Drugs, Seminar and Trials - Drug Discovery Digest

Mexico to hold trials for Chinese and American COVID-19 vaccines

The Pharma Data

AUGUST 12, 2020

Mexico aims to conduct late stage trials for coronavirus vaccines designed by US and Chinese companies. Ebrard said he hoped that trials would start between next month and January if they get approval from Mexico’s food and drug agency. Photo by Ken Kistler ([link].

Vaccine

Vaccine Trials Government Production

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. Start Date End Date Event Event Type Organization 4/30/2024 4/30/2024 Seminar No. The pharma reform package remains in E.U.

Regulations

Regulations Clinical Trials Production Biosimilars

New insights into the role of viral capsids in gene therapy safety

Drug Target Review

DECEMBER 5, 2024

1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2. The large number of ongoing clinical trials of recombinant AAV (rAAV)-based therapies highlights their promise for addressing a wide variety of human genetic disorders.

Therapies

Therapies Virus DNA Compliance

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Women in Stem with Dr Rachel Lagiakos

Drug Target Review

MAY 31, 2024

My career choice was made from an early age when I was deeply affected by both my Uncle’s HIV+ diagnosis and then the extraordinary cocktails of antiretroviral drugs he took, which gave me another 20 years with him beyond his doctor’s initial grim projection. They are only going to do that when they feel valued and heard.

Organic Chemistry

Organic Chemistry Computational Chemistry Small Molecule Disease

Article FDA Thank You What’s on FDA’s new Diagnostics Chief’s mind? Transitions, the LDT rule and cybersecurity

Agency IQ

AUGUST 23, 2024

Introducing Lias for a plenary at the event, Gutierrez said: “Courtney is in the paperwork for the seminar, she’s put down as the Acting Director. 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.,

FDA

FDA Laboratories Regulations Clinical Trials

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

Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials.

Regulations

Regulations Biosimilars Clinical Trials Production

AM-Pharma Announces Enrollment and Financing of COVID-19 Cohort in Phase III REVIVAL Trial

The Pharma Data

JANUARY 6, 2021

The REVIVAL Phase III pivotal trial is a randomized, double-blind, placebo-controlled, two-arm, parallel-group, multi-center trial to evaluate the efficacy and safety of AM-Pharma’s proprietary human recombinant alkaline phosphatase for the treatment of patients with SA-AKI. Seminars in Nephrology, 2015; 35(1): 2-11. pharma.com.

Trials

Trials Hospitals Treatment International

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

Agency IQ

MARCH 29, 2024

regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0:

Regulations

Regulations Production Clinical Trials Biosimilars

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms AgencyIQ analyzed CDER’s novel drug approvals in Fiscal Year 2023, identifying a recovery in approval numbers as the agency resumes a new normal following the pandemic. As a reminder, the U.S.

FDA

FDA Biosimilars Science Drugs

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

Agency IQ

MAY 31, 2024

Start Date End Date Event Event Type Organization 6/03/2024 6/03/2024 Product Management Service (PMS) Product UI and API training (access & navigation) Webinar/Seminar ( OPEN ) EMA 6/03/2024 6/07/2024 Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the E.U.:

Regulations

Regulations Production Compliance Pharmaceuticals

Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

AUGUST 2, 2024

While the work on the pharma package will likely take quite some time, another deadline is coming up fast: the full transition of all clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation.

Regulations

Regulations Clinical Trials Production Trials

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

Agency IQ

OCTOBER 27, 2023

Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes?

Regulations

Regulations Pharmaceuticals Production Packaging

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Agency IQ

OCTOBER 20, 2023

A January 2022 Seminars in Arthritis and Rheumatism publication noted that a “generic [drug] may only cost $1 million to $4 million and take two years to develop vs $100 million to $250 million and seven to eight years for a biosimilar.”

Science

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

Agency IQ

JULY 8, 2024

Device regulators have dropped important guidance recently , publishing guidance on alternative trial designs for orphan devices and updating how to carry out benefit-risk assessments on the use of toxic phthalates in medical devices. elections over, AgencyIQ is also anticipating the new European Parliament to start work again soon.

Regulations

Regulations Pharmaceuticals Production Vaccine

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

Agency IQ

DECEMBER 1, 2023

December also has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may soon receive greater clarity about the FDA’s thinking about prescription drug importation plans. December also typically brings end-of-year perspectives on the agency’s accomplishments.

FDA

FDA Science Regulations Production

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

Agency IQ

DECEMBER 1, 2023

The European Commission also plans to create a Critical Medicines Alliance for a more coordinated effort in managing drug shortages within the E.U. We are expecting to see the release of an E.U. This effort will most likely be set up in early Q1 of 2024.

Regulations

Regulations Clinical Trials Production Biosimilars

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Drug & Device Law

APRIL 16, 2023

DRI’s Drug and Medical Device Committee will hold its annual Seminar on May 3-5, 2023 , at the Hilton New Orleans Riverside, in New Orleans, Louisiana. The Seminar is a preeminent program for practitioners who represent pharmaceutical and medical device manufacturers.

FDA Approval

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Drug Discovery Digest

Mexico to hold trials for Chinese and American COVID-19 vaccines

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

Webinars

Trending Sources

New insights into the role of viral capsids in gene therapy safety

Webinars

Women in Stem with Dr Rachel Lagiakos

Article FDA Thank You What’s on FDA’s new Diagnostics Chief’s mind? Transitions, the LDT rule and cybersecurity

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

AM-Pharma Announces Enrollment and Financing of COVID-19 Cohort in Phase III REVIVAL Trial

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

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

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

Article EMA Thank You What we expect European regulators to do in August and September 2024

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

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

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

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

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

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