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Hovione’s Cork, Ireland API Plant Passes FDA Pre- Approval Inspection

July 31, 2014 1:26 pm | News | Comments

The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued.              

Israel's Ministry of Health Approves Pluristem's Commercial-Scale 3D Cell Manufacturing Process

July 31, 2014 10:58 am | News | Comments

Pluristem Therapeutics has announced that it has completed the approval process and received...

FDA Approves EYLEA Injection for the Treatment of Diabetic Macular Edema

July 30, 2014 8:03 am | News | Comments

Regeneron Pharmaceuticals announced that the FDA has approved EYLEA Injection for the treatment...

European Commission Approves Eliquis for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism

July 29, 2014 8:38 am | News | Comments

Bristol-Myers Squibb and Pfizer announced that the European Commission has approved Eliquis for...

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FDA Grants Full Approval for IMBRUVICA for Two Indications

July 28, 2014 2:39 pm | News | Comments

Pharmacyclics, Inc. announced that the FDA has granted IMBRUVICA regular (full) approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment naive and previously treated del 17p CLL patients.

FDA Approves Aqua Pharmaceuticals' ACTICLATE™ Tablets

July 28, 2014 9:11 am | News | Comments

ACTICLATE™ is a tetracycline-class antibacterial indicated for the treatment of a number of infections, including adjunctive therapy in severe acne.                 

Can Canadian-Style Health Care Work in Vermont?

July 28, 2014 9:01 am | Videos | Comments

In Vermont, a new health care experiment is under the microscope.                                

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After Six Weeks, Finally a Deal on VA Health Care

July 28, 2014 8:26 am | by MATTHEW DALY, Associated Press | News | Comments

After more than six weeks of sometimes testy talks, House and Senate negotiators have agreed on a compromise plan to fix a veterans health program scandalized by long patient wait times and falsified records covering up delays.    

Allergan's OZURDEX® Receives European Positive Opinion for the Treatment of Diabetic Macular Edema

July 25, 2014 8:03 am | News | Comments

Allergan announced today that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has recommended extending the Marketing Authorization for OZURDEX ® (dexamethasone 700 mcg intravitreal implant in applicator) to treat adult patients with vision loss due to diabetic macular edema.

Study: 10M Have Gained Coverage Through Health Law

July 24, 2014 8:43 am | by Associated Press | News | Comments

A new study estimates that more than 10 million adults gained health insurance by midyear as the coverage expansion under President Barack Obama's law took hold in much of the country.           

FDA Approves New Extended-Release Oxycodone with Abuse-Deterrent Properties

July 24, 2014 7:59 am | News | Comments

The FDA has approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

FDA Approves Gilead Sciences Drug for Three Cancers

July 23, 2014 1:07 pm | News | Comments

Regulators approved the drug for patients with forms of chronic lymphocytic leukemia, follicular lymphoma and small lymphocytic lymphoma. The cancers affect an estimated 200,000 patients in the U.S., according to Gilead. The company's tablet, Zydelig, works by blocking signals inside some cancer cells that allow them to grow and survive.

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Government Drafting Birth Control Accommodation

July 23, 2014 8:53 am | News | Comments

The Obama administration is developing a new way for religious nonprofits that object to paying for contraceptives in their health plans to opt out, without submitting a form they say violates their religious beliefs.      

Agents Get Subsidized 'Obamacare' Using Fake IDs

July 23, 2014 8:46 am | News | Comments

Undercover investigators using fake identities were able to secure taxpayer-subsidized health insurance under President Barack Obama's health care law. The weak link in the system seemed to be call centers that handled applications for thousands of consumers unable to get through online.

Judges in Health Care Rulings Vote Party Line

July 23, 2014 8:29 am | News | Comments

In rapid succession, six federal judges on two appeals courts weighed in on a key component of President Barack Obama's health care law. Their votes lined up precisely with the party of the president who appointed them. It was the latest illustration that presidents help shape their legacies by stocking the federal bench with judges whose views are more likely to align with their own.

FDA Approves Eagle Pharmaceuticals’ Ryanodex®

July 23, 2014 8:09 am | News | Comments

Eagle Pharmaceuticals today announced that the FDA has approved Ryanodex® (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures.    

FDA Warns About Dangers of Caffeine Powder

July 22, 2014 9:10 am | Videos | Comments

The medical alert came after an Ohio teen died from a caffeine overdose days before his high school graduation.                       

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FDA Approves New Product to Treat Rare Genetic Disease

July 17, 2014 10:22 am | News | Comments

The FDA has approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).           

FDA Issues Draft Information Sheet Guidance on Informed Consent

July 16, 2014 11:42 am | News | Comments

This draft guidance is intended to assist IRBs, clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent.      

FDA Approves Purdue Pharma’s 7.5 mcg/hour Dosage Strength of Butrans

July 16, 2014 8:31 am | News | Comments

Purdue Pharma announced that the FDA has approved a new 7.5 mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII. Five strengths of Butrans will now be available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour and 20 mcg/hour.

FDA Grants Roche’s Avastin Priority Review for Certain Types of Cervical Cancer

July 15, 2014 8:38 am | News | Comments

Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer.

Compounding Pharmacy Oversight Changes Signed

July 11, 2014 8:22 am | News | Comments

Two years after a deadly nationwide meningitis outbreak linked to a compounding pharmacy in Massachusetts, Gov. Deval Patrick on Thursday signed a law he said would address a "gray area" between state and federal oversight of the pharmacies.  

FDA Approves First Drug from Anacor Pharma

July 8, 2014 1:38 pm | News | Comments

Shares of Anacor Pharmaceuticals Inc. climbed Tuesday morning after federal regulators approved its first drug, the toenail fungus treatment Kerydin, a few weeks ahead of schedule.            

Missouri Governor Vetoes Health Navigator Limits

July 8, 2014 9:11 am | by DAVID A. LIEB, Associated Press | News | Comments

Missouri Gov. Jay Nixon vetoed legislation Monday that would have limited who could work in the state as a health insurance guide and blamed a national conservative group for injecting an error into the model legislation.     

Judge Hears Arguments in Health Care Lawsuit

July 8, 2014 9:08 am | by TODD RICHMOND, Associated Press | News | Comments

A Wisconsin senator on Monday argued that his lawsuit challenging rules that call for congressional members and their employees to seek government-subsidized health insurance through small-business exchanges should be allowed to move forward. 

Free Birth Control is Emerging Standard for Women

July 7, 2014 8:47 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

More than half of privately insured women are getting free birth control under President Barack Obama's health law, a major coverage shift that's likely to advance.               

Nonprofits' Contraceptive Cases Next for Justices

July 7, 2014 8:44 am | by MARK SHERMAN, Associated Press; RACHEL ZOLL, Associated Press | News | Comments

The issue in more than four dozen lawsuits from faith-affiliated charities, colleges and hospitals that oppose some or all contraception as immoral is how far the Obama administration must go to accommodate them.       

Japan Approves First All-Oral, Interferon- and Ribavirin-Free Hepatitis C Treatment, Daklinza® and Sunvepra® Dual Regimen

July 7, 2014 8:19 am | News | Comments

Bristol-Myers Squibb Company has announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Daklinza® (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor ( in vitro ), and Sunvepra® (asunaprevir), a NS3/4A protease inhibitor, providing a new treatment that can lead to cure for many patients in Japan who currently have no treatment options.

FDA Grants Spectrum Pharmaceuticals Accelerated Approval of Beleodaq™ for Injection

July 7, 2014 8:15 am | News | Comments

Spectrum Pharmaceuticals, with a primary focus in Hematology and Oncology, announced that the FDA has granted Accelerated Approval of Beleodaq™ for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).  

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