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Arbor Pharmaceuticals Announces FDA New Drug Approval

October 24, 2014 12:40 pm | News | Comments

Arbor Pharmaceuticals announced that the FDA) has approved its New Drug Application (NDA) for Sotylize (sotalol hydrochloride) oral solution. Read more...                                      

Baxter Announces FDA Approval For New Hemophilia Drug

October 24, 2014 12:27 pm | News | Comments

Baxter International Inc. announced that the FDA has approved Obizur for the treatment of...

Myriad Establishes New Tumor Research Lab in Europe

October 24, 2014 10:18 am | News | Comments

Myriad Genetics Inc. announced it has established a Tumor BRACAnalysis CDx laboratory in Europe...

Pfizer Wins Patent Case in Delaware District Court

October 23, 2014 12:42 pm | News | Comments

Pfizer Inc. announced that the U.S. District Court for the District of Delaware upheld its basic...

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Eli Lilly Adds $375M to Zymeworks Partnership

October 23, 2014 9:52 am | News | Comments

Eli Lilly and Zymeworks said they are expanding a cancer drug development partnership. Read more...                                                   

Sutro BioPharma and Celgene Announce New Collaboration Plan

October 23, 2014 9:41 am | News | Comments

Sutro Biopharma announced it has entered into a strategic collaboration and option agreement with Celgene Corporation to discover and develop multispecific antibodies and antibody drug conjugates. Read more...                

PhosImmune, PureMHC Working Together on Cancer Immunotherapies

October 22, 2014 1:28 pm | News | Comments

PhosImmune Inc. and PureMHC LLC announced they have entered into a license and collaboration agreement to develop novel antibody-based immunotherapies designed to target cancers. Read more...

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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 multiple sclerosis drug suffered a brain inflammation and later died. Read more...                            

Taiho Receives FDA Fast Track for Cancer Treatment

October 22, 2014 1:14 pm | News | Comments

Taiho Oncology Inc. announced that the FDA granted Fast Track designation for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug under investigation for the treatment of refractory metastatic colorectal cancer (mCRC). Read more...

Third Point Urges Amgen to Consider Breakup

October 22, 2014 12:49 pm | News | Comments

A hedge fund run by a famed investor said it has taken a large stake in Amgen and now wants the biotech drugmaker to consider splitting up into two. Read more....               

Study Finds Drugs Still in Recalled Supplements

October 22, 2014 11:48 am | by Lindsey Tanner, AP Medical Writer | News | Comments

Dietary supplements containing potentially dangerous prescription drug ingredients may still be for sale even years after safety recalls, a study found. Read more...                              

Actavis Signs Option to Acquire Rhythm Subsidiary

October 22, 2014 10:24 am | News | Comments

Actavis plc, a leading global specialty pharmaceutical company, and Rhythm, a biopharmaceutical company, announced that Actavis has been granted an exclusive option to acquire Rhythm's wholly owned subsidiary, Rhythm Health Inc. Read more...

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Johnson & Johnson Announces New Spending Plan for Ebola Vaccine

October 22, 2014 10:05 am | News | Comments

Johnson & Johnson announced that it has made a commitment of up to $200 million to accelerate and significantly expand the production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies. Read more...                    

Oramed Gets Positive Data From Oral Insulin Trial

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

Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, reported positive top-line clinical results from its Phase 2a clinical trial of ORMD-0801, the company's proprietary oral insulin capsules, to treat type 1 diabetes. Read more...

Neurocrine Announces Phase 3 Study for Inhibitor

October 21, 2014 2:40 pm | News | Comments

Neurocrine Biosciences Inc. announced that it has initiated a Phase 3 clinical trial (Kinect 3 Study) of its proprietary Vesicular Monoamine Transporter 2 compound, NBI-98854.  Read more...                    

Lilly's Diabetes Treatment Receives NDA

October 21, 2014 2:19 pm | News | Comments

FDA has accepted the filing of a NDA for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination, an investigational compound being studied for the treatment of adults with type 2 diabetes (T2D). Read more...       

RegeneRx Proceeds With Phase 3 Eye Drop Study

October 21, 2014 10:43 am | News | Comments

RegeneRx announced that it met with the FDA in September and as a result of the meeting may begin Phase 3 to evaluate RGN-259 preservative-free eye drops for the treatment of patients with neurotrophic keratopathy (NK), an orphan disease of the cornea. Read more...

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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...

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... 

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...

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...

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