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? Small molecule GLP1s? Whether it’s small molecules to target the incretins (GLP1R ± GIPR), targeting well-validated signaling nodes in I&I (e.g., Join the club.

Small Molecule 139

Small Molecule Trials Therapies Disease 139

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.

Pharmacokinetics 52

Pharmacokinetics Drugs FDA Production 52

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

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. mg/dL at doses of 15, 70 and 120 mg respectively, compared to a -24.8

Vaccine 52

Vaccine Therapies Trials Clinical Trials 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

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.

Production 52

Production Clinical Trials International Small Molecule 52

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.

Regulations 75

Regulations International Disease Small Molecule 75