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Multiple Canadian Provinces to Provide Public Funding for Gilead's Harvoni™

March 24, 2015 8:26 am | News | Comments

Gilead Sciences Canada today announced that multiple provinces will provide public access to Harvoni ™ (ledipasvir/sofosbuvir), the first once-daily, single tablet regimen for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adults.

Bristol-Myers: Drug Combo Cured Hepatitis C in 97% with HIV

February 27, 2015 8:22 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

Bristol-Myers Squibb Co. said Thursday that an experimental combination of two hepatitis C drugs...

Study: Pills Before and After Sex Can Help Prevent HIV

February 25, 2015 8:24 am | by MARILYNN MARCHIONE, AP Chief Medical Writer | News | Comments

The study, done in France and Canada, is the first to test "on demand" use of Truvada, a pill...

Mylan Signs Exclusive Agreement with Gilead Sciences to Distribute Sovaldi and Harvoni in India

February 23, 2015 8:13 am | News | Comments

Mylan announced that its Indian subsidiary, Mylan Pharmaceuticals Private Limited, has entered...

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Competition, Discount Worries Weigh on Gilead Shares

February 4, 2015 3:29 pm | by The Associated Press | News | Comments

Shares of Gilead Sciences Inc. dropped Wednesday after the drugmaker's executives discussed pricing discounts and competition facing its blockbuster hepatitis C drugs.              

FDA Approves BMS’s Evotaz™ for the Treatment of HIV-1 Infection in Adults

January 30, 2015 8:42 am | News | Comments

Evotaz is coformulated to be one pill, once-daily, combining the protease inhibitor atazanavir, which is marketed as Reyataz (atazanavir 200 mg/300 mg) capsules, and cobicistat, a pharmacokinetic enhancer marketed by Gilead Sciences.   

Gilead Expands Hepatitis C Generic Licensing Agreements to Include Investigational Pan-Genotypic Agent

January 26, 2015 8:30 am | News | Comments

Gilead Sciences has expanded its hepatitis C generic licensing agreements to include the investigational NS5A inhibitor GS-5816, which is being evaluated in Phase 3 clinical studies as part of a single tablet regimen that combines the compound and sofosbuvir for the treatment of all six genotypes of hepatitis C.

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Aetna Picks Gilead Sciences Hepatitis C Drugs Over AbbVie's

January 19, 2015 9:43 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

Aetna has reached a deal with Gilead bringing discounts for Sovaldi and Harvoni, which have list prices of about $84,000 and $94,000, respectively, for a course of treatment. The amount of the discount wasn't disclosed.      

Gilead Sciences to Acquire Phenex Pharmaceuticals' Non-Alcoholic Steatohepatitis and Other Liver Diseases Program

January 6, 2015 8:55 am | News | Comments

Gilead Sciences and Phenex Pharmaceuticals AG today announced the signing of a definitive agreement under which Gilead will acquire Phenex’s Farnesoid X Receptor program comprising small molecule FXR agonists for the treatment of liver diseases including nonalcoholic steatohepatitis.

CVS Health Picks Gilead's Hepatitis C Drugs as Preferred Treatment

January 6, 2015 8:46 am | by The Associated Press | News | Comments

CVS Health, which is one of the nation's largest pharmacy benefits managers, said Gilead's Harvoni and Sovaldi will become exclusive starting Wednesday for its Medicare and Medicaid formularies, as well as for some commercial coverage.   

Gilead Amends HIV Treatment Agreements With Janssen

December 29, 2014 10:07 am | News | Comments

Gilead Sciences has announced an expansion to its agreement with Janssen R&D Ireland for the development and commercialization of a new once-daily single tablet regimen containing Gilead’s tenofovir alafenamide (TAF) and emtricitabine, and Janssen’s rilpivirine.

Gilead Names Senior Vice President, Hematology and Oncology Therapeutics

December 15, 2014 9:17 am | News | Comments

Gilead Sciences has announced that Philippe C. Bishop, MD, will join the company as Senior Vice President, Hematology and Oncology Therapeutics. In this position, Dr. Bishop will report to John McHutchison, MD, Executive Vice President, Clinical Research.

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Gilead Faces Lawsuit Over Hepatitis C Drug Pricing

December 11, 2014 1:59 pm | by The Associated Press | News | Comments

Philadelphia's Transportation Authority has filed a lawsuit against Gilead Sciences over the pricing of its hepatitis C drug. Gilead has been selling a 12-week treatment of Sovaldi in the United States for approximately $84,000, or $1,000 per pill.

Mylan and Gilead to Enhance Access to HIV Treatments in Developing Countries

December 1, 2014 8:29 am | News | Comments

Mylan has entered into an agreement with Gilead Sciences under which Mylan has licensed the non-exclusive rights to manufacture and distribute Tenofovir Alafenamide (TAF) as both a single agent product and in combination with other drugs.   

Knight Sells Priority Review Voucher to Gilead

November 19, 2014 8:15 am | News | Comments

Knight Therapeutics today announced the sale of its Neglected Tropical Disease Priority Review Voucher ("PRV"). Knight will receive US$125 million in cash from Gilead Sciences, Inc. in exchange for the PRV.        

States Ask Congress to Intervene on Drug Prices

October 29, 2014 8:24 am | News | Comments

In a letter Tuesday to key congressional committees, the National Association of Medicaid Directors said lawmakers should consider everything from outright price controls on manufacturers to federal help for states trying to pay for the new medications.

GlobalData Analyst: Harvoni Will Keep Gilead Atop Hepatitis C Virus Treatment Landscape

October 22, 2014 10:43 am | News | Comments

The recent FDA approval of Harvoni, Gilead Sciences’ once-daily, single-tablet regimen to treat chronic hepatitis C virus genotype 1 infection in adults, will enable the company to maintain its dominance in an increasingly competitive market, says an analyst with research and consulting firm GlobalData.

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Recent Developments Keep Gilead Ahead of the Pack in HIV Treatment Market, says GlobalData Analyst

October 8, 2014 9:14 am | News | Comments

Gilead’s announcement of positive Phase III results for its investigational single-tablet regimen (STR), elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate (TAF), caps a series of developments bolstering the company’s position as HIV treatment market leader, according to an analyst with research and consulting firm GlobalData.

Gilead to License Generic Version of Sovaldi

September 15, 2014 8:07 am | by The Associated Press | News | Comments

Gilead Sciences says it has reached a deal with several generic drugmakers to produce cheaper versions of its popular, expensive hepatitis C drug Sovaldi for use in developing countries.           

Illinois Medicaid Restricts Use of Hepatitis Drug

July 30, 2014 3:57 pm | by CARLA K. JOHNSON, AP Medical Writer | News | Comments

Facing ballooning costs for a $1,000 pill to treat hepatitis C, Illinois' Medicaid program is putting tight restrictions in place, including requiring patients to meet 25 criteria and get prior approval before the government program will pay for the new drug.

Pharma Economics - 101

July 30, 2014 3:22 pm | by Mike Auerbach, Editor In Chief | Blogs | Comments

There has always been much hand-wringing and shouting regarding the costs of new medications. Most of this comes from people outside the industry – politicians, public health advocates, and a smattering of those that just like to hear themselves talk.

$1,000 Pill Now Hepatitis C Treatment of Choice

July 29, 2014 8:26 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

In less than six months, prescriptions for Sovaldi have eclipsed all other hepatitis C pills combined, according to new data from IMS Health. But clinical and commercial successes have triggered scrutiny for the drug's manufacturer, California-based Gilead Sciences Inc., which just reported second-quarter profits of $3.66B.

FDA Approves Gilead Sciences Drug for Three Cancers

July 23, 2014 1:07 pm | News | Comments

Regulators approved the drug for patients with forms of chronic lymphocytic leukemia, follicular lymphoma and small lymphocytic lymphoma. The cancers affect an estimated 200,000 patients in the U.S., according to Gilead. The company's tablet, Zydelig, works by blocking signals inside some cancer cells that allow them to grow and survive.

HIV Pills Show More Promise to Prevent Infection

July 23, 2014 8:43 am | by The Associated Press | News | Comments

There is more good news about HIV treatment pills used to prevent infection in people at high risk of getting the AIDS virus: Follow-up from a landmark study that proved the drug works now shows that it does not encourage risky sex and is effective even if people skip some doses.

Janssen Submits Supplemental New Drug Application to FDA for OLYSIOT (Simeprevir)

May 7, 2014 8:02 am | News | Comments

Janssen Research & Development, LLC has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for simeprevir, an NS3/4A protease inhibitor marketed as OLYSIOT in the United States, in combination with the nucleotide analog NS5B polymerase inhibitor sofosbuvir developed by Gilead Sciences, Inc.

FDA Accepts Gilead's NDAs for Cobicistat and Elvitegravir for HIV Therapy

April 22, 2014 8:09 am | News | Comments

Gilead Sciences announced that the FDA has accepted the company’s refiling of two New Drug Applications (NDA) for cobicistat, a pharmacoenhancing or “boosting” agent that increases blood levels of the protease inhibitors atazanavir and darunavir to enable once-daily dosing of these medicines in HIV therapy, and elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults.

$1,000-a-Day Hepatitis C Drug Is a Blockbuster

April 3, 2014 8:56 am | Videos | Comments

Runaway demand for a life-saving hepatitis C treatment that costs $1,000 a day could send insurers' earnings per share down by double-digit percentages this year.               

Gilead Announces Results From Phase II Study of Sofosbuvir Among Hepatitis C Patients in Japan

April 3, 2014 8:22 am | News | Comments

Gilead Sciences has announced topline results from a Phase 3 clinical trial (Study GS-US-334-0118) in Japan evaluating the once-daily nucleotide analog polymerase inhibitor sofosbuvir in combination with ribavirin (RBV) for the treatment of genotype 2 chronic hepatitis C virus (HCV) infection.

Idenix Pharmaceuticals Files Patent Infringement Lawsuits Against Gilead Sciences

March 14, 2014 8:38 am | News | Comments

Idenix Pharmaceuticals has filed patent infringement lawsuits against Gilead Sciences and/or certain of its subsidiaries in each of three countries - France, Germany and the United Kingdom.           

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