Meet the New Drugs: Same as the Old Drugs

Erik Greb PharmTech editorStock prices have fluctuated wildly in response to factors such as persistently high unemployment, impending cuts in federal spending, and the downgrade of America’s credit rating. The already conservative pharmaceutical industry is hunkering down and socking away cash to be safe. Since January, Merck has saved $1 billion in cash, and Johnson & Johnson has saved $3 billion. The savings have come at the expense of R&D budgets, making observers wonder where the new drugs will come from.

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Cordis To Axe Up To 1000 Jobs

Stephanie Sutton Pharm Tech EuropeIn a move that the company attributes to “evolving market dynamics”, Johnson & Johnson’s subsidiary Cordis is pulling out of the drug-eluting heart stents sector, cutting 900–1000 jobs in the process. Cordis will cease the development of its NEVO sirolimus-eluting coronary stent, as well as the manufacture of CYPHER and CYPHER Select Plus sirolimus-eluting coronary stents. Manufacturing will cease by the end of 2011. Read more »

Consent Decree (Finally) for J&J

Erik Greb PharmTech editorBeginning in September 2009, I watched with increasing surprise as Johnson & Johnson (J&J) recalled more and more of its products. As the recalls kept coming, my surprise turned to amazement that some of the company’s facilities (particularly the one at Fort Washington, Pennsylvania) could have been maintained and run in such an apparently haphazard way. As time went on, my amazement ebbed, and the continuing stream of recalls elicited little more than a shrug. Read more »

Should FDA Have Drug-Recall Authority?

Alexis Brekke Pellek PharmTech editorOn Jan. 4, President Obama signed the FDA Food Safety Modernization Act. The bill expands FDA’s oversight of the food industry and grants the agency, among other things, the authority to issue mandatory food recalls (see back story).

PharmTech is asking readers in our current poll whether FDA should have the same power over pharmaceutical recalls. Right now, nearly 90% of respondents have said  “Yes.” Read more »

J&J’s Fort Washington Plant Cited for Quality Problems; Two Vice-Chairmen Appointed

Alexis Brekke Pellek PharmTech editorMcNeil Consumer Healthcare, a business unit of Johnson & Johnson (New Brunswick, NJ), failed to ensure the quality of over-the-counter consumer products, according to the Form 483 report released by the US Food and Drug Administration on Wednesday. Read more »

Hearing Reviews J&J “Phantom Recall,” Discusses Granting FDA Recall Authority

Alexis Brekke Pellek PharmTech editorJohnson & Johnson CEO William Weldon admitted last week that the company “should have handled things differently” in regard to its “phantom recall” of Motrin. The second hearing of The House Committee on Oversight and Government Reform focused on the “phantom recall,” in which outside contractors were hired to pose as customers and buy two lots of 8-caplet Motrin vials to remove them from store shelves. Read more »

J&J CEO, FDA to Testify at Second Congressional Hearing Today

Alexis Brekke Pellek PharmTech editorJohnson & Johnson Chairman and CEO William Weldon is scheduled to testify at today’s hearing held by the The House Committee on Oversight and Government Reform. Weldon is expected to answer questions about J&J/McNeil Consumer Healthcare’s April 30, 2010, recall of more than 135 million bottles of infants’ and children’s medication. Read more »

J&J Orthopaedics Unit Recalls Two Hip-Replacement Systems

Alexis Brekke Pellek PharmTech editorDePuy Orthopaedics, a business unit of J&J that makes joint replacements, announced a voluntary recall last week of two hip-replacement products, the ASR XL acetabular system and DePuy ASR hip resurfacing system. Read more »

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 »

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