News

Press Release: Expert panel rejects Hemopure trial

Press Release: Expert panel rejects Hemopure trial

Press Release: MethylGene Will Not Pursue Additional Cinical Trials For MG98

Press Release: MethylGene Will Not Pursue Additional Cinical Trials For MG98

Press Release: Lipoxen Announces $75M Agreement With Baxter

Press Release: Lipoxen Announces $75M Agreement With Baxter

Press Release: Genta Receives Non-Approvable Notice for Application of Genasense

Press Release: Genta Receives Non-Approvable Notice for Application of Genasense

Press Release: Affymax Announces IPO

Press Release: Affymax Announces IPO

Press Release: Roche Decides to Terminate Cancer Collaboration With Epigenomics

Press Release: Roche Decides to Terminate Cancer Collaboration With Epigenomics

GAO: Improvements Needed in FDA’s oversight of Direct-to-Consumer Advertising

Drug company spending on DTC advertising—-such as that on television and in magazines-—of prescription drugs increased twice as fast from 1997 through 2005 as spending on promotion to physicians or on research and development. Over this period, drug companies spent less each year on DTC advertising ($4.2 billion in 2005) than on promotion to physicians ($7.2 billion in 2005) or research and development ($31.4 billion in 2005).

Forest buys Cerexa in $480M deal

Forest Laboratories has joined the lineup of drug developers bidding their way to new prospects with its agreement to buy the antibiotic developer Cerexa for $480 million in cash. Forest gains development and marketing rights for three antibiotics, including one--ceftaroline acetate--which is poised to begin a late-stage trial for skin infections. It could be launched in 2010 or 2011. If its sales break the $500 million mark in any 12-month period after the five years it is launched, …

MedImmune investor urges company to seek bidders

One of MedImmune's shareholders is urging the company to put itself up for sale to a large pharma company. David Katz of Matrix Asset Advisors told the board at MedImmune that a big pharma outfit would be willing to pay as much or more than the company is currently worth if it cashes in on today's hot market for mergers and acquisitions. Analysts noted that Pfizer in particular has been bulling its way into the vaccine market, recently …

OncoGenex outlines plans for $48 million IPO

Canada's OncoGenex Technologies plans to raise up to $48 million in an IPO. The biotech has three products in development to inhibit the production of proteins linked to the resistance of treatments. The drug developer was founded in 2000 and has raised $35 million in venture capital. RBC Capital Markets will be the sole lead manager for the offering, and Needham & Company, Lazard Capital Markets, Canaccord Adams, and Susquehanna Financial Group are the co-managers.

- see this …

Schering-Plough licenses hepatitis B drug

Shares of Valeant Pharmaceuticals and Metabasis Technologies jumped late Wednesday after they announced that Schering-Plough had licensed the experimental pradefovir for chronic hepatitis B. Valeant licensed the drug from Metabasis six years ago. Both companies will earn an up-front payment along with a schedule of milestones.

"Pradefovir has the potential to offer improved treatment options for patients with chronic hepatitis B, a serious blood-borne infection affecting some 400 …

Late-stage data backs new application for Aloxi

MGI Pharma and Helsinn Healthcare plan to file a new marketing application for the nausea drug Aloxi after two late-stage trials demonstrated its effectiveness against nausea and vomiting after surgery. The data demonstrated a complete response by patients up to 72 hours after surgery. The drug is already approved to prevent nausea and vomiting after chemotherapy.

- here's the AP report on the new …

SPOTLIGHT: Encysive fails to satisfy FDA


Shares of Encysive Pharmaceuticals slipped after the FDA announced that the developer's response to its July 24 approvable letter for Thelin was incomplete. Encysive said that it can get the FDA the additional information it needs in a few days. Report

DEALS: GSK, Epix ink $1.2B deal


GSK, Epix ink $1.2B deal

ALSO NOTED: Judge clears Exubera sales; Obagi prices IPO; Novartis sells med nutrition business; and much more...

> A federal judge has refused a demand from Novo Nordisk to block sales of Pfizer's inhalable insulin Exubera, saying that patients' right to obtain the therapy were more important than its claims that Pfizer had violated its patents. Report

> Obagi Medical Products, which makes prescription skin care products, has priced its IPO at $11 a share. …

Does the FDA do enough to regulate drug ads?

Viagra, Imitrex, Allegra, Requip--we’ve all heard of them. It seems that every time you turn on a TV you to see a commercial for the latest and greatest from the world of prescription drugs. Under a Republican-controlled Congress in 1997, drug gained the ability to market prescirption drugs directly to the public and a the era of drug advertising was born. Since then, drug company spending on direct-to-consumer (DTC) advertising increased twice fast from 1997 through 2005 as spending on promotion to physicians or R&D. Having seen drug advertised in print, online and on TV, the public has become incresingly familiar with many brand-name drugs and often ask for them by name when consulting their doctors. This has led critics to point out that DTC pharma advertising creates a huge demand for expensive drugs despite the fact that less expensive generic drugs may work just as well.

Press Release: OSI grants licensing rights to Bristol-Myers

Press Release: OSI grants licensing rights to Bristol-Myers

Press Release: Valeant, Metabasis Therapeutics License Hep B Compound to Schering-Plough

Press Release: Valeant, Metabasis Therapeutics License Hep B Compound to Schering-Plough

Press Release: Canada's OncoGenex Technologies Files For $48 Million IPO

Press Release: Canada's OncoGenex Technologies Files For $48 Million IPO

Press Release: Encysive Pharmaceuticals Receives FDA Clearance to Resume Clinical Studies With TBC3711

Press Release: Encysive Pharmaceuticals Receives FDA Clearance to Resume Clinical Studies With TBC3711