Gilead Expands Hepatitis C Generic Licensing Agreements to Include Investigational Pan-Genotypic AgentJanuary 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.
Aetna has reached a deal with Gilead bringing discounts for Sovaldi and Harvoni, which have list...
Gilead Sciences to Acquire Phenex Pharmaceuticals' Non-Alcoholic Steatohepatitis and Other Liver Diseases ProgramJanuary 6, 2015 8:55 am | News | Comments
Gilead Sciences and Phenex Pharmaceuticals AG today announced the signing of a definitive...
CVS Health, which is one of the nation's largest pharmacy benefits managers, said Gilead's...
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 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.
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 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 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.
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.
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.
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 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.
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