Life sciences giant Johnson & Johnson (J&J) managed to increase first quarter profits by 12.5% despite a decrease in revenue of 0.2%, the company said in a statement. But the company's profits were sorely depressed by a series of regulatory issues, including recalls, shortages and legal battles, reports The Associated Press. Among J&J's many issues during Q1: The US Department of Justice rejected a settlement between the company and the US government ove...

The Supreme Court of the United States ruled 17 April that Caraco Pharmaceuticals can proceed with a lawsuit against Novo Nordisk over Nordisk's purported attempts to prevent Caraco's generic entry into the market, reports various news sources. "At issue was the ability of a brand-name drugmaker to block generic competition by providing the US Food and Drug Administration (FDA) with overly broad descriptions of its patents," writes  Pharmalot . Caraco's lawsuit a...

Researchers have published a new study in the medical journal Archives of Internal Medicine , in which the researchers argue consumers are being short-changed by US Food and Drug Administration (FDA) regulations that promote excessive reformulations and stymie generic substitution, reports various sources. To illustrate their point, the authors, led by Dr. Harlan Krumholz of Yale University, studied the effect of reformulations on pharmaceutical manufacturer Abbott Lab...

Advisers from the US Food and Drug Administration (FDA) are backing a Levaquin, a drug candidate manufactured by Johnson & Johnson, despite the drug not undergoing human clinical trials, reports Fierce Pharma . The backing would involve the extremely rare use of an approval pathway known as the 'Animal Rule' pathway, which was created after a series of anthrax-based terror attacks in 2001 prompted FDA and other governmental officials to seek an approval pathway for ...

Life sciences manufacturer Johnson & Johnson sold its now-controversial vaginal mesh implant for three years prior to being approved by the US Food and Drug Administration (FDA) in 2008, reports Bloomberg . The unauthorized sale of the Prolift vaginal mesh implant product, manufactured by Johnson & Johnson's Ethicon unit, could place the 510(k) approval pathway under additional scrutiny. The company marketed Prolift as early as 2005, reports Bloomberg , reason...

Outgoing Johnson & Johnson (J&J) Chief Executive Officer William Weldon will receive $143 million in retirement pay, according to a regulatory filing released by J&J. The company-and Weldon's reputation-were plagued last year by a large number of quality setbacks that caused the US Food and Drug Administration (FDA) to take notice, including a consent decree between FDA and a Pennsylvania manufacturing plant owned by J&J subsidiary McNeil PPC. Weldon...

Johnson & Johnson's tentative $1 billion settlement with the US Department of Justice over allegations of improper marketing of its schizophrenia drug Risperdal was rejected on 12 March by federal prosecutors, reports The Wall Street Journal . Sources close to the matter told  Bloomberg News  federal prosecutors are demanding an additional $800 million to resolve the civil claims in the government's lawsuit. The charges originate from a US investigation i...

Pharmaceutical manufacturer Warner Chilcott's attempt to delay generic competition for its Doryx acne pill has been rebuffed by the US Food and Drug Administration (FDA), according a response letter posted by the agency . Warner Chilcott had changed the scores on its Doryx tablets from one score to two scores. The scores are used by physicians and patients to properly split the pills. Warner Chilcott's change, it argued, was substantial enough that any generic manufactu...