Remove Compounding Remove Drug Development Remove Vaccines
article thumbnail

Implications of RFK Jr.’s CDC Vaccine Committee Overhaul for the Pharmaceutical Industry

PharmaTech

s CDC Vaccine Committee Overhaul for the Pharmaceutical Industry June 10, 2025 By Christopher Cole News Article The dismissal of all 17 members of the Advisory Committee on Immunization Practices has far-reaching impacts for the industry and beyond. Kennedy Jr.

article thumbnail

Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

CMS is issuing unique J-codes for 505(b)(2) drugs, classifying them as sole-source products if not therapeutically equivalent. This pathway reduces submission denial risk, accelerates drug development, and offers potential market exclusivity for up to 7 years.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Achieving Targeted Delivery with Nanoscale Systems

PharmaTech

Nanoparticles have attracted particular attention, including those based on lipids, polymers (natural and synthetic), lipid-polymer hybrids, dendrimers, inorganic materials (metals, magnetic compounds, carbon nanotubes, silica-based systems, etc.).

Dosage 52
article thumbnail

CAR T and Beyond: The Expanding Pipeline and Promise of Cell Therapies

Pharmacy Times

SHOW MORE With robust pipelines, cell therapy remains the major driver for drug development. Development Trends: Oncology at the Forefront Gene therapy currently ranks third among therapeutic focus areas, with 2151 compounds in development in 2024 ( Figure ).

article thumbnail

MilliporeSigma and Simtra Launch Five-Year Agreement for Drug Substance, Drug Manufacturing Services

PharmaTech

Growth of ADC manufacturing According to the press release, the ADC pipeline has been growing in recent years, driven by early successes against diseases such as human epidermal growth factor receptor 2 (HER2)-positive breast cancer; currently, 70% of these drugs are manufactured by CDMOs (1). Patients can’t wait.

Dosage 52
article thumbnail

European Pharmacopoeia Goes Digital

PharmaTech

link] Recent Videos Related Content Looking Beyond mRNA-based COVID-19 Vaccines to Innovative Therapeutics Cheryl Barton June 24th 2025 Article mRNA technologies offer great promise in immunotherapy and non-immunogenic applications. Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs Paul L. link] Haigney, S.

Dosage 59
article thumbnail

Looking Beyond mRNA-based COVID-19 Vaccines to Innovative Therapeutics

PharmaTech

cancer and vaccines), and non-immunogenic applications (e.g., cancer and vaccines), and non-immunogenic applications (e.g., Several types of mRNA-based vaccines have emerged, namely non-replicating linear mRNAs (NRM), self-amplifying mRNAs (saRNAs), and circular mRNAs (circRNAs). Types of messenger RNA (mRNA)-based vaccines.