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The Lead

Shorter TB Treatment Not a Successful Alternative

October 23, 2014 1:27 pm | News | Comments

A clinical drug trial conducted in five Sub-Sahara African countries shows that a shortened (four month) treatment for tuberculosis (TB) is well tolerated and may work well in subsets of TB patients, but overall could not be considered as an alternative to the current six month standard treatment. Read more...

Biogen Slides as MS Drug Linked to Inflammation

October 22, 2014 1:20 pm | News | Comments

Shares of Biogen Idec slumped 8% after the pharmaceutical said a patient who took its newest...

Oramed Gets Positive Data From Oral Insulin Trial

October 22, 2014 10:03 am | News | Comments

Oramed Pharmaceuticals Inc., a clinical-stage...

Supercomputers Link Proteins to Drug Side Effects

October 21, 2014 1:46 pm | News | Comments

Lawrence Livermore National Laboratory...

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Boehringer Ingelheim Initiates Phase 3 Cancer Study

October 21, 2014 10:34 am | News | Comments

Boehringer Ingelheim announced enrollment of the first patient in a new global Phase 3 study in patients with mCRC. Colorectal cancer is the third most common cancer in the world, with nearly 1.4 million new cases diagnosed each year. Read more...

New Class of Drugs Shows Promise for Treating Chronic Diarrhea

October 21, 2014 10:23 am | News | Comments

A pilot study testing a new type of drug in patients with chronic diarrhea has shown promising effects on reducing their symptoms. Read more...                                    

Anti-Abuse Label Approved for Painkiller Embeda

October 20, 2014 11:45 am | News | Comments

The U.S. Food and Drug Administration (FDA) says it has approved new labeling for another opioid designed to limit painkiller abuse. Read more...                                 

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Sanofi, Regeneron Announce Phase 3 Study of Atopic Dermatitis Drug

October 20, 2014 10:32 am | News | Comments

Sanofi and Regeneron Pharmaceuticals, Inc. announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis (AD) that is not adequately controlled with topical AD medications. Read more..

Anoro's COPD Drug Shows Improved Lung Function

October 17, 2014 11:07 am | News | Comments

Respiratory Medicine has published positive results from a third lung function study comparing the efficacy and safety of Anoro Ellipta. Read more...                                     

Pharmacyclics' Non-Chemo Treatment Approved in Europe

October 17, 2014 10:54 am | News | Comments

Pharmacyclics Inc. announced that the European Commission (EC) has granted marketing approval for Imbruvica (ibrutinib) throughout the 28 member states of the European Union (EU). Imbruvica, a first-in-class, oral, once-daily, non-chemotherapy treatment, now is approved to be marketed in Europe. Read more...

Roche, Cardiorentis AG Collaborate on AHF Drug Safety

October 16, 2014 10:41 am | News | Comments

Cardiorentis AG, a privately held biopharmaceutical company, announced a collaboration with Roche to establish the therapeutic efficacy and safety of Ularitide, the company's investigational drug for acute heart failure (AHF). Read more...

FDA Approves Boehringer Ingelheim's Drug for Lung Disease

October 16, 2014 10:30 am | News | Comments

 Boehringer Ingelheim announced that the FDA approved OFEV (nintedanib) capsules for oral use for the treatment of idiopathic pulmonary fibrosis (IPF). Read more...

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Noven Announces Menopause Drug's Effects on Weight, Sexual Function

October 15, 2014 1:33 pm | News | Comments

Noven Pharmaceuticals Inc., announced the publication of data on the effects of low-dose mesylate salt of paroxetine (LDMP), marketed as Brisdelle (paroxetine) capsules, 7.5 mg, in Menopause, the peer-reviewed, scientific journal of The North American Menopause Society (NAMS). Read more...

BMS, Pharmacyclics and Janssen Collaborate on Non-Hodgkin Lymphoma Drug

October 13, 2014 2:25 pm | News | Comments

Bristol-Myers Squibb Company, Pharmacyclics Inc., and Janssen Research & Development LLC announced they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in combination with Imbruvica. Read more...

Phase 2 Study to Evaluate Hepatitis C Drug Combination

October 13, 2014 10:41 am | News | Comments

Medivir AB announced that its partner Janssen recently initiated patient enrolment in a phase 2 study called IMPACT. This study evaluates the efficacy, safety and pharmacokinetics of the NS3/4A protease inhibitor simeprevir administered once daily in combination with Gilead’s nucleotide inhibitor sofosbuvir and Bristol-Myers Squibb’s (BMS) NS5A replication complex inhibitor daclatasvir. Read more...

FDA Approves Drug for Nausea, Vomiting Associated With Chemo

October 10, 2014 12:18 pm | News | Comments

The FDA approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy. Read more...                                         

Purdue Pharma Launches Smaller Dosage of Chronic Pain Patch

October 9, 2014 3:03 pm | News | Comments

Purdue Pharma L.P. announced the U.S. commercial launch of the new 7.5 mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII. Five strengths of Butrans are now available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour and 20 mcg/hour. Read more...

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AstraZeneca Gets Positive Results for Asthma Drug

October 9, 2014 9:59 am | News | Comments

AstraZeneca announced that The Lancet Respiratory Medicine has published positive safety and efficacy data from a Phase 2b study evaluating benralizumab, a novel investigational monoclonal antibody, in patients with severe, uncontrolled asthma and elevated levels of eosinophils, a type of inflammatory white blood cell. Read more...

Safety advocates seek stronger warnings on Chantix

October 8, 2014 1:13 pm | by Matthew Perrone - AP Health Writer - Associated Press | News | Comments

Public safety advocates are asking the federal government to strengthen warnings on Pfizer's anti-smoking drug Chantix, even as the drugmaker prepares to argue that a bolded warning about psychiatric problems should be removed from its medicine's label. Read more...

What Kind of Research Can We Trust?

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

Research involving pharmaceutical company input is notoriously compromised. While not all industry ties lead to biased research, and not all biases are a consequence of industry ties, many studies show industry influence can make drugs look safer and more effective than they really are. Read more...

Vivolux Cancer Drug Receives FDA Clearance for Clinical Study

October 7, 2014 2:21 pm | News | Comments

Vivolux, a pharmaceutical company specialized in cancer treatment, announced that the FDA has granted clearance to proceed with VLX1570 to clinical phase 1/2 for treatment against relapsed and/or refractory multiple myeloma. Read more...        

Acacia Pharma Gets Positive Results for PONV Treatment

October 7, 2014 10:36 am | News | Comments

 Acacia Pharma announces positive Phase 3 results with APD421 for the management of post-operative nausea & vomiting (PONV). Read more...                                   

Takeda Announces Phase 3 Data for UC, Crohn's Drug

October 2, 2014 10:29 am | News | Comments

Takeda announced that new data from GEMINI LTS, a Phase 3, ongoing, open-label extension study of Entyvio (vedolizumab) for the treatment of adults with moderately to severely active UC and CD will be presented as oral presentations during the 21st United European Gastroenterology Week in Vienna, Austria. Read more...

Discovery Helps to Spot What Makes a Good Drug

October 2, 2014 10:03 am | News | Comments

A new test developed by researchers from The University of Manchester could revolutionize the discovery of new prescription drugs. The test will help determine which drugs are unlikely to work at an early stage, speeding up the time it takes to make safe and effective medicines available. Read more...

Drugmaker Submits Harder-to-Abuse Zohydro to FDA

October 2, 2014 9:33 am | by Matthew Perrone, AP Health Writer | News | Comments

The maker of the much-debated painkiller Zohydro is seeking approval of a harder-to-abuse version of the drug which, if approved, could replace the currently marketed version of the pill by next spring. Read more...          

MicroBiome Therapeutics' Drug May Limit Metformin Side Effects

September 26, 2014 3:47 pm | News | Comments

MicroBiome Therapeutics reported positive topline results from a proof-of-concept study testing whether its investigational drug, NM 505, can improve the tolerability of metformin, the first-line therapy for Type 2 diabetes worldwide. Read more...

One in 10 Antibiotic Prescriptions Fail

September 26, 2014 3:09 pm | News | Comments

Over a 22-year period more than one in 10 of all antibiotic treatments in a primary care setting have failed. This rate has increased and continues to rise, according to a new study which analysed almost 11 million antibiotic prescriptions in the UK. Read more...

Pacira Shares Drop as FDA Warns on Misleading Ads

September 25, 2014 2:13 pm | News | Comments

Pacira Pharmaceuticals Inc. said Thursday that it received a warning letter from regulators about marketing for an injectable drug that numbs post-surgical pain that the letter says is misleading. Read more...           

Anti-Addiction Groups Call for New FDA Chief

September 24, 2014 3:32 pm | by Matthew Perrone, AP Health Writer | News | Comments

Anti-addiction activists are calling for the Food and Drug Administration's top official to step down, saying the agency's policies have contributed to a national epidemic of prescription painkiller abuse. Read more…

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