Agency IQ

AUGUST 16, 2024

The June 2023 guidance recommends that studies involve two monitors (one with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently) to observe study participants during treatment sessions. FDA accepted the Lykos NDA in February 2024, and the submission received priority review.

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The Premier Consulting Blog

MAY 14, 2023

All clinical trial or marketing applications submitted to the FDA must include a form that summarizes the content of the submission and any relevant information on the sponsor and drug for the reviewers. It will be valid until March 31, 2025. Consequently, the subsequent labeled field numbers have shifted by one.

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Agency IQ

FEBRUARY 2, 2024

EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires.

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Agency IQ

MARCH 7, 2024

flu vaccines Yesterday, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) weighed in on strains for seasonal influenza vaccines for the Northern hemisphere 2024-2025 season. Vaccines advisory panel endorses move to trivalent formulation for U.S. Advisory committee members were less convinced.

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Drug Discovery World

SEPTEMBER 16, 2022

In 2021, the Cell and Gene Therapy Catapult estimated that there 168 ongoing clinical trials for advanced therapy medicinal products (ATMPs) taking place – representing 9% of all global trials in the space. And with the FD expecting to approve 10-20 cell and gene therapies per year by 2025, the necessity for manufacturing is vital.

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Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

JULY 22, 2024

Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. Most NMEs approved so far this year relied on one pivotal trial.

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Clinical Trials Trials Science FDA 52

Agency IQ

JULY 26, 2024

In switching studies , a two-arm trial design is commonly employed. The guidance “is intended to inform prospective and current applicants of the nature and type of information that applicants should provide in support of manufacturing changes to licensed biosimilars and licensed interchangeable biosimilars in different reporting categories.”

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PPD

MAY 7, 2024

The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. RWE can even serve as an external comparator group for single-arm trials under certain circumstances.

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Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. New roadmap sets out U.K. Canada, Japan, Brazil and Australia.

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The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. Protease Inhibitor Program.

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Agency IQ

MAY 28, 2024

It would also introduce new requirements for human clinical trials, post-market surveillance and vigilance. Additionally, companion diagnostics and combination products that contain medicinal substances that haven’t yet been licensed in the U.K. Notably, IVDs would be regulated under the same proposed regulation. will not qualify.

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Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Device software Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers CDRH Final By 10/1/24 Priority B List CDRH FY2024 Guidance Agenda Post-approval reporting 3D Printing Medical Devices at the Point of Care CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority B List.

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The Pharma Data

MARCH 11, 2021

In 2024, Bayer anticipates a low- to mid-single digit percentage decline in this division’s sales due to the patent expirations for its established blockbuster products Xarelto and Eylea , with Pharmaceuticals set to return to sustainable growth in 2025. In addition to further strengthening its U.S.

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Agency IQ

JUNE 21, 2024

BY ALEXANDER GAFFNEY, MS, RAC | JUN 20, 2024 10:53 AM CDT Peter Marks on the START Pilot Program: Goals and future PDUFA plans The Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot was formally unveiled in September 2023.

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The Pharma Data

JANUARY 10, 2021

In 2019, we introduced Vision 3×3, the company’s strategic roadmap through 2025, to build a leading biopharma company by achieving sustainable growth through multiple approaches. The company submitted its Biologic License Application to the FDA which has set a Prescription Drug User Fee Act (PDUFA) date for June 25, 2021.

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The Pharma Data

FEBRUARY 4, 2021

billion increase in the Skyrizi contingent consideration liability due to higher estimated future sales driven by stronger market share uptake and favorable clinical trial results as well as lower interest rates. Recorded a $4.7

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The Pharma Data

JUNE 18, 2021

The FDA’s decision is based on evidence from Pfizer’s clinical program in adults, including Phase 1 and 2 trials, and three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975) describing the safety and evaluating the immunogenicity of the vaccine. 2011;364(21):2016-2025. Clin Infect Dis. 2015;61(5):767-775.

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Vaccine FDA Approval FDA Disease 52

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.

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The Pharma Data

FEBRUARY 8, 2021

We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. Outside of the EU, Supemtek is also approved in the U.S.

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The Pharma Data

FEBRUARY 4, 2021

We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. Outside of the EU, Supemtek is also approved in the U.S.

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Vaccine Production FDA Pharmaceuticals 52

Agency IQ

AUGUST 9, 2024

Most research to date has provided doses in a highly controlled, positive environment, often with a licensed mental health practitioner present to help guide the participant through the experience. See AgencyIQ’s analysis on EMA’s draft guidance on clinical trials to treat depression ].

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The Pharma Data

MAY 4, 2021

Even excluding the growth provided from BNT162b2, our revenues grew 8% operationally, which aligns with our stated goal of delivering at least a 6% compound annual growth rate through 2025. Vaccine effectiveness in the study will be inferred through immunobridging to the 16 to 25 year-old population in the pivotal Phase 3 trial.

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Agency IQ

SEPTEMBER 1, 2023

The MHRA notes that the new pathway will be parallel to its innovation pathway (the Innovative Licensing and Access Pathway , or ILAP), which integrates “early regulatory advice with health technology assessment advice.” centralized procedure until 2025, when the Windsor Framework takes effect. market more quickly.

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Agency IQ

JULY 22, 2024

However, it does not explicitly address how it might affect products like companion diagnostics (CDx, or IVDs intended to ensure safe use of specific therapeutics) or the regulatory landscape of non-licensed tests used in the course of clinical trials by drug developers.

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