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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...

Anoro's COPD Drug Shows Improved Lung Function

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

Respiratory Medicine has published positive...

FDA Votes to Keep Boxed Warning on Chantix

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

Federal health advisers say a bold-letter warning...

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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...                                                             

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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...

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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...

Shire Says AbbVie Should Proceed with $55B Buyout

October 15, 2014 1:05 pm | by Tom Murphy | News | Comments

The drugmaker Shire wants AbbVie to stick with its roughly $55 billion acquisition bid, and it is reminding its U.S. counterpart of the hefty breakup fee it could receive if things don't work out. Read more...

Ex-Financial Analyst at Merck Faces Insider Trading Charge

October 15, 2014 12:43 pm | News | Comments

A former senior finance analyst at Merck & Co. is facing an insider trading charge after authorities said that he passed secrets to a friend he met at college that earned $722,000 in illegal profits. Read more...

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Eisai's Thyroid Cancer Drug Gets FDA Priority Review

October 15, 2014 10:45 am | News | Comments

Eisai Inc. announced that the FDA has accepted for review the NDA for its in-house developed agent lenvatinib mesylate as a treatment for progressive RAI-refractory DTC and granted the NDA Priority Review status. Read more...

Clinical Conductor Takes Aim at Optimizing Oncology Clinical Trials

October 15, 2014 10:38 am | News | Comments

 The team behind Clinical Conductor is proud to announce brand new enhancements to the industry-leading CTMS. This first oncology focused release of several in the coming quarters adds a multitude of advanced features and functionalities designed to optimize the management and execution of oncology studies at organizations of all sizes and makeups.Read more...

Selecta, JDRF, Sanofi Collaborate on SVP Immunotherapy for Type 1

October 15, 2014 10:31 am | News | Comments

Selecta Biosciences and JDRF, announced that they have extended their joint research collaboration and attracted Sanofi as a partner in support of their program to develop an SVP immunotherapy with the long-term goal to treat and potentially prevent the underlying cause of type 1 diabetes. Read more...

Reversing Idiopathic Pulmonary Fibrosis

October 15, 2014 10:14 am | by Cynthia Fox, Science Editor | News | Comments

Lethal fibrosis in lungs of mice with idiopathic pulmonary fibrosis (IPF) can be reversed, say Yale University researchers. Read more...                                      

Medtronic Begins Study of First Predictive Low Glucose Management Technology

October 14, 2014 1:39 pm | News | Comments

Medtronic Inc. announced that the first patients have been enrolled in an investigational device exemption (IDE) study of its breakthrough Predictive Low Glucose Management (PLGM) technology, marking a critical step toward development of an artificial pancreas in the U.S. market. Read more...

Astellas Collaborates with Harvard for Retinal Degeneration Treatment

October 14, 2014 12:13 pm | News | Comments

Astellas Pharma Inc. announced a research collaboration with an investigator at Harvard focused on discovering the pathologic mechanism for retinitis pigmentosa and identification of new therapeutic targets. Read more...

C3BS Enrolls Patients in Switzerland in its Phase 3 Clinical Trial Chart-1

October 14, 2014 10:39 am | News | Comments

C3BS, a leader in the discovery and development of regenerative, protective and reconstructive therapies, announced it has received authorization from Swissmedic, the Swiss agency for the authorisation and supervision of therapeutic products, to begin its Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) European Phase 3 trial for C-Cure in Switzerland. Read more...

Nuvilex Applies for Orphan Drug Designation for Pancreatic Cancer Treatment

October 13, 2014 2:43 pm | News | Comments

Nuvilex Inc. (NVLX), a clinical-stage biotechnology company developing cell therapy solutions for the treatment of diseases, announced that it has submitted an application to the FDA for Orphan Drug Designation for its Cell-in-a-Box(R) treatment for pancreatic cancer. Read more...

Pfizer Gets FDA Acceptance of Palbociclib

October 13, 2014 2:35 pm | News | Comments

Pfizer Inc. announced the New Drug Application (NDA) for palbociclib has been accepted for filing and granted Priority Review by the United States Food and Drug Administration (FDA). 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...

Concert Pharmaceuticals' Spasticity Drug Gets Positive Reviews

October 13, 2014 10:54 am | News | Comments

Concert Pharmaceuticals Inc. announced Phase 1 data of CTP-354, a novel, potentially first-in-class, non-sedating, once-daily oral treatment for spasticity. 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...

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