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Daily news and top headlines for drug research professionals

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...

AbbVie to Pay Shire $1.64B Fee Over Nixed Merger

October 21, 2014 10:13 am | News | Comments

AbbVie is walking away from its proposed $55 billion takeover bid of Shire and has agreed to pay the rival drugmaker a $1.64 billion breakup fee. Read more...                            

BioPontis Alliance, HNF Partner to Develop Treatments for CMT

October 20, 2014 2:29 pm | News | Comments

BioPontis Alliance for Rare Disease and the Hereditary Neuropathy Foundation (HNF), both philanthropies, announced the creation of a joint venture to develop drug candidates for the treatment of the rare disease known as Charcot- Marie-Tooth (CMT) Disease. Read more... 

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Revalesio’s Drug Has Potential to Treat Alzheimer’s Disease

October 20, 2014 12:07 pm | News | Comments

Revalesio Corporation and Rush University Medical Center’s Department of Neurological Sciences published findings from two research studies that demonstrate the potential for RNS60 to treat Alzheimer’s disease and other forms of dementia by protecting neuronal function, restoring neuronal connections and promoting neuronal plasticity. Read more...

Taiho Receives FDA Fast Track Designation for Colorectal Cancer Drug

October 20, 2014 11:55 am | News | Comments

Taiho Oncology announced that the FDA granted Fast Track designation for TAS-102, an oral combination anticancer drug under investigation for the treatment of refractory metastatic colorectal cancer (mCRC), and that the company has initiated a rolling NDA submission to the FDA. 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...                                 

Clanotech Receives Orphan Drug Designation in the EU

October 20, 2014 10:48 am | News | Comments

Clanotech AB announced that its anti-fibrotic and anti-angiogenic candidate drug CLT-28643 received orphan drug designation by the European Medicines Agency (EMA) for prevention of scarring post glaucoma filtration surgery.  Read more...

NewLink Genetics, Genentech Enter Into Exclusive Worldwide License

October 20, 2014 10:44 am | News | Comments

NewLink Genetics Corp., a biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapeutics to improve treatment options for patients with cancer, announced that they have entered into an exclusive worldwide license agreement with Genentech, a member of the Roche Group, for the development of NLG919, NewLink's IDO pathway inhibitor. 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..

Takeda, Orexigen Announce Availability of Weight-Management Drug

October 20, 2014 10:25 am | News | Comments

Takeda and Orexigen jointly announced that Contrave (naltrexone HCI and bupropion HCI) extended-release tablets are now available to patients by prescription in pharmacies across the United States. Read more...                 

AbbVie Announces Results for HS Treatment

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

AbbVie announced new results from PIONEER 2, a pivotal Phase 3 study, demonstrating the effect of Humira (adalimumab) in reducing common clinical signs and symptoms in moderate-to-severe hidradenitis suppurativa (HS), specifically the number of abscesses and inflammatory nodules. Read more...

Amgen Files Lawsuit Against Sanofi, Regeneron for Patent Infringement

October 17, 2014 12:57 pm | News | Comments

Amgen announced that it filed a lawsuit against Sanofi and Regeneron Pharmaceuticals, Inc. for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. 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...                                     

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FDA Votes to Keep Boxed Warning on Chantix

October 17, 2014 10:26 am | News | Comments

Federal health advisers say a bold-letter warning about suicide risks with Pfizer's Chantix should remain on the anti-smoking drug until it can reevaluated based on new, rigorous study information. Read more...

FDA Fast Tracks Approval of Two ‘Historic’ IPF Drugs

October 16, 2014 4:22 pm | by Cynthia Fox, Science Editor | Articles | Comments

Two historic drugs for idiopathic pulmonary fibrosis (IPF) received “fast track, priority review, orphan product, and breakthrough designation” approval Wednesday from the Food and Drug Administration (FDA). Read more...

Big Step in Battling Bladder Cancer

October 16, 2014 3:06 pm | News | Comments

The millions of people worldwide who suffer from the painful bladder disease known as interstitial cystitis (IC) may soon have a better, long-term treatment option, thanks to a controlled-release, implantable device invented by MIT researchers. Read more...

Big Step in Battling Bladder Disease

October 16, 2014 1:33 pm | News | Comments

Novel device that stays in the bladder and slowly releases drugs sells to pharmaceutical giant. Read more...                                                             

Eli Lilly's Lechleiter Honored as Watanabe Life Sciences Champion of the Year

October 16, 2014 12:43 pm | News | Comments

BioCrossroads awarded John C. Lechleiter, Ph.D., chairman, president and CEO of Eli Lilly and Company, with the August M. Watanabe Life Sciences Champion of the Year Award, a prestigious honor named in tribute to BioCrossroads' late first Chairman. Read more...

Moderna, Sweden Universities Collaborate on Drug Discovery

October 16, 2014 10:48 am | News | Comments

Moderna Therapeutics announced a strategic, long-term collaboration with Karolinska Institutet (KI) and Karolinska University Hospital (KUH) for the discovery and development of innovative drugs using Moderna's messenger RNA (mRNA) Therapeutics technology. mRNA Therapeutics(TM) enable the in vivo production of both intracellular proteins and secreted proteins. 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...

AbbVie Sours on $55B Shire Deal After Tax Changes

October 16, 2014 10:13 am | News | Comments

AbbVie's board is telling shareholders vote against its own $55 billion takeover bid for the Irish drugmaker Shire after the U.S. made reincorporating overseas a less lucrative tax maneuver. Read more...

NIH Awards $640,000 to Improve Diagnosis of Diseases

October 16, 2014 9:52 am | News | Comments

A two-year grant from the NIH will fund work by a Purdue Research Park-based company to improve methods to screen blood plasma samples for biomarkers, which are measurable indicators of a disease, to expedite diagnosis and treatment. Read more...

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...

FDA: Little Evidence to Drop Chantix Boxed Warning

October 15, 2014 1:22 pm | by Matthew Perrone, AP Health Writer | News | Comments

Federal regulators say Pfizer has provided low-quality evidence to support its request to remove a bold-letter warning from its anti-smoking drug Chantix about suicidal behavior. Read more...

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