BC Week In Review | Mar 4, 2013
Clinical News

Avarofloxacin regulatory update

Furiex said FDA granted Qualified Infectious Disease Product (QIDP) designation for avarofloxacin to treat acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The product has completed Phase II trials in...
BioCentury | Dec 19, 2011
Regulation

Europe speeds away

The European Commission's new action plan to combat antimicrobial resistance could further widen the regulatory gap between the U.S. and Europe, which is already at the point where some physicians worry companies will no longer...
BioCentury | Nov 14, 2011
Regulation

Inching toward feasibility

Clinical work on compounds to treat community-acquired bacterial pneumonia and hospital-acquired or ventilator-associated bacterial pneumonia has been in limbo since 2008 when FDA began reassessing its requirements for clinical trial designs, which many companies said...
BC Week In Review | Apr 25, 2011
Company News

Furiex Pharmaceuticals, J&J deal

Johnson & Johnson's Janssen Pharmaceutica N.V. subsidiary did not exercise an option to regain rights to antibiotic candidate JNJ-Q2 from partner Furiex. According to Furiex, Janssen is focusing future R&D investment in antivirals and vaccines...
BioCentury | Apr 25, 2011
Finance

Highlights of weekly biotech stock moves

Regulatory milestones Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) gained $0.88 (22%) to $4.86 on Monday after clarifying the regulatory path in the U.S. for Northera droxidopa to treat neurogenic orthostatic hypotension (NOH). Chelsea still plans to...
BC Extra | Apr 20, 2011
Company News

J&J unit opts not to regain Furiex antibiotic

Janssen Pharmaceutica N.V. did not exercise an option to regain rights to antibiotic candidate JNJ-Q2 from partner Furiex Pharmaceuticals Inc. (NASDAQ:FURX). According to Furiex, the Johnson & Johnson (NYSE:JNJ) subsidiary is focusing future R&D investment...
BioCentury | Jan 3, 2011
Finance

Trickle-down effect

Although companies in the $1-$1.9 billion market cap range were the big winners for 2010 with a 28% gain, last quarter saw gains migrate into lower rungs of the market cap ladder. Small caps with...
BC Week In Review | Nov 15, 2010
Clinical News

JNJ-Q2: Phase II data

Top-line data from a double-blind, U.S. Phase II trial in 161 patients showed that twice-daily 250 mg oral JNJ-Q2 for 7-14 days missed the primary endpoint of non-inferiority to twice-daily 600 mg Zyvox linezolid in...
BioCentury | Nov 15, 2010
Finance

Regulatory milestones

Dendreon Corp. (NASDAQ:DNDN) gained $0.06 to $35.13 last week after a technology assessment released for this Wednesday's meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) said there is moderately strong evidence that...
BC Extra | Nov 11, 2010
Clinical News

JNJ-Q2 misses ABSSSI endpoint

Furiex Pharmaceuticals Inc. (NASDAQ:FURX) said oral twice-daily JNJ-Q2 missed the primary endpoint of non-inferiority to twice-daily Zyvox linezolid in a Phase II trial to treat acute bacterial skin and skin structure infections (ABSSSI). Non-inferiority was...
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