Hepatitis

Merck looks poised to challenge Gilead

Merck looks poised to challenge Gilead

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Phase-II results indicate Merck's all-in-one HCV oral could put pressure on Gilead.

Merck adds heat to HCV competition

Merck adds heat to HCV competition

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Phase-II data show reduced hepatitis-C RNA levels among HIV-positive patients, the drugmaker shared at a medical meeting. Boehringer also released co-infection data.

Sovaldi price worries states

Insurers and state agencies are wondering if and how they can cover the $84,000 hep. C drug.

Daclatasvir combo gets Breakthrough status

The FDA granted Breakthrough status to the daclatasvir + asunaprevir combo for hepatitis C patients with genotype 1b.

Gilead ponders Sovaldi price break

The drug maker is reportedly talking low rates for India's market.

Sovaldi launch trounces Incivek's

Prescription data shows Gilead's Sovaldi is winning prescriptions at a faster rate than Vertex's Incivek did at launch.

FDA greenlights Gilead's sofosbuvir

FDA greenlights Gilead's sofosbuvir

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The drug is priced at $28,000 a month, before add-ons like ribavirin and (possibly) interferon.

Analyst: Don't underestimate AbbVie

Analyst: Don't underestimate AbbVie

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Goldman Sachs's Jami Rubin says AbbVie's pipeline assets make it a stealth competitor.

J&J HCV drug OK'd; educational push planned

J&J HCV drug OK'd; educational push planned

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Janssen's hepatitis C drug Olysio (simeprevir) offers modest benefit over standard of care, but resistance in a subgroup of patients could hinder broader uptake.

Genotype-1 hep. C race heats up

Genotype-1 hep. C race heats up

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Data released at the Boston meeting of the American Association for the Study of Liver Diseases hints at an upcoming Gilead-Merck brawl.

Vertex lays off 370, focuses on cystic fibrosis

The company's hep. C drug Incivek peaked in 2011. Competition and pipeline drugs have forced the company to regroup.

FDA briefing documents: Sofosbuvir safe, effective

The hep. C drug is safe and effective when used in combination with other therapies, according to information posted by FDA reviewers.

J&J buys GSK hep. C compound, BI completes trial enrollment

J&J buys GSK hep. C compound, BI completes trial enrollment

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A roundup of news related to hepatitis C.

Business briefs: Biogen, Celgene, J&J, plus Obamacare TV push

Biogen extend Isis relationship for six years and $100M; HHS readies healthcare reform TV push; Medivir ends hep. B clinical trial; FDA approves Celgene cancer drug; Baxter seeks Enbrel biosimilar

Business briefs: Gilead, AstraZeneca, Amgen, Otsuka

Gilead in an other sofosbuvir IP fight; study says patients not sticking with Amgen's Brilinta; AstraZeneca and Cytokinetics drug fails to hit Phase II target; Otsuka gets a CRL

Gilead's sofosbuvir clears another HCV hurdle

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Two of the most difficult-to-treat hepatitis C patient groups saw high cure rates in an NIH-led study, results released Tuesday show.

Boehringer drugs, sans interferon, could vie for HCV niche

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The data suggest Boehringer's hep. C combo could find a treatment niche.

In wake of HCV setback, Vertex to contain marketing spend

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While a strong launch of CF drug Kalydeco helped to hike the biotech's forecast, hep. C contender VTX-135 was hit with a partial clinical hold.

Business briefs: Aveo, Dynavax, Gilead, OPDP

Aveo CRL says company's kidney drug information is uninterpretable; Dynavax has to find more hepatitis B clinical trial patients; Gilead's hep C drug gets priority status; OPDP slaps Janssen and Sigma Tau with untitled letters.

J&J's Janssen looks to the margins with hep C agent

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J&J scored an unexpected "priority review status" for its HCV agent simeprivir, whose initial approval is expected to be with interferon.

Merck throws more staff behind Januvia; overall sales slid for quarter

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Sales fell more sharply during the quarter than execs expected, and Merck said it has put more Januvia-only reps behind its diabetes franchise.

AbbVie reports first-ever quarter, downplays Pfizer impact

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Humira led in sales and the company told analysts Pfizer's Xeljanz setback in Europe won't alter its RA future all that much.

BMS scores "breakthrough" label for hep. C candidate

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The regulatory coup means BMS gets to work with FDA to develop its home-grown hep. C cocktail, which is on a competitive track to another hep. C alliance with Merck.

Data show Gilead's sofosbuvir has 'clean' safety profile

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Phase III findings on sofosbuvir, released in a medical journal, suggest no cause for concern from a safety perspective.

Business Briefs: GSK, Astellas, Vertex and Orexigen

GSK and Astellas kick off the race for a new anemia treatment; Orexigen's CEO joins PhRMA; BMS and Merck team up in a hep.-C clinical trial; Novartis lands glaucoma approval; Ireland starts naming preferred drugs; Novo has new New Jersey digs; Vertex releases promising data for new cystic fibrosis treatment.

Business briefs: Roche, Vital Art and Science, Gilead, Sanofi

Roche and Isis pair up for Huntingtons, Vital's prescription vision app gets approved, FDA approval revives maligned morning sickness drug, Gilead sends hep C therapy to regulators and Sanofi's emerging market exposure grabs attention.

Business briefs: BMS, Sanofi, UK Sunshine

BMS fills week's end with shakeup and collaboration news, European regulators tamp down on rare disease drug pricing, association estimates pharma wooed UK docs with $61 million in gifts last year.

Business briefs: Gilead, Xarelto

Gilead combo drug clears HCV; FDA denies Xarelto expanded indication for a second time

Company news: Teva, Merck and BMS

Teva kicks off a succession plan early, and Merck launches Phase II trials of two all-oral hepatitis C regimens.

Vertex pursues parallel Hep C trials

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GlaxoSmithKline, Janssen sign on for mix-and-match trials for an all-oral hep C regimen.

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