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 »

Quality improvements at Johnson & Johnson was the focus of last week’s news about the company. This week, unfortunately, it’s back to recalls and warning letters. Read more »

One of PharmTech’s columnists recently wrote about individuals working in quality assurance and how, after becoming more sensitized to a problem, they significantly increased their performance. Specifically, the employees were in charge of identifying spots on finished vials—if they found a spot of a certain size, they rejected the vial. When one employee starting finding more spots than usual and bragged to his colleagues, they all started finding more spots until the team was rejecting 20% of the finished vials. 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 »

Johnson & Johnson’s CEO William Weldon told The Wall Street Journal this week that the company will change its manufacturing operations and create a new position responsible for company-wide quality that reports directly to him. The company’s numerous recalls and manufacturing problems during the past year have resulted in a Congressional hearing and harsh words from FDA inspectors—in addition to shaken consumer confidence. Read more »

“The pharmaceutical industry is a ‘market for lemons’; a market in which the seller knows much more than the buyer about the product and can profit from selling products less effective and less safe than consumers are led to believe”. 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 »

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 »

The welter of recent product recalls (and phantom recalls) initially got the US Congress talking about the adequacy of Johnson and Johnson’s (J&J, New Brunswick, NJ) manufacturing and quality-control operations. But lawmakers soon began asking questions about our line of defense against potentially harmful products: the US Food and Drug Administration. Read more »

The past two weeks have seen dozens of third-party headlines speculating about sanofi aventis possibly making a move to acquire Genzyme. Officially, there has been no word with both companies remaining extremely cagey about any of the details. However, Reuters, Bloomberg and a few other sources claim to have squeezed out a few dribbles of information from “people familiar with the situation” and anonymous staff members. So let’s take a look at what may (or may not be) the current situation. Read more »