QDIS Blog

I don’t remember the FDA issuing a “refuse to file” letter in recent memory but Pharmacyclics got one from the FDA recently for their drug Xcytrin (motexafin gadolinium). It is intended to treat non-small cell lung cancer patients with brain metastases. Here is the FDA definition of “refuse to file”.

Pharmacyclics: FDA Won’t Take Filing - Forbes.com:

The stock dropped 46% on the news and is definitely bad news. The FDA said there was not enough in the filings to bother with a substantial review and that too many clinical trials had failed to show statistically significant differences from between treatment arms. This leads me to wonder who is heading up the regulatory group as this sort of situation should never be allowed to happen.

Looking up refuse to file I found that Imclone received one back on Jan 2002 over Erbitux.

Pharmacyclics had a webcast conference call yesterday and is available for one month. I’ve listened to it and not much new was added. They will be having meetings with the FDA to determine where they will be going next. The company basically thought the meetings with the FDA previously went well and they thought highly of this drug and the data and felt they were encouraged by the FDA to go ahead and make the submission. They also used outside consultants who agreed that they should go ahead with a filing.

They only have about a years worth cash on hand and so it will be interesting to see what happens in the next twelve months.. Only three questions were asked and it was a very short call.

Here is the company’s press release.

Other Resuorces

Xcytrin - Yahoo! Search Results
Xcytrin - Google Search
Google Blog Search: Xcytrin
IceRocket Blog Search: Xcytrin

Technorati Tags: Pharmacyclics, motexafin gadolinium, Xcytrin

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This is old news by now but I wanted to comment. Merck has decided to suspend for now it efforts to lobby states to require Gardasil vaccinations for girls.

Merck suspends lobbying for vaccine - Yahoo! News:

The main reason Merck was pushing so hard to is because GlaxoSmithKline also has an HPV vaccine in late stage trials which will likely be filed later this year. They are certainly trying to take advantage of being the only cancer vaccine on the market right now. I don’t blame them for that but do think the discussion over their tactics was overshadowing the main discussion of protecting young women from HPV which can lead to cervical cancer.

Technorati Tags: Gardasil, Merck

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With all of these new reports of problems with food safety, I think it is now inevitable that some sort of major reform will occur in the 110th Congress. This time it is not only the FDA but also the USDA since the latest report is of chicken. I’m not sure what will come out of this but there will certainly be changes proposed. My bet is the proposed solution will be to move all the food related problems to a new agency combining the F part of FDA and the USDA as well as maybe parts of CDC. I’m not sure where I come down on that. Until now, I didn’t think the creation f a new agency was needed but I am willing to wait and see what is proposed.

Cooked Chicken Breasts Join Tainted-Food Recalls - Forbes.com

The article has the particulars but it involves Oscar Meyer/Louis Rich chicken breast with rib meat, which is fully cooker and ready to eat. The problem is bacterial contamination, Listeria monocytogenes, which can cause listeriosis, a rare but serious infection.

As the article points out this is the fourth problem within a week. The others were fresh cantaloups, organic baby food and the peanut butter.

Some jars of Earth’s Best Organic 2 Apple Peach Barley Wholesome Breakfast baby food were recalled because they may be contaminated with Clostridium botulinum,, which can cause a life-threatening illness.

FDA Warns Consumers Not to Use Certain Jars of Earth’s Best: “Organic 2 Apple Peach Barley Wholesome Breakfast Baby Food”

The FDA has a web page devoted to the other major food safety problem last week related to Peter Pan brand peanut butter. This has involved more than 290 people in 39 states. At least 46 people were hospitalized. Seems the peanut butter from both Peter Pan brand and Great Value are contaminated with salmonella.

Update on Salmonella Outbreak and Peter Pan Peanut Butter

The cantaloupe info was harder to find but it is also on the FDA website.

Recall of Cantaloupes Due to Potential Health Concerns (FDA web page)

For cat owners the FDA has also warned consumers not to use certain cat foods due to possible salmonella contamination.

FDA Warns Consumers Not to Use Wild Kitty Cat Food Due to Salmonella Contamination

Other Sources

South Carolina Firm Recalls Chicken Breast Strips For Possible Listeria Contamination (USDA web page)

FDA Recalls, Market Withdrawals and Safety Alerts
FSIS Recalls (Meat, Poultry & Egg Products)

Technorati Tags: FDA, food safety

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I became aware of a unique search site recently that I wanted to let you know about. It is CrossEngine and it allows you to search a given site and then immediately go to another site and perform the same search. It is organized first by type of information; quick, web, images, video, audio, news, etc. Then you have a search text box to type in your query. After that, you choose your search engine.

After that, if you want to see the results from a different search engine, just click on a new search engine and the same query will be run on the new search engine and the results displayed. I personally like this as I always recommend checking at least two major sites for any serious search activities.

As an example, I recently wanted to know about the Salmonella in Pater Pan peanut butter for a future posting here. I went to CrossEngine chose the News tab from the top. Then I typed in “Peter Pan” peanut butter Salmonella and then choose Google. I can look down thru the results and I even found an article from my alma mater college paper the Purdue Exponent.

I then wanted to see what else there was so just clicked on Yahoo and I get their news listings for the same query. The first listing showed me that it wasn’t only Peter Pan brand but also Great Value peanut butter. I then clicked on NY Times and found they had two articles, one on the peanut butter problem and other related to Salmonella problems with cantaloupe which mentions the peanut butter problem also. CrossEngine allows me to quickly and easily with very few clicks, look at the results on different search sites.

My only real concern as a power user is that not all the search engines use the same syntax for advanced searching. As an example, inurl: works on most but not all the web search sites. In Wisenut it defaults to searching for the word following inurl instead since Wisenut doesn’t support searching in specific fields. This isn’t a big deal for the vast majority of users and really isn’t a problem.

Since I do a lot of science related searching, I’d like to see them add a tab at the top to search science specific sites. I have sent them a list of my favorite science search sites (for more on this see my latest podcast Science Search Sites) and hope to see this incorporated in the future.

Overall, I like CrossEngine and it has replaced many of my bookmakrks on my web browser window. I use it to quickly look across various sites without having to retype my query. I had previously used bookmarklets to achieve this but there had to be a different bookmarklet for each engine. I like this approach much better. I always recomend checking at least two sites and CrossEngine makes that very easy.

Technorati Tags: CrossEngine

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Wow, this is a major mixup. Seems some people who order drugs over the internet got the wrong drugs! In most cases they were ordering a sleeping pill or an anti-anxiety medication and instead received the schizophrenia drug, haloperidol. Some people actually went to the ER because of complaints such as difficulty breathing, muscles spasms and stffness. It is unclear how many people were affected.

FDA Warns of Dangers of Internet Drugs - Forbes.com:

Seems these were all purchased from commercial websites and the FDA is investigating. It will be interesting to see if and when the web site names come out. The shipments had Greek postmarks and came in clear plastic bags.

Here is the FDA news on the internet drug mixup. Here is the most interesting paragraph to me.

Although the involved consumers have named several Internet Web sites where the products were purchased, identifying the vendors is difficult because of the deceptive practices of many commercial outlets on the Internet. FDA is investigating this illicit trade and plans to release appropriate information when it is available.

If you do have any reports along this line use the FDA’s MedWatch Online Voluntary Reporting Form.
Technorati Tags: drug price, drug safety, FDA

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Pharmaceutical Business Review has a very short article with a few more tidbits about Ranbaxy’s office in New Jersey being raided. Seems no one is commenting about which agency performed the raid but it is thought to be the FDA and that they took not only paper documents but also electronic documents. The FDA has refused to comment.
Technorati Tags: FDA, Ranbaxy

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The mergers continue to move along. Now, British based Shire PLC is buying New River Pharmaceuticalsc here in the US for $2.6 billion.

Shire buying New River Pharmaceuticals - Yahoo! News:

Here’s the Shire press release. Unlike a lot of press releases, this one is full of good useful information including a significant section on the rationale for the acquisitions. This is unusual and I wish more companies would look at this as an example of how to make press releases. Too many times, I find myself wondering what they are deliberately leaving out or it is obvious they are spinning the information to their advantage.

This is another example of a partnership that ends up in a merger. Back in Jan 2005 Shire and New River agreed to a deal on NRP104 which is now called Vyvanse for the treatment of Attention Deficit and Hyperactivity Disorder (“ADHD”). NRP has received an approvable letter and Shire expects to launch for the pediatric indication as well as file for a sNDA for adults in the second quarter of 2007. Shire has always had an interest in ADHD with their Adderall XR product.

It should be noted that Health Canada suspended sales of Addreall XR back in Feb 2005 and so Shire is obviously looking for something new. For another view on the withdrawal in Canada see the article from Pharmaceutical Business Reviews. According to the FDA webpage though, it was brought back to the Canadian market in Aug 2005. Here is the FDA’s statement on Addreall.

I think Shire is hedging its bets and if the situation with Adderall XR should get worse, they have a fall back position. Note the timing of when the Canada situation happened and when they entered into the partnership with New River; Also, the patent for Adderall XR expires this year.

For more information in general about Adderall see the Wikipedia article.

Other Resources

Lisdexamfetamine dimesylate in ADHD phase 3 data presented (Vyvanse)
lisdexamfetamine dimesylate - Yahoo! Search Results
adderall - Yahoo! Search Results
lisdexamfetamine dimesylate - Google Search
adderall - Google Search

Technorati Tags: Adderall, New River Pharmaceuticals, pharma M&A, pharmaceutical deals, lisdexamfetamine dimesylate, Shire Pharmaceuticals, Vyvanse

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Wow, I go to a conference for a week and all kinds of things happened. Here are some of the headlines that caught my attention.

FDA

‘Accelerated Enforcement’ Now Against Unapproved Drugs: FDA will be accelerating enforcing regulations against unapproved and unregulated drugs and are having weekly meetings to discuss priorities.
Killing the Goose That Lays the Golden Drugs: An article stating that there is a need to balance drug safety with access to new therapies.
Press Release: Sanofi-Aventis Announces Update To U.S. Prescribing Information For Ketek - FierceBiotech: More on the Ketek fiasco.
PharmaLive: FDA Announces Label and Indication Changes for the Antibiotic Ketek
Sanofi shares slide as FDA delays Acomplia–again - FierceBiotech: More delays for Acomplia in the US; decision to be made by July.
FDA deny drug application from Advancis - Washington Business Journal: Another antibiotic has hit a snag; Advancis NDA is said to be incomplete and unable to be approved.
US warns Abraxis BioScience about plant problems | Health | Reuters
Abraxis Bioscience, Inc., Warning Letter: From the FDA website.

Government and Congress

GAO warns of Medicare drug overcharging - Boston.com: The GAO is worried about schemes to overcharge the US government for the Medicare Part D Prescription Benefit. The basis is that the complex set of rules makes it difficult to verify the accuracy of drug prices.
Biotech trade group warns of price controls - MarketWatch: The leader of BIO warned against the HHS being able to negotiate drug prices and calls them defacto price controls.
Democrats plan bill for generic biologics - washingtonpost.com: This could be big and I’ve posted before about biogenerics.
Generic Biotech Drugs Could Save $71B - washingtonpost.com: Another article on biogenerics and what impact it may have.
Lawmakers unveil bill to create clear pathway for generic biologic drugs
Newsvine - Texas Gov., Lawmakers in Vaccine Dispute: more about the Gardasil vaccine being required by the govenor for girls in Texas.
Pfizer’s AIDS drug to get faster review - Yahoo! Finance

Pharma News

PharmaLive: Lovenox Patent Infringement Suit Decided Against Sanofi-Aventis
PharmaLive: New Campaign Champions Changes in Medical Prescribing to End Conflicts of Interest
Bayer to file for Nexavar approval for liver cancer - Boston.com: I know folks at Onyx and am glad to see this drug proceeding so well.
Thailand threatens to produce more copycat drugs | Science | Reuters
Thailand plans to break patents on 14 drugs: firms - Yahoo! News
British pharmacy pilots over-the-counter Viagra - International Herald Tribune: Brings new meaning to the question, What’s Up? PharmaLive: Merck Settles Tax Dispute with Internal Revenue Service
Eli Lilly Regains Leaked Papers - washingtonpost.com: A judge orders papers related to Zyprexa to be returned to Eli illy.
PharmaLive: Telik Announces Corporate Restructuring: More lay-offs.
Ariad says close to cancer drug partnership deal | Health | Reuters
PharmaLive: Ranbaxy: Press Statement: Federal officals conducted a suprise search of Ranbaxy’s NJ offices.

Biofuels

Philadelphia Inquirer | 02/12/2007 | Oil firms speak up on alternative fuels: Major oil companies now want a seat at the table for discussing alternative fuels.
New theme heard at oil gathering - Los Angeles Times: Another article on big oil and their interest now in biofuels.
Big Oil says biofuels won’t meet U.S. energy demands - Feb. 15, 2007: more on the big oil views of biofuels.

Biotech

United Press International - Health Business - Seattle Genetics’ drugs get orphan status: I know people at Seattle Genetics and think they have a good business model and am glad to see these products get orphan drug status.
Wired News: Pharm Animals Crank Out Drugs: Another article on pharming, using animals to produce drugs. Covers GTC Biotherapeutics who I’ve mentioned before here and here.
Biotech posts fastest growth globally: Article on the double digit growth (35%) in India’s biotech industry.
Hawaii has more biotech bills - Pacific Business News (Honolulu): The Hawai’i state government had 44 bills before it relating to biotech in 2006.

Other
Refusing to share samples ‘may cause a vaccine delay’-News-World-Asia-TimesOnline: GSK has attacked the Indonesian government for refusing to supply bird flu samples to other companies for research to develop vaccines.
Technology Review: Discovering Drugs with Bubbles: I’ll share my views on this in a later post.
I’ll try to comment on some of these in more detail later this week if I can get some spare time.

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After being away last week, I’m starting to get on track and posting again. Had a successful trip and am ready to get back to the regular postings. Lots of stuff happened and I’ll b commenting on that this week.

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I listened to the podcast of the Newshour on PBS today and they had a good segment on the FDA looking into irradiation as a way to kill off harmful

FDA Weighs Approval of Irradiating Produce

It is a good piece and worth watching of listening to given the number of such outbreaks in the past year.

Technorati Tags: e coli, irradiation

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