Archive for the 'Products' Category

FDA Commissioner Hamburg Discusses Counterfeit Drugs at Conference

Alexis Brekke Pellek PharmTech editorDr. Margaret Hamburg, commissioner of the US Food and Drug Administration, spoke about the growing problem of counterfeit drugs at last Friday’s Counterfeit Drug Interchange Conference in Washington, DC, hosted by the Partnership for Safe Medicines (PSM), a collection of more than 60 non-profit organizations focused on the safety of prescription drugs. 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 »

Sproxil’s Mobile-Phone Technology Tracks Medical and Food Donations, Prevents Diversion

Alexis Brekke Pellek PharmTech editorSproxil, a provider of brand-protection services, has developed a program designed to track donated food and healthcare goods as well as prevent illegal diversion. The company will present its Commitment to Action, “Preventing the Diversion of Medical and Food Donations,” at the 6th annual meeting of the Clinton Global Initiative (CGI), taking place September 20–23 in New York City. Read more »

FDA Panel Votes ‘No’ on Arena’s Obesity Drug

Alexis Brekke Pellek PharmTech editorThe US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee yesterday voted 9–5 against approval of Arena Pharmaceuticals’ (San Diego) appetite-curbing drug candidate lorcaserin hydrochloride. The panel believed that the risks outweigh the benefits of the drug for the treatment of obesity. Concerns focused on increased rates of depression and memory loss in patients as well as the presence of tumors in rats during early testing of lorcaserin. Read more »

More Japanese Interest in Potential Obesity Drugs

Alexis Brekke Pellek PharmTech editorLast week, Japanese drugmaker Takeda (Osaka, Japan) struck a deal with biopharmaceutical company Orexigen (La Jolla, CA) for the commercialization of its investigational obesity drug Contrave (naltrexone SR/bupropion SR). Under the terms of the agreement, Takeda will pay Orexigen $50 million cash up front, more than $1 billion in milestone payments, and royalties for rights to commercialize the drug in the US, Canada, and Mexico (Orexigen will co-promote the drug in the US). 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 »

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 »

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