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Breaking News: Cubist Recalls Cubicin Lot

April 18, 2014 2:02 pm | News | Comments

Cubist Pharmaceuticals Inc. announced it is voluntarily recalling one lot of Cubicin (daptomycin for injection) to the user level due to the presence of particulate matter, reported via customer complaint and identified as glass particles. Read more...

NIH Awards Scripps $2M to Design a Better Diabetes Drug Model

April 17, 2014 1:21 pm | News | Comments

Scientists from the Florida campus of TSRI have been awarded $2.1 million from the NIH to study...

SSRI Use During Pregnancy Linked to Autism, Developmental Delays

April 16, 2014 10:57 am | News | Comments

In a study of nearly 1,000 mother-child pairs, researchers found that prenatal exposure to...

Judge Blocks Zohydro Ban in Massachusetts

April 16, 2014 10:47 am | by Steve LeBlanc | News | Comments

A federal judge has blocked Massachusetts from banning the powerful new painkiller Zohydro...

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Breaking News: EMA Warns of Falsified Herceptin

April 16, 2014 9:09 am | News | Comments

The EMA has been informed that vials of the cancer medicine Herceptin, thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some countries. Read more...

Yeast Provides Genetic Clues to Drug Response

April 11, 2014 10:45 am | News | Comments

Why do people respond differently to the same drug? For the first time, researchers have untangled genetic and environmental factors related to drug reactions, bringing us a step closer to predicting how a drug will affect us. Read more...   

Affimed’s Lymphoma Drug Shows Favorable Safety Profile, Activity

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

Affimed Therapeutics AG announced further results from its Phase 1 clinical trial of AFM13 (a bispecific T and Ab antibody) as monotherapy for the treatment of patients with advanced relapsing/refractory (R/R) Hodgkin lymphoma. Read more... 

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FDA Stops Halozyme PEGPH20 Pancreatic Cancer Trial

April 9, 2014 1:05 pm | News | Comments

Halozyme Therapeutics Inc. announced that the FDA informed the company Tuesday that a clinical hold has been placed on patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial evaluating PEGPH20 in patients with pancreatic cancer. Read more...

Update: Arkansas AG Files Petition on Risperdal Ruling

April 8, 2014 1:47 pm | by Andrew DeMillo | News | Comments

Arkansas Attorney General Dustin McDaniel asked the state Supreme Court to reconsider its decision tossing out a $1.2 billion judgment against drugmaker Johnson & Johnson, saying justices did "significant harm" to the state and broke from 170 years of precedent. Read more...

Zohydro Maker Sues to Block Massachusetts Ban

April 8, 2014 12:27 pm | News | Comments

The maker of Zohydro, a controversial new prescription painkiller, has filed a lawsuit in the U.S. District Court on Monday seeking to block Massachusetts' ban on local doctors prescribing and dispensing the drug. Read more...    

Takeda, Lilly Face Penalty over Actos Cancer Cases

April 8, 2014 9:25 am | by Yuri Kageyama, AP Business Writer | News | Comments

A U.S. jury ordered Japanese drugmaker Takeda Pharmaceutical Co. and Eli Lilly and Co. to pay $9 billion in punitive damages over a diabetes medicine linked to cancer. The drug companies said they will "vigorously challenge" the decision. Read more...

Antibody-Drug Conjugate Benefits Melanoma Patients in Phase 1

April 7, 2014 2:00 pm | News | Comments

The investigational drug DEDN6525A, which is a new member of a class of drugs called antibody-drug conjugates, was safe, tolerable, and showed hints of activity against three different forms of melanoma. Read more...          

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Plant Nanotubes May Improve Chemotherapy Treatment

April 4, 2014 1:52 pm | News | Comments

Researchers took what some would consider garbage and made a remarkable scientific tool, one that could someday help to correct genetic disorders or treat cancer without chemotherapy’s nasty side effects. Read more...         

Arkansas to Ask Court to Reconsider Risperdal Fine

April 4, 2014 1:13 pm | by Andrew DeMillo | News | Comments

Arkansas Attorney General Dustin McDaniel said he plans to ask the state Supreme Court to reconsider its decision tossing out a $1.2 billion judgment against drugmaker Johnson & Johnson over the marketing of the antipsychotic drug Risperdal. Read more...

Halozyme Halts Pancreatic Cancer Trial

April 4, 2014 10:36 am | News | Comments

Halozyme Therapeutics announced that as a result of a recommendation from an independent Data Monitoring Committee, the company is temporarily halting patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial in patients with pancreatic cancer. Read more...

FDA Approves Easy-to-Use Heroin Overdose Antidote

April 4, 2014 10:24 am | by Lauran Neergaard and Mary Clare Jalonick | News | Comments

The FDA approved an easy-to-use device that automatically injects the right dose of an overdose antidote named naloxone before an ambulance arrives, enabling friends and family to take the first step to save a loved one from an overdose before an ambulance arrives. Read more...

Glenmark's Chronic Inflammatory Disease Drug Enters Human Trials

April 3, 2014 1:00 pm | News | Comments

Glenmark Pharmaceuticals announced that its Novel Chemical Entity (NCE) GRC 27864, a potent, selective, and orally bioavailable inhibitor of Microsomal Prostaglandin E synthase-1 (mPGES-1), is entering Phase 1human trials. Read more...   

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FDA Accepts Omeros IND App for TMA Treatment

April 3, 2014 12:45 pm | News | Comments

Omeros Corp. announced that its Investigational New Drug (IND) Application to evaluate OMS721 for the inhibition of complement mediated thrombotic microangiopathies (TMAs) has been cleared by the U.S. Food and Drug Administration (FDA). Read more...

BioDelivery Sciences Opens Phase 3 Trial of Diabetic Neuropathy Gel

April 3, 2014 12:37 pm | News | Comments

BioDelivery Sciences International Inc. announced the enrollment of the first patient in the RHAPSODY Study, a Phase 3 clinical trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy. Read more...       

Fertility Drugs Do Not Increase Breast Cancer Risk

April 3, 2014 12:26 pm | News | Comments

Women who took clomiphene citrate or gonadotropins as a part of fertility treatment did not experience an increased risk for breast cancer over 30 years of follow-up, compared with women who were not treated with these medications, according to a study. Read more...

FDA Gives Go-Ahead for Phase 2a Trial of CardioCell CHF Stem Cell Therapy

April 2, 2014 3:02 pm | News | Comments

CardioCell LLC has just received the FDA’s investigational new drug (IND) approval for a United States-based, Phase 2a clinical study using its allogeneic stem-cell therapy to treat subjects with chronic heart failure (CHF), which generates more than one million hospitalizations annually. Read more...

FDA Approves First Hay Fever Immunotherapy Tablet

April 2, 2014 2:42 pm | by Linda Johnson, AP Business Writer | News | Comments

The Food and Drug Administration said Wednesday that it has approved the first tablet in the U.S. for gradually reducing hay fever symptoms, an alternative to months of weekly doctor visits for uncomfortable allergy-desensitizing shots. Read more...

Committee Backs Approval of Afrezza, MannKind Oral Diabetes Drug

April 2, 2014 2:23 pm | News | Comments

MannKind Corporation announced that an FDA committee recommend that Afrezza Inhalation Powder be granted marketing approval by the FDA to improve glycemic control in adults with type 1 and type 2 diabetes. Read more...         

Tetraphase Receives Fast Track Status for IV, Oral Eravacycline

April 2, 2014 1:57 pm | News | Comments

Tetraphase Pharmaceuticals Inc. announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designations for both the intravenous (IV) and oral formulations of the company's lead antibiotic candidate, eravacycline. Read more...

Committee Backs Approval of Cubist Antibiotic for Skin Infection

April 1, 2014 2:34 pm | News | Comments

Cubist Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) Anti-Infective Drugs Advisory Committee (AIDAC) voted to recommend approval of Cubist’s investigational antibiotic Sivextro (tedizolid phosphate). Read more...

Janssen Submits NDA for New HIV Combo Drug

April 1, 2014 1:38 pm | News | Comments

Janssen Research & Development LLC announced it has submitted a New Drug Application to the FDA seeking approval for a once-daily fixed-dose antiretroviral combination tablet containing darunavir, a protease inhibitor, with cobicistat, an investigational pharmacokinetic enhancer or boosting agent developed for use in combination with other human immunodeficiency virus (HIV-1) medicines. Read more...

Bayer Launches Phase 3 Blood Clot Drug Trials

April 1, 2014 9:50 am | News | Comments

Bayer HealthCare and its U.S. development partner Janssen Research & Development LLC announced the initiation of two new Phase 3 trials to evaluate rivaroxaban in medically-ill patients and children at high risk for blood clots. Read more...

Daiichi Sankyo Initiates Phase 3 Edoxaban Study

April 1, 2014 9:26 am | News | Comments

Daiichi Sankyo Co. Ltd. announced that it has started enrolling patients into the ENSURE-AF multinational Phase 3 study, which will evaluate edoxaban compared to enoxaparin/warfarin for the prevention of stroke and other blood clot complications in patients with non-valvular atrial fibrillation undergoing electrical cardioversion. Read more...

Tampering Forces Massive Alli Recall

March 27, 2014 11:04 am | News | Comments

GlaxoSmithKline Consumer Healthcare is voluntarily recalling all Alli weight loss products from U.S. and Puerto Rico retailers as the company believes that some packages of the product were tampered with and may contain product that is not authentic Alli. Read more...

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