GlobalData believes that either an FDA decision to remove the drug from the...
FDA faces conundrum over future of AMAG’s Makena following drug withdrawal
GlobalData believes that either an FDA decision to remove the drug from the market or a request for a new confirmatory trial will have significant implications for patients and the company.
ObsEva plans to halt clinical programme of IVF nolasiban drug
Biopharmaceutical firm ObsEva will end the current clinical development programme of nolasiban IVF after the drug failed in the Phase III IMPLANT 4 clinical trial in Europe.
Which companies are leading late-stage development in the female infertility space?
While GlobalData projects the female infertility drugs market to grow through 2028 across seven major markets, this growth will be restricted by the sparse pipeline and the limited number of innovative drugs under development.
Novartis still hoping for Entresto success in heart failure with preserved ejection fraction
At ESC 2019, Novartis gave insight into the unsuccessful results of the PARAGON-HF trial for heart failure with preserved ejection fraction (HF-PEF).
Astellas initiates trial to evaluate VMS therapy fezolinetant
Astellas Pharma has initiated the SKYLIGHT 1 Phase III trial to evaluate fezolinetant for the treatment of moderate-to-severe vasomotor symptoms (VMS), hot flashes, and night sweats associated with the menopause.
Lilly reports improved survival in Verzenio’s MONARCH 2 trial
Eli Lilly has reported positive findings from the Phase III MONARCH 2 clinical trial of Verzenio (abemaciclib) with fulvestrant to treat advanced or metastatic breast cancer.
Keytruda improves response in late-stage breast cancer study
Merck has reported positive results from the Phase III KEYNOTE-522 clinical trial of Keytruda in combination with chemotherapy for the treatment of triple-negative breast cancer (TNBC).
Myovant’s relugolix meets Phase III endpoints for uterine fibroids
Myovant Sciences has reported positive results from the Phase III LIBERTY 2 study of its relugolix combination therapy for the treatment of uterine fibroids.
GSK’s Zejula meets primary goal in Phase III ovarian cancer trial
GlaxoSmithKline (GSK) has announced promising data for its Zejula (niraparib) drug as a maintenance therapy in the Phase III PRIMA clinical trial involving ovarian cancer patients.
Eisai and MedSIR study Halaven in breast cancer patients
Eisai Europe has partnered with MedSIR to assess Halaven (eribulin) in the REVERT clinical study, which involves metastatic breast cancer patients.