Intellectual Property - September 1, 2021
Gedea Biotech granted US patent
Gedea Biotech has been granted a patent by the United States Patent and Trademark Office for the treatment of fungal infections by the company’s compound glucono-δ-lactone (GDL). The patent can be kept in force until 2037, states the company in a press release. “The US market for treatment of vaginal infections is worth at least […]
Clinical Trials - March 10, 2021
Gedea adds three Swedish clinics to its ongoing study
Gedea Biotech has added three Swedish clinics to its NEFERTITI clinical study of its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV). The randomized double-blind placebo-controlled study is designed to confirm safety and efficacy of pHyph. The NEFERTITI study is financed by the EU program Horizon 2020 and run by […]
Clinical Trials - February 17, 2021
First patient enrolled in Gedea study
Gedea Biotech has enrolled the first patient in the NEFERTITI clinical study of its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV). The randomized double-blind placebo-controlled study is designed to confirm safety and efficacy of pHyph and is coordinated by Nottingham University NHS Hospitals Trust in the UK. The NEFERTITI […]
Clinical Trials - December 17, 2020
New findings about Gedea’s antibiotic-free treatment
Gedea Biotech has announced that results from a recently published study show that their pHyph antibiotic-free treatment for bacterial vaginosis has a high cure rate and prevents recurrence of the infection. Titled “A novel non-antimicrobial treatment of bacterial vaginosis: An open label two-private centre study” the results were published in peer-reviewed European Journal of Obstetrics […]
Clinical Trials - October 27, 2020
Gedea Biotech receives clinical trial approval
The company has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with the NEFERTITI clinical study of its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV). The randomized double-blind placebo-controlled study is designed to confirm safety and efficacy of pHyph and will be coordinated […]
Pharma Business - April 7, 2020
Gedea Biotech receives certificate for preparation of CE marking
Gedea Biotech has received its certificate in accordance with ISO 13485: 2016 (Medical devices – Quality management system – Requirements for regulatory purposes). The scope of the certificate includes design, development, marketing, distribution and production of antibiotic-free vaginal tablets intended to treat bacterial vaginosis. The certificate has been issued by TÜV SÜD, an accredited notified […]
