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Chimerix Gets FDA OK to Test Drug for Ebola

October 17, 2014 11:39 am | News | Comments

Chimerix has received FDA clearance to proceed with a trial examining the safety and effectiveness of its brincidofovir tablets in patients who have the virus.               

FDA Panel Votes to Keep Boxed Warning on Chantix

October 16, 2014 4:36 pm | by The Associated Press | News | Comments

Federal health advisers say a bold-letter warning about suicide risks with Pfizer's Chantix...

HHS Advances Development of Third Ebola Vaccine

October 16, 2014 3:39 pm | News | Comments

The development of a vaccine to prevent Ebola virus disease will be accelerated with support...

FDA Approves Esbriet to Treat Idiopathic Pulmonary Fibrosis

October 16, 2014 8:41 am | News | Comments

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred...

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Hospira Announces Voluntary Nationwide Recall of Certain Lots of Several Lifecare Products

October 15, 2014 8:44 am | News | Comments

Hospira has announced the voluntary recall of certain lots of several products in its LifeCare™ line of flexible intravenous solutions due to the potential for leakage.              

FDA: Little Evidence to Drop Chantix Boxed Warning

October 14, 2014 11:50 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

Federal regulators say Pfizer has provided low-quality evidence to support its request to remove a bold-letter warning from its anti-smoking drug Chantix about suicidal behavior. The twice-a-day tablet has carried the FDA's strongest warning label, known as a black box, since 2009 following reports of suicidality, hostility and depression among some patients.

FDA Accepts Pfizer's Palbociclib New Drug Application for Priority Review

October 14, 2014 8:52 am | News | Comments

This NDA requests FDA approval of palbociclib, in combination with letrozole, as a first-line treatment for postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease.

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FDA Approves VELCADE® for Injection for Previously Untreated Patients with Mantle Cell Lymphoma

October 9, 2014 1:48 pm | News | Comments

Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, today announced that the FDA has approved VELCADE® for injection for use in previously untreated patients with mantle cell lymphoma. VELCADE is the first treatment in the United States to be approved for use in previously untreated patients with MCL.

FDA Grants Priority Review for Genentech’s Lucentis in Diabetic Retinopathy

October 8, 2014 3:35 pm | News | Comments

Genentech announced that the FDA has accepted to file the company's supplemental Biologics License Application and granted Priority Review of Lucentis® for the treatment of diabetic retinopathy, an eye disease that impacts nearly 7.7 million Americans. The FDA confirmed action date is February 6, 2015.

Bristol-Myers Squibb Withdraws NDA for Hepatitis C Treatment

October 7, 2014 8:43 am | News | Comments

Bristol-Myers Squibb has decided that it will not pursue FDA approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor.

Experimental Drug Provided to Dallas Ebola Patient

October 6, 2014 3:14 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

Officials at Texas Health Presbyterian Hospital said Monday that their patient, Thomas Eric Duncan, is in critical condition and being treated with brincidofovir, an oral medicine developed by Chimerix Inc.        

Sunesis Pharma Shares Sink

October 6, 2014 8:52 am | by The Associated Press | News | Comments

Shares of Sunesis Pharmaceuticals tanked Monday, wiping out all their gains for 2014 and then some, after the drug developer said its treatment for an aggressive form of blood cancer missed its main goal in late-stage testing.     

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FDA Approves AbbVie's HUMIRA for Patients Ages Two and Older

October 6, 2014 8:20 am | News | Comments

AbbVie has announced that the FDA has approved the extension of the HUMIRA indication for moderately to severely active polyarticular juvenile idiopathic arthritis to reducing signs and symptoms in patients ages 2 and older. HUMIRA was approved in the United States in 2008 for polyarticular juvenile idiopathic arthritis in patients ages 4 and older.

Zogenix Submits Harder-to-Abuse Zohydro to FDA

October 1, 2014 3:11 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

Zogenix has submitted a Food and Drug Administration application for a new formulation of Zohydro that is designed to be more difficult to snort or inject — two common methods for abusing painkillers. Zogenix expects approval in the first quarter of 2015, which would allow the drugmaker to replace the older version of Zohydro in the second quarter.

FDA Approves NeuroGenetic Pharmaceuticals Application to Begin Clinical Trials for Its Alzheimer’s Disease Compound

September 29, 2014 12:06 pm | News | Comments

The U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application from NeuroGenetic Pharmaceuticals, Inc. (NGP) to begin clinical trials on its NGP 555 compound to treat and prevent Alzheimer’s disease (AD).

FDA Approves Revised Indication for Allergan's OZURDEX®

September 29, 2014 10:06 am | News | Comments

Allergan announced today that the U.S. Food and Drug Administration (FDA) has approved OZURDEX® (dexamethasone intravitreal implant) 0.7 mg, a sustained-release biodegradable steroid implant, for the treatment of diabetic macular edema (DME).  

Alimera, pSivida say FDA Clears Eye Implant

September 26, 2014 5:45 pm | by The Associated Press | News | Comments

Alimera Sciences and pSivida said Friday the FDA approved their eye disease implant Iluvien. Iluvien is an implant delivered by injection that is intended to treat diabetic macular edema, a condition that can cause blurred vision and blindness. 

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AbbVie Gets Approval For Humira

September 26, 2014 10:48 am | News | Comments

The FDA cleared Humira as a treatment for moderate to severe Crohn's disease in children ages six and older when those children haven't been helped by other treatments, AbbVie said. Humira can be administered at home, unlike similar drugs used to treat the condition.

Pacira Pharmaceuticals Shares Drop As FDA Warns On Misleading Ads

September 25, 2014 9:34 am | by Associated Press | News | Comments

Pacira Pharmaceuticals Inc. said Thursday that it received a warning letter from regulators about marketing for an injectable drug that numbs post-surgical pain that the letter says is misleading.                                        

Anti-Addiction Groups Call for New FDA Chief

September 24, 2014 3:07 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

In a letter released Wednesday, more than a dozen groups ask the Obama administration's top health official to replace FDA Commissioner Dr. Margaret Hamburg, who has led the agency since 2009. The FDA has been under fire from public health advocates, politicians and law enforcement officials since last October, when it approved a powerful new painkiller called Zohydro against the recommendation of its own medical advisers.

New FDA Label Bolsters Safety Case for Chantix

September 24, 2014 11:43 am | News | Comments

New government-approved labeling on Pfizer's drug Chantix suggests that the anti-smoking medication may not carry the risks of suicidal behavior that first earned it the government's strongest warning more than five years ago.    

FDA Warns Doctors to Beware Fake Drug Distributors

September 23, 2014 3:21 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

U.S. health regulators are trying to help doctors spot counterfeit and unapproved drugs by raising awareness of illegal operations that peddle bogus drugs to health professionals. Beginning Tuesday the FDA will push back with its own educational campaign, faxing flyers to physicians across the country on how to recognize bogus offers and counterfeit drugs.

FDA Approves Fast Track Designation for Galmed Pharmaceuticals’ Aramchol

September 23, 2014 11:51 am | News | Comments

Galmed Pharmaceuticals announced that the U.S. Food and Drug Administration approved its request for Fast Track Designation of its product candidate, aramchol, for the treatment of Non-Alcoholic Steato-Hepatitis, or NASH.     

MedImmune Receives FDA Fast Track Designation for Development of MEDI3902 for Prevention of Nosocomial Pneumonia

September 23, 2014 8:22 am | News | Comments

AstraZeneca announced today that its global biologics research and development arm, MedImmune, has received fast track designation from the FDA for its investigational monoclonal antibody (mAb) MEDI3902 for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa (P. aeruginosa), a highly drug-resistant bacterial pathogen.

Amgen Submits BLA for Investigational BiTE Immunotherapy Blinatumomab

September 22, 2014 2:20 pm | News | Comments

The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow. BiTE antibody constructs represent an innovative immunotherapy approach that helps the body's immune system target cancer cells.

FDA Revises Food Safety Rules Due Next Year

September 22, 2014 8:16 am | by MARY CLARE JALONICK, Associated Press | News | Comments

The Food and Drug Administration on Friday revised sweeping food safety rules proposed last year after farmers complained that the regulations could hurt business. The new proposals would relax water quality standards and allow farmers to harvest crops sooner after using raw manure as fertilizer.

FDA Approves Eli Lilly's Injectable Diabetes Drug

September 18, 2014 4:46 pm | by The Associated Press | News | Comments

The Food and Drug Administration has approved a new injectable diabetes drug from Eli Lilly and Co. for adults with the most common form of the disease. The agency on Thursday cleared the drug, Trulicity, as a weekly injection to improve blood sugar control in patients with type 2 diabetes.

Better Way to Diagnose Kidney Stones

September 18, 2014 9:02 am | Videos | Comments

A study in the New England Journal of Medicine found that the less expensive and radiation-free ultrasounds can detect kidney stones as well as the more expensive CT scans. Also, the FDA is investigating the increase in testosterone therapy by older men.

FDA OKs Faster-Acting Label for Stendra

September 18, 2014 8:37 am | by The Associated Press | News | Comments

Federal regulators have approved a new label for Vivus' impotence drug, stating that it becomes effective in half the time that the previous label had stated.                

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