GSK, Theravance submit sNDA to FDA for fluticasone furoate/vilanterol to treat asthma
The product is marketed under the brand name ‘Breo Ellipta’ and is indicated for asthma patients aged 12 years and older. The sNDA is for approval of two
The product is marketed under the brand name ‘Breo Ellipta’ and is indicated for asthma patients aged 12 years and older. The sNDA is for approval of two
Developed by Eli Lilly and Boehringer Ingelheim, the new insulin glargine product is the first biosimilar insulin recommended for approval in the European Union (EU). The new insulin
The inhalation powder in AFREZZA is delivered using a small, discreet and easy-to-use inhaler. The company said that the AFREZZA should be administered at the start of a
According to the company, the CHMP positive opinion of Triumeq (dolutegravir/abacavir/lamivudine) is based upon data from two major studies. The first study is a Phase III trial of
The single-center, randomized withdrawal trial will enrol about 12 PWS patients between 10 and 20 years old. During the trial, patients will be titrated through five doses of
The company said that the CHMP has recommended doctors to prescribe Avastin to treat ovarian cancer in cases where the disease proves resistant to chemotherapies containing platinum. Roche
PH-COPD is a serious complication of COPD that can affect the health status of patients with this condition. Current standard of care for PH-COPD patients is primarily limited
FDA breakthrough therapy status helps in accelerating the development and review of drugs for serious or life-threatening conditions if preliminary clinical evidence indicates the therapy may show a
The Phase IIb trial, called AURA–LV (Aurinia Urine protein Reduction in Active Lupus with voclosporin) or AURA, is planned to be carried out in about 20 countries. The
The agreement includes exclusive commercialization in Mexico by Liomont of two biosimilars developed by Oncobiologics. As part of the deal, Liomont will provide Oncobiologics with upfront licensing and