Roche (Basel, Switzerland) announced last week that it signed a drug-development deal worth up to $1.1 billion with the biopharmaceutical company Aileron Therapeutics (Cambridge, MA) to discover, develop, and commercialize “stapled peptides,” or drug candidates that use peptide-stabilization technology to enhance potency and cell permeability. So are stapled peptides a potential magic bullet in biopharmaceutical development? Read more »

Pharmaceutical companies sometimes explain their unimpressive pipelines by saying that it’s become harder to discover and develop new drugs. Believing that the low-hanging fruit has been picked already, manufacturers are focusing on serving small patient populations. But a new paper suggests that the industry may be overlooking the potential of a particular class of drugs to treat tens of millions of patients. Read more »

Pfizer Global Engineering and Manufacturing has been working with students and faculty from Rowan University’s chemical engineering department to investigate green approaches to drug manufacturing, according to a July Rowan press release. The partnership is aimed at analyzing and quantifying the economic viability and environmental benefit, respectively, of investing in a small solvent-recovery system. Such a system provides an alternative to incineration for small volumes of waste.   Read more »

A new clinical trial for an AIDS vaccine will take place in Africa and the United States. The program, announced this week, is a collaboration between the International AIDS Vaccine Initiative (IAVI), which will lead the trial, biopharmaceutical company Crucell (Leiden, Netherlands), Harvard Medical School’s Beth Israel Deaconess Medical Center, and the Ragon Institute, an organization dedicated to HIV/AIDS research. Read more »

Last week, Sens. Sherrod Brown (D-OH), Sam Brownback (R-KS), and Al Franken (D-MN) introduced legislation, the Creating Hope Act of 2010 (S 3697), to provide incentives for drug companies to develop treatments for rare and neglected pediatric diseases. The legislation hopes to build on a private–public model to encourage targeted development for rare diseases. Read more »

It’s been a few months since President Obama signed into law the Patient Protection and Affordable Care Act (H.R. 3590). The bill includes a provision to “address gaps in quality, efficiency, comparative effectiveness information, and health outcomes measures and data aggregation techniques.”

Last week, the Partnership to Improve Patient Care (PIPC), which includes a wide range of healthcare organizations working to support the government’s role in and awareness of CE research, held a forum about delivering patient-centered comparative effectiveness (CE) research. Senator Max Baucus (D-MT) was the forum’s keynote speaker.

Read more »

FDA’s Jesse Goodman, chief scientist and deputy commissioner for Science and Public Health, testified before the US Senate Agriculture, Rural Development, FDA, and Related Agencies’ Appropriations Subcommittee last week. He brought good news regarding the agency’s research and technological efforts toward finding treatments for rare and neglected diseases. Read more »

The Office of the Inspector General at the US Department of Health and Human Services (HHS) issued a report this month citing the US Food and Drug Administration’s need to improve its oversight of foreign clinical trials. The report raises questions over the effectiveness of federal regulatory practices and resources to keep pace with an increasingly global pharmaceutical industry, and in doing so, also engenders larger policy considerations on how to best address this problem. Read more »

In an online commentary in the New England Journal of Medicine, US Food and Drug Administration Commissioner Margaret Hamburg and the National Institutes of Health (NIH) Director Francis Collins provided their perspectives on the challenges and opportunities in personalized medicine and the ways in which FDA and NIH are seeking to facilitate scientific and commercial efforts in this still nascent field. Read more »

At the annual meeting of the American Society of Clinical Oncology, a large cancer research meeting, which was held in Chicago this week, Merck & Co. (Whitehouse Station, NJ) announced the launch of the Merck Oncology Collaborative Trials Network, a clinical-trial network focusing on the development of Merck drug and vaccine candidates being investigated for the treatment and prevention of cancer. Although the initiative is centered on improving clinical-trial management, it is also important for development and manufacturing organizations that supply clinical-trial materials. Read more »