Viewpoints

FDA notes progress in drug development, but cites scientific and funding roadblocks.

Within the past few years, key players have left the sterile manufacturing business. Can new technology and investment revitalize this critical market?

FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.

As more patents make their way through IPRs, the balance of how the pharmaceutical industry selects between IPRs and district court litigation will likely evolve.

The bio/pharma industry enjoys success, but it cannot ignore patient access to medications.

Peer-reviewed papers and technical articles can help advance bio/pharmaceutical development.

The basic principle behind QbD is that quality should be built into a product with an understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks.

Pharma can boast of big-picture successes, but needs to work on operational issues.

Pharmaceutical companies should take into consideration intellectual property protection when outsourcing the packaging of their products.

With the Indian pharmaceutical industry on the rise, manufacturing businesses are working together with European and American partners to harness their longstanding experience and reputation in cleanroom manufacturing for a broader pharmaceutical manufacturing marketplace.

The past six months has seen some major changes to the sterile manufacturing landscape in Europe. There have been a number of exits and acquisitions that have no doubt grabbed headlines, but has anything really changed?

The growing threat and spread of antimicrobial resistance continue to ring alarm bells worldwide.

FDA approves a biosimilar and loses a commissioner in March.

Sessions address cell therapies, tableting, continuous processes, serialization, and more.

Initiatives to speed drug development must pass Congress and special interest groups.

New designations lead to faster drug approvals, but there is more work to be done.

Professionals share the ups and downs of working in the bio/pharma industry.

Ebola Virus Disease (EVD) is a severe, often fatal disease that is transmitted human-to-human through bodily fluids.

AAPS supports graduate-level programs impacted by cutbacks in funding and resources.

Quality is a matter of culture more than metrics. In this opinion article, the author presents arguments for an FDA Dean's List as a means to nurture a quality culture within the industry.

Industry associations play a strong role in helping the pharmaceutical industry meet challenges.

A review of how mergers and acquisitions have shaped the pharmaceutical industry landscape.

Pharmaceutical Technology Europe Marks 25 years of drug-development advances.

FDA draft guidances seek to maintain accurate drug information for patients in new media.

Protecting intellectual property rights is vital to biopharmaceutical innovation.

Changes are needed to maintain US biopharma innovation leadership.

More media options open publishing opportunities for drug development experts.

To gain insights into the current trends of the biotechnology sector in the United Kingdom, Pharmaceutical Technology Europe spoke with Steve Bates, chief executive officer of the BioIndustry Association (BIA), the trade association for biotech companies in the UK.

Conference sessions from PDA and PharmTech expand educational opportunities at INTERPHEX 2014.

Last year, the Turkish Government unveiled plans to position the country in the top 10 most-preferred locations for R&D investment in the pharmaceutical sector by 2023. This article provides an overview of the incentives introduced under the Technopolis Law and the R&D Act.