Safe Biologics

OCTOBER 10, 2023

As we intended, this approach has been incredibly successful in controlling costs: the Congressional Budget Office projected drug spending between 2004-2013 to be $770 billion; actual expenses were 45% lower- at $421 billion. director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research.

Biosimilars 130

Biosimilars Drug Pricing Drug Development 130

FDA Law Blog: Biosimilars

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

Documentation 105

Documentation Adverse Reactions Communication Drug Development 105

pharmaphorum

JUNE 24, 2021

Lucentis has been approved by the FDA since 2006 for wet AMD and is a big earner for both Roche and Novartis, who share rights to the product with Roche selling the drug in the US and Novartis selling it in Europe and other markets. billion in US sales, while Novartis’ sales of the drug topped $1.9

Diabetes 95

Diabetes Biosimilars Drug Development 95

Pharmaceutical Technology

JULY 23, 2008

Despite the enormous growth being enjoyed by the global oncology market, potential cancer cures are left on laboratory shelves on a regular basis, according to Dr Victoria John, head of clinical partnerships at Cancer Research UK’s Drug Development Office. That will affect the intellectual property of oncology drug manufacturers.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Compounding Biosimilars 40

PharmaShots

FEBRUARY 27, 2023

As a renowned chemist, Dr. Senanayake discussed the need to adopt green chemistry in the process of drug development for cost reduction, timely innovation, and generating less waste than the standard process. To provide the audience with an Indian viewpoint, the presenters pointed out the country's requirements for biosimilar PV.

Biosimilars 40

Biosimilars Diabetes Packaging Hospitals 40

Safe Biologics

SEPTEMBER 11, 2023

As we intended, this approach has been incredibly successful in controlling costs: the Congressional Budget Office projected drug spending between 2004-2013 to be $770 billion; actual expenses were 45% lower- at $421 billion.

Drug Pricing 150

Drug Pricing Biosimilars Vaccines Drug Development 150

Express Pharma

JANUARY 1, 2025

It has a strong presence across various modalities, such as RNAi, ADC, peptides, lipids and oligonucleotides, and manufacturing techniques, such as flow chemistry, enzymatic processes, biocatalysis and fermentation, offering a broad range of technology capabilities for drug development. Its revenue from operations increased by 34.3

Biosimilars 105

Biosimilars Drug Development 105