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FDA Names Deputy Commissioner for Medical Products and Tobacco

January 27, 2015 7:28 am | News | Comments

U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D., has appointed Robert Califf, M.D., a recognized global leader in cardiology, clinical research, and medical economics, as FDA Deputy Commissioner for Medical Products and Tobacco. 

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...

Inherited Gene Variation Helps Explain Drug Toxicity in Patients Of East Asian Ancestry

January 27, 2015 7:01 am | News | Comments

About 10 percent of young leukemia patients of East Asian ancestry inherit a gene variation that...

Firm Seeks FDA Approval to Release Genetically Modified Mosquitoes

January 26, 2015 11:43 am | by Andrew Szal, Editor, Pharmaceutical Processing | News | Comments

The U.S. Food and Drug Administration is...

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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 Medicines Agency has adopted a positive opinion recommending approval of the investigational antibiotic SIVEXTRO® for the treatment of acute bacterial skin and skin structure infections in adults.

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.         

FDA Approves Octapharma's Second Octagam® 10% Manufacturing Site

January 26, 2015 10:24 am | News | Comments

Octapharma announced that the FDA has approved the company’s manufacturing facility in Vienna, Austria for the production of Octagam 10% [Immune Globulin Intravenous (Human) 10% (100 mg/mL) Liquid Preparation], which became available in the U.S. during October 2014.

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Dr. Fauci: It's a "Shame" Children Are Not Being Vaccinated for Measles

January 26, 2015 9:03 am | Videos | Comments

The measles outbreak with roots in Disneyland continues to spread, with at least 75 confirmed cases in six states. At least 54 of those cases have been traced back to the resort, and many of those infected were not vaccinated. National Institute of Allergy and Infectious Diseases director Dr. Anthony Fauci joins "CBS This Morning" to discuss the severity of the outbreak.

Regeneron and Sanofi Announce Praluent BLA Accepted for Priority Review by FDA

January 26, 2015 8:56 am | News | Comments

Regeneron Pharmaceuticals and Sanofi today announced that the FDA has accepted for priority review the Biologics License Application (BLA) for  (alirocumab). Under the Prescription Drug User Fee Act (PDUFA), the goal for a priority review is six months, for a target action date of July 24, 2015.

Bungled Ebola Response Prompts WHO to Adopt Reforms to Repair Reputation

January 26, 2015 8:43 am | by MARIA CHENG, AP Medical Writer | News | Comments

The World Health Organization has proposed reforms that could overhaul its structure after botching the response to the biggest-ever Ebola outbreak, a sluggish performance that experts say cost thousands of lives.       

Insys Therapeutics Receives FDA Orphan Drug Designation for Ovarian Cancer Treatment

January 26, 2015 8:25 am | News | Comments

Insys Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its Liposomal Encapsulated Paclitaxel (LEP) candidate for the treatment of ovarian cancer.      

PwCReport: Regulatory Innovation Should Adapt to New Health Economy

January 26, 2015 8:19 am | News | Comments

Consumers and drug and device manufacturers are changing practices and shifting attitudes toward the Food and Drug Administration (FDA).  Increased pressures for speedy access to breakthrough drugs and medical devices, and a focus on value in addition to medical benefit, are driving these changes.

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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.

EMA Recommends Suspending GVK Biosciences Medicines over Flawed Studies

January 23, 2015 8:06 am | News | Comments

A number of medicines for which authorization in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended, says the European Medicines Agency (EMA).     

US: Long-Awaited Ebola Vaccine Study Coming Soon in Liberia

January 22, 2015 4:32 pm | by LAURAN NEERGAARD, AP Medical Writer | News | Comments

The first study will compare the two experimental vaccines with dummy shots in hopes of proving whether either really protects against the Ebola virus, which has devastated Liberia, Guinea and Sierra Leone over the past year. A second study of one of the vaccines is being planned for Sierra Leone.

FDA Panel Recommends Approval of Astellas’ CRESEMBA for Treatment of Invasive Aspergillosis and Mucormycosis

January 22, 2015 3:45 pm | News | Comments

The FDA Anti-infective Drugs Advisory Committee voted unanimously to recommend approval of the investigational once-daily intravenous and oral broad-spectrum CRESEMBA for the treatment of invasive aspergillosis, and 8 to 2 with one abstention to recommend approval for the treatment of invasive mucormycosis.

Senator Warren to File Bill Targeting Top Pharma Companies

January 22, 2015 2:24 pm | by STEVE LeBLANC, Associated Press | News | Comments

Warren's bill would require that whenever drug companies enter into a settlement with the government over alleged wrongdoing, they must pay a portion of their annual profits over five years to support research at the NIH and the FDA.   

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One Dose, Then Surgery: A New Way to Test Brain Tumor Drugs

January 22, 2015 1:33 pm | by MARILYNN MARCHIONE, AP Chief Medical Writer | News | Comments

With special permission from the Food and Drug Administration and multiple drug companies, an Arizona hospital is testing medicines very early in development and never tried on brain tumors before.         

FDA Approves Novartis’ Cosentyx for Moderate-to-Severe Plaque Psoriasis

January 21, 2015 2:12 pm | News | Comments

Novartis announced that the FDA has approved Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.         

Hospitals Overwhelmed as Flu Epidemic Death Toll Climbs

January 21, 2015 8:36 am | Videos | Comments

Forty-five deaths so far this season after the flu vaccine proves to be only 23% effective.                           

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.

UCB Announces US and EU Regulatory Filings for the Investigational Antiepileptic Drug Brivaracetam

January 21, 2015 7:58 am | News | Comments

In the US, the FDA has accepted for review the New Drug Application (NDA) for brivaracetam as adjunctive therapy for the treatment of partial-onset seizures in patients from 16 years of age with epilepsy, and in the EU, the European Medicines Agency has validated for review the Marketing Authorization Application (MAA) for brivaracetam in the same proposed indication.

FDA Grants Priority Review for Janssen’s Three-Month Schizophrenia Treatment

January 20, 2015 7:05 am | News | Comments

Janssen Research & Development has announced  that the U.S. Food and Drug Administration has granted Priority Review for the New Drug Application (NDA) for three-month atypical antipsychotic paliperidone palmitate to treat schizophrenia in adults.

Federal Judge Approves Consent Decree with California Dietary Supplement Maker

January 19, 2015 12:11 pm | News | Comments

A California dietary supplement manufacturer was ordered by a federal court to stop selling its products until the company comes into compliance with the U.S. Food and Drug Administration’s dietary supplement manufacturing regulations and other requirements listed in the consent decree.

UN: At Least 50 Ebola Hotspots Remain, But New Cases Falling

January 19, 2015 9:57 am | by EDITH M. LEDERER, Associated Press | News | Comments

At least 50 Ebola hotspots remain in the three hardest-hit West African countries but new cases are declining and the deadly disease will be defeated, the U.N.'s Ebola chief said. The latest report from the WHO showing reductions in Guinea, Liberia and Sierra Leone "is very good news," said Dr. David Nabarro.

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.           

AMRI Receives NIH Contract Award

January 19, 2015 9:29 am | News | Comments

AMRI has received a 10-year federal contract award from the NIH for drug development and manufacturing services. This NIH/National Institute of Neurological Disorders and Stroke award will support NIH's Drug Manufacturing and Formulation Program, which is a component of the Blueprint Neurotherapeutics Network. AMRI has supported the NIH BPN since 2011, providing chemistry services and discovery technologies.

Flu Vaccine Not Working Well - Only 23% Effective

January 15, 2015 2:00 pm | by MIKE STOBBE, AP Medical Writer | News | Comments

As predicted, this year's flu vaccine is doing a pretty crummy job. Health officials say a new study shows it's only 23 percent effective. That's one of the worst performances since the government started tracking how well vaccines work a decade ago.

Auspex Pharmaceuticals Receives FDA Orphan Drug Designation for Tourette Syndrome Treatment

January 15, 2015 11:14 am | News | Comments

Auspex Pharmaceuticals has announced that the FDA has granted orphan drug designation to Auspex's investigational compound SD-809 for the treatment of Tourette syndrome in the pediatric population (defined as zero through 16 years of age).  

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