Manufacturing, Biologic Drugs

Shifting Biopharma Strategies Shape Outsourcing Market

March 30, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

Small- to medium-sized companies are expected to drive near-term growth of the global biomanufacturing outsourcing market.

FDA Expands Usage of Regeneron’s Eylea

March 26, 2015

FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.

Emergent Dives Further into the Anthrax Treatment and Vaccine Market

March 25, 2015

Emergent BioSolutions announced FDA approval of Anthrasil, an inhalable treatment that targets Anthrax toxins, as well as a contract with BARDA to develop NuThrax, an anthrax vaccine candidate.

FDA Issues Guidance on Environmental Assessments

March 24, 2015

The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.

FDA Issues Guidance on Lot Distribution Reports for Biologics

March 23, 2015

Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.

BIO Encourages Transparency with Support of Biologic Interchangeability Bill

March 13, 2015

BIO and the Colorado BioScience Association urge Colorado Governor Hickenlooper to sign a bill that will help patients gain access to interchangeable biologic products following FDA approvals.

Vaccine Development and Production Challenges Manufacturers

March 02, 2015

Scientists and industry experts seek effective preventive therapies to combat global disease.

The Global Biomanufacturing Outsourcing Market

March 02, 2015

The fast growth of the global biopharmaceutical market has prompted global pharmaceutical and biotechnology companies to increase their R&D investment in biologics.

New Financial Strategies Needed to Support Biomedical Innovation

February 17, 2015

The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high United States revenues to fund biopharmaceutical R&D.

Obama Seeks Drug Pricing Authority, Shortened Data Exclusivity Period for Biologics

February 02, 2015

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.