FDAnews Drug Daily Bulletin
Jan. 3, 2005 | Vol. 2 No. 1
The pharmaceutical industry's primary methods of pricing products -- through intellectual property rights and diversity pricing, which allows firms to charge higher prices to those with greater ability to pay -- are under attack, a free-market think tank concludes in a new paper opposing drug importation proposals.
Centocor and Eli Lilly are sending "Dear Healthcare Professional" letters to physicians to alert them about severe liver reactions associated with a rheumatoid arthritis product and an attention-deficit/hyperactivity disorder (ADHD) drug, according to announcements posted at the FDA's Medwatch website.
The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) has issued an untitled letter to AstraZeneca for safety claims about the company's cholesterol-lowering drug Crestor that the agency has deemed false or misleading.
The FDA has announced that it is requiring evaluation of all prevention studies involving Celebrex and Bextra to ensure that adequate precautions are implemented in the studies and instructing institutional review boards to reevaluate them in the wake of recent evidence that the compounds may cause increased cardiac risk.
aaiPharma has announced that SICOR Pharmaceuticals, a wholly owned subsidiary of Teva Pharmaceutical Industries, has reacquired its U.S. marketing rights for calcitriol injection in exchange for certain payments to aaiPharma.
Quintiles Transnational will provide a Seattle-based biotechnology firm with $30 million in cash and services in return for at least $53 million in royalties.
The parents of a 7-year-old girl have sued the makers of Children's Motrin and several other companies that distribute the painkiller, claiming their daughter lost her eyesight and suffered other severe side effects after taking the medication.
Praecis Pharmaceuticals (PRCS) allegedly failed to disclose material facts regarding its prostate cancer drug, Plenaxis, leading to fiscal-2004 projections that weren't "reasonably founded," according to a purported class-action lawsuit.
Bristol-Myers Squibb Company and Somerset Pharmaceuticals, a joint venture between Mylan Laboratories and Watson Pharmaceuticals, have entered into an agreement for the commercialization and distribution of Somerset's Emsam (selegiline transdermal system), an investigational monoamine oxidase inhibitor administered as a transdermal patch for the acute and maintenance treatment of patients with major depressive disorder.
The deal is done. Human Genome Sciences has officially made its exit from the 318,000-sf multistructure facility at the 300-acre Shady Grove Life Science Center.
U.S. drug manufacturers are planning a New Year's push to pressure Canberra to unwind initiatives to cut medicine prices.
Timing and unprecedented funding propelled several Birmingham-based biotechnology companies to the forefront of national development trends in 2004, strengthening a sector often relegated to the halls of academia.
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