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).

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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.

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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.

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Drug Discovery World

OCTOBER 13, 2022

Samsung Biologics’ Senior Vice President, James Park, explores the opportunities emerging for CDMOs to support mRNA developers as they explore new therapeutic areas for patients. . One aspect that makes mRNA technology popular with drug developers is that its proteins can be easily edited. billion by 2026 9.

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Vaccine Therapies Drugs RNA 130

Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation. Orphan designation in the E.U.

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Marketing Biosimilars Regulations Drugs 40

Drug Discovery World

NOVEMBER 14, 2022

Using synthetic DNA to develop drugs and to better understand the toxic effects of them is a key driver for this market. BCC Research reports that the global market for synthetic biology is estimated to increase from $9.5 billion by 2026, at a compound annual growth rate (CAGR) of 28.4% billion in 2021 to $33.2

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Drug Discovery World

JANUARY 24, 2024

Fibrocor Therapeutics, a developer of novel therapeutics to treat fibrosis, recently appointed Piet Wigerinck as Chief Scientific Advisor. Wigerinck has taken four drugs (Prezista, Olysio, Jyseleca and Rekambys) to market. MT: What technologies are Fibrocor Therapeutics utilising to advance its drug development process?

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Small Molecule Research Pharma Companies Disease 147

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.

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Drug Discovery World

FEBRUARY 26, 2024

Challenges “There are some cell therapies on the market but the cost of those is maybe $500,000 a dose. Bit.bio plans to generate initial clinical data in 2026 but is basing its approach for bbHEP01 on preclinical and clinical data 2 that show the feasibility of this type of cell therapy.

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Therapies Treatment Engineering Disease 130

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.

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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%.

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Marketing Production 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.

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Marketing 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.

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Drug Discovery World

FEBRUARY 22, 2024

In the early 20th century, a combination of hard work and luck produced three broad types of psychiatric drugs: antidepressants, antipsychotics and anxiolytics. But psychopharmacology developments petered out, and few new drugs reached the market during the last four decades.

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Drugs Clinical Trials Disease Therapies 147

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.,

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