Rita C. Peters

FDA report says drug shortages are underappreciated and patients pay a price.

Climbing out of a reputation hole starts with adopting a quality culture.

While overall industry performance is trending positive, quality failures continue to negatively impact patients and the bio/pharma industry.

The editors welcome technical article contributions from the bio/pharma industry.

Fifty years after the man walked on the Moon, space-based science is benefiting Earth.

A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.

Pharmaceutical Technology spoke with Anil Kane, executive director, global science and technology, pharmaceutical development services, at Thermo Fisher Scientific about the industry’s need for more capacity in the manufacture of highly potent APIs.

FDA and USP take sides in debate on biologic drug standards.

FDA’s annual manufacturing report card shows more quality compliance is needed.

Pharma delivers a positive message with renewed efforts to eradicate malaria.

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

Better drug design and patient education may promote improved personal and public health.

Do patients get what they pay for when they demand cheaper drugs?

Biosimilars, pricing strategies, and technology will influence growth in spending on drugs.

Pricing pressures, investment volatility, and government disfunction greet Pharma in 2019.

While pharma is proving its capabilities to develop novel therapies, the industry still needs to work on manufacturing innovation.

Keeping valuable employees happy-and on the job-may test bio/pharma business decisions.

Intellectual challenge, work/life balance, compensation, and an unclear business outlook create uncertainty among European bio/pharma employees.

Bio/pharma companies cannot spell success without solving all elements of quality programs.

By adapting techniques from other sciences-and exploring better tools for biologics drug development-researchers are addressing challenges of protein characterization.

Survey results and record attendance show positive signs for various bio/pharma regions.

Sharing know-how can help resolve common bio/pharma technical challenges.

Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.

By minding knowledge gaps, bio/pharma companies can avoid development pitfalls.

A skilled workforce is needed to deliver on technology’s promising medical advances.

New therapies and tighter budgets challenge bio/pharma to think outside the industry.

FDA enforcement efforts and drug approvals trend upward.

Assessing potential formulation and manufacturing issues in early development phases can improve a drug’s chances for success.