Author Archive

More J&J Quality Problems Revealed with New Recall

Alexis Brekke Pellek PharmTech editorQuality 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 »

J&J Plans to Improve Manufacturing Quality

Alexis Brekke Pellek PharmTech editorJohnson & 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 »

AIDS Vaccine Trial Planned by IAVI, Crucell, Harvard, Ragon Institute

Alexis Brekke Pellek PharmTech editorA new clinical trial for an AIDS vaccine will take place in Africa and the United States. The program, announced this week, is a collaboration between the International AIDS Vaccine Initiative (IAVI), which will lead the trial, biopharmaceutical company Crucell (Leiden, Netherlands), Harvard Medical School’s Beth Israel Deaconess Medical Center, and the Ragon Institute, an organization dedicated to HIV/AIDS research. Read more »

Lundbeck Voluntarily Recalls Injectable Ibuprofen Used to Treat Premature Infants

Alexis Brekke Pellek PharmTech editorLundbeck (Deerfield, IL) issued a voluntary recall of its anti-inflammatory drug NeoProfen (ibuprofen lysine) Injection last Friday because it contains visible particulates, according to a company press release. The recall will cause a temporary shortage of the drug because the company recalled both lots that are currently available to prescribers. Read more »

sanofi aventis Unhappy About Generic Lovenox Approval

Alexis Brekke Pellek PharmTech editorThe 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 »

A Timeline of J&J/McNeil’s Recent Recall Troubles

Alexis Brekke Pellek PharmTech editorJohnson & 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 »

Report: Obesity Rates Hit More Than 25% in Most of America

Alexis Brekke Pellek PharmTech editorColorado is the country’s only state with an adult obesity rate below 20%. (Its rate is 19.1%.) More than two-thirds of states (38) have adult obesity rates above 25%, and rates increased in 28 states in the past year. These statistics were released this week in F as in Fat: How Obesity Threatens America’s Future 2010, a report from the Trust for America’s Health (TFAH) and the Robert Wood Johnson Foundation. This sobering news comes just in time for America’s 234th birthday, when millions of us will head to cookouts and celebrate with family, friends, and food. Read more »

J&J CEO Invited to Second Congressional Hearing

Alexis Brekke Pellek PharmTech editorThe House Committee on Oversight and Government Reform asked Johnson & Johnson CEO Bill Weldon to testify at a second hearing to explore the company’s recent massive recalls of over-the-counter medication, according to reports this week (see Reuters and Bloomberg). Weldon was unable to attend the committee’s May 27 hearing because he was recovering from back surgery at the time. Read more »

Five More Lots Added to January 2010 Tylenol and Benadryl Recall

Alexis Brekke Pellek PharmTech editorMcNeil 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 »

Heavy Metals Contamination a Problem for McDonalds, Pharma

Alexis Brekke Pellek PharmTech editorLast week’s McDonalds glassware recall is another example of the problem of heavy metals appearing in consumer products. The fast-food giant, in cooperation with the Consumer Product Safety Commission (CPSC), recalled its promotional Shrek glassware because of the elevated level of cadmium found in the glasses. Read more »

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