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FDA Approves IMBRUVICA for Treatment of Waldenstrom's Macroglobulinemia

January 29, 2015 12:54 pm | News | Comments

Pharmacyclics has announced that the FDA has granted single-agent IMBRUVICA (ibrutinib) regular (full) approval in all lines of therapy as the first and only treatment for patients with Waldenstrom's macroglobulinemia (WM), a rare, indolent type of B-cell lymphoma.

Obama Administration on Track to Surpass Health Care Goal

January 28, 2015 8:21 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

Some 9.5 million people have already signed up for 2015 coverage under President Barack Obama's...

FDA Approves Teva's Generic Nexium® Delayed-Release Capsules

January 27, 2015 7:06 am | News | Comments

Teva Pharmaceutical has announced the Food and Drug Administration (FDA) approval of the first...

CHMP Issues Positive Opinion for Merck's Investigational Antibiotic SIVEXTRO®

January 26, 2015 11:00 am | News | Comments

Merck announced that the Committee for Medicinal Products for Human Use of the European...

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FDA Approves Symplmed's Prestalia® for Treatment of Hypertension

January 26, 2015 10:44 am | News | Comments

Symplmed Pharmaceuticals has announced that the FDA has approved Prestalia® (perindopril arginine and amlodipine) tablets, licensed from Servier (Suresnes, France), for the treatment of hypertension.         

Added Protections for Consumer Information on Health Website

January 26, 2015 8:46 am | by RICARDO ALONSO-ZALDIVAR, Associated Press; JACK GILLUM, Associated Press | News | Comments

The Obama administration appears to be making broader changes to protect consumer information on the government's health insurance website, after objections from lawmakers and privacy advocates.          

Impax Receives FDA Approval for a Generic Version of Lamictal

January 26, 2015 8:11 am | News | Comments

Impax Laboratories announced today that the  FDA has approved generic Lamictal (lamotrigine) Orally Disintegrating Tablets, 25mg, 50mg, 100mg and 200mg in blister packaging. Impax will promptly initiate commercialization of this product through Global Pharmaceuticals, Impax's generic division.

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Obama Administration Reverses on Health Care Privacy Problem

January 23, 2015 2:14 pm | by RICARDO ALONSO-ZALDIVAR, Associated Press; JACK GILLUM, Associated Press | News | Comments

The Obama administration is reversing itself after an outcry over consumer privacy on HealthCare.gov, the government's health insurance website.                  

New Government Standards Target Pathogens in Poultry Products

January 22, 2015 8:12 am | by MARY CLARE JALONICK, Associated Press | News | Comments

Standards proposed Wednesday by the Agriculture Department aim to reduce rates of salmonella and campylobacter, another pathogen that can cause symptoms similar to salmonella, in chicken parts, ground chicken and ground turkey. The standards would be voluntary but designed to pressure companies to take steps to reduce contamination.

Government Closer to Goal of 9.1M Enrolled Under Health Law

January 22, 2015 7:57 am | News | Comments

The Obama administration is moving closer to its goal of 9.1 million people signed up for private coverage under the president's health care law. The Health and Human Services Department says at least 400,000 people signed up last week.   

Government Health Care Website Quietly Sharing Personal Data

January 21, 2015 8:23 am | by RICARDO ALONSO-ZALDIVAR, Associated Press; JACK GILLUM, Associated Press | News | Comments

The government's health insurance website is quietly sending consumers' personal data to private companies that specialize in advertising and analyzing Internet data for performance and marketing.               

FDA Approves Baxter's PHOXILLUM Solution for Electrolyte Management During Continuous Renal Replacement Therapy

January 21, 2015 8:15 am | News | Comments

Baxter International has announced the FDA has approved PHOXILLUM Renal Replacement Solutions as replacement solutions in continuous renal replacement therapy to correct electrolyte and acid-base imbalances, and in case of drug poisoning when CRRT is used to remove dialyzable substances.

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New Privacy Concerns Over Government's Health Care Website

January 20, 2015 7:11 am | by RICARDO ALONSO-ZALDIVAR, Associated Press; JACK GILLUM, Associated Press | News | Comments

A little-known side to the government's health insurance website is prompting renewed concerns about privacy, just as the White House is calling for stronger cybersecurity protections for consumers.         

Fresenius Kabi Receives FDA Approval for Neostigmine Methylsulfate Injection

January 19, 2015 9:33 am | News | Comments

This is the first Fresenius Kabi drug approved by the FDA since the agency upgraded the status of the company’s pharmaceutical manufacturing facility in Grand Island, N.Y., earlier this month.           

Large Gathering Causes Spike in Water Contaminants

January 15, 2015 2:37 pm | by Andrew Szal, Editor, Pharmaceutical Processing | News | Comments

Research by Taiwanese scientists shows a large music festival on the island resulted in a spike in a slew of chemical contaminants -- both over-the-counter and illicit -- in nearby waterways. The findings underscore the potential impact of pharmaceuticals and recreational drugs on the environment -- along with the lack of regulations needed to address those threats.

Study: Fewer Struggle with Medical Costs as Coverage Grows

January 15, 2015 8:21 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

Not only do more Americans have health insurance, but the number struggling with medical costs has dropped since President Barack Obama's health care law expanded coverage, according to a study released Thursday.       

FDA Approves Appetite-Zapping Implant for Obese Patients

January 14, 2015 4:24 pm | News | Comments

The Maestro Rechargeable System uses electrodes implanted in the abdomen to stimulate the vagus nerve, which signals to the brain that the stomach is empty or full. Patients and doctors can adjust the device settings using external controllers. 

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FDA Approves Cytori's Scleroderma Trial

January 12, 2015 8:15 am | News | Comments

Cytori Therapeutics announced today that the Center for Biologics Evaluation and Research, a division of the FDA, has given final approval to its application for an Investigational Device Exemption to begin a pivotal trial to evaluate Cytori Cell Therapy™ as a potential treatment for impaired hand function in scleroderma.

FDA Approves Daiichi Sankyo's Once-Daily SAVAYSA

January 9, 2015 8:21 am | News | Comments

Daiichi Sankyo Company today announced that the FDA has approved SAVAYSA Tablets, an oral, once-daily selective factor Xa-inhibitor, to reduce the risk of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF).

Health Care Sign-Ups Steady as Uninsured Rate Hits New Low

January 8, 2015 8:19 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

The Obama administration reported Wednesday that nearly 103,000 people signed up last week in the 37 states where the federal government is running online health insurance markets, bringing total enrollment for 2015 to 6.6 million in those states. The remaining states are running their own exchanges.

FDA Approves Impax Pharmaceuticals’ RYTARY for the Treatment of Parkinson's Disease

January 8, 2015 8:12 am | News | Comments

Impax Pharmaceuticals today announced that the FDA approved RYTARY, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication.

House Bill: Firms Could Skirt Health Law by Hiring Vets

January 7, 2015 8:46 am | by ALAN FRAM, Associated Press | News | Comments

On the new Congress' first day, the House unanimously approved Republican legislation Tuesday making it easier for smaller companies to avoid providing health care coverage to their workers by hiring veterans.       

FDA Approves Aethlon Medical's Ebola Treatment Protocol

January 2, 2015 3:58 pm | News | Comments

Aethlon Medical announced that the FDA has approved a clinical protocol to treat Ebola-infected individuals in the U.S. with the Aethlon Hemopurifier®. The device targets antiviral drug resistance and serves as a first-line countermeasure against Ebola and other viruses that are not addressed with proven drug therapies.

Report Prompts Mixed View of Health Care Sign-Ups

January 2, 2015 11:46 am | by CARLA K. JOHNSON, AP Medical Writer | News | Comments

The first 50-state report on the latest sign-up season under President Barack Obama's health care law shows that more than 4 million people selected plans for the first time or re-enrolled. The administration called it "an encouraging start." 

FDA Drug Approvals Reached 18-Year High in 2014

January 2, 2015 11:35 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

The Food and Drug Administration approved 41 first-of-a-kind drugs in 2014, including a record number of medicines for rare diseases, pushing the agency's annual tally of drug approvals to its highest level in 18 years.     

GOP Legislators Thwart Bids to Expand Medicaid

January 2, 2015 8:43 am | by CHARLES BABINGTON, Associated Press | News | Comments

Governors across the political spectrum are hitting a roadblock in their bids to expand Medicaid with federal funds: Republican legislators who adamantly oppose "Obamacare." While some of these governors themselves have criticized the president's health care law in general, they've come to see one component — Medicaid expansion — as too generous to reject.

Valeant Pharmaceuticals Recalls Virazole®

January 2, 2015 8:38 am | News | Comments

Valeant Pharmaceuticals is issuing a voluntarily recall of one lot of Virazole® (ribavirin powder for solution), 100 mL, 6g Vial, 4-pack to the user level. Inhalation of a non-sterile product with microbial contamination into the airways could increase the risk of respiratory infection.

FDA Approves Hospira’s Dyloject Injection

January 2, 2015 8:30 am | News | Comments

Hospira has received approval from the FDA for Dyloject Injection, a proprietary nonsteroidal anti-inflammatory drug analgesic.  Dyloject is indicated for use in adults for the management of mild to moderate pain and for the management of moderate to severe pain alone or in combination with opioid analgesics.

Hospira Recalls Ten Lots of Mitoxantrone

December 24, 2014 10:46 am | News | Comments

Hospira has initiated a voluntary recall of 10 lots, identified below, of MitoXANTRONE (both human and veterinary), due to confirmed subpotency and elevated impurity levels.             

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