FDA: Highly Anticipated Merck Drug Eliminated Traces of Hepatitis C
FDA officials say a highly-anticipated drug to treat hepatitis C made by Merck appears to cure more patients in less time than established drugs.
Federal health officials say a highly-anticipated drug to treat hepatitis C made by Merck appears to cure more patients in less time than established drugs that have been used for 20 years. But the agency has questions about how the drug should be combined with older medicines for the maximum effect.
The Food and Drug Administration posted its review of Merck & Co. Inc.'s boceprevir ahead of a public meeting next week to consider whether to approve the medication. The meeting brings to a head more than 15 years of research to find a better therapy for a virus that infects about 3.2 million people in the U.S.
Another "potential safety signal" is a higher number of patients who reported psychiatric symptoms such as suicidal and homicidal thoughts, the FDA review
Related News
-
News Updated – Changing abortion pill access according to the US FDA and Supreme Court
After the approval of the medical abortion pill, mifepristone, by the US FDA, states across the USA approach the distribution of the pill differently, some ruling against allowing access to the drug. -
News CPHI North America 2024 – From the Floor
Welcome to Philly! CPHI North America once again graces the Philadelphia Convention Center, 7–9 May 2024. -
News Drug Patent Expiries: a steep cliff or opportunity for innovation?
The pharmaceutical industry faces a patent cliff together in the years leading up to 2030. Learn what this means for drug pricing, their outsourcing partners, and drug innovation of the future. -
News A Day in the Life of a President and Chief Scientific Officer
We are continuing to get to know the people working day-to-day behind the pharma companies shaping the industry, the ones who keep the wheels turning and ultimately bring better healthcare to the population; we are talking to the individuals at the hea... -
News Gerresheimer predicts weight-loss drug deals to account for 4% of yearly growth
Dietmar Siemssen, CEO of German primary packaging manufacturer Gerresheimer, states that approximately 4% of the company’s revenue growth each year to come from deals with drugmakers of weight loss and diabetes products, particularly GLP-1 class ... -
News LEAP-ing into the future of pharma – the CPHI Middle East Vision
On March 6, 2024, the CPHI team hosted the Future of Pharma Forum at LEAP 2024, Saudi Arabia’s premier destination for tech leaders and innovators to meet and collaborate. -
News Informa Markets International Women’s Day Panel Discussion
On March 7, 2024, the Informa Markets Amsterdam office hosted an International Women’s Day Breakfast and Panel Discussion to celebrate the women who drive the B2B events industry forward, including members of the CPHI team. -
News Generics threat to Merck’s Bridion as Hikma seeks pre-patent expiry approval
Merck has disclosed they received notice from Hikma Pharmaceuticals for seeking a pre-patent expiry US FDA approval for Hikma’s generic version of Merck’s Bridion.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance