This week, vaccine manufacturers won increased protection from liability in a closely watched case before the US Supreme Court. In Bruesewitz v. Wyeth, the Court ruled that federal law prohibits patients who claim to have been injured by a vaccine from suing the manufacturer. Pfizer hailed the decision as a victory for public health, but its effect is to diminish patients’ recourse when they suffer harm from taking faulty products. Read more »

Sanofi aventis and Genzyme have finally agreed on a deal for Sanofi’s acquisition of the Cambridge, MA-based biotechnology company. The agreement values Genzyme at roughly $20.1 billion, or $74 per share, according to a joint statement by the companies. 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 »

On Monday, Feb. 14. 2011, President Obama released his fiscal year 2012 budget plan, which aims to tackle the trillion-dollar deficit with several program cuts and freezes, but also increases spending in programs such as infrastructure, clean energy, innovation, and research. The administration is also placing a large focus on science education. Experts and critics alike have been pointing to decreasing pipelines, lack of training/education (as scientists retire and take their expertise with them), and flagging innovation as areas of concern in the pharma industry for years, and now, the government is opening the door to fix these very problems. Read more »

A sizeable chunk of Big Pharma’s sales will fall off the dreaded patent cliff before the year is out. Patent expirations will allow competitors to market, and patients to buy, generic versions of branded drugs. A renewed focus on discovering and developing new therapies would seem to be the obvious solution for Big Pharma. Yet at least one observer predicts cuts in research and development (R&D) spending throughout the industry. Read more »

A possible link between cases of the chronic sleep disorder narcolepsy and GlaxoSmithKline’s H1N1 pandemic vaccine, Pandemrix, has led to a call from the World Health Organization (WHO) for further investigation. Narcolepsy is a rare condition with no currently available cure. Read more »

I am here in Charlotte, North Carolina, this week for Informex 2011, the trade show of custom and batch manufacturers, which raises a fundamental question. What is the future for outsourcing of chemically synthesized active pharmaceutical ingredients (APIs) and pharma intermediates? Read more »

When Hospira stopped manufacturing sodium thiopental, which is used in lethal injections, it caused a drug shortage, and states began looking for alternate suppliers. At first, the developments made me wonder whether FDA should oversee nonmedical uses of drugs. Now the shortage has led to a federal lawsuit that raises questions about the way the agency controls imported drugs. Read more »

It’s not too often that a pharma facility closure tops the TV news headlines but that was the case in the UK this week following Pfizer’s announcement that it is to close the UK-based R&D centre that achieved worldwide fame as “the home of Viagra”. Read more »

A recent poll on PharmTech.com asked readers whether FDA should have the authority to issue recalls for pharmaceutical products, and 86% of readers were in favor of allowing the agency to do so. Read more »