Clinical Research, International, Licensing and Pharmaceuticals

Women in STEM with Kristina Torfgard

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

Pharma Companies Licensing Licensing Disease

Where is the promise for plant-based medicines? Part 1: Cannabis

Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. The situation in Europe follows a similar narrative of “more” – more research, more trials, and more results are needed for medical cannabis to reach its full potential.

Clinical Trials

Clinical Trials Regulations Production FDA

Where is the drug discovery expertise happening in the UK?

Drug Discovery World

OCTOBER 16, 2023

Next, Saleko highligts how Northumberland and the North East of the UK are recognised for pharmaceutical manufacturing prowess. Academic translational sciences is an approach which translates scientific discoveries and research into practical applications that benefit human health. billion in funding.

Drugs

Drugs Science Therapies Targeted Protein Degradation

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Conversations in Drug Development Trends

AUGUST 9, 2024

However, implementing adaptive trial designs within MRCTs requires careful consideration of international regulatory standards to optimize patient outcomes and resource efficiency. The International Council for Harmonisation of Technical Pharmaceuticals for Human Use provides guidelines, but local adaptations and interpretations still vary.

Trials

Trials Clinical Trials Regulations FDA

Dr. Kent R. Van Kampen Celebrated for Dedication to the Field of Pharmaceutical Research

The Pharma Data

NOVEMBER 5, 2020

Drawing upon 50 years of expertise in clinical research, biopharmaceuticals, biotechnology and drug discovery, Dr. Van Kampen excels as the chief executive officer of The Van Kampen Group, which assists other companies in research and liaisons with government and industry regarding licensing products for commercial use.

Research

Research Vaccine Doctors Pharmaceuticals

FDA Action Alert: Merck, Aurinia and Amgen

The Pharma Data

JANUARY 17, 2021

It was co-sponsored by Merck and Bayer, conducted with the scientific oversight of the Canadian VIGOUR Centre and the Duke Clinical Research Institute. Aurinia Pharmaceutical’s Voclosporin for Lupus Nephritis. On December 17, 2020, Aurinia inked a collaboration and license deal with Japan’s Otsuka Pharmaceutical Co.

FDA

FDA Small Molecule Immune Response Hospitals

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

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

FDA Science Clinical Trials Regulations

BetterLife’s Recent Acquisition: Taking LSD from Experimental to a Major Therapeutic Application

The Pharma Data

DECEMBER 14, 2020

Our highly experienced clinical team will be placing 2-Bromo-LSD into multi-center United States clinical research locations without restriction.”. is an emerging biotechnology company engaged in the development and commercialization of therapeutic pharmaceuticals as well as drug delivery platform technologies.

Bioethics

Bioethics Clinical Research Regulations Compliance

RECOVERY Trial Data Monitoring Committee Recommends Continuing Evaluation of REGN-COV2 in All Hospitalized Patients

The Pharma Data

NOVEMBER 5, 2020

The trial is supported by a grant to the University of Oxford from UK Research and Innovation / National Institute for Health Research (NIHR) and by core funding provided by NIHR Oxford Biomedical Research Centre , Wellcome , the Bill and Melinda Gates Foundation , the Department for International Development , Health Data Research UK , the (..)

Hospitals

Hospitals Trials Clinical Trials Production

TG Therapeutics Announces Pricing of Upsized Public Offering of Common Stock – Dec 15, 2020

The Pharma Data

DECEMBER 14, 2020

The Company anticipates using net proceeds from the offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes. Morgan Securities LLC, Goldman Sachs & Co.

Clinical Trials

Clinical Trials Clinical Development Production Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

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.

FDA

FDA Science Clinical Trials Regulations

Phase 2 FIGHT Trial Results Presented at ASCO GI Validate Importance of FGFR2b Overexpression and Reinforce Potential of Bemarituzumab Plus Chemotherapy as a Frontline Targeted Treatment for FGFR2b+ Gastric and GEJ Cancers

The Pharma Data

JANUARY 14, 2021

Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID: 2063209.

Trials

Trials Treatment Therapies Clinical Trials

Analysis Life Sciences Thank You The U.S. regulatory landscape for probiotics and other microbiome-based therapies

Agency IQ

NOVEMBER 3, 2023

One non-profit organization, the International Society Association for Probiotics and Prebiotics (ISAPP) , which is dedicated to promoting research in this area, has published consensus statements that have helped to define some of these terms and their associated substances.

Therapies

Therapies Science FDA Production

Exploring alternatives to animal testing in drug discovery

Drug Target Review

JULY 6, 2023

Animal testing plays a significant role in pre-clinical research and therefore requires the use of millions of animals. 1 Over a quarter of those were for basic research purposes, with most common areas focused on the immune system, the nervous system and oncology. In Britain, 2.88

Animal Testing

Animal Testing Drugs Clinical Trials Clinical Research

Global Roundup: EU Approves ViiV’s HIV-1 Drug and More

The Pharma Data

DECEMBER 23, 2020

based Avacta Group entered into a license agreement with Astrea Bioseparations that allows that company to use Avacta’s Affimer platform in affinity purification applications. Astrea is a leading provider of affinity separation solutions to the pharmaceutical and biomanufacturing industries. It is a division of Gamma Biosciences.

Licensing

Licensing Licensing Vaccine Compliance

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

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

FDA Science Regulations Production

Clinical Catch-Up: January 18-22 | BioSpace

The Pharma Data

JANUARY 24, 2021

It will be run through the NIAID-supported Infectious Diseases Clinical Research Consortium (IDCRC), with support from the Bill & Melinda Gates Foundation. Innovation Pharmaceuticals received the greenlight from the FDA to initiate a Phase II trial of Brilacidin in hospitalized COVID-19 patients.

Long-Term Care Facilities

Long-Term Care Facilities Trials Virus Clinical Trials

BioDAOs are Community-Owned Research Translation Engines, Not Investment DAOs

Molecule Blog

MARCH 17, 2023

The Primitives of Biomedical Discovery and Development It’s noteworthy that the majority of approved medicines, around 60%, have their roots in academia, with the remaining 40% stemming from pharmaceutical research and discovery. These studies involve more in vivo testing in increasingly larger animals to evaluate safety and efficacy.

Engineering

Engineering Research Government Clinical Trials

Merck Advances Phase 3 Trial to Evaluate Investigational Islatravir as Once-Monthly Oral PrEP for Women at High Risk for Acquiring HIV-1

The Pharma Data

NOVEMBER 22, 2020

Per the agreement between the foundation and Merck, the foundation, in its role as a funder, intends to provide grant funding to the International Clinical Research Center (ICRC) at the University of Washington Department of Global Health, which is collaborating with Merck on the IMPOWER 22 study. Merck’s Commitment to HIV.

Trials

Trials Clinical Trials International Production

Article EMA Thank You EMA’s psychedelic workshop leaves stakeholders with as many questions as answers

Agency IQ

AUGUST 9, 2024

Most research to date has provided doses in a highly controlled, positive environment, often with a licensed mental health practitioner present to help guide the participant through the experience. Many studies have also employed a follow-up session for the participant to discuss their experience with the practitioner.

Clinical Trials

Clinical Trials Regulations Trials FDA

How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

JULY 31, 2023

International Trade Commission , 810 F.3d 2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. Medicis Pharmaceutical Corp. , Cory International Corp. , Honeywell International, Inc. , Honeywell International, Inc. , 3d 1283 (Fed. In United States v.

Production

Production International Trials Government

Drug Discovery Digest

Women in STEM with Kristina Torfgard

Where is the promise for plant-based medicines? Part 1: Cannabis

Trending Sources

Where is the drug discovery expertise happening in the UK?

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Dr. Kent R. Van Kampen Celebrated for Dedication to the Field of Pharmaceutical Research

FDA Action Alert: Merck, Aurinia and Amgen

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

BetterLife’s Recent Acquisition: Taking LSD from Experimental to a Major Therapeutic Application

RECOVERY Trial Data Monitoring Committee Recommends Continuing Evaluation of REGN-COV2 in All Hospitalized Patients

TG Therapeutics Announces Pricing of Upsized Public Offering of Common Stock – Dec 15, 2020

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Phase 2 FIGHT Trial Results Presented at ASCO GI Validate Importance of FGFR2b Overexpression and Reinforce Potential of Bemarituzumab Plus Chemotherapy as a Frontline Targeted Treatment for FGFR2b+ Gastric and GEJ Cancers

Analysis Life Sciences Thank You The U.S. regulatory landscape for probiotics and other microbiome-based therapies

Exploring alternatives to animal testing in drug discovery

Global Roundup: EU Approves ViiV’s HIV-1 Drug and More

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Clinical Catch-Up: January 18-22 | BioSpace

BioDAOs are Community-Owned Research Translation Engines, Not Investment DAOs

Merck Advances Phase 3 Trial to Evaluate Investigational Islatravir as Once-Monthly Oral PrEP for Women at High Risk for Acquiring HIV-1

Article EMA Thank You EMA’s psychedelic workshop leaves stakeholders with as many questions as answers

How the Fifty States View Electronic Data as a “Product”

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