Biotech Analysis

VIA Pops on Subset Analysis from Phase II ACS Trial

Shares of VIA Pharmaceuticals Inc. jumped 50 percent in midday trading Friday after the company presented a subset analysis from its Phase II trial of VIA-2291 in acute coronary syndrome. The trial previously met its primary endpoint of significantly inhibiting Leukotriene B4 production. The subset analysis showed that patients receiving longer treatment with VIA-2291 had fewer new plaque lesions and lower plaque volumes than the placebo group.

AGTC Raises $11.8M to Fund Gene Therapy Trials

Applied Genetic Technologies Corp. has raised $11.8 million in a venture-funded financing round, providing the company with enough cash to complete efficacy trials for two of its gene therapy product candidates. The financing was led by InterWest Partners. Other participants in the round include Intersouth Partners and MedImmune Ventures Inc.

Washington News: H1N1 Flu and Botox

A top World Health Organization official today said it would be “too much of a gamble” for public health not to produce a vaccine against the 2009 H1N1 swine-origin influenza A virus. Meanwhile, the Department of Health and Human Services said it was buying 13 million more treatment courses of Tamiflu and Relenza to replenish the national stockpile and also sending 400,000 courses of the drugs to Mexico. In other Washington news, the FDA ordered the makers of botulinum toxin products to include a black-box warning about serious risks associated with the drugs.

Altruists vs. Profiteers: Whom Do You Root For?

In a fight between rich corporate raiders and the management of modestly sized biotech companies, all instincts are to side with the latter. As popularity contests go, it seems like a pretty uneven match-up. But in the growing number of battles between companies and activist investors, it’s often the Wall Street guys who have been coming out looking more reasonable than our homegrown champions of medical progress. Karl Thiel opines.

Northfield Falls on Complete Response Letter for PolyHeme

Shares of Northfield Laboratories Inc. were down 50 percent in morning trading after the Evanston, Ill.-based firm said it received a complete response letter for its blood substitute product, PolyHeme. In its letter, the FDA pointed to the fact that the company’s pivotal trial failed to meet its primary endpoint and noted safety data that indicated PolyHeme actually placed patients at a higher risk of adverse events.

Also in the News:

BioMarin, CSL Behring, Emisphere, Isis, Neurobiological Technologies, Novozymes, Oncolytics Biotech, Oxygen Biotherapeutics, ProMetic, Protein Sciences, RegeneRx, Tercica, Tigris Pharmaceuticals, United Therapeutics