Even more than visiting the exhibit floor, I enjoy attending the presentations at INTERPHEX, which will take place next week in New York. The sessions always reflect the current hot topics within the pharmaceutical industry, and this year is no exception. Observers have been predicting that vaccines will be the industry’s new growth area, so my eye was drawn to the various biopharmaceutical talks listed on the INTERPHEX schedule of events. Read more »

The Biotechnology Industry Organization (BIO) and BioMedTracker, an institutional research service, released results of a study this week that examined the success rate of drugs moving through clinical development during the last seven years. What did the study show? Key findings showed lower success rates in early-stage clinical development compared with previous years and greater success rates for large-molecule drugs compared with small-molecule drugs, two important considerations as pharmaceutical companies re-think their research and development (R&D) models. Read more »

Only a few weeks into the new year, biosimilars or follow-on biologics already are occupying a prominent space in public policy and business developments. Following hearings in November 2010, FDA will continue to pave a regulatory pathway for biosimilars in the United States. On the other side of the Atlantic, the six-month consultation period on the draft guidelines issued by the European Medicines Agency on biosimilar monoclonal antibodies will end in May 2011. As these key regulatory matters are considered, both large and small bio/pharmaceutical companies are positioning themselves in the biosimilars market. Read more »

Journalists continue to comb through the latest batch of diplomatic cables released by WikiLeaks, seeking to interpret the mass of raw information. Until now, the cables’ significance has seemed to be limited to political circles. But one cable turns out to contain the 2008 version of the Critical Foreign Dependencies Initiative (CFDI) list, which names international facilities that could be considered crucial for American security. Perhaps not surprisingly, the list cites several pharmaceutical and biopharmaceutical facilities. Read more »

Biopharmaceutical manufacturers have successfully patented isolated DNA molecules for some time. The Biotechnology Industry Organization recently described these patents as critical tools that enable the research and development of new biotech therapies. A new development in a federal court case, however, could redefine what legitimately can and cannot be patented. The court’s decision could have ramifications for all biopharmaceutical manufacturers. Read more »

Pharmaceutical manufacturers are always chasing the twin goals of greater efficiency and reduced costs, regardless of whether the economy is doing well or badly. Each of these goals can be elusive, and achieving both at once even more so. That’s why news about a promising method for producing paclitaxel caught my attention. Read more »

The global recession is still prompting a lot of belt tightening. Patients and healthcare payers are looking for ways to cut costs, and drugmakers are trying to boost their manufacturing efficiencies. Developing countries naturally are feeling the squeeze more keenly. Budget constraints in those nations could keep patients from receiving necessary vaccines, which often are produced from recombinant proteins in a multistep process that is complicated and expensive. Read more »

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 »

Now it’s official. Rumors about sanofi-aventis’s (Paris) desire to purchase Genzyme (Cambridge, MA) have stirred speculation for weeks. The French drugmaker laid its cards on the table on Sunday by publishing its offer letter to Henri Termeer, Genzyme’s CEO. Sanofi proposed to pay $69 in cash per Genzyme share, or a total of about $18.5 billion, to acquire the biologics manufacturer. On Friday, Genzyme shares closed at $67.62.

Termeer’s response came this morning. It can be summed up in two words: nothing doing. Read more »

Have you ever allowed yourself what you thought was ample time to drive somewhere, only to be delayed by a construction crew that was repairing the roads? Obviously, things don’t always work out as we plan them. Judging by its latest announcement about its facility ameliorations, Genzyme (Cambridge, MA) must have learned this lesson, too. Read more »