Drug Development, Packaging, Therapies and Webinar

Exclusive event on using adeno-associated virus (AAV) vectors in gene therapy

Drug Discovery World

JULY 5, 2023

Join DDW for this exclusive free event , A Comprehensive Guide to Using Adeno-Associated Virus (AAV) Vectors in Gene Therapy, which is supported by Azenta Life Sciences. AAV is optimal for gene therapy due to its efficiency and safety in humans; however, AAV processes can present obstacles for researchers.

Virus

Virus Therapies Bioinformatics Packaging

Learn how to use adeno-associated virus (AAV) vectors in gene therapy

Drug Discovery World

JUNE 29, 2023

Join DDW for this exclusive free event , A Comprehensive Guide to Using Adeno-Associated Virus (AAV) Vectors in Gene Therapy, which is supported by Azenta Life Sciences. AAV is optimal for gene therapy due to its efficiency and safety in humans; however, AAV processes can present obstacles for researchers.

Virus

Virus Therapies Bioinformatics Packaging

A guide to using adeno-associated virus (AAV) vectors in gene therapy

Drug Discovery World

JUNE 22, 2023

Join DDW for this exclusive free event , A Comprehensive Guide to Using Adeno-Associated Virus (AAV) Vectors in Gene Therapy, which is supported by Azenta Life Sciences. AAV is optimal for gene therapy due to its efficiency and safety in humans; however, AAV processes can present obstacles for researchers.

Virus

Virus Therapies Bioinformatics Packaging

This week in drug discovery (19-23 June)

Drug Discovery World

JUNE 23, 2023

Advanced Therapy Medicinal Products (ATMPs) have been making the news this week. FDA approves first gene therapy for Duchenne muscular dystrophy Sarepta Therapeutics’ Elevidys has become the first gene therapy for Duchenne muscular dystrophy (DMD) to gain marketing authorisation in the US.

FDA Approval

FDA Approval Therapies Packaging Drugs

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

According to the Wellcome Trust 5 , it can take between 10 and 15 years and over $1billion to develop a new antibiotic, so systems such as this aim to provide incentive to drug developers.

Clinical Trials

Clinical Trials Biosimilars Pharma Companies Production

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

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. How does “potency” apply to cell and gene therapy (CGT) products?

Production

Production FDA Therapies Biochemical Assays

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

Agency IQ

AUGUST 2, 2024

September 30, 2024 PDUFA Novel Approaches to Development of Cell and Gene Therapy Convene a public meeting to solicit input on methods and approaches (e.g., use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

FDA

FDA Science Regulations Biosimilars

How big data analytics can make personalised care a reality

Drug Discovery World

FEBRUARY 6, 2023

Johannes Goll, Global Head of Emmes’ Biomedical Data Science and Bioinformatics department, explains how big data analytics can deliver improved therapies and bring clinical research one step close to realising the potential of personalised care. Figure 2: Advanced data visualisation examples for transcriptomics data.

Bioinformatics

Bioinformatics RNA Vaccine Clinical Trials

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

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs. Prohaska, Kavita C.

FDA

FDA Science Regulations Production

Drug Discovery Digest

Exclusive event on using adeno-associated virus (AAV) vectors in gene therapy

Learn how to use adeno-associated virus (AAV) vectors in gene therapy

Trending Sources

A guide to using adeno-associated virus (AAV) vectors in gene therapy

This week in drug discovery (19-23 June)

European Commission vs Big Pharma, or profit vs access?

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

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

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

How big data analytics can make personalised care a reality

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

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