Latest Headlines

Latest Headlines

Johnson & Johnson unit wins FDA panel backing for new tuberculosis therapy

Johnson & Johnson's Janssen has taken a step closer to gaining approval for the first new way of combating tuberculosis in decades. And an FDA advisory committee voted 18-0 in favor of efficacy of the experimental med, bedaquiline, for combating multidrug-resistant cases of the infection.

Danish-made TB vaccine sickens Romanian children

A Danish-made tuberculosis vaccine sickened more than 100 children in Romania, according to a European Centre for Disease Prevention and Control report.

J&J preps case for quick FDA approval of new TB drug

Later in the week a panel of outside FDA experts will give J&J's bedaquiline team a thorough examination to see whether the company warrants a preliminary approval based on Phase II data. And today the agency released its carefully neutral view of the data on safety and efficacy.

Gates Foundation funds tuberculosis vaccine research

Continuing a streak of donations to the field of vaccine research and biotech in general, the Bill & Melinda Gates Foundation granted $100,000 to an AgResearch scientist for research into a new tuberculosis vaccination method.

Oral vaccine relies on 'good bacteria'

Oral vaccines prove an alluring alternative to painful shots, and scientists at Royal Holloway, University of London, are pioneering a new method of oral vaccination using probiotic spores--"good bacteria." The method could help boost immunity to tuberculosis and influenza, as well as prevent C. difficile.

Will GlaxoSmithKline's transparency pledge force pharma rivals to open up?

Stung by intense criticism of its past penchant for secrecy and data manipulation, GlaxoSmithKline CEO Andrew Witty today took the transparency pledge, vowing to shine a light on all trial results--good and bad--while welcoming outside investigators into its data vaults and offering up some 200 potential tuberculosis-fighting compounds for public use.

GSK, Aeras partner for TB vaccine trial

GlaxoSmithKline ($GSK) will work with nonprofit biotech Aeras to test a tuberculosis vaccine in Africa and India, making headway in developing new ways to prevent the disease.

Tuberculosis vaccine may reverse Type 1 diabetes

A 90-year-old tuberculosis vaccine may help reverse Type I diabetes, Harvard University researchers say.

FDA wags finger at Sanofi for no-nos at vaccine plants

The FDA admonished Sanofi Pasteur on more than two dozen counts for "objectionable" conditions in two plants in Canada and France, according to a warning letter dated July 12 and made public July 24.

TB cocktail developers hope promising data point to regulatory shortcut

A new cocktail therapy that matches an experimental therapy with a long-approved antibiotic and TB treatment effectively wiped out signs of a drug-resistant form of tuberculosis in a mid-stage trial. And the developers are hoping that new guidelines at the FDA on urgently needed remedies could pave the way to a quick approval.