The makers and marketers of Erbitux announced today that their late-stage study of the colon cancer drug was a success, a fact that may lead to broader usage of the medication. ImClone, producer of Erbitux, and Bristol-Myers Squibb, who markets the drug in the U.S., reported that the drug was valuable in slowing the progress of colon cancer in patients who had not received prior treatment.

Currently, the U.S. Food and Drug Administration (FDA) has approved Erbitux only for patients on whom chemotherapy was not successful. The new findings may very well spur the FDA to expand its “label” for the drug. The companies plan to present their research at the American Society of Clinical Oncology’s annual meeting in Chicago this coming June.
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According to a report in today’s New York Times, State Farm Fire & Casualty Co. is close to reaching a huge settlement of hundreds of lawsuits related to Hurricane Katrina’s destruction of the Mississippi Gulf Coast.

The Times said that the $80 million settlement is expected to address 639 lawsuits. In addition, there is also a provision in the settlement that calls for the review of previously settled claims made by policyholders who did not file suit. The company’s expenditure may grow into hundreds of millions of dollars once these previously handled claims are reopened.
“State Farm, under the tentative accord, would provide an average of about $125,000 to homeowners who filed lawsuits, although the payments would range from as little as about $2,000 to about $2 million,” the paper noted. “The treatment of those cases would serve as a guide for increasing payments to any of the 35,000 homeowners who request a review of their claim, according to lawyers privy to the details.”
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A new study published in today’s edition of the journal Neurology has raised serious safety concerns about the blood-thinning drug warfarin. According to researchers at the University of Cincinnati College of Medicine, the drug may lead to an increased risk of a brain hemorrhage, especially among the older population.

“The rate of brain hemorrhages associated with blood-thinning drugs quintupled during the 1990s,” says the American Academy of Neurology, the organization that publishes the journal. “In people over age 80, the rate increased more than tenfold.”
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The U.S. Food and Drug Administration issued a proposal to officially allow food and supplement manufacturers to tout the benefits of calcium and vitamin D in preventing osteoporosis. The new rule would allow the manufacturers to make the health claim on its product labeling.

“This is important information for all citizens,” said Dr. Robert E. Brackett, director of FDA’s Center for Food Safety and Nutrition. “All persons lose bone with age, and the loss can influence an individual’s risk of developing osteoporosis. Maintenance of an adequate intake of calcium and vitamin D in all stages of life can help lower one’s risk.”
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According to a report from McClatchy News, the U.S. Justice Department is currently in negotiations with large Internet service providers (ISPs) in the hopes of improving their ability to monitor online traffic.

The report says that the Justice Department is seeking new guidelines that would allow federal officials to track website traffic for domestic online users.
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By Marc Greilsamer

When the Democratic-controlled 110th Congress was sworn in on Capitol Hill last week, it was no cause for celebration inside the pharmaceutical industry. During the previous dozen years, the outgoing Republican majority had delivered to the industry an era of unprecedented prosperity and regulatory kindness. However, it’s not hard to decipher the message being pounded home by the newly minted Democratic Congressional leaders: The jig is up.

The next few months will determine whether or not the industry’s dread is warranted as the Democrats pursue a number of initiatives intended to lower the costs of prescription drugs for the American consumer. Chief among them is a proposal to drastically revamp the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which currently prohibits the government (i.e. Medicare) from directly negotiating with drug companies to obtain lower drug prices for seniors. Democrats have also debated lifting the ban on large-scale drug importing from nations such as Canada. It is suspected that Democrats may attempt to allow generic drugs onto the market more quickly than is currently allowed.

Other subjects being bandied about by Democrats may not directly affect prescription prices, but may well affect the drug industry’s bottom line. Many Democrats favor a tightening of the drug-approval process at the U.S. Food and Drug Administration (FDA). In addition, it is widely believed that Democrats, as part of a larger purge of corruption on the Hill and a pledge to rein in big business in general–will intensely scrutinize a variety of conflicts-of-interest issues that the old guard may have been willing to let slide. What’s more, there is the issue of the FDA’s “preemption rule,” which attempts to shield drug companies from private lawsuits in state courts.
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Last week, Eli Lilly annnounced the second phase of settlements surrounding its blockbuster anti-psychotic drug Zyprexa. The drug generated more than $4.2 billion in sales in 2005, and makes up more than 25% of Lilly’s entire revenue. By settling these cases, the company hoped it would remove the dark cloud over the drug and regain the confidence of doctors and patients. However, with competing drugs gaining in popularity it may be difficult for Lilly to get the results out of Zyprexa that they expect.

Further complicating the complicating the outlook for Lilly is Zyprexa’s patent situation. The drugs patent is set to expire in just four years, meaning that the company needs to capitalize on the drug’s sales before generic competitors are allowed to enter the market. The company is also facing patent expirations for several other medications.
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German pharmaceutical company Boehringer Ingelheim has commenced clinical trails on a drug that works to restore women’s libido. The drug, flibanserin, could become the female equivalent of Viagra. The libido increasing effects were discovered by accident when it was being tested as an anti-depressant. Participants in the trials reported that their depression was no better but that they had experienced a boost in sexual desire.

The company is conducting four trials on 5,000 women in 220 locations and hopes for approval from the US Food and Drug Administration in 2009.
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In a triumph for New Jersey environmentalists, the DuPont Co. announced today that it is backing out of a U.S. Army plan to dispose of wastewater derived from the nerve agent VX. Although the project had been approved by both the Environmental Protection Agency (EPA) and the Centers for Disease Control and Prevention (CDC), the company decided against participation in the project, fearing various legal and regulatory challenges.

The plan was to transport millions of gallons of the VX wastewater, called hydrolysate, from a Newport, Indiana, weapons depot to Deepwater, N.J., where it would be treated by a DuPont facility and eventually dumped in the Delaware River. Last month, the Delaware Riverkeeper Network joined with a variety of environmental groups to file suit against the Army in U.S. District Court. Citing a violation of the National Environmental Policy Act (NEPA), the complaint claimed that the Army had not conducted enough research about the impact of the disposal plan on factors such as groundwater and local marine life. The suit also cited a federal regulation that bars interstate transportation of chemical weapons.
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For those among us who might feel that the American people are “overmedicated,” you may have a new dilemma on your hands. The U.S. Food and Drug Administration (FDA) issued its approval of the first-ever drug to treat dog obesity, a condition that affects approximately 5 percent of dogs in the U.S.

The new drug, called Slentrol (generic: dirlotapide), is manufactured by Pfizer Inc. and, according to the FDA, it “reduces appetite and fat absorption to produce weight loss” in canines. “This is a welcome addition to animal therapies, because dog obesity appears to be increasing,” said Dr. Stephen Sundlof, director of the FDA’s Center for Veterinary Medicine. “Veterinarians are well aware that overweight pets are at a higher risk of developing various health problems, from cardiovascular conditions to diabetes to joint problems.”
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