If you’re not in Baltimore this week, you’re missing out on a lot of great educational information regarding the use of excipients in the pharma industry. ExcipientFest in partnership with IPEC is hosting its annual conference and exhibition. The entertainment for participants, including a reception on the USS Constellation naval  ship in the Inner Harbor, has also been quite an experience.  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 »

FDA issued an alert today that it has detected “excessive levels of peroxide in one lot of Crospovidone (cross linked polyvinyl N-pyrrolidone) manufactured by China-based Tianjin Boai NKY International Ltd.” Although there have not been any related adverse-event reports to date and although the level of peroxide found does not pose a major health risk, said the agency in an advisory statement yesterday, there is concern that elevated levels of peroxide can cause “subpotent finished products.” Read more »

While attending CPhI Worldwide, a large exhibition of contract manufacturing organizations (CMOs) of active pharmaceutical ingredients (APIs) and intermediates and fine-chemical suppliers, in Paris this week, I am hearing a familiar theme: business is better compared with what it had been during the last several years, but it has not returned to the levels it had been at prior to the economic crisis. The ongoing pressures felt by the pharmaceutical companies, both large and small, are filtering down to the supplier base as well. In a phrase, cautious optimism. Read more »

So I’ve just returned from an exhausting but a fantastic week in Paris. The beautiful French capital played host to this year’s CPhI exhibition and whilst I didn’t get to take advantage of the cultural and architectural wonders that the city has to offer, I have to say that I came away with a real feeling of optimism (accompanied by a pair of very sore feet of course). 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 »

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 »

The US Food and Drug Administration approved the first generic version of the anticoagulant drug enoxaprin sodium injection on last Friday, July 23. Lovenox is the drug’s brand name, and it’s manufacturer, sanofi Aventis (Paris), was not happy about FDA’s decision. Read more »

Johnson & Johnson and its McNeil Consumer Healthcare unit have been all over the news lately for all the wrong reasons. Another recall was issued last week, as was news of a class-action lawsuit in the works against the company. The timeline below summarizes the recent events surrounding J&J/McNeil’s recalls and news. Read more »

McNeil Consumer Healthcare/Johnson & Johnson is expanding its Jan. 15, 2010, recall to include four lots of Benadryl and one lot of Tylenol, the company announced on Tuesday. The company said these products were “inadvertently omitted from the initial recall action,” which took effect because of consumer reports of a moldy, musty odor from the medication. As in previous recalls, McNeil said that the risk of serious adverse events is remote. Read more »