In a letter Tuesday to key congressional committees, the National Association of Medicaid...
The recent FDA approval of Harvoni, Gilead Sciences’ once-daily, single-tablet regimen to treat...
Gilead’s announcement of positive Phase III results for its investigational single-tablet...
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.
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.
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.
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.
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.
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 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.
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.
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 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 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.
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.
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.
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 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 Sciences, Inc. today announced several promotions within the company’s senior management team.
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.
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
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 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 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.
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.
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.
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.
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.
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