BI says there is no unmet need for faldaprevir.
The all-oral genotype 1 medication got the Breakthrough Therapy designation Friday.
Phase-II results indicate Merck's all-in-one HCV oral could put pressure on Gilead.
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.
Insurers and state agencies are wondering if and how they can cover the $84,000 hep. C drug.
The FDA granted Breakthrough status to the daclatasvir + asunaprevir combo for hepatitis C patients with genotype 1b.
The drug maker is reportedly talking low rates for India's market.
Prescription data shows Gilead's Sovaldi is winning prescriptions at a faster rate than Vertex's Incivek did at launch.
The drug is priced at $28,000 a month, before add-ons like ribavirin and (possibly) interferon.
Goldman Sachs's Jami Rubin says AbbVie's pipeline assets make it a stealth competitor.
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.
Data released at the Boston meeting of the American Association for the Study of Liver Diseases hints at an upcoming Gilead-Merck brawl.
The company's hep. C drug Incivek peaked in 2011. Competition and pipeline drugs have forced the company to regroup.
The hep. C drug is safe and effective when used in combination with other therapies, according to information posted by FDA reviewers.
A roundup of news related to hepatitis C.
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
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
Two of the most difficult-to-treat hepatitis C patient groups saw high cure rates in an NIH-led study, results released Tuesday show.
The data suggest Boehringer's hep. C combo could find a treatment niche.
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.
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 scored an unexpected "priority review status" for its HCV agent simeprivir, whose initial approval is expected to be with interferon.
Sales fell more sharply during the quarter than execs expected, and Merck said it has put more Januvia-only reps behind its diabetes franchise.
Humira led in sales and the company told analysts Pfizer's Xeljanz setback in Europe won't alter its RA future all that much.
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.
Phase III findings on sofosbuvir, released in a medical journal, suggest no cause for concern from a safety perspective.
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.
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.
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.
Gilead combo drug clears HCV; FDA denies Xarelto expanded indication for a second time
Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.