The Week in Review: September 8 – September 15, 2017

Friday, September 15, 2017 News Recap: President’s Report from HepCBC’s Annual General Meeting (AGM) HepCBC held its Annual General Meeting on September 12, 2017, and we are pleased to note that all the issues that we needed to address were covered.  Rosemary Plummer has stepped down as president after 2 GREAT YEARS of service, but the rest of the Board of Directors has been re-elected, and some very important changes to our Constitution and Bylaws ...

Johnson & Johnson pulls plug on Medivir-Achillion hep C cocktail to focus on hep B

Citing a crowded market of innovative meds, Janssen has canned work on its hep C cocktail program with partners Medivir and Achillion. The pair were working on the hepatitis C treatment regimen known as JNJ-4178, a combo of three direct acting antivirals: AL-335, Achillion’s odalasvir and the Janssen-Medivir med Olysio (simeprevir). The Big Pharma said that the ongoing phase 2 tests with JNJ-4178 will be completed as planned, “but there will be no additio

Regulus Hep C Drug Stays On Clinical Hold (RGLS)

Regulus Therapeutics Inc. (RGLS) said the U.S. Food and Drug Administration (FDA) is maintaining a clinical hold on its hepatitis C drug candidate, RG-101. The drug was placed on clinical hold in June 2016, when a second case of jaundice was reported during clinical trials. FDA Requests More Data Although Regulus submitted a response following the clinical hold last summer, the FDA has requested final safety and efficacy data from an ongoing clinical tri

Regulus Reports Clinical Hold of RG-101

Timelines of On-going Studies are not Expected to be Impacted Conference Call Today at 5:00 p.m. ET LA JOLLA, Calif., June 27, 2016 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced it received verbal notice from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) for RG-101 for the t

Enanta Pharmaceuticals Initiates Proof-of-Concept Study with Pan-genotypic Cyclophilin Inhibitor EDP-494 in Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C Virus

EDP-494 represents a new host-targeted approach that may play an important role in future treatment regimens for chronic hepatitis C virus (HCV) patients that have failed therapy due to resistance arising from direct-acting antiviral (DAA) therapies currently on the market New non-DAA mechanism retains potency against important DAA resistance-associated variants (RAVs), regardless of class WATERTOWN, Mass.--(BUSINESS WIRE)--Jun. 20, 2016-- Enanta...

Drug Pipeline

Promising new treatments are on the way. Shorter. More successful. Fewer side-effects. So, if your liver is not in bad shape yet, you may want to wait a little while before being treated.  Or, if you’re willing to take the risks and live close enough to a research clinic, you may want to participate in a clinical trial yourself. Over the last couple decades, the success of treatment has gone from 10% up to 75-90%, depending on your genotype, presence o

Regulus to Present New RG-101 Data at The International Liver Congress™ 2016 (ILC 2016)

-Oral presentation during general session on interim RG-101 Phase II results & three posters to be presented-LA JOLLA, Calif., March 16, 2016 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that new data on RG-101, the company's anti-miR-122 in Phase II development for the treatment of Hepatitis C Virus infection (HCV...

Regulus hep C combo drug effective in mid-stage study

Regulus Therapeutics Inc said interim mid-stage data for its hepatitis C combination drug showed it had the potential to sharply reduce the duration of the treatment to four weeks from 12 weeks.The company's shares recorded their best day in more than 15 months, rising as much as 41 percent to $8.85 in heavy trading on Wednesday.Regulus tested its injectable drug, RG-101, separately with FDA-approved hepatitis C drugs such as Gilead Sciences Inc's Harvoni,

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C

-- If Approved, Combination Would Be First All-Oral, Pan-Genotypic Single-Tablet Regimen for Chronic HCV Infection ---- Filing is Company’s Third in Three Years for a New HCV Medicine -- October 28, 2015 05:52 PM Eastern Daylight TimeFOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily fix...