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Actavis Announces FDA Acceptance for Filing of NDA for Eluxadoline

September 2, 2014 9:34 am | News | Comments

Actavis plc today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' New Drug Application (NDA) for eluxadoline, an investigational drug for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant Irritable Bowel Syndrome (IBS-D).

Regeneca Worldwide Expands Voluntarily Recall of Regeneslim Appetite Control Capsules

September 2, 2014 9:04 am | News | Comments

Regeneca Worldwide a division of VivaCeuticals, Inc. Las Vegas, NV is expanding the voluntary...

Pfizer and Protalix BioTherapeutics Announce FDA Approval of Pediatric Indication for ELELYSO™

August 28, 2014 1:41 pm | News | Comments

Pfizer and Protalix BioTherapeutics announced that the FDA approved ELELYSO™ for injection for...

FDA Removes Partial Clinical Hold on OncoMed Pharmaceuticals' Vantictumab

August 28, 2014 8:40 am | News | Comments

Vantictumab is being studied in combination with standard-of-care chemotherapy in three Phase 1b...

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Pfizer’s Vaccine Candidate for Clostridium difficile Receives FDA Fast Track Designation

August 28, 2014 8:10 am | News | Comments

Currently in Phase 2 clinical development, the vaccine candidate is designed to prevent C. difficile -associated disease, which can include life-threatening diarrhea and pseudomembranous colitis.         

FDA Grants Amgen Priority Review Designation for Ivabradine

August 27, 2014 11:53 am | News | Comments

Amgen announced that the FDA has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). Ivabradine is an oral drug that inhibits the If current ("funny" current) in the sinoatrial node, the body's cardiac pacemaker.

Ligand Partner GlaxoSmithKline Receives FDA Approval for Promacta®/Revolade™

August 27, 2014 8:07 am | News | Comments

Ligand Pharmaceuticals Incorporated announced that its partner GlaxoSmithKline has received approval of a supplemental New Drug Application (sNDA) for the once-daily use of Promacta®/Revolade™ (eltrombopag) in patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).

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Fresenius Kabi Receives FDA Approval for Kabiven® and Perikabiven®

August 26, 2014 9:19 am | News | Comments

Fresenius Kabi announced today it has received approval from the U.S. Food and Drug Administration for Kabiven ® and Perikabiven ®, parenteral nutrition (PN) products in a three-chamber bag – the only container of its kind available in the United States.

FDA Names Potential Insys Treatment an Orphan Drug

August 26, 2014 8:40 am | by The Associated Press | News | Comments

A potential treatment from Insys Therapeutics Inc. for an aggressive form of brain cancer will have some marketing exclusivity if regulators eventually approve it. The Food and Drug Administration has granted an orphan drug designation to the Chandler, Arizona, drugmaker's pharmaceutical cannabidiol, or CBD.

Alkermes Submits New Drug Application to FDA for Aripiprazole Lauroxil for Treatment of Schizophrenia

August 25, 2014 8:44 am | News | Comments

Alkermes today announced that it has submitted a New Drug Application to the FDA for approval of aripiprazole lauroxil, the company’s investigational, novel, once-monthly, long-acting injectable atypical antipsychotic for the treatment of schizophrenia.

FDA Approves Iroko Pharmaceuticals’ ZORVOLEX for Management of Osteoarthritis Pain

August 25, 2014 8:23 am | News | Comments

Iroko Pharmaceuticals, LLC,  announced today the United States Food and Drug Administration (FDA) has approved ZORVOLEX (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain.   

Japan Ready to Offer Flu Drug for Ebola Treatment

August 25, 2014 8:16 am | by MARI YAMAGUCHI, Associated Press | News | Comments

Japan said Monday it is ready to provide a Japanese-developed anti-influenza drug as a possible treatment for the rapidly expanding Ebola outbreak. Chief Cabinet Secretary Yoshihide Suga said that Japan can offer favipiravir, developed by a subsidiary of Fujifilm Holdings Corp., at any time at the request of the World Health Organization.

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Turkish Man Pleads Guilty to Importing Illegal Cancer Drugs

August 15, 2014 2:41 pm | News | Comments

Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.          

FDA Accepts CorMedix’ Pivotal Phase 3 Study Protocol

August 15, 2014 8:57 am | News | Comments

CorMedix announced that the FDA has agreed with the design of their pivotal Phase III protocol for Neutrolin in Hemodialysis patients, and the company plans to submit the IND for Neutrolin within the next 30 days.      

FDA Warns Consumers About Fraudulent Ebola Treatment Products

August 15, 2014 8:27 am | News | Comments

The U.S. Food and Drug Administration is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection.

FDA Approves Genentech’s Avastin Plus Chemotherapy for Treatment of Advanced Cervical Cancer

August 15, 2014 8:23 am | News | Comments

Genentech, a member of the Roche Group, announced that the FDA approved Avastin® (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix.

FDA Committee Recommends Approval of Tiotropium Respimat for the Maintenance Treatment of COPD

August 15, 2014 8:20 am | News | Comments

Boehringer Ingelheim Pharmaceuticals announced that the FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted [10 yes, 3 no] that existing data supports approval of Boehringer Ingelheim's investigational tiotropium bromide inhalation spray for long-term, once-daily maintenance treatment of bronchospasm associated with COPD.

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FDA Accepts Pfizer's Biologics License Application For Investigational Meningococcal B Vaccine

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

Pfizer announced that the FDA has accepted for review the Biologics License Application (BLA) for bivalent recombinant LP2086 (rLP2086), the company’s vaccine candidate for the prevention of invasive meningococcal disease.     

Scientists Racing to Test Ebola Vaccines in Humans

August 14, 2014 6:30 pm | by Matthew Perrone - Associated Press - Associated Press | News | Comments

Scientists are racing to begin the first human safety tests of two experimental Ebola vaccines, but it won't be easy to prove that the shots and other potential treatments in the pipeline really work. There are no proven drugs or vaccines for Ebola, a disease so rare that it's been hard to...

Amgen Recalls Aranesp Prefilled Syringes in Several Countries Outside of the U.S. Due to the Presence of Visible Particulates

August 14, 2014 9:05 am | News | Comments

Amgen initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination.

FDA Approves New Sleeping Drug from Merck

August 13, 2014 4:29 pm | by The Associated Press | News | Comments

Merck & Co. has won federal approval for a new type of sleeping pill designed to help people with insomnia stay asleep. The tablet, Belsomra, works by temporarily blocking chemicals known as orexins that control the sleep cycle and can keep people awake at night.

FDA Approves Lung Preservation Machine

August 13, 2014 8:13 am | News | Comments

The Food and Drug Administration said Tuesday that the approval of the XVIVO Perfusion System could lead to more successful transplants of lungs for people with cystic fibrosis and other deadly respiratory diseases.      

FDA Approves DNA-Based Test for Colon Cancer

August 12, 2014 8:33 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

The Cologuard test from Exact Sciences detects irregular mutations in stool samples that can be an early warning sign of cancer. Patients who test positive for the mutations should undergo a colonoscopy to confirm the results.    

Firm Halting Sales of Dietary Supplement Anatabloc

August 12, 2014 8:22 am | by MICHAEL FELBERBAUM, AP Business Writer | News | Comments

Rock Creek Pharmaceuticals Inc. said Monday it is voluntarily stopping sales of Anatabloc and another supplement called CigRx while it sorts out issues with the Food and Drug Administration.          

Health Canada OKs GSK's Plan to Fix Quebec Flu Vaccine Plant Problems

August 12, 2014 8:15 am | by Helen Branswell, The Canadian Press | News | Comments

Health Canada says it has approved a plan by GlaxoSmithKline to fix contamination problems it has been experiencing at its Ste. Foy, Que., flu vaccine production plant. The department says GSK's action plan and the timelines proposed in it are satisfactory.

AIDS Activist Takes Up A New Fight: Defending the FDA

August 11, 2014 2:22 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

As an AIDS activist in the early 1990s, Gregg Gonsalves traveled to Washington to challenge the Food and Drug Administration. A quarter century later, Gonsalves still travels to Washington, but with a different agenda: to defend the FDA.   

FDA Approves INVOKAMET for the Treatment of Adults with Type 2 Diabetes

August 11, 2014 8:26 am | News | Comments

INVOKAMETT provides the clinical attributes of INVOKANA (canagliflozin), the first sodium glucose co-transporter 2 (SGLT2) inhibitor available in the United States, together with metformin, which is commonly prescribed early in the treatment of type 2 diabetes.

FDA Approves VELCADE® Retreatment in Patients with Multiple Myeloma

August 11, 2014 8:19 am | News | Comments

Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, has announced that the FDA has approved VELCADE® for the retreatment of adult patients with multiple myeloma who had previously responded to VELCADE therapy and relapsed at least six months following completion of prior VELCADE treatment.

Genentech Submits Supplemental Biologics License Application to FDA for Lucentis Indication in Diabetic Retinopathy

August 8, 2014 11:39 am | News | Comments

The submission is based on results of the RISE and RIDE Phase III clinical trials demonstrating the safety and efficacy of Lucentis for this serious eye disease. There are currently no ocular medications approved for the treatment of diabetic retinopathy.

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