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Spark Therapeutics Appoints Former Chief of FDA’s Gene Therapy Branch as Head of Regulatory Affairs

November 25, 2014 2:06 pm | News | Comments

Spark Therapeutics has announced today appointment of Daniel M. Takefman, Ph.D., as head of regulatory affairs. Dr. Takefman previously served as chief of the gene therapy branch of the Center for Biologics Evaluation and Research at the FDA, a position he held since 2006.

Mylan Files Patent Challenge Relating to BREVIBLOC(R)

November 25, 2014 11:07 am | News | Comments

Mylan has confirmed that it and several subsidiaries have been sued by several Baxter...

FDA Approves Valeant’s ONEXTON Acne Gel

November 25, 2014 8:13 am | News | Comments

Valeant Pharmaceuticals has received approval from the FDA for ONEXTON Gel (clindamycin...

Plague Outbreak Kills 40 People in Madagascar

November 25, 2014 8:05 am | by LYNSEY CHUTEL, Associated Press | News | Comments

WHO said a national task force has been set up to manage the outbreak, with the cost of the...

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New FDA Rules Will Put Calorie Counts on Menus

November 25, 2014 8:01 am | by MARY CLARE JALONICK, Associated Press | News | Comments

Whether they want to or not, consumers will soon know how many calories they are eating when ordering off the menu at chain restaurants, picking up prepared foods at supermarkets and even eating a tub of popcorn at the movie theater.    

FDA Grants Priority Review to Two Bayer Respiratory Meds

November 25, 2014 7:51 am | by The Associated Press | News | Comments

Two medicines Bayer HealthCare Pharmaceuticals Inc. is testing for respiratory disorders will get priority review by U.S. regulators and other benefits under a 2012 program to boost development of new antibiotics.      

Aurobindo Pharma Recalls Northstar Label Gabapentin Capsules, USP 300 mg Due to Complaints of Empty Capsules

November 24, 2014 3:04 pm | News | Comments

Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules.         

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FDA Issues Additional Guidance for Outsourcing Facilities That Compound Sterile Human Drugs

November 24, 2014 1:18 pm | News | Comments

The FDA has issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the DQSA, which was enacted in November 2013.

FDA Strengthens Warning on Device Linked to Cancer

November 24, 2014 11:50 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

The FDA is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.

US Looking Past Ebola to Prepare for Next Outbreak

November 24, 2014 8:50 am | by LAURAN NEERGAARD, AP Medical Writer | News | Comments

The next Ebola or the next SARS. Maybe even the next HIV. Even before the Ebola epidemic in West Africa is brought under control, public health officials are girding for the next health disaster.         

EMA: No Consistent Evidence of an Increased Risk of Heart Problems with Testosterone Medicines

November 21, 2014 8:13 am | News | Comments

The CMDh, a regulatory body representing EU Member States, has agreed by consensus that there is no consistent evidence of an increased risk of heart problems with testosterone medicines in men who lack the hormone (a condition known as hypogonadism).

Officials Downplay Debates Over Ebola Aid Response

November 21, 2014 7:58 am | by MIKE STOBBE, AP Medical Writer; MARIA CHENG, AP Medical Writer | News | Comments

U.S. officials acknowledged disagreements over coordinating the international response to the Ebola epidemic in Liberia, but they say most issues are being worked out and the overall fight against the disease there seems to be succeeding.  

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FDA Approves Hard-to-Abuse Hydrocodone Pill

November 20, 2014 3:27 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

Federal health regulators have approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking such safeguards.       

Soaring Generic Drug Prices Draw Senate Scrutiny

November 20, 2014 8:35 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

Some low-cost generic drugs that have helped restrain health care costs for decades are seeing unexpected price spikes of up to 8,000 percent, prompting a backlash from patients, pharmacists and now Washington lawmakers.     

WHO: Ebola Transmission 'Intense' in Sierra Leone

November 20, 2014 8:12 am | by CLARENCE ROY-MACAULAY, Associated Press | News | Comments

The spread of Ebola remains "intense" in most of Sierra Leone even as things have improved somewhat in the two other countries hardest hit, the World Health Organization says. Some 168 new confirmed cases emerged in a single week in Sierra Leone's capital of Freetown recently, according to a WHO report.

Dupilumab Receives FDA Breakthrough Therapy Designation in Atopic Dermatitis

November 20, 2014 8:09 am | News | Comments

Regeneron Pharmaceuticals and Sanofi have announced that the FDA has granted Breakthrough Therapy designation to dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate.

Early Statin Use May Give Long-Term Heart Benefits

November 19, 2014 4:15 pm | by MARILYNN MARCHIONE, AP Chief Medical Writer | News | Comments

Taking a cholesterol-lowering drug for five years in middle age can lower heart and death risks for decades afterward, and the benefits seem to grow over time, a landmark study finds. Doctors say it's the first evidence that early use of a statin can have a legacy effect, perhaps changing someone's odds of disease for good.

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Government Wants More Clinical Trial Results Made Public

November 19, 2014 3:28 pm | by LAURAN NEERGAARD, AP Medical Writer | News | Comments

Doctors and patients may soon find it easier to learn if clinical trials of treatments worked or not, as the government proposed new rules Wednesday expanding what researchers are required to publicly report.       

CDC Chief Drops Worst-Case Ebola Estimate

November 19, 2014 3:10 pm | by MIKE STOBBE, AP Medical Writer | News | Comments

The government's worst-case scenario forecast for the Ebola epidemic in West Africa won't happen, a U.S. health official said Wednesday. In September, the Centers for Disease Control and Prevention estimated the number of people sickened by the Ebola virus could explode to as many as 1.4 million by mid-January without more help.

The Fight to Get Female Viagra on the Market

November 18, 2014 8:56 am | Videos | Comments

Cindy Whitehead is trying to get Flibanserin, the first low libido drug for women, approved by the FDA.                         

Heart Stents May Require Longer Blood Thinner Use

November 18, 2014 8:37 am | by MARILYNN MARCHIONE, AP Chief Medical Writer | News | Comments

Millions of people with stents that prop open clogged heart arteries may need anti-clotting drugs much longer than the one year doctors recommend now. A large study found that continuing for another 18 months lowers the risk of heart attacks, clots and other problems.

Study Lifts Cloud Over Heart Drugs Zetia, Vytorin

November 18, 2014 8:31 am | by MARILYNN MARCHIONE, AP Chief Medical Writer | News | Comments

A major study lifts a cloud around Zetia and Vytorin, blockbuster drugs for lowering cholesterol. The study found that these pills modestly lower the risk of heart attacks and other problems in people at high risk for them — evidence that's been missing for more than a decade as the drugs racked up billions in sales.

DEA Agents Raid NFL Medical Staffs after Games

November 17, 2014 8:40 am | by JIM LITKE, AP Sports Writer | News | Comments

Federal drug enforcement agents showed up unannounced Sunday to check at least three visiting NFL teams' medical staffs as part of an investigation into former players' claims that teams mishandled prescription drugs.      

Lemtrada Approved for Multiple Sclerosis

November 17, 2014 8:18 am | News | Comments

The U.S. Food and Drug Administration has approved Lemtrada, a treatment for relapsing multiple sclerosis made by the drugmaker Genzyme. The drug has already been approved by the European Medicines Agency for use in the European Union and in Canada and Australia.

CDC: Lazy Contact Lens Use Main Cause of Eye Infections

November 13, 2014 2:28 pm | by MIKE STOBBE, AP Medical Writer | News | Comments

The reports estimates that there are nearly 1 million patient visits to doctor's offices, clinics and hospitals for treatment of an infection of the cornea called keratitis. Most cases are mild irritations or redness, but a very small number are severe and can lead to blindness.

FDA Approves Janssen’s Schizoaffective Disorder Treatment

November 13, 2014 1:53 pm | News | Comments

Janssen Pharmaceuticals has announced that the FDA approved the supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic INVEGA SUSTENNA (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy.

Pharmaceutical Processing’s Nov/Dec 2014 Digital Issue

November 13, 2014 11:13 am | Digital Editions | Comments

Pharmaceutical Processing’s Nov/Dec 2014 issue features an in-depth look at SAFC’s recently expanded high-potency API manufacturing facilities in Madison, WI. In addition, our Annual CMO/CSO Survey is included in this issue detailing the trends driving the CMO/CSO market. Other articles take a look at elastomeric closure in parenteral manufacturing, cleanroom energy efficiency, package integrity, deduster design efficiency, and desiccant canister design and feeding options.

Medical Aid Group to Host Three Ebola Clinical Trials

November 13, 2014 8:37 am | by JOHN HEILPRIN, Associated Press | News | Comments

Accelerated clinical trials will be launched in West Africa to speed the search for a treatment for the deadly Ebola virus, Doctors Without Borders announced Thursday. The international humanitarian group said it will host clinical trials starting next month in three Ebola treatment centers using experimental drugs that haven't been through the usual lengthy process of study with animals and healthy people.

Mallinckrodt Responds to FDA’s Reclassification of Methylphenidate ER

November 13, 2014 8:12 am | News | Comments

Mallinckrodt has been informed by the FDA that the agency has reason to believe that the company’s methylphenidate hydrochloride extended-release (ER) tablets, USP (CII) may not be therapeutically equivalent to the category reference drug Concerta®.

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