TOP 100 MEDICAL SITES
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| AstraZeneca Settles Seroquel Case: Biotech's Latest Mishaps The Burrill Report submits: AstraZeneca (AZN) has agreed to pay $520 million to settle civil allegations that it inappropriately marketed its antipsychotic Seroquel. AstraZeneca said as part of the settlement it denied the allegations. The final agreement is with the United States Attorney’s Office for the Eastern District of Pennsylvania, the United States Department of Justice, various other federal agencies, and the National Association of Medicaid Fraud Control Units. A portion of the payment will be distributed to states participating in the National Association of Medicaid Fraud settlement. AstraZeneca said it has entered into a corporate integrity agreement with the Office of Inspector General of the United States Department of Health and Human Services. The corporate integrity agreement will be in effect for five years. Ortho-McNeil Pharmaceutical and Ortho-McNeil-Janssen Pharmaceuticals, both subsidiaries of Johnson & Johnson (JNJ), have agreed to pay more than $81 million to resolve criminal and civil liability arising from the illegal promotion of the epilepsy drug Topamax, the U.S. Department of Justice said. Ortho-McNeil Pharmaceutical has agreed to plead guilty to a misdemeanor and pay a $6.1 million criminal fine for the misbranding of Topamax in violation of the Food, Drug and Cosmetic Act. The U.S. Food and Drug Administration approved Topamax as an anti-epileptic drug, for the treatment of partial onset seizures, but not for any psychiatric use. The government alleged that Ortho-McNeil Pharmaceutical promoted the sale of Topamax for off-label psychiatric uses through a practice known as the "Doctor-for-a-Day" program. Using this program, Ortho-McNeil hired outside physicians to join sales representatives in their visits to the offices of health care providers and to speak at meetings and dinners about prescribing Topamax for unapproved uses and doses. In addition to the criminal fine, Ortho-McNeil-Janssen Pharmaceuticals will pay $75.4 million to resolve civil allegations under the False Claims Act that they illegally promoted Topamax and caused false claims to be submitted to government health care programs for a variety of psychiatric uses that were not medically accepted indications and therefore not covered by those programs. Schwarz Pharma will pay $22 million to resolve False Claims Act allegations that the company failed to advise the Centers for Medicare and Medicaid Services that two unapproved products did not qualify for coverage under federal health care programs, the U.S. Department of Justice said. Schwarz, now a subsidiary of Belgium-based UCB, is alleged to have submitted false quarterly reports to the government related to a pair of drugs, Deponit and Hyoscyamine Sulfate Extended Release. Deponit is a nitroglycerin skin patch that has been used to prevent angina. Hyoscyamine Sulfate ER is an antispasmodic medication that has been used to treat various stomach, intestinal, and urinary tract disorders that involve cramps, colic, or other painful muscle contractions. While the active ingredients in Deponit and Hyoscyamine Sulfate ER had been in products on the market for many years, the Food and Drug Administration made determinations in 1997 and 1999 that resulted in the drugs being ineligible for reimbursement by government healthcare programs such as Medicaid. The United States alleges that Schwarz misrepresented the regulatory status of both drugs and failed to advise CMS that these unapproved drugs did not qualify for coverage under federal healthcare programs. The U.S. Food and Drug Administration notified Salix Pharmaceuticals (SLXP) that it would not approve Giazo, the company’s experimental drug for mild to active ulcerative colitis at this time because of concerns over deficiencies at a manufacturing facility. The company said the FDA is not seeking any new pre-clinical or clinical trials. Salix said the manufacturer has responded to the FDA and continues to work with the agency to resolve the matter. The U.S. Food and Drug Administration notified Teva Pharmaceutical Industries (TEVA) about violations at a manufacturing facility in California, Reuters reported. The FDA said a July 2009 inspection found problems with the manufacture of the sedative propofol at the company’s plant in Irvine, Califronia. Teva said it is working with the agency to address the problems.Complete Story » seekingalpha.com |
Ventas to Acquire Lillibridge Healthcare Ventas agreed to acquire privately held Lillibridge Healthcare and real-estate interests in 95 medical office buildings and ambulatory facilities for between $300 million and $400 million. online.wsj.com |
Eli Lilly Profit Rises 16%; Bristol Posts 5.7% Drop Drug maker Eli Lilly reported a 16% increase in second-quarter profit as price increases in the U.S. helped offset pricing pressures abroad. Bristol-Myers reported a 5.7% decline in net income despite slightly higher sales. online.wsj.com |
Genomic Health to Present at Two Upcoming Investor Conferences [PR Newswire] - Genomic Health, Inc. today announced that members of its management team will present at the following conferences in September: us.rd.yahoo.com |
Here We Go Again: Novartis Fined for Off-Label Marketing Pharmalot submits: Another week, another drugmaker agrees to settle off-label marketing charges brought by the federal government. This time, Novartis (NVS) will pay $422.5 million for illegally promoting its Trileptal epilepsy med for unapproved uses, such as bipolar disorder and neuropathic pain, along with five other drugs - Diovan, Zelnorm, Sandostatin, Exforge and Tekturna. The fine includes roughly $237 million to settle four lawsuits brought by whistleblowers, while $185 million goes toward criminal penalties. One of the lawsuits was filed by Jeremy Garrity, a former cardiovascular sales rep, who worked for Novartis between 2002 and 2008 before being fired (you can read it here, and another whistleblower suit here, and you can read the settlement here. Oh, and this is the guilty plea [pdf files]). (Update: Read interview with Garrity here.)Complete Story » seekingalpha.com |