On Sept. 18, Advaxis reported "encouraging" data from a Phase II trial of its cervical cancer vaccine, axalimogene filolisbac, dubbed ADXS-HPV. Now, the biotech is reporting an FDA clinical hold on the candidate--5 days after the FDA placed the hold.
Operating in a field that can leave patients with few options, Advaxis rolled out data for its cervical cancer vaccine this week that represent a "meaningful step" for those afflicted, according to one expert.
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.
Women's health startup Femasys has raised $10.2 million in a Series B round. The financing will go to support pivotal testing for its FemBloc non-surgical female sterilization device and to marketing the company's two commercial diagnostics tools, one for female infertility and the other for cervical cancer.
An Israeli company, Biop Medical, is developing the Biop diagnostic medical device to detect cervical cancer.
Advaxis, on a partnering spree after joining with Merck and AstraZeneca to test its cancer vaccine candidates in immunotherapy combos, has teamed up with Incyte to trial one of its prospects in cervical cancer.
After promising last month to fast track its review of Roche's Avastin in cervical cancer, the FDA has come back with a positive verdict--a full two months before its deadline. The agency approved the blockbuster drug to be used in combination with chemotherapy in women with advanced cervical cancer.
Roche has won FDA approval for its HPV test used for primary screening of cervical cancer. The regulatory nod is expected to increase the company's profile in the U.S. and grow its 20% share of the global diagnostics markets.
Cepheid announced Wednesday it has released Xpert HPV for sale in Europe. The fast test is designed to detect cervical-cancer-related human papillomaviruses (HPV) in women and return results in an hour.