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Allergan, Merck Enter into Licensing Agreement for Migraine Program

July 7, 2015 9:21 am | News | Comments

Allergan plc and Merck, known as MSD outside the United States and Canada, today announced that they have entered into an agreement under which Allergan will acquire the exclusive worldwide rights to Merck's investigational small molecule oral calcitonin gene-related peptide (CGRP) receptor antagonists. Read more...

The Next Anti-Tuberculosis Drug May Already Be in Your Local Pharmacy

July 7, 2015 9:07 am | by Ecole Polytechnique Federale De Lausanne | News | Comments

Testing thousands of approved drugs, EPFL scientists have identified an unlikely anti-...

Cancer Drug 49 Times More Potent than Cisplatin

July 7, 2015 8:59 am | by University of Warwick | News | Comments

Tests have shown that a new cancer drug, FY26, is 49 times more potent than the clinically used...

New Drug Helps Improve Sunshine Tolerance for Patients with Rare Disease

July 6, 2015 12:38 pm | by Ryan Bushey, Associate Editor | Articles | Comments

An estimated 5,000 to 10,000 people suffer from this condition worldwide with it typically...

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Vanda: Listing of New Hetlioz Patent in FDA Orange Book

July 6, 2015 11:15 am | News | Comments

Vanda Pharmaceuticals Inc. (Vanda) today announced that a Hetlioz patent, number 9,060,995 ('995 patent), is now listed in the U.S. Food and Drug Administration publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Read more..

Allergan to Acquire Oculeve Dry Eye Disease Development Programs

July 6, 2015 8:34 am | News | Comments

The acquisition of Oculeve adds novel, complementary dry eye development programs to Allergan's current eye care research and development programs. Read more...

FDA Clears Drug for Leading Form of Cystic Fibrosis

July 2, 2015 1:54 pm | by Matthew Perrone, AP Health Writer - Associated Press | News | Comments

The Food and Drug Administration cleared the twice-a-day pill from Vertex Pharmaceuticals for a variation of cystic fibrosis that affects about 8,500 people in the U.S. who are 12 years and older. The approval notice was posted to the agency's website Thursday. Read more...

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ViiV Healthcare, Desano Will Allow Competitive Supply of Dolutegravir in China

July 2, 2015 1:23 pm | News | Comments

ViiV Healthcare and Desano Pharmaceuticals (Desano) today announced a strategic manufacturing agreement to enable production in China of dolutegravir. Read more...

Diabetes Drug Spurs Weight Loss, But Not Without Side Effects

July 2, 2015 12:30 pm | by Stephanie Guzowski, Editor | News | Comments

The injectable drug liraglutide, marketed as Saxenda, can help overweight or obese patients lose a significant amount of weight — but a study in the New England Journal of Medicine reports that the drug also carries several side effects. Read more...

Small, Magnetic Robots Aim to Inject Drugs into the Bloodstream

July 1, 2015 4:38 pm | by Ryan Bushey, Associate Editor | Videos | Comments

The team has been working on a system of “milirobots” that are capable of swimming through a person’s bloodstream or spinal fluid. Read more...

Study Offers Clue to Link Between Swine Flu Shot, Narcolepsy

July 1, 2015 4:21 pm | by Lauran Neergaard, AP Medical Writer | News | Comments

One vaccine used in Europe during the 2009 swine flu pandemic was linked to rare cases of a baffling side effect - the sleep disorder narcolepsy. Now new research offers a clue to what happened. Read more...

Novo Nordisk to Cease Distribution of Tresiba in Germany

July 1, 2015 3:59 pm | News | Comments

The decision to cease distribution of Tresiba in Germany has no implications for the other countries where the product is available. Read more...

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Recent Drug Approvals will Boost Parkinson's Disease Therapeutics Market

July 1, 2015 3:41 pm | by Heather Leach, Ph.D., Immunology and Neurology Analyst, GlobalData | Articles | Comments

The most promising products are Xadago and Rytary for early and advanced patients, and Acorda’s CVT-301 for advanced patients. Read more...

Aridis Pharmaceuticals Receives FDA Fast Track Designation for Aerucin

July 1, 2015 10:17 am | News | Comments

Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel therapies for infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to its fully human monoclonal antibody Aerucin for the treatment of hospital-acquired and ventilator-associated pneumonia caused by Pseudomonas aeruginosa. Read more...

Oxycontin Maker Bows Out of Meeting on Harder-to-Abuse Drug

July 1, 2015 10:02 am | by Matthew Perrone, AP Health Writer - Associated Press | News | Comments

The makers of the potent painkiller OxyContin have pulled out of a federal meeting to review the company's harder-to-abuse version of the much-debated drug. Read more...

Oramed Enrolls First Patient in its Phase 2B Oral Insulin Study

July 1, 2015 8:36 am | News | Comments

This U.S. based study will be performed under the active Investigational New Drug application on file with the U.S. Food and Drug Administration. Read more...

BiondVax Announces Positive Preliminary Phase 2 Results for Universal Flu Vaccine

July 1, 2015 8:29 am | News | Comments

These results support BiondVax’s claim that M-001 provides a broaden and improved coverage against multiple influenza type A and B virus strains. Read more...

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Novartis to Try Novel Pricing Strategy for Heart Failure Drug

July 1, 2015 8:27 am | by Ryan Bushey, Associate Editor | Articles | Comments

The company is treading carefully in establishing the exact cost per pill. Read more...

The Leukemia & Lymphoma Society Accelerates Payment Linked to Phase 3 AML Study

June 30, 2015 12:24 pm | by The Leukemia & Lymphoma Society | News | Comments

Celator Pharmaceuticals, Inc. today announced that The Leukemia & Lymphoma Society (LLS) is accelerating a portion of the final payment linked to the Phase 3 study of CPX-351 (cytarabine:daunorubicin) liposome injection, Celator's lead product candidate, for the treatment of patients with high-risk (secondary) acute myeloid leukemia (AML). Read more...

National Study Finds Life-Threatening Barriers in Access to Breakthrough Drugs

June 30, 2015 12:16 pm | by Lifespan | News | Comments

Most states violate federal Medicaid law because they deny coverage for sofosbuvir, a new and highly effective treatment to cure hepatitis C, according to Lynn E. Taylor, M.D., director of The Miriam Hospital's HIV/Viral Hepatitis Coinfection Program.  Read more...

Stiolto Respimat Now Available in the U.S. for COPD Treatment

June 30, 2015 11:52 am | News | Comments

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray is now available by prescription at pharmacies across the United States. Read more...                      

Merck: Phase 3 Study of Single-Dose Emend Met Primary Endpoint

June 30, 2015 11:36 am | News | Comments

Merck, known as MSD outside the United States and Canada, today announced results from a Phase 3 study investigating the safety and efficacy of single-dose EMEND (fosaprepitant dimeglumine) for Injection, Merck’s substance P/neurokinin (NK-1) receptor antagonist, in combination with other anti-vomiting medicines, for the prevention of chemotherapy-induced nausea and vomiting (CINV). Read more...

FDA's New HCT/P Draft Guidance Document: What is Minimal Manipulation in 2015?

June 30, 2015 10:04 am | by Kelly L. Lightfoot, Esq., Fuerst Ittleman David & Joseph | Articles | Comments

The first step in assessing how a HCT/P will be regulated by the FDA, and whether the resulting product will require an expensive and lengthy approval process, is determining if the HCT/P is more than minimally manipulated. Read more...

Regeneron's Retinal Vein Occlusion Treatment Receives Approval in Japan

June 30, 2015 8:39 am | News | Comments

This new indication includes macular edema secondary to branch retinal vein occlusion in addition to the previously-approved indication of macular edema secondary to central retinal vein occlusion. Read more...

Global Biosimilars Market Value Could Hit $55B by 2020

June 30, 2015 8:28 am | by Sumith Ladda, Analyst, GBI Research | Articles | Comments

The 30 percent to 50 percent reduction in biosimilar prices compared with branded biologics could lead to considerable savings in healthcare expenditure. Read more...

CHMP Recommends EU Approval for Novartis' Multiple Myeloma Treatment

June 30, 2015 8:18 am | News | Comments

Multiple myeloma is a cancer of the plasma cells, a type of white blood cell present in the bone marrow, and affects approximately 84,000 people in Europe. Read more...

Pharmaceutical Trade Association: Greek Medicine Supply May Be At Risk

June 30, 2015 8:17 am | by Ryan Bushey, Associate Editor | Articles | Comments

The organization is calling for the European Union to take emergency action. Read more...

Conn. Nurse Pleads Guilty to Prescribing Pain Meds for Drug-Company Kickbacks

June 29, 2015 11:56 am | by Seth Augenstein, Digital Reporter | News | Comments

A nurse admitted in federal court to prescribing pain medications in exchange for kickbacks from a drug company, according to authorities. Read more...

Lilly, Immunocore: Immunotherapy-based Clinical Trial Collaboration in Melanoma

June 29, 2015 9:48 am | News | Comments

Eli Lilly and Company and Immunocore Limited today announced that they have entered into an immunotherapy-based clinical trial collaboration to explore the utility of Immunocore's lead T cell receptor-based investigational therapeutic, IMCgp100, in combination with Lilly's galunisertib (LY2157299) and merestinib (LY2801653) for the treatment of melanoma. Read more...

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