Content about Antivirals

December 13, 2013

According to published reports, Express Scripts may be looking to start a "price war" among the makers of the latest generation of drugs for hepatitis C — which promise much shorter treatment times than standard therapies, but also cost significantly more — in an effort to bring down prices.

The stakes are certainly high. According to Centers for Disease Control and Prevention, there are 3.2 million people in the United States chronically infected with hepatitis C and hence at risk for liver cancer, and the CDC recommends that anyone born between 1945 and 1965 get tested for the virus.

According to published reports, Express Scripts may be looking to start a "price war" among the makers of the latest generation of drugs for hepatitis C — which promise much shorter treatment times than standard therapies, but also cost significantly more — in an effort to bring down prices.

December 10, 2013

Nearly all patients taking an experimental treatment for hepatitis C developed by AbbVie were cured, the drug maker said Tuesday.

NORTH CHICAGO, Ill. — Nearly all patients taking an experimental treatment for hepatitis C developed by AbbVie were cured, the drug maker said Tuesday.

December 6, 2013

The Food and Drug Administration has approved a new drug for hepatitis C made by Gilead Sciences, the drug maker said Friday.

FOSTER CITY, Calif. — The Food and Drug Administration has approved a new drug for hepatitis C made by Gilead Sciences, the drug maker said Friday.

December 6, 2013

Teva Pharmaceutical Industries' U.S. subsidiary has launched a generic drug for treating warts and skin lesions, the company said.

NORTH WALES, Pa. — Teva Pharmaceutical Industries' U.S. subsidiary has launched a generic drug for treating warts and skin lesions, the company said.

Teva Pharmaceuticals announced the launch and availability of imiquimod cream, a generic version of Medicis Pharmaceutical Corp.'s Aldara.

The drug is used to treat external genital and rectal warts, certain types of actinic keratosis and basal cell carcinoma. Various versions of the drug had sales of about $244 million in 2011, according to IMS Health.

 

November 25, 2013

The Food and Drug Administration has approved a new treatment made by Johnson & Johnson for hepatitis C, the drug maker said.

TITUSVILLE, N.J. — The Food and Drug Administration has approved a new treatment made by Johnson & Johnson for hepatitis C, the drug maker said.

October 25, 2013

A Food and Drug Administration expert panel has recommended approval for a drug made by Johnson & Johnson for treating hepatitis C, the company said.

NEW YORK — A Food and Drug Administration expert panel has recommended approval for a drug made by Johnson & Johnson for treating hepatitis C, the company said.

J&J subsidiary Janssen Research & Development said the 19-member FDA Antiviral Drugs Advisory Committee voted unanimously to recommend approval for TMC435 (simeprevir), a 150-mg drug meant for administration once per day with the generic antiviral ribavirin and a biotech drug known as an interferon, for treating genotype 1 chronic hepatitis C.

October 24, 2013

An experimental drug under development by Gilead Sciences for hepatitis C is safe and effective when combined with other treatments, according to a review posted on the Food and Drug Administration's website ahead of an expert panel meeting to take place Friday.

NEW YORK — An experimental drug under development by Gilead Sciences for hepatitis C is safe and effective when combined with other treatments, according to a review posted on the Food and Drug Administration's website ahead of an expert panel meeting to take place Friday.

May 21, 2013

More evidence is emerging that interventions by pharmacists can have a profound beneficial effect on patient outcomes.

The latest example comes from Walgreens Specialty Pharmacy, which released the results of a study May 17 showing that more than two-thirds of patients with hepatitis C “achieved sustained virologic response or cure after completing newer ‘triple therapy’ treatment” backed up by a regimen of care and oversight by pharmacists, according to a Drug Store News report from senior editor Michael Johnsen.

Why the pharmacist interventions? They help improve patient compliance with the complicated drug therapy, which involves the administration of two newer protease inhibitors to prevent the HCV virus from reproducing, in combination with peginterferon and ribavirin. According to Johnsen, that powerful medicinal cocktail “significantly increased the cure rate and cut treatment time in half” for the 406 HCV patients in the study who received triple therapy with either telaprevir or boceprevir.

More evidence is emerging that interventions by pharmacists can have a profound beneficial effect on patient outcomes.

May 17, 2013

More than two-thirds of patients with hepatitis C achieved sustained virologic response or cure after completing newer “triple therapy” treatment, according to a Walgreens Specialty Pharmacy study released Friday.

DEERFIELD, Ill. — More than two-thirds of patients with hepatitis C achieved sustained virologic response or cure after completing newer “triple therapy” treatment, according to a Walgreens Specialty Pharmacy study released Friday. 

May 6, 2013

An experimental drug regimen under development by AbbVie could change the way hepatitis C is treated, according to a special designation it received from the Food and Drug Administration.

NORTH CHICAGO, Ill. — An experimental drug regimen under development by AbbVie could change the way hepatitis C is treated, according to a special designation it received from the Food and Drug Administration.

May 3, 2013

Actavis' had $1.9 billion in sales in first quarter 2013, the drug maker said.

PARSIPPANY, N.J. — Actavis' had $1.9 billion in sales in first quarter 2013, the drug maker said.

The latest figure represented a 24% increase from first quarter 2012's $1.52 billion. "The new Actavis is off to a strong start in 2013, and as a result, we are increasing our 2013 forecast based on the strong performance and execution against our objectives to date," president and CEO Paul Bisaro said.

April 5, 2013

Actavis will market and distribute an authorized generic version of a genital herpes ointment made by Valeant Pharmaceuticals International, the companies said Friday.

PARSIPPANY, N.J. — Actavis will market and distribute an authorized generic version of a genital herpes ointment made by Valeant Pharmaceuticals International, the companies said Friday.

The agreement centers around Zovirax, known generically as acyclovir, in the 5% strength. The Food and Drug Administration approved the generic version, made by Mylan, on Wednesday. Financial terms of the deal were not disclosed.

April 4, 2013

The Food and Drug Administration approval this week of a generic genital herpes ointment made by Mylan could make a slight dent in the stock price of the company that makes the branded version.

MONTREAL — The Food and Drug Administration approval this week of a generic genital herpes ointment made by Mylan could make a slight dent in the stock price of the company that makes the branded version.

Canada-based Valeant Pharmaceuticals International said that while it expected Mylan to receive approval for a generic version of Zovirax (acyclovir) ointment, it did not include the approval in its original budget expectations and thus expected its earnings per share in fiscal year 2013 to be reduced by 30 to 40 cents.

April 3, 2013

The Food and Drug Administration has approved a new drug for genital herpes made by Mylan, the drug maker said.

PITTSBURGH — The Food and Drug Administration has approved a new drug for genital herpes made by Mylan, the drug maker said Wednesday.

Mylan announced the approval of acyclovir ointment in the 5% strength. The drug is a generic version of Valeant International's Zovirax, used to manage initial genital herpes and in limited, non-life-threatening mucocutaneous herpes simplex virus infections in patients with compromised immune systems.

February 19, 2013

Drug maker Gilead Sciences has recalled a single lot of an injected drug used to treat an opportunistic infection in AIDS patients due to the presence of foreign matter, the company said.

FOSTER CITY, Calif. — Drug maker Gilead Sciences has recalled a single lot of an injected drug used to treat an opportunistic infection in AIDS patients due to the presence of foreign matter in some vials, the company said.

Gilead announced the voluntary recall of lot B120217A of Vistide (cidofovir), an injected drug used to treat cytomegalovirus retinitis in patients with AIDS, due to particulate matter.

January 17, 2013

Boehringer Ingelheim Pharmaceuticals has enrolled the first patients in its late-stage trial of a treatment for hepatitis C, the drug maker said Thursday.

RIDGEFIELD, Conn. — Boehringer Ingelheim Pharmaceuticals has enrolled the first patients in its late-stage trial of a treatment for hepatitis C, the drug maker said Thursday.

BI Pharmaceuticals is conducting the "HCVerso" trial of an HCV drug that combines faldaprevir, the experimental compound BI 207127 and ribavirin. The company has established trial sites in more than 25 states.

June 14, 2012

Kadmon Pharmaceuticals earlier this month announced that it has launched a new 600 mg/day dose pack of Ribasphere RibaPak (ribavirin, USP), Kadmon's proprietary ribavirin regimen available in a daily, two-pill compliance package for enhanced therapy adherence.

NEW YORK — Kadmon Pharmaceuticals earlier this month announced that it has launched a new 600 mg/day dose pack of Ribasphere RibaPak (ribavirin, USP), Kadmon's proprietary ribavirin regimen available in a daily, two-pill compliance package for enhanced therapy adherence.

The new dose pack is designed to provide added dosing control to improve the management of hemolytic anemia in certain patients prescribed the triple therapy of a protease inhibitor, pegylated alpha interferon and ribavirin for the treatment of chronic hepatitis C virus infection.

April 20, 2012

Merck is testing two means of treating patients with chronic hepatitis C for anemia, a common side effect of certain treatments for the viral infection, the drug maker said.

BARCELONA, Spain — Merck is testing two means of treating patients with chronic hepatitis C for anemia, a common side effect of certain treatments for the viral infection, the drug maker said.

Merck announced results of a phase-3 study comparing two strategies for managing anemia and how they affect the curing of hepatitis C in patients taking Victrelis (boceprevir) with Pegintron (peginterferon alfa-2b) and ribavirin.

September 6, 2011

Hemispherx Biopharma and Armada Health Care have entered a sales and marketing agreement for a drug designed to treat genital warts.

PHILADELPHIA — Hemispherx Biopharma and Armada Health Care have entered a sales and marketing agreement for a drug designed to treat genital warts.

The two companies announced Tuesday an agreement under which Hemispherx will manufacture and supply Alferon N injection (interferon alfa-n3 [human leukocyte derived]) to physicians and patients through Armada's national specialty pharmacy network. Specialty distributor BioRidge Pharma will warehouse, ship and distribute the drug, the companies said.

July 25, 2011

A phrase like “silent killer” sounds creepy enough on its own, but it’s an often-used one for a virus that, according to the Centers for Disease Control and Prevention, infects 1.3% to 1.9% of people in the United States.


A phrase like “silent killer” sounds creepy enough on its own, but it’s an often-used one for a virus that, according to the Centers for Disease Control and Prevention, infects 1.3% to 1.9% of people in the United States.


July 19, 2011

The Food and Drug Administration has approved a drug made by Graceway Pharmaceuticals for actinic keratoses, Graceway said.

BRISTOL, Tenn. — The Food and Drug Administration has approved a drug made by Graceway Pharmaceuticals for actinic keratoses, Graceway said.

The agency approved Zyclara (imiquimod) cream in the 2.5% strength for AK, a precancerous lesion that affects about 10 million Americans and can develop into skin cancer later on.

June 30, 2011

Canadian drug maker Valeant Pharmaceuticals International will acquire rights to topical drugs for eczema and cold sores from Swedish drug maker Meda.

MISSISSAUGA, Ontario — Canadian drug maker Valeant Pharmaceuticals International will acquire rights to topical drugs for eczema and cold sores from Swedish drug maker Meda.

Valeant said it would buy rights for the eczema drug Elidel (pimecrolimus) and the cold sore drug Xerese (acyclovir and hydrocortisone) for the United States, Canada and Mexico. Valeant said, however, that Xerese has not yet received regulatory approval in Canada.

June 16, 2011

Specialty pharmacy provider Axium Healthcare Pharmacy has introduced two recently approved hepatitis C drugs to its HepVisions therapy management program, the company said Thursday.

LAKE MARY, Fla. — Specialty pharmacy provider Axium Healthcare Pharmacy has introduced two recently approved hepatitis C drugs to its HepVisions therapy management program, the company said Thursday.

Axium announced the addition of Merck ’s Victrelis (boceprevir) and Vertex Pharmaceuticals’ Incivek (telaprevir) to the program, through which it provides comprehensive compliance support, patient education, side effect management, clinical interventions and communication with the patient and physician.

May 23, 2011

The Food and Drug Administration has approved a treatment for hepatitis C made by Vertex Pharmaceuticals, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for hepatitis C made by Vertex Pharmaceuticals, the agency said Monday.

The FDA approved Incivek (telaprevir) to treat adults with chronic hepatitis C infection, particularly those who either have not received interferon-based drug therapy or who have not responded to prior therapies. The drug is approved for use with therapies that include ribavirin and peginterferon alfa.

May 23, 2011

The $290 billion that poor medication adherence costs the U.S. economy every year cuts across every imaginable disease state, but one in which it can be particularly problematic is mental health.


The $290 billion that poor medication adherence costs the U.S. economy every year cuts across every imaginable disease state, but one in which it can be particularly problematic is mental health.