Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. The “skinny label” has been used many times previously to enable ANDA applicants to reach the market in similar circumstances.

Development 242

Development Bioequivalency Generic Drugs Production 242

pharmaphorum

JULY 4, 2022

And this is where modern technologies and data-driven medical informatics can really bridge the gaps in rare disease research,” said Dr Joanne Hackett, head of Genomic and Precision Medicine at IQVIA, during a recent pharmaphorum webinar. Navigating rare disease research and treatment.

Genome 100

Genome Genomics Research Medicine 100

XTalks

MAY 23, 2024

Advances in genomic sequencing and molecular diagnostics are helping healthcare providers to identify specific mutations and biomarkers associated with skin cancer. TDDS are advantageous due to their high bioavailability, low systemic toxicity and improved patient compliance. How is Medicus Pharma innovating in this space?

Life Science 72

Life Science Dermatology Drug Delivery Systems Medicine 72

pharmaphorum

JULY 27, 2021

For example, delivering step-by-step best practice guidance to mobile devices can strengthen confidence, compliance and consistency. They cover up the cracks in the system, using huge amounts of time and energy to smooth over the bumps, repeat lost processes, generate paperwork and backdate signatures to satisfy compliance audits.

Compliance 58

Compliance Manufacturing Genome Genomics 58

Cloudbyz

MARCH 6, 2024

Longer Lasting Effects: Many biologics have prolonged therapeutic effects, allowing for less frequent dosing regimens and improved patient compliance. As we continue to harness the power of biotechnology, genomics, and digital health, the potential for transformative breakthroughs in healthcare is virtually limitless.

Gene 73

Gene Immune Response Manufacturing Gene Therapy 73

Drug Discovery World

MARCH 2, 2023

In the UK, Contract research organisations (CROs) form an important part of the drug discovery and development process, with many organisations reliant on CROs and their experience to help bring drugs to market, quicker and more cost effectively.

Development 52

Development Drugs Clinical Trials Clinical Trials 52

pharmaphorum

MAY 18, 2022

says Charl van Zyl, UCB’s executive vice president neurology & head of Europe & International Markets. Genomics has unlocked entirely new insights to what exactly may cause certain neurological conditions. Charl van Zyl is executive vice president neurology & head of Europe & International Markets at UCB.

Gene Therapy 69

Gene Therapy Gene Genetics Development 69

The Pharma Data

NOVEMBER 17, 2021

Sotrovimab has been granted a provisional marketing authorisation in Australia and a tentative marketing authorisation in Saudi Arabia. Vir has assembled four technology platforms that are designed to stimulate and enhance the vulnerable system by exploiting critical compliances of natural vulnerable processes.

Antibody 52

Antibody In-Vitro Vaccination Vaccine 52

Drug Discovery World

DECEMBER 8, 2023

This meticulous approach not only facilitates regulatory compliance but also establishes a clear and traceable record of the therapeutic development journey that will help determine which patient will benefit the most.

Gene Therapy 64

Gene Therapy Gene In-Vitro Development 64

The Pharma Data

NOVEMBER 15, 2020

Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. She earned a BA from Durham University, U.K., and an MBA from Harvard Business School. Most recently, she was a senior executive at Celgene Corporation, where she led corporate strategy from 2012 to 2017.

Clinical Trials 40

Clinical Trials Clinical Trials Production Trials 40

The Pharma Data

AUGUST 6, 2020

Marketing, selling and administrative expenses increased 51% to $1.6 Cash, cash equivalents and marketable debt securities were $22.2 FDA for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. billion, or $1.63 0.9B – $1.1B.

Production 52

Production Branding Marketing Licensing 52

The Pharma Data

MAY 7, 2021

Review will support a formal Marketing Authorisation Application. The rolling review will continue until enough evidence is available to support a formal marketing authorisation application. The EMA will assess the medicine’s compliance with the usual standards for efficacy, safety and quality.

Antibody 52

Antibody Trials Vaccination Vaccine 52

The Pharma Data

NOVEMBER 24, 2020

The Notice of Compliance was granted under priority review and marks the first Health Canada approval of a PARP inhibitor in prostate cancer. “Circulating Tumor DNA Genomics Correlate with Resistance to Abiraterone and Enzalutamide in Prostate Cancer.” MISSISSAUGA, ON , Nov. ” European urology vol.

Gene 52

Gene Hormones DNA Medicine 52

The Pharma Data

DECEMBER 12, 2020

AstraZeneca has developed a broad range of technologies, initially focused on small molecules and biologics and with a growing focus in precision medicine, genomics, oligonucleotides and epigenetics. 1 The global rare disease market is forecasted to grow by a low double digit percentage in the future.

Development 75

Development Regulation Medicine Containment 75