The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. Prescription Drug User Fee Rates for Fiscal Year 2025.

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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. This change promises a more efficient use of resources, improved patient access to innovative health technologies and strengthened HTAs across the EU.

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Drug Target Review

SEPTEMBER 19, 2024

Top-line data from the Phase IIb study is expected at the beginning of 2025. IRL1117 is expected to be ready to move into clinical development at the end of 2024/first half 2025. The third project in clinical phase, IRL757, is in Phase I and is being developed for the treatment of apathy.

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The Pharma Data

NOVEMBER 26, 2020

The EGM resolved to approve the Board of Directors’ previous resolution on October 27, 2020 on a directed issue of 29,395,311 new shares and 14,697,655 new warrants of series 2020/2025, both to CASI Pharmaceuticals, Inc. per share during the period from and including 27 November 2020 up to and including 27 November 2025.

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Agency IQ

FEBRUARY 15, 2024

Modeled after a similar pathway for pharmaceuticals – the Innovative Licensing Access Pathway (ILAP) – the new pilot program intends to ensure end-to-end assistance for developers of innovative devices addressing unmet medical needs. This program intends to set up the U.K.

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Agency IQ

JULY 26, 2024

In its Fiscal Year 2025 budget proposal , the FDA requested that Congress “eliminate the statutory distinction between the approval standard for biosimilar and interchangeable biosimilar products” and “deem all approved biosimilars to be interchangeable with their respective reference products.”

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Codon

SEPTEMBER 29, 2024

2025 While the broader life sciences community had pivoted towards working on traditional mechanistic interpretations of biology, one graduate student still believed there was something to be learned using the models of life so celebrated previously. The 2025 genetic network paper fit that bill exactly.

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The Premier Consulting Blog

MAY 14, 2023

It will be valid until March 31, 2025. While the previous form was still in use during the last year, we are pleased that the new Form FDA 1571 has now been published to replace it. Here is a summary of the changes: Field 1: This is a new field in which sponsors can indicate the center that the IND is being routed to (CDER or CBER).

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The Pharma Data

SEPTEMBER 7, 2021

7.125% Notes due 2025. 2.750% Notes due 2025. In any jurisdiction where the laws require the tender offer to be made by a licensed broker or dealer, the tender offer will be deemed made on behalf of Lilly by the dealer managers, or one or more registered brokers or dealers under the laws of such jurisdiction. 1,000,000,000.

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Agency IQ

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. The anticipated date of publication is June 2023, meaning we should see this regulation imminently. Read our analysis of that rule here and here. ] the drug and device) of the combination product.

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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.

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LifeSciVC

JANUARY 16, 2024

Rise of the best-in-class biologics plays: Are you looking to in-license or invest in “de-risked” biology that is already in the clinic? Cheers to all the innovative medicines we will collectively shepherd through discovery and development in 2024, and can’t wait to discuss at JPM in 2025! Join the club.

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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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The Pharma Data

APRIL 1, 2021

License approval for the United States and Canada is expected in 2024 for the five-component-pertussis and in 2025 for diphtheria and tetanus. Sanofi Pasteur’s commitment to improve influenza prevention.

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Agency IQ

JULY 22, 2024

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER.

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Agency IQ

JUNE 21, 2024

Sponsors would , if selected for the pilot, “receive more frequent advice related to such specific issues through additional interactions to facilitate novel drug and biological product program development and generate high quality and reliable data intended to support a Biologics License Application (BLA) or New Drug Application (NDA).”

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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

As part of the event, AbbVie raised its 2025 risk-adjusted combined sales guidance for Skyrizi and Rinvoq to greater than $15 billion , above previous guidance of greater than $10 billion. The company reiterated its expectation for greater than $15 billion of risk-adjusted combined Rinvoq and Skyrizi global sales in 2025.

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Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources.

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Translation

SEPTEMBER 5, 2023

The Act proposes a significant shift in the way federally-funded inventions are licensed, pressuring entities that receive federal funding to exclusively license new products to American manufacturers. are likely to have a licensing advantage. federally funded lab.

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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

JUNE 18, 2021

2011;364(21):2016-2025. Impact of the 13-valent pneumococcal conjugate vaccine on pneumococcal meningitis in US children. Clin Infect Dis. 2015;61(5):767-775. 20 Thigpen MC, Whitney CG, Messonnier NE, et al. Bacterial Meningitis in the United States, 1998–2007. 21 Grant L, Slack M, Theilacker C, et.

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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

DECEMBER 12, 2020

Double-digit revenue growth through 2025; acquisition strengthens AstraZeneca’s broad-based revenue and the company will further globalise Alexion’s portfolio . The combined company is expected to deliver double-digit average annual revenue growth through 2025. Dedicated rare disease unit to be headquartered in Boston.

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Agency IQ

MAY 28, 2024

Additionally, companion diagnostics and combination products that contain medicinal substances that haven’t yet been licensed in the U.K. These include medical devices with risk Classes Is/m/r that have licenses in Canada or de novo or 510(k) clearance in the U.S. Devices with Canadian licenses or those cleared via the U.S.

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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. This study is planned to start in late 2024 and conclude in late 2025.

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Agency IQ

FEBRUARY 15, 2024

CDER, CBER Draft 12/29/2025 FDA must issue final guidance no later than 18 months after the close of the public comment period for draft guidance. Priority B List. use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

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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. 7) BNT162b2 has not been approved or licensed by the U.S. CAPITAL ALLOCATION. If approved, TicoVac would be the first vaccine in the U.S.

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Agency IQ

JULY 12, 2024

A closer look at the seven new proposed regulations Stage of Rulemaking Title Estimated Publication Synopsis Proposed Rule Amendments to the Current Good Manufacturing Practice Regulations for Drug Products February 2025 FDA is proposing to amend the Current Good Manufacturing Practice Regulations for Drug Products.

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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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The Pharma Data

FEBRUARY 8, 2021

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. The CRL refers to certain deficiencies identified by the agency during a pre-license inspection of a third-party facility responsible for manufacturing. glucosidase deficiency).

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The Pharma Data

FEBRUARY 4, 2021

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. The CRL refers to certain deficiencies identified by the agency during a pre-license inspection of a third-party facility responsible for manufacturing. glucosidase deficiency).

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Agency IQ

JUNE 16, 2023

This action proposed the applicable volumes and percentage standards for 2023 through 2025 for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel. This action also proposed the second supplemental standard addressing the remand of the 2016 standard-setting rulemaking.

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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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Agency IQ

FEBRUARY 2, 2024

The following PDUFA dates were obtained from publicly available sources.

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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. This study, set to begin in January 2025, received 6.5 million euros from the E.U.’s

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