The Pharma Data

MAY 15, 2023

Just – Evotec Biologics has developed an optimized proprietary ecosystem for cost-efficient, state-of-the-art drug development and manufacturing. Work is set to begin this year, with full operations provisionally planned for late 2026. Under the terms of the agreement, Sandoz has optionality to use of this technology.

Biosimilars 40

Biosimilars Production Government Clinical Trials 40

Codon

SEPTEMBER 29, 2024

2026 Another lab, one with a greater appreciation for what machine learning could pull from noisy, high-throughput biological data, stumbled across the 2025 paper and discussed it in a Monday morning lab meeting. It wasn’t a silver bullet to the hard problem of drug development, but it wasn’t too far off either.

Engineering 130

Engineering Virus DNA Therapies 130

The Pharma Data

JANUARY 18, 2021

Under this program, companies are eligible to receive a priority review voucher following approval of a product with rare pediatric disease designation if the marketing application submitted for the product satisfies certain conditions, including approval prior to September 30, 2026 unless changed by legislation.

Therapies 52

Therapies Disease Treatment FDA 52

Perficient: Drug Development

SEPTEMBER 17, 2024

Up until the middle of 2026, when Drupal 12 is released, Drupal 10 will be maintained. Action UI Activity Tracker Book Forum Statistics Tour What is Drupal 10’s support lifespan and upgrade timeline? This means that upgrading to Drupal 11 is not urgent.

Marketing 52

Marketing 52

Agency IQ

AUGUST 23, 2024

At a high level, the establishment of OPEQ brought together previously disparate offices involved in pre-market review (the Office of Device Evaluation and its divisions) and post-market work related to compliance and surveillance (the Office of Compliance) and Office of Surveillance and Biometrics).

FDA 40

FDA Laboratories Regulations Clinical Trials 40

Agency IQ

AUGUST 2, 2024

Happy 40 th Birthday, generic drugs: September 24 will mark the 40 th anniversary of the 1984 signing of the Hatch-Waxman Act, which created a formal pathway for the approval of generic drugs. We expect the FDA to mark the occasion, especially since drug pricing continues to be such a potent issue in the Presidential election.

FDA 40

FDA Science Regulations Biosimilars 40

Perficient: Drug Development

SEPTEMBER 27, 2023

The overall EV market is quickly gaining momentum as governments worldwide push for a future with net-zero emissions and automakers rev up production to meet growing demand. In the first quarter of 2023, the total EV market share increased to 7.2% And demand is indeed growing. of total sales, representing a 50% jump year over year.

Regulations 59

Regulations Marketing Production Government 59

Perficient: Drug Development

AUGUST 29, 2023

Market Overall, the automotive industry is up 13%. Further, there are fresh signs of labor market strength that reinforce a picture of an economy with broad momentum despite high interest rates. Tighter than expected labor market. An Overview of the U.S. On the retail side, it is up 9% while the fleet side is up 35%.

Marketing 52

Marketing Production 52

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. Priority A List.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. The study is planned to begin in 2026 and conclude in 2028.

FDA 40

FDA Trials Therapies Regulations 40

Agency IQ

FEBRUARY 2, 2024

This means that the medical device frameworks – including the pre-market pathways and evidentiary requirements, as well as post-market quality system frameworks and reporting requirements – are applied to the vast majority of all (CDRH-regulated) IVD products. IVDs used in blood donation screening/processing). In the E.U.,

FDA 40

FDA Laboratories Regulations Production 40