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Anadys gets FDA nod on hepatitis C drug study, shrs up 3:08 PM 7/30/2009
Reuters
Anadys Pharmaceuticals said the US FDA cleared the study protocol for hepatitis C drug ANA598 and patient dosing is expected to commence within the next several weeks. ...

United Therapeutics lung drug gets FDA nod, shares rise 2:05 PM 7/30/2009
Reuters
United Therapeutics Corp said the US FDA approved its inhaled drug Tyvaso for the treatment of pulmonary arterial hypertension (PAH). ...

FDA advisers back Schering antipsychotic drug 1:09 PM 7/30/2009
Reuters
An advisory panel supported Schering-Plough Corp's experimental drug Saphris as a safe and effective therapy for adults with acute schizophrenia and a more severe type of bipolar disorder. ...

Roche eye drug effective against retinal occlusion 12:23 PM 7/30/2009
Reuters
Roche Holding's eye disease drug Lucentis proved effective in helping to improve vision in patients suffering from central retinal vein occlusion. ...

Mylan CEO reasserts FDA probe complete, despite agency rebuttal 9:15 AM 7/30/2009
Bizjournals.com
Mylan CEO asserts quality was never compromised following article describing production employees overriding computer alerts about potential quality problems. Bad cGMPs equals bad product last time we looked. ...

AstraZeneca ups outlook after generic drugs stall 7:38 AM 7/30/2009
Reuters
AstraZeneca raised its full-year earnings forecast helped by the absence of generics to heart drug Toprol XL and cancer treatment Casodex. ...

Lundbeck, Solvay stop schizophrenia drug studies 6:54 AM 7/30/2009
Reuters
Lundbeck and Solvay have stopped Phase III clinical trials on the experimental schizophrenia drug bifeprunox following an interim analysis. ...

AstraZeneca Mulls Second Swine Flu Vaccine Delivery System 5:54 AM 7/30/2009
Wall Street Journal
AstraZeneca PLC is considering an alternative delivery system for a swine flu vaccine because of a shortage of nasal sprayers. ...

Inovio's longer-term outlook on flu vaccine boosts stock 5:46 AM 7/30/2009
San Diego Union Tribune
Not an immediate solution to the potential crisis this fall. ...

Teva Fights for Biotech Generics 4:26 AM 7/30/2009
BusinessWeek
The biggest hurdle facing generic biologics is the missing regulatory pathway, not how long biotech drugs should be protected from generic competition. ...

Federal panel issues H1N1 vaccine guidelines 7:13 PM 7/29/2009
CNN International
Priority groups include pregnant women, health care and emergency services personnel, children, adolescents and young adults up to age 24, household and caregiver contacts of children younger than six months, and healthy adults with certain medical conditions. ...

Malaria Strain Resists Drugs, May Threaten Millions, Study Says 3:25 PM 7/29/2009
Bloomberg
The failure of artemisinin-based drugs to wipe out malaria poses a major threat to eradicating the mosquito-borne disease. ...

FDA issues public health warning about steroid-spiked supplements 5:18 AM 7/29/2009
New York Daily News
The US FDA has issued a public health advising consumers to avoid the use of steroid-spiked supplements from American Cellular Labs and the store Max Muscle. ACL products may be laced with the designer steroids Madol (DMT) and 4-estra (Tren). ...

US FDA panel rejects King imaging drug data 3:38 AM 7/29/2009
Reuters
King Pharmaceuticals failed to show proposed imaging drug CorVue worked as well as approved adenosine in tests to diagnose heart disease. ...

NIH stops trial of drug for sickle cell patients 12:14 PM 7/28/2009
Los Angeles Times
The National Institutes of Health halted a clinical trial using sildenafil to treat pulmonary hypertension in sickle cell patients. Preliminary results showed that the drug was increasing sickle crises. ...

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