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Biotechnology/Pharmaceutical News
Jackson doctor denies manslaughter charge
(AFP)
AFP - Michael Jackson's doctor pleaded not guilty to involuntary manslaughter...
AstraZeneca gets OK for expanded Crestor use
(AP)
AP - Federal regulators have granted AstraZeneca approval to market its chole...
Charles River reports profit, but revenue slides
(AP)
AP - Medical research equipment and services company Charles River Laboratori...
Lechleiter pay rises in 1st full year as Lilly CEO
(AP)
AP - Eli Lilly and Co. CEO John Lechleiter received a compensation package va...
CVS Caremark profit tops view; shares up 6 percent
(Reuters)
Reuters - CVS Caremark Corp said recent problems at its pharmacy benefits ma...
CVS Caremark 4Q profit grows 11 percent
(AP)
AP - CVS Caremark Corp., one of the nation's biggest drugstore operators, sai...
Earnings Preview: CVS Caremark to report 4Q
(AP)
AP - Drugstore operator and pharmacy benefits manager CVS Caremark Corp. repo...
Teva Pharma settles some Medicaid drug price suits
(AP)
AP - Teva Pharmaceutical Industries Ltd., the world's largest generic drugmak...
Miss. settles Zyprexa suit for more than $18M
(AP)
AP - Mississippi will receive $18.5 million from drug maker Eli Lilly and Co....
GlaxoSmithKline hints at job cuts as profits soar
(AFP)
AFP - British pharmaceuticals giant GlaxoSmithKline on Thursday announced a 6...
Drugmaker employee in NY charged with trade theft
(AP)
AP - A fired Bristol-Myers-Squibb Co. employee stole trade secrets from the d...
Ironwood shares rise after IPO prices low
(AP)
AP - Shares of Ironwood Pharmaceuticals Inc. are up in their IPO debut after ...
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FDA News
FDA Updates Statement on the Investigation into the Salmonella Montevideo Out...
The Food and Drug Administration, along with the Centers for Disease Control ...
FDA Issues Guidance to Help Streamline Medical Device Clinical Trials
The U.S. Food and Drug Administration today issued guidance on Bayesian stati...
United States Seizes more than 1500 Cases of Food from Wisconsin Distribution...
At the request of the U.S. Food and Drug Administration, U.S. Marshals on Tue...
FDA Approves Xiaflex for Debilitating Hand Condition
The U.S. Food and Drug Administration today approved Xiaflex (collagenase clo...
FDA Requests $4.03 Billion to Transform Food Safety System, Invest in Medical...
The U.S. Food and Drug Administration is requesting $4.03 billion to promote ...
FDA Announces Safety Risk Associated with HIV Drug
The U.S. Food and Drug Administration today announced that non-cirrhotic port...
FDA Collaboration Seeks to Speed Development of Pneumococcal Vaccines for Chi...
The U.S. Food and Drug Administration (FDA) today announced a collaboration w...
FDA Statement on the Investigation into the Salmonella Montevideo Outbreak
The Food and Drug Administration, along with the Centers for Disease Control ...
FDA Expands Use of Approved Breast Cancer Drug
The U.S. Food and Drug Administration today approved Tykerb (lapatinib) in co...
United States Seizes Unapproved Ozone Generators
At the request of the U.S. Food and Drug Administration, U.S. Marshals today ...
FDA Announces Class I Recall of Certain Infusion Set Needles
The U.S. Food and Drug Administration today announced a Class I recall of Exe...
FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain
The U.S. Food and Drug Administration today approved Morphine Sulfate Oral So...
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New Drug Applications
XenoPort Announces Horizant as Brand Name for XP13512
SANTA CLARA, Calif.--(BUSINESS WIRE)--Feb 4, 2010 - XenoPort,
Inc. announced ...
Lux Biosciences Files for Luveniq Approval in US and Europe for Noninfectious...
JERSEY CITY, N.J.--(BUSINESS WIRE)--Feb 4, 2010 - Lux
Biosciences, Inc. today...
FDA Accepts Javelin Pharmaceuticals' Dyloject New Drug Application for Formal...
NDA for Management of Acute Moderate-to-Severe Pain Includes
Data from 16 Cli...
Teva Announces FDA Accepts BLA for XM02
JERUSALEM--(BUSINESS WIRE)--Feb 2, 2010 - Teva Pharmaceutical
Industries Ltd....
Protalix Announces NDA Submission Update for taliglucerase alfa for the Treat...
CARMIEL, Israel, Feb. 2 /PRNewswire-FirstCall/ -- Protalix
BioTherapeutics, I...
FDA Extends PDUFA Action Date for Stedesa New Drug Application
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Jan 27, 2010 - Sepracor Inc. today annou...
FDA Issues Complete Response Letter for Low Dose Oral Contraceptive WC
3016
ARDEE, Ireland, Jan. 27 /PRNewswire-FirstCall/ -- Warner
Chilcott plc announc...
Somaxon Provides Update on New Drug Application for Silenor for the Treatment...
Resubmission has been filed, with 2 month review
cycle
SAN DIEGO--(BUSINESS W...
Genzyme's Lumizyme BLA Receives Six-Month FDA Review
PDUFA Date Set For June 17, 2010
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan 21, 2...
MannKind Updates Status of Afrezza New Drug Application
VALENCIA, Calif.--(BUSINESS WIRE)--Jan 8, 2010 - MannKind
Corporation announc...
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Clinical Trials
AMAG Pharmaceuticals Provides Feraheme® Safety Update
~ Conference call will be held today at 4:45 p.m. Eastern
time ~
LEXINGTON, M...
Researchers Report Elevated Levels of Tβ4 Levels Predict Patient Surviv...
Tβ4 – Potential New Therapeutic Agent for
Liver Failure
BETHESDA, Md.--...
NOVAVAX Reports Additional Positive Data from Its Trivalent Seasonal Influenz...
Data show significant Neuraminidase Inhibition Antibody
Titers in VLP vaccine...
Addex Pharmaceuticals (CH) - Addex: ADX71943 Demonstrates Analgesic Effects i...
Geneva, Switzerland, 8 February 2010 - Addex
Pharmaceuticals (SIX:ADXN), the...
Cara Therapeutics Reports Positive Phase II Data for Novel Peripheral Analges...
SHELTON, Conn., Feb. 8 /PRNewswire/ -- Cara Therapeutics, Inc.
today announce...
Synta Announces STA-9090 Results Demonstrating Potent in vitro and in vivo Ac...
- Results presented at hematologic malignancies conference in
Singapore -
- S...
Inovio Biomedical Cervical Cancer Therapeutic Vaccine Generates Dose-Related ...
Increased antigen-specific T-cell and antibody responses
shown in second, hig...
Inovio's Cervical Cancer Therapeutic Vaccine Generates Dose-Related Immune Re...
Increased antigen-specific T-cell and antibody responses shown
in second, hig...
LEO Pharma's PEP005 Meets Primary Endpoint in Phase III Trial for Pre-Cancero...
BALLERUP, Denmark, Feb. 1 /PRNewswire-USNewswire/ -- LEO Pharma
today announc...
Shire to Present Important Study Findings for Gaucher Disease Treatment and G...
Data sponsored by the Canadian Fabry Disease Initiative
(CFDI) to be presente...
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