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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Engineering Virus DNA Therapies 141

Perficient: Drug Development

DECEMBER 27, 2023

The effective date of the new rule is April 1, 2024, with key provisions taking effect on January 1, 2026, and January 1, 2027. Banks Additionally, the recent rule by the OCC, the Federal Reserve, and the FDIC strengthens and modernizes Community Reinvestment Act (CRA) regulations.

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Compliance Regulations Production 52

Perficient: Drug Development

OCTOBER 15, 2024

A recent study from IDC suggests that by 2026, 70% of financial institutions will have formalized data governance frameworks in place. With the rise of AI, machine learning, and real-time data analytics, banks will need to be even more diligent in how they manage and govern their data.

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Government Compliance Regulations Production 52

Perficient: Drug Development

NOVEMBER 21, 2024

The first compliance deadline of April 1, 2026, impacts the largest organizations. Under this ruling, banks, credit unions, credit card issuers, and other financial service providers must enhance consumer access to personal financial data. The ruling demands action from all non-depository firms (e.g.,

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Compliance Engineering Regulations Production 52

The Pharma Data

MAY 15, 2023

Development of the biosimilars will ramp-up over the coming 12-18 months.” 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.

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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 40

Therapies Disease Treatment FDA 40

Perficient: Drug Development

SEPTEMBER 17, 2024

Up until the middle of 2026, when Drupal 12 is released, Drupal 10 will be maintained. Less frequently used modules, those not included in an ecosystem, and modules that weren’t expanded upon by other modules are the ones that were eliminated. This means that upgrading to Drupal 11 is not urgent.

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Agency IQ

AUGUST 2, 2024

While this would not affect existing vouchers, it would prevent FDA from issuing new ones after September 2026. FDA September 30 Deadline for submission of Advancing RWE Pilot Program projects A semi-annual deadline for FDA’s Advancing Real-World Evidence Program is set for the end of the fiscal year.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

AUGUST 23, 2024

The rule has significant implications for the way that LDTs are regulated in general, but also has additional impact on the use of LDTs in the context of drug development (i.e., There are several high-level takeaways from these updates for drug developers.

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FDA Laboratories Regulations 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

JUNE 9, 2023

Orphan drug developers may set higher prices to recoup their return on investment lost due to the haircut. Spain is followed by Belgium, Hungary, Poland, Denmark, Cyprus and Ireland at the end of 2026. Sweden will hand presidency to Spain at the end of June.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2026 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Patient-Focused Drug Development FDA must issue or update guidance regarding the Agency’s collection of information from medical device facilities prior to inspection.

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FDA Science Biosimilars Clinical Trials 40

Perficient: Drug Development

SEPTEMBER 27, 2023

While Tesla has maintained a 60-70% market share, analysts predict that will drop to 18% by 2026. Fifty more new models are estimated to be on the horizon, promising additional inventory and variety — and testing Tesla’s dominance.

Regulations 59

Regulations Marketing Production Government 59

Perficient: Drug Development

AUGUST 29, 2023

million 20% Biden Administration emission rules require EVs to be at 17% of sales by 2026 and 66% of sales by 2030. million 1 million 7% 2023 24 16.7 million 1.7 million 10% 2024 25 17.5 million 2.5

Marketing 52

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Agency IQ

FEBRUARY 2, 2024

There are also continued questions about regulatory capacity and what the field will look like going forward, with implications for drug developers who rely on diagnostic products. A sea change for lab tests, the implications for drug developers and outstanding questions about endpoints In the U.S.,

FDA 40

FDA Laboratories Regulations Production 40

Perficient: Drug Development

NOVEMBER 12, 2024

Prior Authorization, In a Nutshell The CMS Prior Authorization mandate , which goes into effect on January 1, 2026, aims to reduce guesswork for healthcare consumers and the administrative burden on care teams, and to improve patient/member care by streamlining processes and enhancing the exchange of health information.

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Engineering Regulations 105

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

No rare pediatric disease vouchers could be awarded even to designated applications after September 30, 2026. It is extremely difficult, if not impossible, to do the long-term planning and substantial fundraising required for drug development without knowing whether such an important and valuable incentive will be there.

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Disease FDA FDA Approval Government 64

FDA Law Blog: Drug Discovery

DECEMBER 23, 2024

This means that, at the current moment, FDA cannot award any priority review vouchers for rare pediatric disease product applications unless it is for a drug that was designated as a drug for a rare pediatric disease not later than December 20, 2024, and such application is approved not later than September 30, 2026.

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Disease Government FDA Production 59

FDA Law Blog: Drug Discovery

FEBRUARY 11, 2025

However, as we suggested in a recent blog post , the statute did not actually provide any limitations on FDAs authority to grant rare pediatric disease designations , only its authority to grant vouchers.

Disease 59

Disease FDA Therapies Drugs 59

Perficient: Drug Development

NOVEMBER 21, 2024

The first compliance deadline of April 1, 2026, impacts the largest organizations. Under this ruling, banks, credit unions, credit card issuers, and other financial service providers must enhance consumer access to personal financial data. The ruling demands action from all non-depository firms (e.g.,

Compliance 52

Compliance Engineering Regulations Production 52

Drug Target Review

MARCH 20, 2025

LILAC is an event-driven study so we do not know exactly when the study will end, but we anticipate having final data in 2026.” Ultimately, this development has the potential to address a longstanding gap in current treatments and improve patient outcomes and the future of anticoagulation therapy.

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Therapies Trials Clinical Development FDA 52

Perficient: Drug Development

MARCH 20, 2025

We hope to see you again at Adobe Summit 2026. Thank you to our panelists, attendees, and everyone who made this event a success. We look forward to continuing these important conversations and supporting each other in our digital journeys.

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