QDIS Blog

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.

Email Ed Vawter

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