WEEK OF MARCH 14, 2011 BioCentury
Volume19 Number 12 Page A1 of 17
Chronically obstructed By Aaron Bouchie BioCentury This Week Senior Writer
The FDA panel review of Novartis AG’s Arcapta Neohaler for COPD will Cover Story Regulation History Lesson — An FDA panel’s recommen- Chronically Obstructed — The FDA
dation could make epilepsy monotherapy the
panel review of Novartis’ Arcapta Neohaler
only setting in which a drug can be approved
using a historical-controlled trial./A10
toward pulmonary drugs in the U.S. and the
Ebb & Flow
remains in the lead in the race to bringa once-daily long-acting adrenergic re-
‘Phenomenal’ Bump — Pharmasset added Marketing
more than a half billion dollars to its market
LEAPing Forward — Gilead has successfully
investors speculated will enable the com-
removed the boxed warning for hepatoxicity
B u t i t s i n d a c a t e r o l l o n g - a c t i n g
from Letairis in PAH, but will need to move fast
treatment of HCV./A11
to capture share from Actelion’s market lead-
ing Tracleer./A6 Still Some Pop — Seeing upside for
Benlysta. Exelixis taps the excitement. Aerie
Product Discovery & Development
has horsepower. IPOs: Tranzyme. Also: Elan;
Making Sense of CRP — Isis, the first
SkyePharma, et al./A12
reactive protein in the clinic, is readying a
Future Leaders
Phase II study in multiple myeloma, and is
Online this week/A16
looking to trials in RA and renal diseases as
Only a month to go before the 18thStock charts & tables/A17
well./A8 annual Future Leaders in the BiotechCompany index/A5 Emerging Company Profile BioCentury 100TM Indicators Finding Nimo — Edge believes local delivery Week ended 3/11/11 BIO Savings
of its sustained-release nimodipine to prevent
delayed complications of brain hemorrhage
Early bird registration rates still
will provide greater efficacy and fewer safety
701.4M shrs available for the 2011 BIO Interna-
risks than the generic oral formulation./A9 tional Convention and the BIO Busi-ness Forum. Please see announcementThis Week in SciBX BioCentury TV This Week KICk-Starting European Enterprise — After cutting its teeth with investments Vaccines for the Poor -- Making the case
in energy and communications, the European Institute for Innovation and
Technology is moving into the biopharmaceutical space with plans for a round
of seed-stage financing. Please see Table of Contents on A5. www.biocenturytv.com BioCentury, THE BERNSTEIN REPORT ON BIOBUSINESS Edge Therapeutics: Finding nimo By Erin McCallister
orally or via a feeding tube at 60 mg every
Senior Writer Edge Therapeutics Inc.
4 hours for 21 days. It is not adjusted for
the calcium channel blocker must be given
at suboptimal doses to reduce the risk of
work demonstrates it can deliver effective
decreased blood pressure and heart rate. Edge Therapeutics Inc. believes its
any “untoward side effects” such as hy-
NimoGel nimodipine will avoid these risks
lished safety profile will likely enable the
noid hemorrhage, patients are susceptible
straight into Phase II studies in 2012.
to cerebral vasospasm, which limits blood
whether or when it will seek a partner for
strokes and additional tissue damage.
NimoGel. “Once we complete the Phase II
study we will look at our options,” Leuthner
traction of smooth vascular muscle in the
H o w e v e r , s y s t e m i c d e l i v e r y o f
muscle in the heart, and thus is associated
microcatheter into the subarachnoid space.
given at doses that limit its efficacy.
trauma: EG-1964, EG-1960 and EG-1967.
bleeding vessels, NimoGel can be injected
die despite treatment with nimodipine.
into the site of injury during this opera-
proved, off-patent drugs. They do not use
process of raising additional funds,” to
back to their previous way of life,” he told
intraventricular catheter for patients who
directly to the site of injury will allow a
cal data at the American Stroke Association’s International Stroke Con-
ference in Los Angeles showing that 30 mg
American Stroke Association, Dallas,
from SurModics Inc. Edge Therapeutics Inc., Newark, N.J. SurModics Inc. (NASDAQ:SRDX), Eden The search for intelligent life
We know you have many choices for headlines. But finding real intelligence is a lot harder. That’swhy top managers and investors in the life sciences community depend on BioCentury, theBernstein Report on BioBusinessTM for its leading perspective on the strategic issues essential to theformation, development and sustainability of life science ventures in 2011 and beyond. ‘It’s the BioCentury’TM
Vesícula A vesícula biliar é um órgão sacular, com paredes finas, como se fosse uma bexiga (Foto) que se encontra junto ao fígado. A bile é uma substância produzida pelo fígado e que é em parte armazenada e concentrada na vesícula. A função da bile é digerir gorduras quando em contato com os alimentos no intestino. Quando nos alimentamos, a vesícula biliar é estimulada a em
WEEK OF MARCH 14, 2011