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The Lead

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...

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...

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...

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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.

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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.

FDA Approves New Antibiotic Combo from Actavis

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

Federal health officials have approved a new antibiotic combination to treat several hard-to-treat infections. The drug contains two ingredients, cephalosporin and avibactam, designed to help fight antibiotic-resistant bacteria.

Report: FDA Recalls Fell in Fourth Quarter of 2014

February 25, 2015 3:42 pm | by Andrew Szal, Editor, Pharmaceutical Processing | News | Comments

A recent report found that recalls of products overseen by the U.S. Food and Drug Administration fell during the final quarter of 2014 but the number of affected units increased.  

Administration: No Quick Fix if Court Kills Health Subsidies

February 25, 2015 8:33 am | by ALAN FRAM, Associated Press | News | Comments

President Barack Obama's health secretary told Congress Tuesday that she has no administrative actions available to fix the "massive damage to our health care system" that would result should the Supreme Court invalidate federal subsidies that help millions of Americans buy health care coverage.

California Lawmakers Consider Soft Drink Warning Label

February 24, 2015 2:23 pm | by Andrew Szal, Editor, Pharmaceutical Processing | News | Comments

A prominent California lawmaker will again seek to place warning labels on soft drinks and other beverages containing added sugar, while industry groups gear up to combat the effort.

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FDA Approves Farydak for Treatment of Multiple Myeloma

February 24, 2015 10:14 am | News | Comments

The U.S. Food and Drug Administration has approved Farydak (panobinostat) for the treatment of patients with multiple myeloma. Multiple myeloma is a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow.

Sagent Pharmaceuticals Initiates Voluntary Recall of Atracurium Besylate Injection

February 23, 2015 2:05 pm | News | Comments

Sagent Pharmaceuticals has announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent.

Governors: No Clear Plan if Health Care Subsidies Fall

February 23, 2015 11:35 am | by STEVE PEOPLES, Associated Press | News | Comments

Millions of people could lose health insurance subsidies in the coming months if the Supreme Court sides with opponents of President Barack Obama's health care overhaul. And one thing was clear this weekend as the nation's governors gathered in Washington: Many of the states that could be affected are not prepared for the potential fallout.

FDA Eases Access to DNA Screening for Inherited Diseases

February 20, 2015 8:25 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

Federal health officials are easing access to DNA tests used to screen parents for devastating genetic disorders that can be passed on to their children. The surprise announcement offers a path forward for Google-backed genetic testing firm 23andMe, which previously clashed with regulators over its direct-to-consumer technology.

Florida Has Highest Number of Enrollees Under Health Law

February 19, 2015 8:47 am | by KELLI KENNEDY, Associated Press | News | Comments

Florida has eclipsed California to become the state with the highest number of consumers buying health coverage through new insurance markets under the Affordable Care Act, according to federal statistics released Wednesday.

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FDA Issues Warning as Peanuts Found in Cumin Spice

February 19, 2015 8:28 am | by MARY CLARE JALONICK, Associated Press | News | Comments

Hundreds of products are being pulled from store shelves after traces of peanut were found in cumin spice — a life-threatening danger to some people with peanut allergies.

White House: Health Law Sign-Ups Top 11M

February 18, 2015 8:21 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

More than 11 million people signed up for subsidized private health insurance under President Barack Obama's law this year, the White House announced Tuesday evening. But that preliminary estimate — 11.4 million people — comes with a couple of asterisks.

FDA Approves Eisai's LENVIMA for Thyroid Cancer

February 17, 2015 8:27 am | News | Comments

Eisai has announced that the FDA approved the company's receptor tyrosine kinase inhibitor LENVIMA (lenvatinib) for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC).

FDA Clears New TB Test

February 13, 2015 8:25 am | News | Comments

The FDA has cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation.

As Sign-Up Deadline Nears, A New Risk for Obama Health Law

February 12, 2015 3:17 pm | by RICARDO ALONSO-ZALDIVAR, Associated Press Writer | News | Comments

Thousands of people signing up for health insurance this weekend may not realize it, but their coverage under President Barack Obama's law could be short-lived.

Hospira Voluntarily Recalls Multiple Lots of Ketorolac Tromethamine Injection

February 11, 2015 11:49 am | News | Comments

Hospira has announced a voluntary recall of ketorolac tromethamine injection, USP in the United States and Singapore due to potential particulate. The presence of particulate has been confirmed through a customer report of visible, floating particulate identified in glass fliptop vials.

Mississippi, West Virginia Toughest on School Immunizations

February 11, 2015 8:12 am | by JOHN RABY, Associated Press; EMILY WAGSTER PETTUS, Associated Press | News | Comments

With rampant diabetes and obesity, Mississippi and West Virginia have struggled with health crises. Yet when it comes to getting children vaccinated, these states don't mess around.

FDA Approves Genentech’s Lucentis® for Treatment of Diabetic Retinopathy in People With Diabetic Macular Edema

February 9, 2015 7:12 am | News | Comments

Genentech, a member of the Roche Group announced that the FDA approved Lucentis® for the treatment of diabetic retinopathy (DR) in people with diabetic macular edema (DME). DME impacts nearly 750,000 Americans, about 10 percent of people with DR.

Democrats Hit GOP Plan for Replacing Obama Health Care Law

February 6, 2015 8:19 am | by ALAN FRAM, Associated Press | News | Comments

A plan by three Republican lawmakers for replacing President Barack Obama's health care overhaul would leave Americans with less coverage and higher costs than the landmark law they want to repeal, Democrats said Thursday.     

California Lawmakers Aim to Limit Vaccine Exemptions

February 4, 2015 3:49 pm | by FENIT NIRAPPIL, Associated Press | News | Comments

California lawmakers are proposing legislation that would require parents to vaccinate all school children unless a child's health is in danger, joining only two other states with such stringent restrictions.       

Bill Would Require HPV Vaccine for Nevada School Enrollment

February 4, 2015 3:44 pm | by MICHELLE RINDELS, Associated Press | News | Comments

A bill introduced this week in the state Senate would require Nevada preteens to be immunized against meningitis and the sexually transmitted human papillomavirus before they enroll in public or private school or daycare, potentially raising Nevada's below-average HPV vaccination rate.

Fitch: Breakthrough, Fast Track Therapy Approvals Accelerating

February 3, 2015 3:25 pm | News | Comments

Closer and more frequent communications with the FDA are likely the main factors leading to a shorter approval time for breakthrough drug therapies, according to Fitch Ratings. Breakthrough therapy approvals more than tripled in 2014 versus 2013.

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