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POZEN’s YOSPRALA™ Receives Second Complete Response Letter from the FDA

December 18, 2014 1:52 pm | News | Comments

POZEN said that their investigational drug candidates YOSPRALA™ 81/40 and 325/40 have received a second complete response letter from the FDA, with wording identical to the first.            

Alcon's Xtoro Approved to Treat Swimmer’s Ear

December 17, 2014 4:17 pm | News | Comments

The FDA has approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis...

FDA Accepts Apotex’ Filing of its Biosimilar Application for Pegfilgrastim

December 17, 2014 11:24 am | News | Comments

Apotex has announced that the FDA has accepted for filing the company's application for...

FDA Approves Pathogen Reduction System to Treat Plasma

December 17, 2014 10:24 am | News | Comments

The FDA has approved the Intercept Blood System for plasma, the first pathogen reduction system...

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FDA Approves Ipsen's Somatuline® Depot® Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors

December 17, 2014 8:23 am | News | Comments

Ipsen Biopharmaceuticals announced that Somatuline® Depot® Injection 120 mg (referred to as Somatuline®) was approved by the FDA for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic disease to improve progression-free survival.

Bayer Submits BLA Hemophilia Treatment

December 17, 2014 8:11 am | News | Comments

Bayer HealthCare has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration seeking approval for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, for the treatment of hemophilia A in children and adults.

FDA Approves Novartis’ Signifor for Acromegaly

December 16, 2014 8:12 am | News | Comments

Acromegaly is a rare, debilitating endocrine disorder caused by the excess production of growth hormone (GH) and insulin-like growth factor-1 (IGF-1). In the majority of cases, the disease is caused by a non-cancerous tumor on the pituitary gland.

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FDA OKs Test That Helps Predict Risk of Coronary Heart Disease

December 15, 2014 4:18 pm | News | Comments

The FDA has cleared a new screening test that predicts a patient’s risk of future coronary heart disease events, such as heart attacks. FDA cleared the test for use in all adults with no history of heart disease, but studies submitted by the company and reviewed by the FDA show that the test is better at discerning this risk in women, particularly black women. 

Baxter Recalls Two Lots of Sodium Chloride Injection

December 15, 2014 3:10 pm | News | Comments

Baxter announced it voluntarily initiated a recall in the United States of two lots of 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container to the hospital/user level. The recall is being initiated as a result of two complaints (one per lot) of particulate matter that was identified as a fragment of the frangible from the vial adapter.

FDA Approves Sanofi Pasteur’s Fluzone Vaccine

December 15, 2014 8:30 am | News | Comments

Sanofi Pasteur, the vaccines division of Sanofi, has announced that the FDA has approved the supplemental biologics license application for Fluzone Intradermal Quadrivalent vaccine. Fluzone Intradermal vaccine, which has been available in trivalent formulation for three years, is now available in a quadrivalent formulation to help protect against four strains of influenza virus.

Scilabs Nutraceuticals Responds to FDA Consent Decree

December 15, 2014 8:18 am | News | Comments

Scilabs Nutraceuticals Inc.™, a contract manufacturer of nutraceuticals based in Irvine, California, has commented on the recent consent decree that it entered into with the FDA, in which the company agreed to suspend nutraceutical manufacturing operations.

Lilly's Cyramza Gets New Marketing Approval

December 15, 2014 8:12 am | News | Comments

The Food and Drug Administration is allowing Lilly to market the drug as a treatment for cases that have spread. Earlier this year the FDA approved the drug as a treatment for gastric cancer.          

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FDA Approves Test to Confirm Presence of Human T-cell Lymphotropic Virus-I/II Antibodies

December 11, 2014 1:53 pm | News | Comments

The FDA has approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II). This test is intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive on an FDA-licensed HTLV-I/II blood donor screening test.

FDA OKs Gardasil 9 to Prevent Cancers Caused by Five Additional Types of HPV

December 10, 2014 3:27 pm | News | Comments

The FDA has approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil, Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers.

Lawmakers Wary of Genetically Modified Food Labels

December 10, 2014 2:06 pm | by MARY CLARE JALONICK, Associated Press | News | Comments

Republicans and Democrats on a House Energy and Commerce subcommittee questioned Wednesday whether requiring a label on any packaged food including genetically modified organisms — or foods grown from seeds engineered in labs — would be misleading to consumers since there is no evidence that such foods are unsafe.

FDA Approves Amgen's XGEVA

December 8, 2014 10:40 am | News | Comments

Amgen announced that the FDA has approved a new indication for XGEVA (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy. XGEVA was approved and granted Orphan Drug Designation by the FDA.  

FDA Approves Labeling Update of Abilify Maintena®

December 8, 2014 8:30 am | News | Comments

Otsuka Pharmaceutical and H. Lundbeck A/S announced that FDA approved the labeling update of Abilify Maintena® for extended-release injectable suspension. The approval was based on results from a controlled clinical study of acutely relapsed adults with schizophrenia.

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Cholera Vaccine Trial Meets Phase III Goals

December 8, 2014 8:10 am | News | Comments

PaxVax has announced positive results from a Phase 3 safety and lot-to-lot consistency trial of its single-dose oral cholera vaccine candidate, PXVX0200, which utilizes the same attenuated vaccine strain (CVD 103-HgR) previously approved and marketed in several countries under the brand name Orochol®

E-Cigarette Tech Takes Off as Regulation Looms

December 8, 2014 7:58 am | by MICHAEL FELBERBAUM, AP Tobacco Writer | News | Comments

Just a few years ago, early adopters of e-cigarettes got their fix by clumsily screwing together a small battery and a plastic cartridge containing cotton soaked with nicotine. Now, the battery-powered contraptions have computer chips to regulate puffs and temperature, track usage, talk to other electronic devices and even blink when "vapers" are near each other.

FDA Approves Jakafi for Patients with Uncontrolled Polycythemia Vera

December 4, 2014 11:21 am | News | Comments

Incyte Corporation announced that the FDA has approved Jakafi® for the treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi, an oral medication, is the first and only product approved by the FDA for PV, a rare and progressive blood cancer.

FDA Tentatively Approves Mylan’s Pediatric Formulations of Abacavir/Lamivudine for HIV

December 4, 2014 10:22 am | News | Comments

Mylan has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients.

FDA Approves Blincyto for Rare Form of Acute Lymphoblastic Leukemia

December 3, 2014 3:09 pm | News | Comments

The U.S. Food and Drug Administration has approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.      

FDA Issues Final Rule on Changes to Pregnancy and Lactation Labeling Info for Rx Drug and Biological Products

December 3, 2014 11:43 am | News | Comments

The FDA published a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.

FDA Wary of Lifting Gay Blood Donor Ban

December 3, 2014 8:26 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

Government health advisers have concerns about lifting a nationwide ban on blood donations from gay and bisexual men, despite growing pressure from gay rights advocates, medical experts and blood banks.         

Meda and Cipla Sue Apotex

December 3, 2014 8:12 am | News | Comments

Meda Pharmaceuticals and Cipla have sued Apotex in Federal District Court in Delaware to enforce the Orange-Book listed patents covering Dymista Nasal Spray in response to Apotex's submission to the FDA of an Abbreviated New Drug Application.   

FDA Approves Priftin Tablets for the Treatment of Latent Tuberculosis Infection

December 2, 2014 9:08 am | News | Comments

Sanofi announced today that following a priority review, the FDA has approved Priftin in combination with isoniazid for a new indication for the treatment of latent tuberculosis infection in patients two years of age and older at high risk of progression to tuberculosis disease.

FDA Accepts New Drug Application for IRESSA

December 2, 2014 8:09 am | News | Comments

AstraZeneca today announced that the FDA has accepted for filing the NDA for IRESSA® (gefitinib) as a targeted monotherapy for the first line treatment of patients with advanced or metastatic epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC).

FDA Blocks BMS' Hepatitis C Drug

November 26, 2014 2:11 pm | by By The Associated Press | News | Comments

U.S. regulators have declined to approve Bristol-Myers Squibb's daclatasvir as part of a combination hepatitis C treatment with another antiviral drug called asunaprevir. The company says data it submitted to the FDA to win approval of daclatasvir focused on that drug's use with asunaprevir.

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.

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