PharmTech Talk

Can the feds negotiate Medicare Part D prices?

FDA and industry seek a more consistent, flexible CMC review process for breakthrough therapies.

More “me-betters” and more focused breakthroughs could enhance new drug development.

The FDA program that encourages biopharma companies to develop new treatments for rare and neglected diseases has been in the spotlight recently.

Janet Woodcock, director of the Center for Drug Evaluation, highlights FDA's priority list for 2016.

This month marks the death of a pragmatic, original thinker who helped make PAT and QbD a reality at more pharmaceutical facilities throughout the world.

The use of drug compounding facilities to produce over-priced generic drugs raises quality and regulatory questions.

Cambridge Consultants engaged in a workshop-style dialogue with a cross section of senior personnel from both Indian and multinational pharma companies to debate whether emerging markets are an opportunity to drive sustainable growth. Conclusions from the workshop are presented in this article.

Text from a merger prospectus reveals the termination fee for the proposed Pfizer-Allergan deal would change if any new tax regulations were passed prior to the closing of the transaction.

FDA emphasizes the surveillance aspects of quality metrics to concerned drug manufacturers.

Experts at the ISPE annual meeting describe best practices, including containment and production in classified spaces.

Robert Califf addresses questions about drug pricing at the Senate hearing to weigh his appointment to be the next commissioner of FDA.

Even though rising production and use of generic pharmaceuticals is saving billions for the nation’s healthcare system, policy makers continue to slap the industry with policies it claims will limit product development and sales.

Biotech boom, niche markets, smaller batch sizes and high potency manufacturing are among the key trends shaping the pharmaceutical industry of the 21st century, according to Christian Treitel from Bosch Packaging Technology.

Everyone talks about “open innovation,” but without the right working culture it won’t succeed. MeetingZone’s Anthony Prior explains how unified communications can help kick-start the necessary change.

Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.

A CPhI report suggests that the pharma industry should be careful not to outsource to lower labor-cost countries rather than investing in manufacturing technology and innovation.

A CPhI report predicts how two potential mega free-trade deals, one among Pacific-Rim countries and the other between the US and EU, could affect pharmaceutical companies.

In the development of biopharmaceuticals and pharmaceuticals, the line is blurring.

Although the presidential candidate seeks to cap monthly drug costs to $250 for covered drugs, what will happen to drug costs that are associated with co-insurance?

In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.

CPhI expert, Girish Malhotra, warns that without urgent regulatory reform, the industry would remain reluctant to make process changes that will improve manufacturing efficiency due to the financial and time constraints of re-approval.

The White House nominates Robert Califf to head FDA, but will he be confirmed?

Worldwide, meetings take place for several reasons, such as to share new findings, learn about novel technologies, discuss international issues, exchange know-hows, and network, to name a few. While each of these reasons has its significant importance, what really matters in scientific inquiry is progress.

Andrew Bulpin, executive vice president of EMD Millipore’s Process Solutions Business, speaks to Pharmaceutical Technology about the trends shaping the biopharmaceutical manufacturing industry.

The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations.

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.

Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.

Competitive pressures are driving more companies to repurpose APIs that had originally been developed for other indications. The industry has only "scratched the surface" of what might be possible, says consultant Hermann Mucke

The broader aim of FDA's metrics initiative is to encourage quality manufacturing operations that will help avoid drug shortages.