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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.
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.