PDUFA

ALSO NOTED: Pharma growth sinking to historic low; Neurocrine gains Japanese partner; OccuLogix suspends development program;an

Thu, 01 Nov 2007 07:59:50 -0400

> Here's statistical confirmation of the gloom-and-doom facing Big Pharma. Worldwide sales growth will slow next year to around 5 percent from 6 to 7 percent this year, according to a new report from IMS Health. Report

> Japan's Dainippon Sumitomo Pharma will pay Neurocrine Biosciences $20 million up front plus an additional milestone payment of $10 million for the Japanese licensing rights to the insomnia drug indiplon, which has been filed for approval by the FDA. The PDUFA action date on indiplon is December 12. Release

> OccuLogix has already put itself up on the sales block as it signals its willingness to do a deal of some sort. Now the company says it is suspending development of its RHEO System for dry, age-related macular degeneration. In early October the company announced that it would consider every option in maximizing shareholder value, including a sale, but couldn't confirm whether or not it could complete a deal. Release

> ZymoGenetics is boosting spending in preparation for launching rThrombin, designed to control bleeding during surgery, causing its losses for the third quarter to go up. Report

> It's a one-two punch for AstraZeneca today. A Canadian drug maker is challenging AZ's patent on the cholesterol drug Crestor, one of its top sellers at $2 billion--and a linchpin of its profits over the next few years. Meanwhile, the company reported a 15 percent drop in profits. Report

> Score one for GlaxoSmithKline. The company won an injunction against the U.S. Patent and Trademark Office, successfully blocking implementation of new rules governing patent continuances, at least temporarily. Report

> What's your pick for the most memorable drug ad of the 2006-2007 season? If you picked that Lunasta moth, you win. Report

And Finally... Nematode worms treated with lithium show a 46 percent increase in lifespan, raising the tantalizing question of whether humans taking the mood affecting drug are also taking an anti-aging medication. Release

FDA, Big Pharma team up on drug research center

Thu, 18 Oct 2007 06:59:56 -0400

In all the hoopla over the new FDA funding-and-reform legislation last month, a key provision was eclipsed--the creation of a new research center paid for by drug makers. The Reagan-Udall Foundation is designed to streamline and improve drug development. But as the Associated Press notes, a research collaboration yoking pharma with the FDA creates an entirely new form of regulator-regulatee relationship--one that might get drugs to market more quickly and more cheaply, but even less safely.

The FDA is fast-tracking nominations to the new center's board, with members slated to be named by October 27. Four of the fourteen members are expected to be pharma executives.

- check out the FDA release seeking nominations for the board
- read the AP's take on the foundation

Related Articles:
FDA, Big Pharma collaborate on genetic tests. Report
House overhauls, passes PDUFA. Report
Bickering may stall trial database. Report
PDUFA debate highlights drug safety issues. Report

Read more on: FDA news

FDA, Big Pharma collaborate on genetic tests

Thu, 27 Sep 2007 06:59:54 -0400

Seven of the world's biggest drug makers are banding together to create a research consortium that will develop genetic tests that can identify patients vulnerable to dangerous adverse events. Under prodding from the FDA, Pfizer, Roche and others will back a research program that will develop tests for serious liver toxicity as well as Stevens-Johnson syndrome. Their work will go into the public domain, available to anyone wishing to develop a genetic test on that data. The development of pharmacogenetics is considered crucial to a new generation of biotech drugs, which are intended to produce higher efficacy rates among smaller groups of patients.

- check out this release for details on the program
- read the article from The New York Times

Related Articles:
House overhauls, passes PDUFA. Report
Bickering may stall trial database. Report
PDUFA debate highlights drug safety issues. Report
Senate toughens drug safety supervision in PDUFA bill. Report

House passes PDUFA: bill heads to Senate

Thu, 20 Sep 2007 06:59:57 -0400

The U.S. House of Representatives has passed a bill to renew the Prescription Drug User Fee Act (PDUFA), positioning it to be passed by the Senate and signed by the President before the Friday deadline. The PDUFA has to be renewed every five years. Recently FDA Commissioner Andrew von Eschenbach (photo) sent out a memo warning that 2,000 workers could get pink slips if Congress doesn't renew the act by Friday's deadline.

According to The New York Times, "The bill combined several pieces of legislation governing drug industry user fees, new rules involving the disclosure of clinical trial results, money for studies of older medicines, incentives for tests in children and even the conflicts of interest of drug agency advisers." There were, however several highly-debated issues that didn't make it into the bill. Many patient advocacy groups want the FDA to allow severely ill patients to have access to unapproved drugs; the bill passed yesterday doesn't address these concerns. And as anticipated, legislation that would pave the way for biosimilars was not part of the bill--much to the relief of branded drugmakers everywhere.

- see BIO's reaction to the bill
- read the New York Times article

Related Articles:
FDA: 2,000 layoffs if PDUFA not passed. Report
Bickering may stall trial database. Report
Congress juggles two crucial drug bills. Report
PDUFA debate highlights drug safety issues. Report

ALSO NOTED: FDA approves MedPointe's SOMA; EntreMed secures $20M loan; and much more...

Mon, 17 Sep 2007 06:59:50 -0400

> The FDA has approved MedPointe's SOMA (carisoprodol) 250 mg as a new recommended dose for the relief of discomfort associated with acute, painful musculoskeletal conditions, such as backache. Release

> EntreMed has completed a $20 million secured loan agreement with a syndicate of lenders led by GE Healthcare Financial Services. Release

> AstraZeneca is planning to outsource its manufacturing--all of it--starting with the basic, active ingredients in its products and then fanning out from there. Contract manufacturers in China and India are most likely to get the business. Report

> For years there's been talk of a centralized repository for all drug-testing data, one that's easily searchable and open to all comers. Now, as a September 30 deadline looms for the PDUFA, House and Senate negotiators are duking it out over the database. Report

> Speaking of the PDUFA, Andrew von Eschenbach (photo) sent out a memo saying that 2,000 workers could get pink slips this week if Congress doesn't renew user fees for drugs and medical devices. Report

And Finally... Researchers believe Chronic Fatigue Syndrome may be linked to a common stomach virus. Report

Waiting game continues for biogenerics

Mon, 10 Sep 2007 06:59:59 -0400

The folks at BIO are breathing a sigh of relief over Congressman Henry Waxman's comment that new legislation on biosimilars was unlikely to reach the House floor this week. He chalked the delay up to scheduling issues. Of course, with the Democrats in charge of the House and Senate, one wonders why a piece of legislation like this can't go ahead swiftly. It's more than apparent that lawmakers are willing to create a regulatory pathway for generic versions of biotech drugs. And they'll more than likely follow the FDA's position that each of these biogeneric--or biosimilar--applications should be reviewed on a case-by-case basis. Where regulators see complexity in a biologic, they will raise the bar on data. Where a therapy can be copied without raising serious safety issues, which is now done routinely, it will be approved without a terribly demanding set of trials.

All of that is clear enough. So why the delay? I suspect lawmakers are just finding it tough to get their act together. That's one good reason for the growing level of public frustration at lawmakers of every stripe. PDUFA legislation will go ahead because it has to. The FDA needs the money to operate. Meanwhile, the demand for less expensive biologics will only grow. Does anyone in Washington know how this game is played? - John Carroll