FDAnews Drug Daily Bulletin

The FDA has issued a warning letter to New Jersey-based drugmaker Mayne Pharma for failing to submit and investigate numerous adverse drug experience (ADE) reports between 2002 and 2004.

Nearly two-thirds of Americans want the government to do more to regulate prescription drug prices, according to a new healthcare poll that finds most adults still have a low opinion of the drug industry.

Fewer generic drug approvals combined with increased competition from authorized generics and foreign drugmakers will limit growth in the U.S. generics industry in 2005, a Wall Street analyst predicted at a recent industry event.

As expected, Sens. Chuck Grassley (R-Iowa) and Christopher Dodd (D-Conn.) have introduced legislation that would create an electronic clinical trials registry to which drugmakers must submit the results of their drug studies or face monetary penalties.

Caremark Rx Inc. executives say they are well positioned to take advantage of the growth in mail order prescriptions.

United Therapeutics, coming off its first-ever profitable year, says it has received regulatory approval in France for Remodulin, its treatment for pulmonary hypertension, a rare lung disorder.

Millennium Pharmaceuticals has landed about $40 million in licensing fees and milestone payments from collaborations with pharmaceutical giants GlaxoSmithKline Group (GSK) in London and Johnson & Johnson Pharmaceutical Research and Development LLC in New Jersey.

Cardinal Health, the leading provider of products and services supporting the healthcare industry, has announced the opening of a new manufacturing plant in Las Piedras, Puerto Rico for its Pyxis Products business.

A study released at the American College of Cardiology in Orlando, Fla., showed that a combination of Norvasc, from Pfizer, and Aceon, co-marketed in the U.S. by Solvay and CV Therapeutics outperformed an older combination of blood-pressure therapies.

Washington University School of Medicine received a $14 million, five-year grant to find better ways to prevent and treat heart disease in patients with diabetes, it said Monday.

Chiron and the Respiratory Disease Network have reached a settlement regarding the lawsuit initiated by Chiron in October 2004, relating to product marketing practices for a cystic fibrosis treatment.

Pharma major Orchid Chemicals & Pharmaceuticals said the U.S. FDA has completed inspection of its state-of-the-art formulations facility located at Irungattukottai in Chennai.