Challenges And Changes in Vaccine Manufacture

Stephanie Sutton Pharm Tech EuropeEarlier this week I took a trip to Liverpool (UK) to the Downstream Processing Day hosted by SAFC and Sartorius Stedim Biotech. A lot of interesting topics were discussed, including vaccine manufacture, which is a particularly hot issue both inside and outside of the industry at the moment. Read more »

Success Is Unlikely on sanofi’s Terms

Erik Greb PharmTech editorThere was no joy in Paris, at least at sanofi-aventis (Paris) headquarters, on Friday. When the company’s offer to acquire Genzyme (Cambridge, MA) at $69 per share expired that day, fewer than 1% of the biopharmaceutical company’s outstanding shares had been tendered. In response, sanofi extended its deadline to January 21, 2011 without modifying the terms of its offer. Why should the company expect a different result in six weeks’ time? Read more »

Big Pharma Gets Caught in the WikiLeaks Spotlight

Erik Greb PharmTech editorJournalists 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 »

Memo to Congress: Hands off FDA

Erik Greb PharmTech editorIn January 2011, control of the US House of Representatives will shift to the Republican party. Reducing the federal deficit is one of the party’s top priorities, and Republican leaders have proposed to cut domestic spending as a means to accomplish this end. But should all programs be put on the chopping block? Read more »

Could Lawsuits Threaten Vaccine Makers’ Livelihood?

Erik Greb PharmTech editorDoes federal law shield the makers of vaccines from product-liability lawsuits? Last week, the US Supreme Court began considering this question, which is the heart of a lawsuit against Wyeth, now a part of Pfizer (New York). Read more »

Producing Taxol through Non-Taxing Means

Erik Greb PharmTech editorPharmaceutical 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 »

Cheap and Easy Vaccine Production Coming Soon?

Erik Greb PharmTech editorThe 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 »

Sanofi’s Courtship of Genzyme in Limbo

Erik Greb PharmTech editorNow 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 »

A Turning Point for Genzyme?

Erik Greb PharmTech editorHave 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 »

Congress Moves Again on Drug Safety and Quality

Patricia Van Arnum PharmTech editor 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 »

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