Packaging, Pharmaceuticals, Trials and Workshop

Streamlining development with containment in early drug discovery

Drug Discovery World

AUGUST 4, 2022

The increasing complexity of drug products has raised concern among pharmaceutical developers. During a 2021 workshop sponsored by West Pharmaceutical Services, 32% of attendees said they were most concerned about generating the right technical data to support their applications to the U.S. Testing compatibility.

Drugs

Drugs Clinical Trials FDA Pharmaceuticals

Target validation in psychiatry: addressing unmet therapeutic needs

Drug Discovery World

NOVEMBER 7, 2022

EP : The Psychiatry Consortium, launched in 2019, is a strategic collaboration of leading medical research charities and pharmaceutical companies focusing on the challenge of identifying and validating novel drug targets to address the unmet therapeutic needs of people living with mental health conditions. .

Packaging

Packaging Pharmaceutical Companies Clinical Trials Disease

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Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)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

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

Agency IQ

JULY 8, 2024

Letter Program Tag Commitment Due Date PDUFA Advancing RWE Program Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER. and the E.C.

FDA

FDA Science Regulations Production

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

Agency IQ

MAY 31, 2024

Even small changes in the Parliament’s composition could have an impact on ongoing legislative discussions, such as the revisions to the pharma reform package. The current European Parliament and Commission have confirmed their position on the pharma package, but the European Council is still working on its negotiation position.

Regulations

Regulations Production Compliance Pharmaceuticals

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 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

What it takes to make cancer research more inclusive

Drug Discovery World

AUGUST 16, 2022

These observations may come to light in the clinic, but these disparities can be attributed to every phase of the drug development pipeline – clinical trials, translational research and, ultimately, drug discovery. . Additionally, the lack of diversity in patients participating in clinical trials can also contribute to cancer disparities.

Research

Research Clinical Trials Trials Drug Development

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

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

FDA

FDA Science Regulations Production

Codon Digest: Hackathon Prize Winners

Codon

JUNE 26, 2023

The company behind the latter work, SNIPR BIOME , also recently announced results from a phase I clinical trial. For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) A fifth clinical trial for base editing is now enrolling patients. Throughout the 1940s, several U.S. coli in mice.

DNA

DNA Therapies Engineering Clinical Trials

Codon Digest: Hackathon Prize Winners

Codon

JUNE 26, 2023

The company behind the latter work, SNIPR BIOME , also recently announced results from a phase I clinical trial. For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) A fifth clinical trial for base editing is now enrolling patients. Throughout the 1940s, several U.S. 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

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. The workshop will solicit and include industry and public feedback.

FDA

FDA Science Biosimilars Regulations

Drug Discovery Digest

Streamlining development with containment in early drug discovery

Target validation in psychiatry: addressing unmet therapeutic needs

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

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What it takes to make cancer research more inclusive

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

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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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