Last week, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to outline the agency’s case for supporting the fifth authorization of the Prescription Drug User Fee Act (PDUFA), also known as PDUFA V. In addition to offering her support for PDUFA V, Hamburg also discussed renewal of legislation for promoting pediatric drug testing, the need of FDA to invest in science and innovation, and the agency’s efforts in confronting the continual challenges of globalization. In tackling globalization, a basic question arises: does the United States face a pharmaceutical manufacturing disconnect? Read more »

Personalized medicine, which targets individualized treatment and care based on personal and genetic variations, holds much promise for the pharmaceutical industry. Several pharmaceutical majors continue to invest in this emerging field as evident by Roche’s $5.7-billion bid last week for Illumina, a provider of gene-sequencing tools and related analytics. Read more »

FDA issued last week its recommendations for three user-fee programs: the fifth authorization of the Prescription Drug User Fee Act (PDUFA) and new user-fee programs for human generic drugs and biosimilar biological products. The recommendations were transmitted to Congress, which will evaluate the recommendations. Read more »

A new year is often reason to reflect on what has occurred and to consider what the future may hold. And for 2012, Pharmaceutical Technology is doing just that. Next year will mark Pharmaceutical Technology’s 35th anniversary, and as part of a special issue to be published in July 2012, we are seeking to gain your input on what you feel have been the most noteworthy achievements in the pharmaceutical sciences and manufacturing and what future developments may shape the industry. Read more »

Improving drug delivery is an important consideration in new drug development and in managing the product life cycle of existing drugs. Delivery mechanisms that can improve patient compliance, facilitate administration, and target delivery of an active are crucial goals. Drugs that are delivered topically provide an opportunity to realize these objectives, and an upcoming webcast on Dec. 7th by Pharmaceutical Technology gains insight from leading industry experts on how to optimize topical drug formulations and manufacturing. Read more »

Fujifilm took another step in its strategy of building its biosimilars business with the announcement this week that it had reached an agreement with the biopharmaceutical company Kyowa Hakko Kiron to form a 50–50 joint venture for biosimilars. The move is the latest by Fujifilm, begun earlier this year with the acquisition of the former Merck Biomanufacturing Network, to position itself in the biosimilars market. Read more »

Topical drugs are an important sector in the pharmaceutical market, particularly as pharmaceutical companies seek innovative ways to improve drug delivery and patient compliance. An upcoming webcast on Dec. 7th by Pharmaceutical Technology gains insight from leading industry experts on how to optimize topical drug formulations and manufacturing. Read more »

In attending CPhI this week in Frankfurt, one theme that repeatedly emerged was the increasing importance of CROs, CDMOs, and CMOs to build more strategic, deeper, and collaborative relationships with pharmaceutical companies as a way to meet the evolving needs of the industry and as a a mutual tool in value creation. Read more »

The development of an HIV vaccine is an important, but difficult goal, but researchers at the Massachusetts Institute of Technology (MIT) recently reported on an important advance in this area. One challenge in developing an HIV vaccine has been the difficulty in measuring how effective a vaccine is in producing an immune response. The MIT researchers have resolved that challenge by developing a high-throughput automated assay to evaluate individual T-cell response. Read more »

AstraZeneca’s announcement this week that it is investing $200 million in a new manufacturing site in China, the largest investment by the company in a single manufacturing facility, reflects not only the ongoing trend on pharmaceutical industry investment in emerging markets, but also speaks to the larger issue of ways to stimulate manufacturing investment in the United States. As President Barack Obama looks for support for his jobs bill from Congress and the public, a basic question is whether federal policy is on the right track to stimulate business investment in the US. Read more »