Pharmaceutical industry
Natrecor, Johnson & Johnson's treatment for heart failure, has been revised to include data on deaths in its package insert. This change comes after studies published in medical journals raised concerns about an increased risk of fatal kidney problems in patients treated with the drug. The updated label
Medical equipment industry
After a 13-year ban, a Food and Drug Administration advisory panel has approved the sale of silicone breast implants manufactured by Mentor, a move that has improved the chances for more implants to re-enter the market. Industry analysts say the decision has opened the door for other companies to follow
Medical equipment industry
The Food and Drug Administration's advisory panel voted 7-2 to recommend approval of Mentor's application to sell its silicone-gel implants to any woman who wants them. This decision marks a significant step towards the return of the implants to the U.S. market, which has been
Pharmaceutical industry
The US Food and Drug Administration (FDA) has requested that Pfizer withdraw its Bextra arthritis drug from the market, citing an unfavorable risk versus benefit profile. This decision comes despite Pfizer's hopes to consider resuming sales of its cox-2 painkiller, Vioxx, which was withdrawn in September due to
Pharmaceutical industry
The Food and Drug Administration's intervention against Pfizer's Bextra and Celebrex marks the end of the illusion that cox-2 pain inhibitors are safe and effective alternatives to conventional pain medications. The withdrawal of Bextra, following a request from the FDA, leaves only one cox-2 blockbuster on
Pharmaceutical industry
The battle for the cosmetic dollar in the US has taken a significant turn with Medicis Pharmaceutical announcing its intention to acquire Inamed, a manufacturer of breast implants, for $2.8 billion. The merger aims to create a stronger rival to Allergan, the maker of the popular Botox anti-wrinkle treatment.
Pharmaceutical industry
Foreign pharmaceutical companies have struggled to navigate China's heavily regulated and bureaucratic market, but US-based Wyeth has found a way to thrive. By focusing on infant nutrition products and leveraging the mainland's low-cost laboratory capabilities, Wyeth has generated significant revenue and expanded its presence. The company&
Pharmaceutical industry
The US Food and Drug Administration (FDA) and Biogen Idec announced on Wednesday that Avonex, the top-selling multiple sclerosis (MS) treatment, will carry a stronger warning label about its rare risk of causing liver failure. This move comes after a series of setbacks in the MS community, including the withdrawal
Medical equipment industry
Boston Scientific Corporation announced that the U.S. Food and Drug Administration (FDA) has approved its Quincy Distribution Center as a sterilization site for the Cutting Balloon microsurgical dilatation device product line. Additionally, the company's Letterkenny, Ireland facility has received FDA approval to manufacture two versions of the
Pharmaceutical industry
A recent poll conducted by Associated Press and Ipsos Public Affairs sheds light on the changing dynamics between pharmaceutical manufacturers and informed health consumers. The survey found that despite concerns over COX-2 inhibitors, Americans remain confident in the safety of prescription drugs. However, they also expect the FDA to do
Medical equipment industry
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Baxter Healthcare Corporation for its wireless pump connectivity interface. This technology enables healthcare providers to connect Baxter's Colleague CX infusion pump to its Patient Care System, allowing for real-time monitoring and tracking of patient
United States. Food and Drug Administration
Liz Szabo writes that an FDA advisory panel will review recent research showing that the lung cancer drug Iressa, which received fast-track approval two years ago, fails to improve survival. The drug, approved in 2003, was given accelerated approval on the condition that its maker conduct additional studies to confirm
