2023, Biosimilars, Packaging and Therapies

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

Agency IQ

JANUARY 19, 2024

EMA’s 2023 new medicines report suggests return to pre-pandemic volume This week, the EMA released its 2023 New Medicines Highlights report, providing insights into the number of opinions provided and the types of products reviewed. Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars.

Biosimilars

Biosimilars FDA Production Treatment

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. He pointed out that Europe was the first region to approve biosimilars. He said: “The products that are authorised in EU are largely the same as other regions.

Clinical Trials

Clinical Trials Biosimilars Pharma Companies Production

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

Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations

Regulations Pharmaceuticals Production Packaging

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

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

Agency IQ

AUGUST 2, 2024

Letter Program Tag Commitment Due Date MDUFA International Harmonization Commencing with FY 2024, publish an annual assessment of the international harmonization activities described the strategic plan due by the end of FY 2023. use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

FDA

FDA Science Regulations Biosimilars

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

Agency IQ

JULY 8, 2024

12/29/2023 FDORA, Section 3202 Rare Diseases: GAO to release a report to Congress assessing the policies, practices, and programs of the FDA with respect to the review of applications for approval of drugs and biologics intended to treat rare disease, with a focus on the effectiveness of FDA’s policies and challenges encountered by sponsors.

FDA

FDA Science Regulations Production

Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)

The Pharma Data

MAY 2, 2022

The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Zuranolone has been granted Fast Track and Breakthrough Therapy Designation for MDD and Fast Track Designation for PPD by the U.S.

Treatment

Treatment Clinical Pharmacology Drugs 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

Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

Agency IQ

MARCH 1, 2024

Notably, shutdowns can be either total or partial – as noted above, there are 12 appropriations bills, and if a subset of those bills are passed then only those agencies and Departments without an appropriations package will shut down (partial shutdown). If none of the 12 bills are completed, then all government operations shut down.

Government

Government FDA Biosimilars Regulations

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. CDER approved 51 new molecular entities in FY 2023.

FDA

FDA Biosimilars Science Production

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

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Science Regulations Production

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

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Science Regulations Production

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

Agency IQ

MAY 3, 2024

BY CHELSEY MCINTYRE, PHARMD , KIRSTEN MESSMER, PHD, RAC , COREY JASEPH, MS, RAC , KARI OAKES , SEBASTIAN GODOY, MPH | OCT 25, 2023 5:20 PM CDT | UPDATED APR 30, 2024 12:57 PM CDT What we expect to be talking about in May: Regulators, especially from the EMA and national competent authorities, will be busy with lots of meetings in May.

Regulations

Regulations Clinical Trials Production Biosimilars

Article EMA Thank You What will the orphan drug market exclusivity haircut mean for industry?

Agency IQ

JUNE 9, 2023

Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation. High-priced cell and gene therapies are being increasingly developed for rare diseases.

Marketing

Marketing Biosimilars Regulations Drugs

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

Agency IQ

JULY 28, 2023

Everything the FDA is planning to do in Q3 2023 The third quarter of the 2023 calendar year is shaping up to be one of the busiest periods of regulatory policymaking at the FDA in at least the last decade. Notably, one aspect of its transition plan will come into effect on August 9, 2023.

FDA

FDA Science Biosimilars Regulations

Drug Discovery Digest

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

European Commission vs Big Pharma, or profit vs access?

Trending Sources

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

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

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

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

Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)

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

Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

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

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

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

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

Article EMA Thank You What will the orphan drug market exclusivity haircut mean for industry?

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

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