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. Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies.

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The Pharma Data

MARCH 11, 2021

And at Pharmaceuticals, we are seeing success in our late-stage pipeline and are very well positioned with the investments we are making in our future. We plan to continue to grow at Pharmaceuticals despite patent expirations and only expect to register a modest decline in sales in 2024,” he said. through 2023.

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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

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. UPDATES ON COVID-19 DEVELOPMENT PROGRAMS. BNT162 mRNA-based Vaccine Program.

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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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Regulations Science Production Vaccine 40

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. ]

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Regulations FDA Science Production 40

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.” Any CMC changes (e.g.,

Biosimilars 40

Biosimilars Science FDA Production 40

Agency IQ

JULY 22, 2024

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. 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).

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Clinical Trials Trials Science FDA 52

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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Clinical Trials Clinical Development Small Molecule Trials 40

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 . 12, 2020– AstraZeneca and Alexion Pharmaceuticals, Inc. The combined company is expected to deliver double-digit average annual revenue growth through 2025.

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Regulations International Disease Small Molecule 75

Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources. and the E.C.

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FDA Science Regulations Production 40

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

Pharmaceuticals. Fourth-quarter 2020 Pharmaceutical sales increased 2.4% Fourth-quarter 2020 Pharmaceutical sales increased 2.4% In 2020, Pharmaceuticals sales increased 3.1% Pharmaceuticals business operating income. In the fourth quarter, business operating income (BOI) of Pharmaceuticals increased 3.7%

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Vaccine Production FDA Therapies 52

The Pharma Data

FEBRUARY 4, 2021

Pharmaceuticals. Fourth-quarter 2020 Pharmaceutical sales increased 2.4% Fourth-quarter 2020 Pharmaceutical sales increased 2.4% In 2020, Pharmaceuticals sales increased 3.1% Pharmaceuticals business operating income. In the fourth quarter, business operating income (BOI) of Pharmaceuticals increased 3.7%

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Vaccine Production FDA Therapies 52

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. In April 2021, Pfizer announced that it has acquired Amplyx Pharmaceuticals, Inc. CAPITAL ALLOCATION.

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Vaccine Production FDA Clinical Trials 40

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.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

SEPTEMBER 1, 2023

pharmaceutical law ceased to apply to the U.K. The Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. centralized procedure until 2025, when the Windsor Framework takes effect.

International 40

International Regulations Production Marketing 40

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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Regulations Compliance Production Science 40

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. and the E.C.

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Regulations FDA Science Production 40

Agency IQ

FEBRUARY 2, 2024

Legal Deadline March 7 Considerations for the Development of CAR T Cell Products FDA CBER March 15 Patient Listening Session: Patients with ADHD FDA March 22 Patient Listening Session: Patients with ADHD FDA March 25 Deadline to participate in the Quality Management Maturity Program Pilot.

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FDA Science Clinical Trials Regulations 40

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 Stakeholders were critical of EMA’s proposed mitigating measures.

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