharmacology information comprises more than 50% of a drug label. Click here to login. Click here to login.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Regulations Marketing 52

Drug Target Review

JULY 4, 2023

Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 3D rendering of Antibody Drug Conjugate Molecules.

Small Molecule 145

Small Molecule Drugs Clinical Pharmacology Trials 145

Drug Target Review

AUGUST 7, 2024

The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world.

Drug Development 59

Drug Development Clinical Pharmacology Clinical Trials Drugs 59

Cytel

OCTOBER 27, 2023

Speakers discussed investigator, regulatory (FDA), industry, and patient perspectives during the special symposium “Challenging the Status Quo of Early Phase Clinical Trial Design: Project Optimus.” Since its launch in 2021, Project Optimus has been reforming the dose optimization and dose selection paradigm in oncology drug development.

Clinical Trials 64

Clinical Trials Trials Clinical Pharmacology Clinical Development 64

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. Dr. Löbenberg. ” Prof.

Drug Development 40

Drug Development Drugs Clinical Pharmacology Pharmaceuticals 40

FDA Law Blog: Drug Discovery

JULY 17, 2024

As originally proposed, this new Committee could be convened in conjunction with the existing medical specialty area-focused advisory committees, akin to the Drug Safety and Risk Management Advisory Committee. clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

FDA 105

FDA Disease Clinical Pharmacology Science 105

Alta Sciences

OCTOBER 5, 2023

About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.

Clinical Pharmacology 52

Clinical Pharmacology Compliance Drug Development Pharmaceuticals 52

Alta Sciences

OCTOBER 31, 2023

“Our integrated CRO/CDMO services combine bioanalytical services with preclinical and clinical study solutions, manufacturing services, and all complementary research support services, for maximum efficiency.” Altasciences helps sponsors get better drugs to the people who need them, faster.

Laboratories 52

Laboratories Clinical Pharmacology Cell Based Assays Drug Development 52

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

Clinical Pharmacology Drug Development Drugs Research 52

Alta Sciences

JANUARY 23, 2024

With close to a decade of experience in the healthcare and pharmaceutical sectors, including clinical pharmacology, James will apply his knowledge to oversee the day-to-day management of clinical operations at Altasciences’ 140-bed, Phase I clinical pharmacology unit in Kansas City. “It

Clinical Pharmacology 40

Clinical Pharmacology Clinical Trials Drug Development Clinical Research 40

The Premier Consulting Blog

JUNE 8, 2023

In this blog post, we will share valuable strategies and insights for conducting an optimal meeting and navigating the recovery process to get your drug development program back on track if needed. Additionally, assembling the right development and regulatory team is critical for success.

Clinical Pharmacology 52

Clinical Pharmacology FDA Drug Development Clinical Trials 52

Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects.

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. Altasciences helps sponsors get better drugs to the people who need them, faster.

Clinical Trials 40

Clinical Trials Trials Clinical Pharmacology Drug Development 40

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

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. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions.

Clinical Pharmacology 40

Clinical Pharmacology Drug Development Science Clinical Trials 40

The Premier Consulting Blog

SEPTEMBER 11, 2024

The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to. The overall development strategy for GT123 was to include a complete CMC package.

Drugs 52

Drugs Clinical Pharmacology Packaging Small Molecule 52

Alta Sciences

JULY 25, 2024

39 Key Considerations for Nonclinical Dermal Studies—Advancing to Phase I An increasing number of advanced methods for dermal drug delivery can contribute to successful 505(b)(2) applications and extend the patent life of a drug for its sponsor. The Altascientist: Issue No. View the podcast. The Altascientist: Issue No.

Science 52

Science Clinical Trials Clinical Pharmacology FDA 52

Conversations in Drug Development Trends

FEBRUARY 21, 2024

Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.

Clinical Trials 80

Clinical Trials Pharmacy Clinical Pharmacology FDA 80

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. Altasciences helps sponsors get better drugs to the people who need them, faster.

Virus 40

Virus Clinical Pharmacology Drugs FDA Approval 40

Drug Target Review

MAY 7, 2024

How do AI-enhanced approaches accelerate the drug development process for rare diseases? AI holds the potential to revolutionise different aspects of healthcare, particularly in the realm of clinical trials. In 2020, 78 percent of orphan drugs and biologics approved were targeted therapies.

Disease 59

Disease Clinical Trials Clinical Pharmacology Trials 59

Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Watch the video. Read the blog. TOP MANUFACTURING AND ANALYTICAL RESOURCES The Altascientist : Issue No.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

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. . - Electronic security access to the pharmacy and video monitoring. - 24/7 monitoring of temperature and humidity.

Compounding Pharmacies 40

Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply 40

The Pharma Data

NOVEMBER 1, 2020

CAMBRIDGE, England–( BUSINESS WIRE )– Mission Therapeutics (“Mission”), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), has appointed Dr Suhail Nurbhai as Chief Medical Officer (CMO) with immediate effect. 2, 2020 08:00 UTC. This press release features multimedia.

Clinical Pharmacology 52

Clinical Pharmacology Small Molecule Clinical Research Science 52

The Premier Consulting Blog

NOVEMBER 4, 2023

Key to the IND opening studies is that the CMC information is sufficient to support the safety of the drug substance and drug product and establish the phase-appropriate quality of the drug product. Other safety considerations for the drug substance include potential impurities, such as process impurities and degradants.

Clinical Pharmacology 52

Clinical Pharmacology Production FDA Packaging 52

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

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]

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

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.

Drug Development 52

Drug Development Disease Clinical Trials Drugs 52

Alta Sciences

MAY 15, 2023

TOP 5 WAYS INTEGRATED DRUG DEVELOPMENT SOLUTIONS SAVE YOU TIME AND MONEY aasimakopoulos Mon, 05/15/2023 - 16:06 Since 2004, the average cost of bringing a new drug to market has increased from $800 million to about $2.6 billion , without, for the most part, shorter development timelines.

Drug Development 52

Drug Development Clinical Trials Laboratories Compounding Pharmacies 52

Alta Sciences

AUGUST 28, 2023

s novel, proprietary cytoprotective drug candidate, CMX-2043, for the treatment of acute TBI. The trial was performed at Altasciences’ clinical facility in Montréal. Importantly, the Principal Investigator determined that few adverse events were drug-related.” is a privately held drug development company based in Grafton, MA.

Trials 40

Trials Treatment Clinical Pharmacology Pharmacokinetics 40

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 111

Pharma Companies Licensing Licensing Disease 111

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.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Drug Development 52

Agency IQ

DECEMBER 11, 2023

By our count, the FDA’s Oncologic Drugs Advisory Committee held seven meetings in 2023; additionally, the Oncology Center of Excellence authored nine new (draft) and six final guidance documents. A key fact about the dostarlimab phase 2 trial for LARC: The drug was stunningly effective. months, according to the GSK presentation.

FDA 40

FDA Science Clinical Trials Trials 40

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 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

OCTOBER 27, 2023

December has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may start the month of November with greater clarity about the FDA’s thinking about prescription drug importation plans.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 2, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. The proposed rule would include requirements for Patient Medication Information development and distribution.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JULY 28, 2023

First, an audit of communications and meeting management under the Prescription Drug User Fee Act (PDUFA) Quick background: As AgencyIQ has previously discussed, the FDA collects user fees as part of an essential bargain between regulators and industry. This week, FDA posted several new special notice contract opportunities on SAM.

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40