Packaging, Therapies and Workshop - Drug Discovery Digest

Article EMA Thank You What we expect European regulators to do in November 2023

Agency IQ

OCTOBER 27, 2023

A wide range of other meetings that will be occurring this month, with various webinars, committee meetings, and workshops spanning a variety of topics. Many of these are open to any interested listener. Upcoming E.U.

Regulations

Regulations Pharmaceuticals Production Packaging

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

AUGUST 2, 2024

Title Type Comments Close Risk Evaluation and Mitigation Strategy Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance Draft Guidance August 5 Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research (..)

FDA

FDA Science Regulations Biosimilars

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

FDA

FDA Science Regulations Clinical Trials

April 2023 Highlights

KIF1A

APRIL 24, 2023

You will meet individuals, advocacy leaders, industry, and research experts who have been there and done it, over two days of in-person only panel discussions, hands-on workshops, and expert office hours.” RDDS 2023 focuses on collaboration – the foundation of success in rare disease research.

Packaging

Packaging Research Drug Development Therapies

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

Science

Science FDA Trials Clinical Pharmacology

Article FDA Thank You FDA quietly kicks off process that could inform future rare disease regulatory reforms

Agency IQ

JUNE 26, 2023

For example, top FDA executives have previously heralded international convergence and harmonization as the solution to gene therapy development for diseases with small populations. Read full AgencyIQ analysis of the workshop here. ]. But if we had to guess, international regulatory harmonization will be a topic of interest for NASEM.

FDA

FDA Disease Regulations Production

New Data Shows AbbVie’s VENCLYXTO®/VENCLEXTA® Fixed Duration Combination Demonstrates Sustained Progression-Free Survival in Chronic Lymphocytic Leukemia Patients after Three Years off Treatment

The Pharma Data

JUNE 18, 2021

The therapies were administered for a fixed duration of 12 months for VENCLYXTO/VENCLEXTA in combination with six cycles of obinutuzumab. The trial enrolled 432 patients, all of whom were previously untreated according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. with Ven-Obi versus 83.1% AbbVie Inc.

Treatment

Treatment Trials Therapies Clinical Trials

Article EMA Thank You What we expect European regulators to do in May 2024

Agency IQ

MAY 3, 2024

Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U.

Regulations

Regulations Clinical Trials Production Biosimilars

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in December and January FDA comment periods are typically open for 30-60 days, unless they are extended.

FDA

FDA Science Regulations Production

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

The Pharma Data

JUNE 18, 2021

Time to subsequent therapy was longer for I+V (HR 0.143, 95% CI 0.05-0.41). “We are encouraged by these results, which further support the efficacy of these two well-established therapies,” said Mohamed Zaki, M.D., IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S.

Treatment

Treatment Therapies FDA FDA Approval

Analysis Life Sciences Thank You Revised ICH viral safety guideline: NGS is in, animal use (mostly) out

Agency IQ

JANUARY 19, 2024

This process is more thoroughly covered in guidances on gene therapy and vaccine development, and in other guidelines, such as the ICH Q5B Guideline. a recombinant protein or gene therapy packaged via AAV virus) which has been produced by the cells, in addition to other debris such as the remaining media and the remnants of the cells.

Virus

Virus Science Production FDA

What it takes to make cancer research more inclusive

Drug Discovery World

AUGUST 16, 2022

This would entail remotely engaging with underserved populations by shipping clinical trial packages directly to patients’ homes. We need to rework our messaging and provide patients with well-crafted resources that clearly explain the benefits of different therapies.” . Dr TJ Bowen, Chief Scientific Officer, Deep Lens . References.

Research

Research Clinical Trials Trials Drug Development

Codon Digest: Hackathon Prize Winners

Codon

JUNE 26, 2023

Since the last Codon Digest, I’ve published: Reasons to Be Grateful for Biotechnology (with Avadhoot Jadhav) AAV Foundations (Part I) An overview of AAV-based gene therapies, how they get made, and where they go wrong. Nevertheless, phage therapy did have a stint in the U.S. I’ll post an update soon. coli in mice.

DNA

DNA Therapies Engineering Clinical Trials

Codon Digest: Hackathon Prize Winners

Codon

JUNE 26, 2023

Since the last Codon Digest, I’ve published: Reasons to Be Grateful for Biotechnology (with Avadhoot Jadhav) AAV Foundations (Part I) An overview of AAV-based gene therapies, how they get made, and where they go wrong. Nevertheless, phage therapy did have a stint in the U.S. I’ll post an update soon. coli in mice.

DNA

DNA Therapies Engineering Clinical Trials

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

JULY 28, 2023

September 30, 2023 PDUFA Sentinel: Pregnancy Hold a public workshop on post-market safety studies in pregnant women to facilitate determination of the ideal post-market study design(s), including industry experience and use of Sentinel Initiative and other real-world data resources. But despite the law’s age, it is not yet fully operational.

FDA

FDA Science Biosimilars Regulations

Drug Discovery Digest

Article EMA Thank You What we expect European regulators to do in November 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Trending Sources

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

April 2023 Highlights

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Article FDA Thank You FDA quietly kicks off process that could inform future rare disease regulatory reforms

New Data Shows AbbVie’s VENCLYXTO®/VENCLEXTA® Fixed Duration Combination Demonstrates Sustained Progression-Free Survival in Chronic Lymphocytic Leukemia Patients after Three Years off Treatment

Article EMA Thank You What we expect European regulators to do in May 2024

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

Analysis Life Sciences Thank You Revised ICH viral safety guideline: NGS is in, animal use (mostly) out

What it takes to make cancer research more inclusive

Codon Digest: Hackathon Prize Winners

Codon Digest: Hackathon Prize Winners

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

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