Rachel Sherman, MD, Associate Director for Medical Policy, within FDA’s Center for Drug Evaluation and Research, gave a press briefing today. Below is a summary. Read more »
Archive for the 'Biotech' Category
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 »
New Jersey is known to many as a pharmaceutical mecca on the international stage with several leading pharmaceutical majors headquartered and/or with operations in the state. So to say that lawmakers need to create an economic climate conducive to foster growth is an understatement.
Just over a week ago, I decided to hop on the early train to Glasgow, Scotland, so that I might catch at least half of the 8th bioProcess UK conference, focusing on advancing next generation therapies. The meeting was held in the very fitting Glasgow Science Center and, given the strikes over public sector pensions that day, there were plenty of youngsters mingling with the crowds—the next generation of bioprocess engineers perhaps? Amazingly, presentations were delivered in the IMAX theatre—I have never seen PowerPoint slides on such a scale before—but given the eminence of some of the keynote speakers involved, it too was quite apt. 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 »
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 »
Biopharmaceutical characterization—especially of unknowns—is becoming far more complex and far higher on the regulators’ radar. Of particular interest for industry is compliance with harmonized guidelines that address FDA’s concept of a “well-characterized biological product,” which involves being able to measure and control the product’s identity, purity, impurities, potency, and concentration. Read more »
As the unemployment rate hovers around 9.1%, the federal government needs to find ways to create jobs. Congress is debating whether a tax break on repatriated money would prompt companies to hire more workers, as I mentioned last week. Meanwhile, the Obama administration is eyeing another potential means of stimulating job growth: investing in biological research. 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 »
Worried about our persistently high rate of unemployment (and his bid for re-election), President Obama is urging Congress to pass portions of his jobs bill. In addition to aiding the economy, creating jobs could help reduce the number of people who are forgoing medications, which would be a boon for the pharmaceutical industry. Perhaps with this in mind, the Association of Clinical Research Organizations (ACRO) has thrown its weight behind a bill it says would create American jobs.