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FDA Approves BMS’s Evotaz™ for the Treatment of HIV-1 Infection in Adults

January 30, 2015 8:42 am | News | Comments

Evotaz is coformulated to be one pill, once-daily, combining the protease inhibitor atazanavir, which is marketed as Reyataz (atazanavir 200 mg/300 mg) capsules, and cobicistat, a pharmacokinetic enhancer marketed by Gilead Sciences.   

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...

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...

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...

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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 considering a proposal that would allow Oxitec to release millions of mosquitoes in an effort to fight the painful dengue and chikungunya viruses.           

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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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.

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.

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.

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.

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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.   

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.         

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.

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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.

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.           

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).  

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. 

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).

FDA Panel Endorses Novartis' Biosimilar

January 8, 2015 8:34 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

A panel of Food and Drug Administration experts ruled that the Novartis' version of Neupogen is highly similar to Amgen's original blockbuster biotech drug, which is used to boost blood cells that help cancer patients fight off infections.  

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.

Soligenix Gets Fast Track Designation for Lymphoma Treatment

January 7, 2015 8:16 am | News | Comments

Soligenix announced today that its SGX301 (synthetic hypericin) development program for the first-line treatment of cutaneous T-cell lymphoma (CTCL) has received "Fast Track" designation from the FDA.         

LSNE Receives Approval To Manufacture Commercial Aseptic Product

January 7, 2015 8:08 am | News | Comments

Lyophilization Services of New England, Inc. (LSNE) announced today that following an FDA Pre-Approval Inspection (PAI) in November 2014, their Harvey Road manufacturing site has received approval to manufacture commercial drug product for US distribution.

Actavis and Gedeon Richter Announce FDA Receipt of NDA Resubmission for Cariprazine

January 6, 2015 8:41 am | News | Comments

Actavis and Gedeon Richter today announced that FDA has acknowledged receipt of Actavis' New Drug Application resubmission for its atypical antipsychotic cariprazine, a potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors.

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