Agency IQ

JULY 8, 2024

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

FDA 40

FDA Science Regulations Production 40

Broad Institute

MAY 14, 2024

His T7 expression technology can be used to make large quantities of nearly any RNA or protein and has been for decades, and continues to be, a mainstay of biomedical research and pharmaceutical production. Nominations for the 2025 Merkin Prize open on August 5, 2024. and around the world.

RNA 84

RNA Production Molecular Biology Laboratories 84

Agency IQ

AUGUST 4, 2023

pharmaceutical law ceased to apply to the U.K. s 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. on June 20, 2023 and will apply starting January 1, 2025. as of January 1, 2021.

Packaging 40

Packaging Licensing Licensing Regulations 40

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.

Regulations 52

Regulations Pharmaceutical Companies International Pharmaceuticals 52

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year. state pharmaceutical assistance programs).

Compliance 105

Compliance Pharmacy Drugs Licensing 105

Drug Discovery World

SEPTEMBER 16, 2022

Since the approval of Kymirah in 2017, the cell and gene therapy sector has emerged as an exciting and innovative market, representing some of the most promising drugs the pharmaceutical industry has ever seen. . Neelam Patel, CEO of London cluster organisation, MedCity. . Last year, Pfizer opened a $68.5

Therapies 130

Therapies Clinical Trials Production Trials 130

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 Licensing 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.

Regulations 75

Regulations International Disease Small Molecule 75

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.

Science 52

Science Pharmaceuticals Licensing Licensing 52

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.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

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. ]

Regulations 40

Regulations FDA Science Production 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 Production 40

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%

Vaccine 52

Vaccine Production FDA Pharmaceuticals 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%

Vaccine 52

Vaccine Production FDA Pharmaceuticals 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.

Clinical Trials 40

Clinical Trials Clinical Development Small Molecule Trials 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).

Clinical Trials 52

Clinical Trials Trials Science FDA 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.

FDA 40

FDA Science Regulations Production 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.

Regulations 40

Regulations FDA Science Production 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

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.

Vaccine 40

Vaccine Production FDA Biosimilars 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.

Regulations 40

Regulations Compliance Production Science 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.

Clinical Trials 40

Clinical Trials Regulations Trials FDA 40