Suggesting that India's chief drug regulator may not be doing enough to protect certain volunteers in clinical trials, the Supreme Court ordered the agency to provide adequate oversight, particularly when drugs to treat the human papillomavirus are concerned.
For years, Merck and GlaxoSmithKline have battled safety worries and other stigmas with their HPV vaccines. But this week, the companies received a piece of positive news from the European Medicines Agency, which reported that a committee found no link between the shots and two rare conditions it had been studying.
Roche won a contract in the Netherlands to provide its HPV test for primary screening of cervical cancer through the country's national cervical cancer screening program, a milestone for the company more than a year after its scored FDA approval for its diagnostic for frontline HPV testing.
While the European Medicines Agency said it "does not question that the benefits of HPV vaccines outweigh their risks," on Monday it announced a safety review of the shots that have thus far failed to live up to expectations partly due to safety concerns and a sex-related stigma.
Immuno-oncology innovator Kite Pharma is joining gene therapy luminary bluebird bio to craft new treatments for HPV-related cancers, combining two high-profile technologies in hopes of developing targeted therapies.
Following behind a blockbuster is no easy task, but with a European Commission decision on Wednesday in favor of the vaccine, Merck's Gardasil 9 may just be up to the challenge of succeeding Gardasil.
The recommended schedule for HPV vaccination is two or three doses, but some patients never make it back for all of the shots. This may cease to be a concern if future trials prove what scientists reported on Wednesday: A single dose of GlaxoSmithKline's Cervarix could work as well as the recommended two- or three-dose regimens at preventing the majority of cervical cancers.
A new analysis shows that healthcare systems can prevent throat cancer cases and save in long-term treatment costs by covering the HPV vaccine in young boys. Currently, Australia, Canada and the United States recommend the jab for boys, but only cover it for young girls.
Merck's new-and-improved Gardasil is making headway in Europe with the word late last week that the European Medicines Agency has recommended the jab against 9 types of human papillomavirus and will send its blessing to the European Commission.
Serum Institute of India, which has a history of undercutting its competition in the vaccine sphere, is expanding this undercutting game to HPV. Its low-cost competitor to Merck's Gardasil could hit the market in late 2018 at one-third the price.