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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....

$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...

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...

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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.

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$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.           

Price of New Hep C Drug Questioned by Medical Groups

March 11, 2014 11:55 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

An innovative hepatitis C drug that was only recently hailed as a breakthrough treatment is facing skepticism from some health care providers, as they consider whether it is worth the $1,000-a-pill price.             

HIV Prevention Drug Studies Show Big Promise

March 4, 2014 1:32 pm | by MARILYNN MARCHIONE, AP Chief Medical Writer | News | Comments

New research suggests that a shot every one to three months may someday give an alternative to the daily pills that some people take now to cut their risk of getting HIV.              

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New Hepatitis C Pill Lifts Gilead's Fourth Quarter Sales

February 5, 2014 9:24 am | News | Comments

Gilead Sciences said that sales of its hepatitis C pill Sovaldi totaled $139.4 million after the drug was approved in December, helping its fourth-quarter profit rise 4 percent.            

Mylan Named as Gilead's Business Partner for India

January 31, 2014 8:30 am | News | Comments

Mylan Inc. has announced that its India-based subsidiary Mylan Pharmaceuticals Private Limited has been named Gilead Sciences, Inc.'s exclusive branded medicines business partner for India.          

Gilead Announces Executive Promotions

January 28, 2014 8:03 am | News | Comments

Gilead Sciences, Inc. today announced several promotions within the company’s senior management team.                        

Health Canada Approves Hepatitis C Drug

December 17, 2013 8:12 am | by Sheryl Ubelacker, The Canadian Press | News | Comments

The drug Sovaldi (sofosbuvir) is to be taken in combination with older medications to treat the main forms of hepatitis C, which is caused by a blood-borne virus. Left untreated, the disease can lead to liver failure, cirrhosis and cancer.

FDA Approves Gilead’s Once-Daily Single Tablet HIV-1 Regimen

December 16, 2013 8:46 am | News | Comments

Gilead Sciences has announced that the FDA has approved the single tablet HIV-1 regimen Complera ® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for use in certain virologically-suppressed (HIV RNA <50 copies/mL) adult patients on a stable antiretroviral regimen in order to replace their current antiretroviral treatment regimen

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FDA Approves Breakthrough Hepatitis C Drug

December 6, 2013 6:23 pm | by MATTHEW PERRONE - AP Health Writer - Associated Press | News | Comments

U.S. health officials have approved a highly anticipated hepatitis C drug from Gilead Sciences Inc. that is expected to offer a faster, more palatable cure to millions of people infected with the liver-destroying virus.     

Gilead Q3 Profit Grows 17% on HIV Drug Sales

October 30, 2013 8:11 am | News | Comments

Gilead Sciences said that its third-quarter profit rose 17 percent on higher sales of its best-selling HIV drugs. Net income was $788.6 million, or 47 cents per share, in the July-September period, compared with $675.5 million, or 43 cents per share, for the third quarter of 2012.

FDA Panel Backs Gilead Sciences' Hepatitis C Drug

October 28, 2013 8:26 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

FDA advisers on Friday unanimously voted in favor of a highly anticipated hepatitis C drug from Gilead Sciences that holds promise for millions of Americans infected with the liver-destroying virus. All 15 members of the FDA's panel of virus experts voted to recommend approval of Gilead's pill, sofosbuvir, to treat several forms of hepatitis C.

FDA Issues Positive Review for Gilead's Hep C Drug

October 23, 2013 10:00 am | by MATTHEW PERRONE - AP Health Writer - Associated Press | News | Comments

The Food and Drug Administration has issued a positive review for a highly anticipated hepatitis C drug from Gilead Sciences, saying the pill cures more patients in less time than currently available treatments. The agency posted its review of Gilead's sofosbuvir online ahead of a meeting Friday.

FDA Reviews Two Promising New Drugs for Hepatitis C

October 22, 2013 2:40 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

The Food and Drug Administration holds a public meeting this week to review two experimental medications from Johnson & Johnson and Gilead Sciences. The new drugs, if approved, could offer a quicker, more effective approach to eliminating hepatitis C, a blood-borne disease blamed for 15,000 deaths in the U.S. this year.

Gilead to Stop Phase 3 Study 116 of Idelalisib in Chronic Lymphocytic Leukemia Early

October 10, 2013 8:06 am | News | Comments

Following a recommendation by an independent Data Monitoring Committee (DMC), Gilead Sciences has announced that its Phase 3 study (Study 116) evaluating idelalisib in previously-treated chronic lymphocytic leukemia (CLL) patients who are not fit for chemotherapy will be stopped early.

FDA Approves New Drug to Treat HIV Infection

August 13, 2013 8:22 am | News | Comments

The FDA has approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection. Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is a pill taken daily in combination with other antiretroviral drugs.

Gilead Sciences Climbs to All-Time Highs

May 3, 2013 4:55 pm | by The Associated Press | News | Comments

Shares of Gilead Sciences Inc. rose to all-time highs Friday after the company reported its first-quarter results and new trial data for two of its experimental hepatitis C drugs. THE SPARK: Gilead posted its quarterly results after the market closed Thursday. The company said its net income...

Gilead Sciences First Quarter Income Climbs 63%

May 3, 2013 8:09 am | News | Comments

Gilead said sales of its two biggest-selling drugs, the HIV medicines Atripla and Truvada, both fell. But its total revenue increased because of stronger sales of other products, including other HIV drugs, its heart drug Letairis, angina treatment Ranexa, and growing sales of Stribild, a four-in-one HIV pill that was approved in August.

Gilead Submits NDA to FDA for Sofosbuvir for the Treatment of Hepatitis C

April 9, 2013 8:04 am | News | Comments

Gilead Sciences today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection.

Idenix Pharma Shares Sink on Patent Decision

March 26, 2013 8:14 am | News | Comments

Idenix Pharmaceuticals Inc. shares sank Monday after the U.S. Patent and Trademark Office determined a competitor was the first to request a patent for a hepatitis therapy. The biopharmaceutical company said an appeals board decided that Idenix's patent application for compounds used to treat hepatitis C was filed after Gilead Pharmasset LLC's application.

Gilead Sciences Rises on New HIV Drug Data

March 6, 2013 7:56 am | News | Comments

Shares of Gilead Sciences Inc. moved higher Tuesday after the company reported more clinical trial data for an experimental HIV pill.Gilead had previously said the new pill, called TAF, worked about as well as the company's Stribild tablet in a mid-stage clinical trial, but had lower rates of side effects related to kidney problems and bone loss.

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