investigation

FDA designation turns into fast track to nowhere

Mon, 03 Dec 2007 06:59:56 -0500

Life in the biotech fast lane is good for investors, not so great for patients--or so says the Cleveland Plain Dealer after a seven-month investigation of the FDA's record on fast-track drugs. Created in 1998, the fast-track designation was held out as a potential savior for patients with life-threatening illnesses. Helpful drugs could make it to market more quickly, rescuing victims of serious disease.

That's not how it's worked, though. The fast track hasn't increased the number of drugs approved or put them on the market faster, the newspaper concluded after poring over government documents. Instead--in a manifestation of the law of unintended consequences--the designation has lined the pockets of day traders, hedge funds, and executives who get stock options when the FDA shuttles one of their drugs into the express lane.

Meanwhile, many of the drugs in that express lane were subsequently scrapped by their developers, and the FDA only ushered a small number of them onto the market.

- read the report from the Cleveland Plain-Dealer

Related Articles:
EU, U.S. regulators offer single orphan drug path. Report
The FDA: Caught between a rock and a hard place. Report
New drug approval lags in 2007. Report
FDA quick to reject drugs as it gets more cautious. Report
Industry exec says FDA approval process too strict. Report

Mixed data for Novo's diabetes drug

Fri, 21 Sep 2007 06:59:57 -0400

Novo Nordisk's long-lasting insulin drug Levemir turned in mixed results in a Phase III trial. Bad news first: Patients taking the drug were less likely to achieve blood sugar control than those taking shorter-acting forms of insulin. But on the flip side, Levemir was less likely to cause weight gain or hypoglycemia. The drug is under investigation for both type 1 and 2 diabetes. The findings were based on results from the first year of a three-year, 5,000 patient study.

"The fact that Levemir provides better glycaemic control, less nocturnal hypoglycaemia and less weight gain relative to NPH insulin over a period of two years is a clinical confirmation of the superior action profile of Levemir," commented Professor Luigi Meneghini, associate director at the Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, Florida.

- check out this release

ALSO: The FDA has approved Novo Nordisk's Norditropin, a treatment for children with short stature associated with Turner syndrome. Release

Related Articles:
Novo Nordisk reports positive data in diabetes trials. Report

SPOTLIGHT: Drug makers delaying generics

Thu, 18 Jan 2007 19:01:33 -0500

With lawmakers poised to consider new legislation on generic drugs, the FTC has concluded that the drug industry is increasingly paying generic drugmakers to stop them from rolling out cheap knockoffs. Half of the 28 patent litigation settlements struck in the year leading up to Sept. 30 included such a pact. The Senate Judiciary Committee has begun an investigation into the payments, which two appeals court decisions concluded were legal in 2005. Report

FDA review may force extension of Nuvigil deadline

Wed, 06 Dec 2006 19:01:35 -0500

The FDA is continuing to investigate a case of sometimes fatal rash that developed during a clinical trial of Sparlon, an experimental therapy for sleep disorder, according to an announcement from Cephalon. And that investigation could cause a delay in the agency's decision on Nuvigil, a next-generation therapy that follows Provigil. All three therapies rely on modafinil as the active ingredient. Cephalon says that the time needed to finish the Sparlon review may require an extension of the FDA's Dec. 31 deadline for a decision on its Nuvigil application. The FDA issued an approvable letter for Nuvigil earlier this year.

- here's the report on Cephalon from the Philadelphia Business Inquirer

Related Articles:
Cephalon provides update on Sparlon. Report
FDA committee rejects Cephalon's Sparlon. Report
FDA issues approvable letter for Nuvigil. Report

Taro CFO resigns in face of accusations

Sun, 29 Oct 2006 19:01:36 -0500

Israel's Taro Pharmaceutical's CFO, Kevin Connelly, has resigned following an investigation into the company's restatement of earnings for 2003 and 2004. A report from the law firm Jenner & Block asserted that the company's financial team had made "misrepresentations" to the SEC and Ernst & Young. Connelly and another member of Taro's financial team, who was unnamed, resigned from the company after disagreeing strongly with the conclusions of the report. Taro also announced that it had hired a turnaround expert to help the company cut costs and restructure debt. Taro faces delisting if it misses a deadline to file its 2005 report.

- here's the AP report on Taro

Morgellons: New disease or mental illness?

Maureen Martino — Fri, 27 Oct 2006 12:28:41 -0400

If you haven't heard of Morgellons disease, you may soon. Fueled by a popular website outlining its symptoms, thousands of patients are reporting that they have the as-yet undocumented illness. Patients claiming to have Morgellons flooded the Centers for Disease Control and Prevention, which has launched an investigation of the phenomenon. The CDC plans to conduct its investigation in California, which along with Texas and Florida has served as a focal point for alleged disease. The symptom list proposed for Morgellons includes slow-healing sores, a sense of things crawling under the skin, fatigue and joint pain. To date, physicians have not been able to detect a unique cause for the symptoms, though many patients do test positive for Lyme disease. Some are suggesting that mental illness, not an infectious disease, is causing these symptoms, which also fit the pattern for a mental illness known as delusional parasitosis. They suggest that the outbreak is generated by Internet-fueled hysteria and picked up by emotionally susceptible patients. Get more information on Morgellons: - read this New York Times Article

ConjuChem shares dive on study death

Thu, 13 Jul 2006 20:01:39 -0400

Shares of ConjuChem Biotechnologies took a nasty hit Friday morning, plunging 34 percent after the company announced it had suspended a Phase II trial of an HIV therapy as it investigates the death of a patient in the study. ConjuChem announced it would halt dosing in the trial of an experimental therapy for HIV lipodystrophy. "The cause of death and the relationship of the study drug to the event, which occurred at a clinical site in Argentina, is currently under investigation," the Montreal-based company announced.

- read this report from the Globe and Mail

Cypress halts trial for sleep apnea therapy

Tue, 27 Jun 2006 20:01:35 -0400

Cypress Bioscience has pulled the plug on its development program for a combination therapy including mirtazapine for sleep apnea. Phase IIa results don't warrant further investigation, researchers say. Cypress and Organon--a division of Akzo Nobel--each conducted independent studies and are now looking at alternatives to continue their collaboration.

- here's the report on Cypress from StreetInsider.com

Ketek report spurs call for FDA reform

Mon, 01 May 2006 20:01:37 -0400

Following yesterday's troubling review of Sanofi-Aventis' antibiotic Ketek in The Wall Street Journal, a number of Congressmen have launched calls for an investigation into its approval. Some, like Representative Henry A. Waxman, say the FDA's action highlights the need for reform at the agency. The Journal reported that a number of patients taking the drug have died and raised a number of questions about Aventis' last drug trial.

"Recently the GAO found that the FDA does not have a good enough system in place to protect the public from drugs once they are on the market," said Rep. Edward Markey. "However, the Ketek case shows that the FDA may also not be doing a good enough job deciding which drugs should or should not be approved in the first place."

- read this release for Washington's reaction

Unexpected reaction blamed for UK trial mishap

Wed, 05 Apr 2006 20:01:35 -0400

An investigation into a small drug trial that went disastrously wrong in the UK has found that the drug maker and the clinical trial organization that mounted the study had not made any mistakes in formulating the drug or administering it. Instead, the regulators said, TGN1412 had provoked an unexpected biologic reaction in humans, sending six men to the hospital.

- here's the article from the Guardian

FTC to investigate 190 pharma companies

Wed, 29 Mar 2006 19:01:39 -0500

The Federal Trade Commission will subpoena 190 pharmaceutical companies as part of it's Authorized Generic Drug Study, an investigation of possible anticompetitive practices in the industry. Currently, federal law grants generic drug makers a six-month grace period during which generic first-filers have market exclusivity in order to make a profit. But pharmas have started issuing their own authorized generic versions of their brand name drugs to compete with generic companies during this period. The FTC will study whether this inhibits competition from generic drug makers and benefits brand name makers in the long run. The subpoenas are expected to go out late this summer.

- read this AP report for more

Magazine retracts discredited paper on embryonic stem cells

Wed, 04 Jan 2006 19:01:35 -0500

Science magazine is retracting a paper by disgraced Korean scientist Hwang Woo-suk after it obtained the permission of everyone named in the paper. The retraction follows an investigation by Seoul National University that concluded that Hwang had faked the results of his work cloning embryonic stem cell lines. In addition, new allegations have been raised that Hwang actually pressured colleagues to donate their eggs to the research program. Hwang allegedly misrepresented the source of the eggs and now has to face claims of ethics violations in demanding eggs from two of the women who were involved in the program for his work on cloning.

- read this article in The Register for more

MedImmune prepares human trials for new lupus therapy

Thu, 13 Oct 2005 20:01:35 -0400

MedImmune of Gaithersburg, MD, is preparing to ramp up human trials of a new lupus treatment. The drug developer filed an IND application with the FDA and plans to begin human tests next year. The application springs from a collaboration MedImmune struck with Medarex in 2004 on two antibodies. MedImmune believes that it can develop a therapy to prevent flareups of lupus and trials would show if it can cure the ailment. Its work follows a recent announcement from Human Genome Sciences that its experimental lupus drug saw disappointing trial results. HGS added, though, that the data warranted further investigation. No new drug for lupus has been approved in the last 40 years.

- read this article from The Washington Post for more

Forest Labs reports Phase III failure for fibromyalgia drug

Wed, 28 Sep 2005 20:01:38 -0400

Forest Laboratories reported that a late-stage trial of milnacipran as a treatment for fibromyalgia failed to hit the primary endpoint. But Forest and its development partner, Cypress Bioscience, said that the results warranted continued investigation of the drug in an ongoing Phase III trial and another late-stage study that would soon be initiated. Researchers said the drug was generally well tolerated with most patient withdrawals coming early in the study.

- read this press release for more information

PhRMA blasts FDA plans to post preliminary info on side effects

Mon, 08 Aug 2005 20:01:37 -0400

PhRMA is fighting the FDA's plans to post preliminary information about the potentially harmful side effects of drugs, saying that the early warning system is likely to lead to "irrational fears" and confusion among consumers. The FDA has proposed launching a "Drug Watch" page on its website, listing the safety concerns it had under investigation. PhRMA President Billy Tauzin says that bad data on the site could prompt patients to stop taking medications that they need.

- read this story from Pharmaceutical News for more

FDA's Crawford cleared of affair

Wed, 08 Jun 2005 20:01:37 -0400

An inspector general's probe of a relationship between acting FDA commissioner Lester Crawford and a senior official of the agency concluded that he gave conflicting evidence in the investigation but could not corroborate if he was having an illicit affair. As a result, Republicans moved to push forward with his nomination as commissioner. Investigators said, however, that the unidentified woman told investigators that Crawford had provided improper assistance in gaining a promotion for her, which Crawford denied. Another FDA official contradicted Crawford's statement that he had endorsed the woman for the promotion, saying that he had, in fact, questioned her qualifications.

- read this article from The Washington Post

Drug companies keeping trial info under wraps

Mon, 30 May 2005 20:01:37 -0400

Eli Lilly has made a point of registering all but its smallest drug trials at clinicaltrials.gov, as promised, but many other drug companies persist in holding back much of their trial information. The New York Times looks at how Merck, Pfizer, GlaxoSmithKline and other drug giants have been reluctant players in the push for more transparency in drug trials. In some cases, the companies refuse to reveal even the name of the drug under investigation. The latest push for transparency began after a series of revelations that drug companies had hidden data that raised safety questions regarding some of their most popular medications.

- read this story from The New York Times on the trials