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 »

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 »

As Congress prepares to go into summer recess and begin the legislative season again after Labor Day, a subject that has been of ongoing concern for the pharmaceutical and fine-chemical industries has resurfaced: drug safety by reforming regulatory oversight for foreign drug-manufacturing facilities and related issues. The bill, the Drug Safety and Accountability Act of 2010, introduced this week by Sen. Michael Bennet (D-CO), raises again the issue on how best to oversee an increasingly global pharmaceutical supply chain. Read more »

There is no secret that China’s role in the current and future global pharmaceutical market is and will be substantial, but the mindset for Western pharmaceutical companies has largely focused on the opportunity in that country. In looking at recent investment trends, however, perhaps the bio/pharmaceutical industry needs to more fully consider the potential competition from domestic Chinese pharmaceutical companies. Read more »

Merck & Co.’s (Whitehouse Station, NJ) announcement last week that it plans to cut 15% of its workforce and cease operations at eight manufacturing sites and eight research sites as part of an integration plan following its 2009 acquisition of Schering-Plough (Kenilworth, NJ) is yet another sobering statistic regarding the employment patterns in the pharmaceutical industry. So in light of this news, where does the pharma industry stand in recent job losses? Read more »

The investment community is speculating that sanofi-aventis is interested in making a US-based acquisition, according to a July 2 Bloomberg News article, with possible acquisition targets being Allergan (Irvine, CA), Biogen Idec (Cambridge, MA), or Genzyme (Cambridge, MA). In a July 4 Wall Street Journal article, sanofi-aventis would not confirm such plans, stating that it does not respond to speculation. Only time will tell if such reports are accurate as information becomes available, but as the waiting game begins, would an acquisition be a good move for sanofi aventis? 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 »

In a speech before the Detroit Economic Club last week, John C. Lechleiter, chairman, president, and CEO of Eli Lilly, addressed what he regards as declining competitive scientific advantage in the US and the policies that he thinks are important for the US not to lose its position in the life sciences. 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 »