Researcher calls FDA 'shortcuts' into question

A high-profile researcher has issued what is now one of many public challenges to the manner in which the FDA speeds approval of certain drugs. Researcher Dr. Clifford J. Rosen is concerned, in

Amgen, J&J win a round in anemia controversy

An FDA expert committee has rejected a proposal to set a clear limit on the use of anemia drugs made by

Trubion releases Phase II data; Investors bail

Shares of Trubion got whacked yesterday after investors and analysts got to take a second look at the data from its mid-stage study of its lead therapy for rheumatoid arthritis--TRU-015--and the news

OpGen to restart following new venture round

After laying off most of its staff earlier this year during a cash crunch, Madison, WI-based OpGen has received a $23.6 million shot in the arm that will allow the biotech to "restart" operations.

PTC Therapeutics gets the Forbes treatment

Forbes is profiling the development work underway at the "unknown" PTC Therapeutics, one of this year's Fierce 15. The

SPOTLIGHT: Biomira bound for USA

Canada's Biomira plans to reincorporate in the U.S., headquartering its parent company in Seattle. CEO Robert Kirkman says the relocation to the U.S. will raise the company's profile in U.S.

C&L: Fogelman new CFO at CytRx

CytRx Corporation has appointed Mitchell K. Fogelman as chief financial officer, effective immediately, replacing Matthew Natalizio, who plans to pursue other opportunities. Clarus Ventures

ALSO NOTED: Flamel inks licensing deal;Alfacell trial hits a milestone; and much more...

> France's Flamel Technologies gets an undisclosed upfront payment and a schedule of potential milestone payments after signing a licensing and development deal with Wyeth for using its technology

Amgen discusses the future with analysts

Sure, we've got trouble, says Amgen CEO Kevin Sharer.

Erbitux clears late-stage hurdle for lung cancer

ImClone once again is feeling the tonic effects of positive trial data. Its stock price took off this morning, rising 19 percent after its European partner, Merck KGaA, reported that Erbitux helped

The case of the disappearing cancer trials

The vast majority of Phase II cancer therapies go nowhere, according to researchers investigating the fate of 200 drug trials. Only 13 percent of the cancer drugs make it to Phase III, they say, with

Nabi sells unit for $185M, plans Maryland move

Nabi Biopharmaceuticals plans to sell its biologics unit to Germany's Biotest for $185 million. Biotest gains a headquarters facility in Boca Raton, a plasma protein plant, Nabi-HB Hepatitis B immune

Enobia gins $40M in second VC round

Canada's Enobia Pharma has raised $40.1 million Canadian in its second round, enough money to get its lead therapy through Phase II. New investors OrbiMed Advisors and CTI Life Sciences Fund of

SPOTLIGHT: The top 5 deals of the first half of 2007

Deal-making continued at a blistering pace in the first half of 2007, as drug giants snapped up promising therapies from smaller developers in order to beef up their pipelines. Check out this report

ALSO NOTED: GSK to commercialize Lunesta; second headline; and much more...

> GlaxoSmithKline has signed on to commercialize Sepracor's insomnia drug Lunesta, agreeing to pay $20 million up front and up to $155 million in total for milestones and licensing fees. Glaxo

Amgen layoffs: Good news for Ventura County?

Suffering from falling sales of its blockbuster anemia drugs, Amgen recently chopped its workforce as part of a widespread

Waiting game continues for biogenerics

The folks at BIO are breathing a sigh of relief over Congressman Henry Waxman's comment that new legislation on

Medivation forges $100M deal to fund trial

The venture capital firm Azimuth Opportunity has agreed to buy up to $100 million of Medivation's stock over the next 18 months as the drug developer pushes through a late-stage trial of an

King bails on Palatin's FSM program

Less than two weeks after U.S. drug regulators raised serious doubts about the safety of bremelanotide for ED, King