December 1, 2014 marked World AIDS Day, with roughly 40 million deaths worldwide over the past three decades attributed to this virulent disease. While there is no known cure for AIDS the advent of multiple drug regimens has made the treatment of the HIV virus which causes AIDS manageable for many patients globally. Unfortunately there[…]
Winning the Fight Against AIDS One Drug at a Time
Anti-Retroviral / Anti-HIV, Antiviral, Drug Research & Development API Tags: antiretroviral therapyHIV virus Dec 02, 2014
Sofosbuvir Continues to Shine as Optimal Hepatitis C Treatment
Anti-Retroviral / Anti-HIV, Antiviral, Drug Research & Development API Tags: Hepatitis CSofosbuvir Jul 16, 2014
The FDA’s approval of Sofosbuvir in December 2013 paved the way for an exciting new treatment option for patients suffering from Hepatitis C. Known as the brand name Sovaldi, which is marketed by Gilead, Sofosbuvir is a unique nucleotide analog inhibitor that is the first Hepatitis C drug to demonstrate efficacy without the co-administration of[…]
FDA Accepts Peramivir NDA for Influenza Virus Treatment
Anti-Retroviral / Anti-HIV, Antiviral, Drug Research & Development API, NDA Mar 24, 2014
BioCryst Pharmaceuticals recently announced that the Peramivir NDA has been accepted for review by the FDA. The exciting news about the antiviral comes on the heels of a deadly flu season around the world, with the H1N1 virus being most commonly found. Widespread flu activity around the United States has caused alarm for practitioners and patients who[…]
Daclatasvir Awarded FDA Breakthrough Therapy Designation
Anti-Retroviral / Anti-HIV, Antiviral, FDA Breakthrough Therapy Status Mar 10, 2014
Daclatasvir has been in the pharmaceutical spotlight lately as part of a new hepatitis C cocktail. Bristol-Myers Squibb revealed their achievement of a breakthrough drug designation from the FDA for the Daclatasvir based combination hepatitis C treatment. The FDA’s decision to grant a breakthrough designation for this oral drug combination of Daclatasvir and Asunaprevir is[…]
FDA Announces Approval of Gileads Once-A-Day Pill Sofosbuvir
Antiviral, Drug Research & Development API Tags: GileadHepatitis CSofosbuvir Dec 10, 2013
On December 6th, 2013 the FDA announced the approval of Gilead’s once-a-day pill Sofosbuvir, marketed as Sovaldi. The approval comes shortly after an FDA advisory committee awarded Gilead breakthrough therapy status for the once-a-day pill Sofosbuvir at the end of October 2013 (see previous Sofosbuvir article). The FDA committee also unanimously recommended the approval of[…]
Canada Approves Simeprevir for Hepatitis C
Anti-Retroviral / Anti-HIV, Antiviral, Drug Research & Development API, FDA Priority Status, Health Canada Approved 2013 Tags: Hepatitis Cribavirin Dec 04, 2013
On November 20, 2013 Health Canada revealed the approval of Simeprevir, known as the brand name GALEXOS, to treat hepatitis C. Janssen, the company that markets GALEXOS offered excitement for the approval of it’s once a day hepatitis C treatment. Simeprevir is designed to be administered adjunctively with both ribavirin and pegylated interferon, for the[…]
Cidofovir Shortage Affects HIV Positive Patients with Cytomegalovirus Retinitis
Anti-Retroviral / Anti-HIV, Antiviral, Drug Research & Development API, FDA Drug Shortage Tags: HIV virus Nov 06, 2013
As an antiviral medication used to treat cytomegalovirus retinitis, also known as CMV in patients infected with the HIV virus, the current Cidofovir shortage is alarming (see the FDA Cidofovir shortage posting). Administered as an injectable treatment intravenously, the dosing of Cidofovir can take up to six hours to complete. The treatment of 75 mg/ml[…]
Telbivudine Makes Headlines in China for the Treatment of Hepatitis B
Antiviral, Patent Expiration 2019 Tags: Chinachronic hepatitis B Nov 05, 2013
As a formidable and known nucleoside analogue, Telbivudine is one of a few oral treatments to combat HBeAg positive and negative chronic hepatitis B. Known as the brand name Tyzeka, Telbivudine has a patent expiration of August 10, 2019. While the use of Telbivudine has been extremely successful in the United States, other countries around[…]
FDA Grants Sofosbuvir Breakthrough Therapy Designation
Anti-Retroviral / Anti-HIV, Antiviral, FDA Breakthrough Therapy Status Tags: GileadHepatitis CribavirinSofosbuvir Nov 01, 2013
The end of October 2013 saw a nod from the FDA given to Gilead’s New Drug Application for Sofosbuvir. As a greatly needed treatment for hepatitis C Sofosbuvir has proven to be effectual and tolerable in a number of studies. Sofosbuvir is marketed by Gilead Science, Inc. and is clearly set up for success in[…]
Shortage of Acyclovir Leads to Dire Situation for Patients with Encephalitis
Anti-Retroviral / Anti-HIV, Antiviral, Drug Research & Development API, FDA Drug Shortage, OTC and Compounding Product, Patent Expiration 2017 Sep 18, 2013
The current shortage of Acyclovir, CAS number 59277-98-3, is of great concern to the medical community. As a valued and integral treatment for encephalitis, the shortage of Acyclovir for compounding pharmacies has created an urgent need for both patients and practitioners. The August 27, 2013 issue of the Neurology journal cautioned healthcare professionals to be[…]