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The Lead

House OKs Bipartisan Medicare Doctor Bill; Fate Up to Senate

March 26, 2015 3:30 pm | by ALAN FRAM, Associated Press | News | Comments

In uncommon bipartisan harmony, the House approved a $214 billion bill on Thursday permanently blocking physician Medicare cuts, moving Congress closer to resolving a problem that has plagued it for years.

Orexigen's Mysimba Approved in Europe for the Treatment of Obesity

March 26, 2015 3:17 pm | News | Comments

Orexigen Therapeutics has announced that the European Commission has granted marketing...

FDA Approves Sanofi Pasteur’s Quadracel DTaP-IPV Vaccine for Children

March 25, 2015 12:24 pm | News | Comments

Sanofi Pasteur, the vaccines division of Sanofi announced that FDAhas approved use of Quadracel...

Emergent BioSolutions Receives FDA Approval for Anthrasil

March 25, 2015 11:40 am | News | Comments

Emergent BioSolutions has announced that the FDA has approved Anthrasil™ [Anthrax Immune...

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FDA Approves New Treatment for Diabetic Retinopathy in Patients with Diabetic Macular Edema

March 25, 2015 11:31 am | News | Comments

The FDA has expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema.

Uncertainty About Doctors' Pay Has Taken a Toll on Medicare

March 25, 2015 8:41 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

New momentum for a lasting fix to Medicare's doctor-payment problem shows that lawmakers may finally be recognizing what has long bothered their constituents.

GOP Hits Medicaid to Offset Doctor Fee Hikes

March 24, 2015 8:35 am | by DAVID ESPO, AP Special Correspondent | News | Comments

House Republicans quietly deepened recommended budget savings from the government's chief health care program for the poor by about $140 billion in recent weeks to offset part of the cost of higher payments to doctors who treat Medicare patients, according to officials familiar with the tradeoff.

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Boehner, Pelosi See Victories in Fixing Medicare Doctors' Fees

March 19, 2015 8:42 am | by ALAN FRAM, Associated Press | News | Comments

An uncharacteristic joint effort by House Speaker John Boehner and his usual nemesis, Minority Leader Nancy Pelosi, to resolve a gnawing problem about how Medicare pays doctors underscores the political victories each sees in finally sweeping the issue off the deck — if they can.

Poll: Many Unaware Some Health Subsidies Could Be Ruled Out

March 19, 2015 8:01 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

With a decision due by summer in a Supreme Court case that could unravel President Barack Obama's health care law, a new poll finds many Americans have heard nothing about the case. But when the potential fallout is explained, most say it would hurt the country and they would look to Congress or the states to fix it.

Vertex Gets FDA Approval of KALYDECO® for Children with Cystic Fibrosis

March 18, 2015 3:54 pm | News | Comments

Vertex Pharmaceuticals has announced that the FDA approved KALYDECO® for use in children ages 2 to 5 with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator ( CFTR) gene.

Chemical Regulation Overhaul Bill Faces Opposition in Senate

March 18, 2015 3:47 pm | by MATTHEW DALY, Associated Press | News | Comments

A bipartisan bill that would update regulation of harmful chemicals for the first time in nearly 40 years is drawing opposition from some Democrats and environmental groups, who charged on Wednesday that the measure is a step backward in protecting health and the environment.

Obama Administration: 16.4M Have Gained Health Insurance

March 17, 2015 8:15 am | by RICARDO ALONSO-ZALDIVAR, Associated Press; JULIE PACE, Associated Press | News | Comments

More than 16 million Americans have gained coverage since President Barack Obama's health care law took effect five years ago, the administration said Monday. But measuring a different way, an independent expert who took into account insurance losses during some of those years had a much lower estimate: 9.7 million.

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Actavis Receives FDA Approval for VIIBRYD

March 17, 2015 8:10 am | News | Comments

Actavis announced that the FDA has approved a lower therapeutic dose of VIIBRYD (vilazodone HCl) (20mg) to accompany the 40 mg daily therapeutic dose.

New Sign-Up Under Health Care Law Gets Lukewarm Reception

March 16, 2015 8:14 am | by RICARDO ALONSO-ZALDIVAR, Associated Press Writer | News | Comments

Several million people hit with new federal fines for going without health insurance are getting a second chance to sign up, and that could ease the sting of rising penalties for being uninsured.

Hospira Issues a Voluntary Nationwide Recall of One Lot of Lactated Ringer's Irrigation Due to Mold Contamination

March 13, 2015 8:40 am | News | Comments

Hospira is initiating a voluntary recall of one lot of Lactated Ringer's Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report of several dark, fibrous particulates floating within the solution of the primary container.

FDA Approves Actavis’ SAPHRIS

March 13, 2015 8:15 am | News | Comments

Actavis announced that the FDA has approved its supplemental new drug application (sNDA) for SAPHRIS (asenapine) as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients (ages 10 - 17).

Powdered Alcohol Gets Fed's Approval

March 12, 2015 8:31 am | by CANDICE CHOI, AP Food Industry Writer | News | Comments

A powdered alcohol intended to be mixed up into drinks has gained approval from a federal regulator. The product, called Palcohol, had received the greenlight from the Alcohol and Tobacco Tax and Trade Bureau briefly last year before the bureau backtracked and said the label approvals had been given in error.

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Bills Banning Most Vaccine Exemptions Fail in Northwest

March 12, 2015 8:24 am | by SHEILA V KUMAR, Associated Press; RACHEL LA CORTE, Associated Press | News | Comments

Legislative efforts to increase pressure on parents to get their kids vaccinated failed in Oregon and Washington state Wednesday amid stiff opposition as a handful of other statehouses consider similar bills prompted by a measles outbreak at Disneyland.

Paul Joins Democrats in Bid to Boost Medical Marijuana

March 11, 2015 8:31 am | by MATTHEW DALY, Associated Press | News | Comments

Two Democratic senators and a possible Republican presidential candidate joined forces Tuesday to push a bill to remove federal prohibitions on medical marijuana in 23 states where it's already legal.

Legislation Targets Detergent Packets Following Rash of Child Poisonings

March 10, 2015 2:42 pm | by Andy Szal, Digital Reporter | News | Comments

Democratic members of Congress hope to make substantial changes to single-load laundry detergent packets amid rising concerns about accidental ingestion by children.  

FDA Approves First Biosimilar

March 9, 2015 8:12 am | by MATTHEW PERRONE, AP Business Writer; LINDA A. JOHNSON, AP Business Writer | News | Comments

Government health officials on Friday approved the first lower-cost copy of a biotech drug in the U.S., a long-awaited milestone that could save billions for insurers, doctors and patients.

Fate of Obama Health Law Subsidies Rests with Two Justices

March 5, 2015 3:55 pm | by MARK SHERMAN, Associated Press | News | Comments

 The Supreme Court argument over subsidies that help millions of people afford their health insurance suggests that the Obama administration has two chances to attract one critical vote.

FDA Approves Opdivo for the Treatment of Patients with Previously Treated Metastatic Squamous Non-Small Cell Lung Cancer

March 4, 2015 11:04 pm | News | Comments

Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

Photo of the Day: Native Americans and Medical Marijuana

March 3, 2015 11:35 am | by Mike Auerbach, Editor-In-Chief | News | Comments

Audience members look on at a tribal marijuana conference for tribal governments considering whether to legalize marijuana for medicinal, agricultural, or recreational use.

Explained: Supreme Court Case Against Obama's Health Law

March 3, 2015 9:16 am | by ALEXANDRA OLSON, Associated Press | News | Comments

he U.S. Supreme Court this week hears a challenge to President Barack Obama's health care overhaul. If successful, the lawsuit would cripple Obama's prized domestic achievement, a program that has brought the U.S. as close as it has ever come to universal health care.

Pfizer Receives European Approval for New Indication for Prevenar 13

March 3, 2015 8:47 am | News | Comments

Pfizer has announced that the European Commission approved an expanded indication for the use of Prevenar 13 for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older.

Young Girl's Story May Lead Idaho to Approve Marijuana Oil

March 2, 2015 8:57 am | by KIMBERLEE KRUESI, Associated Press | News | Comments

Ten-year-old Alexis Carey has a rare but intractable form of epilepsy, Dravet Syndrome. The genetic disease causes severe and multiple seizures, which often leave parents guessing if the terror of watching their child seize up will pass or turn fatal.

PBOA Supports FDA SOS Act

March 2, 2015 8:14 am | News | Comments

Bipartisan Act would preserve FDA user fees from sequestration.

Presidential Panel: Base Quarantines, Other Outbreak Decisions on Science

February 26, 2015 12:10 pm | by LAURAN NEERGAARD, AP Medical Writer | News | Comments

Attempts to quarantine health workers returning from Ebola-stricken West Africa were a mistake, the president's bioethics advisers said Thursday.

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