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FDA Clears Drug for Leading Form of Cystic Fibrosis

July 2, 2015 1:54 pm | by Matthew Perrone, AP Health Writer - Associated Press | News | Comments

The Food and Drug Administration cleared the twice-a-day pill from Vertex Pharmaceuticals for a variation of cystic fibrosis that affects about 8,500 people in the U.S. who are 12 years and older. The approval notice was posted to the agency's website Thursday. Read more...

Diabetes Drug Spurs Weight Loss, But Not Without Side Effects

July 2, 2015 12:30 pm | by Stephanie Guzowski, Editor | News | Comments

The injectable drug liraglutide, marketed as Saxenda, can help overweight or obese patients lose...

Novo Nordisk to Cease Distribution of Tresiba in Germany

July 1, 2015 3:59 pm | News | Comments

The decision to cease distribution of Tresiba in Germany has no implications for the other...

Recent Drug Approvals will Boost Parkinson's Disease Therapeutics Market

July 1, 2015 3:41 pm | by Heather Leach, Ph.D., Immunology and Neurology Analyst, GlobalData | Articles | Comments

The most promising products are Xadago and Rytary for early and advanced patients, and Acorda’s...

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Aridis Pharmaceuticals Receives FDA Fast Track Designation for Aerucin

July 1, 2015 10:17 am | News | Comments

Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel therapies for infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to its fully human monoclonal antibody Aerucin for the treatment of hospital-acquired and ventilator-associated pneumonia caused by Pseudomonas aeruginosa. Read more...

Oxycontin Maker Bows Out of Meeting on Harder-to-Abuse Drug

July 1, 2015 10:02 am | by Matthew Perrone, AP Health Writer - Associated Press | News | Comments

The makers of the potent painkiller OxyContin have pulled out of a federal meeting to review the company's harder-to-abuse version of the much-debated drug. Read more...

BiondVax Announces Positive Preliminary Phase 2 Results for Universal Flu Vaccine

July 1, 2015 8:29 am | News | Comments

These results support BiondVax’s claim that M-001 provides a broaden and improved coverage against multiple influenza type A and B virus strains. Read more...

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The Leukemia & Lymphoma Society Accelerates Payment Linked to Phase 3 AML Study

June 30, 2015 12:24 pm | by The Leukemia & Lymphoma Society | News | Comments

Celator Pharmaceuticals, Inc. today announced that The Leukemia & Lymphoma Society (LLS) is accelerating a portion of the final payment linked to the Phase 3 study of CPX-351 (cytarabine:daunorubicin) liposome injection, Celator's lead product candidate, for the treatment of patients with high-risk (secondary) acute myeloid leukemia (AML). Read more...

FDA's New HCT/P Draft Guidance Document: What is Minimal Manipulation in 2015?

June 30, 2015 10:04 am | by Kelly L. Lightfoot, Esq., Fuerst Ittleman David & Joseph | Articles | Comments

The first step in assessing how a HCT/P will be regulated by the FDA, and whether the resulting product will require an expensive and lengthy approval process, is determining if the HCT/P is more than minimally manipulated. Read more...

Regeneron's Retinal Vein Occlusion Treatment Receives Approval in Japan

June 30, 2015 8:39 am | News | Comments

This new indication includes macular edema secondary to branch retinal vein occlusion in addition to the previously-approved indication of macular edema secondary to central retinal vein occlusion. Read more...

CHMP Recommends EU Approval for Novartis' Multiple Myeloma Treatment

June 30, 2015 8:18 am | News | Comments

Multiple myeloma is a cancer of the plasma cells, a type of white blood cell present in the bone marrow, and affects approximately 84,000 people in Europe. Read more...

Pharmaceutical Trade Association: Greek Medicine Supply May Be At Risk

June 30, 2015 8:17 am | by Ryan Bushey, Associate Editor | Articles | Comments

The organization is calling for the European Union to take emergency action. Read more...

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Conn. Nurse Pleads Guilty to Prescribing Pain Meds for Drug-Company Kickbacks

June 29, 2015 11:56 am | by Seth Augenstein, Digital Reporter | News | Comments

A nurse admitted in federal court to prescribing pain medications in exchange for kickbacks from a drug company, according to authorities. Read more...

Ascletis Files Clinical Trial Applications for Hepatitis C Drugs in China, Taiwan

June 29, 2015 8:30 am | News | Comments

Ascletis is now the first Chinese company to file clinical trial applications in China for an IFN-free regimen. Read more...

EU Recommends Approval for Alexion's Rare Disease Drugs

June 29, 2015 8:26 am | News | Comments

The drugs are called Strensiq and Kanuma. Read more...

Drug Discovery Spotlight: ASCO’s Cancer Drugs Rating Scale; Hepatitis C Drug Patent Rejected in China

June 26, 2015 12:59 pm | by Stephanie Guzowski, Editor | News | Comments

The American Society of Clinical Oncology said it would provide a rating scale for cancer drugs, and now it’s delivered — and not all the score results are assuring. Pharma’s next five years look promising, according to an industry report. Read more...

Eli Lilly Wins U.K. Alimta Drug Patent Case

June 25, 2015 1:22 pm | by Stephanie Guzowski, Editor | News | Comments

Eli Lilly won a patent case in the U.K. that prohibits competitors from manufacturing a generic form of its blockbuster Alimta lung cancer drug before the patent expires in 2021. Read more...

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BiondVax Announces FDA Acceptance of IND Application for Investigational Flu Vaccine

June 19, 2015 9:23 am | News | Comments

This IND continues BiondVax's clinical program, and will allow BiondVax to conduct an FDA approved Phase 2 clinical trial that will involve the administration of M-001, BiondVax's product candidate. Read more...

Big Shareholder Backs Drugmaker Mylan's Growth Strategy

June 17, 2015 9:08 am | by The Associated Press | News | Comments

Mylan's largest shareholder has backed the generic drugmaker's plan to remain a stand-alone company as it fights a takeover bid from larger rival Teva Pharmaceutical. Read more...

Richter, Allergan Announce FDA Extended Review Period for Cariprazine to September 2015

June 17, 2015 8:47 am | News | Comments

Cariprazine is being reviewed for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Read more...

Oramed Granted Patent in Russia for Oral Administration of GLP-1

June 17, 2015 8:38 am | News | Comments

GLP-1 is an incretin hormone that stimulates the secretion of insulin from the pancreas. Read more...

Ventana Receives FDA Approval for Lung Cancer Diagnostic

June 15, 2015 10:23 am | News | Comments

Ventana Medical Systems, Inc.  (Ventana), a member of the Roche Group, today announced approval of the VENTANA ALK (D5F3) CDx Assay by the US Food and Drug Administration (FDA) as a companion diagnostic to aid in the identification of patients for Pfizer's FDA approved targeted therapy, Xalkori (crizotinib). Read more...

FDA Approves Brain Implant to Help Reduce Parkinson's Disease, Tremor Symptoms

June 15, 2015 10:01 am | News | Comments

The U.S. Food and Drug Administration today approved the Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson’s disease and essential tremor, a movement disorder that is one of the most common causes of tremors. Read more...

Target Selling Pharmacy, Clinic Businesses to CVS Health

June 15, 2015 9:47 am | by Tom Murphy, AP Business Writer | News | Comments

Target will sell its pharmacy and clinic businesses to the drugstore chain CVS Health for about $1.9 billion in a deal that combines the resources of two retailers seeking to polish their health care reputations. Read more....

Arcturus, J&J to Collaborate on RNA Medicines

June 12, 2015 1:50 pm | News | Comments

Arcturus Therapeutics, Inc., a leading RNA medicines company, announced today that it has entered into a research collaboration and worldwide license agreement with Janssen Pharmaceuticals, Inc. (Janssen). Read more...

Cancer Patient Treated as ‘Lab Rat’ Speaks Out After Duke Lawsuit

June 12, 2015 8:37 am | by Seth Augenstein, Digital Reporter | News | Comments

A woman who was a patient in a series of clinical trials called one of the biggest cases of medical fraud in history has spoken out about the devastation it wrought on her life. Joyce Shoffner, one of eight plaintiffs on a lawsuit over the bogus research by former Duke University researcher Anil Potti, told TV affiliate WRAL she was, “nothing but a laboratory rat,” to justify research. Read more...

Amgen to Discuss Repatha (Evolocumab) for Treatment Of High Cholesterol

June 11, 2015 9:42 am | News | Comments

Amgen today announced that the Company will discuss the data supporting the RepathaTM (evolocumab) Biologics License Application (BLA) for the treatment of high cholesterol with the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). Read more...

Mylan Expands Voluntary Recall of Select Injectable Products

June 10, 2015 12:16 pm | by Ryan Bushey, Associate Editor | Articles | Comments

This medication could cause severe health problems if administered when infected with an unknown pollutant. Read more...

FDA Panel Recommends Approval of New Cholesterol-Lowering Drug

June 10, 2015 11:25 am | by Stephanie Guzowski, Editor | News | Comments

A Food and Drug Administration (FDA) advisory panel on Tuesday recommended approval of a new injectable drug, alirocumab (Praluent) from Sanofi SA and Regeneron Pharmaceuticals, to help prevent heart attacks by lowering cholesterol. The new drug may be more powerful and carry fewer side effects than statins. Read more...

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