Latest News
Biogen’s Gosuranemab (BIIB092) Fails to Meet its Primary Endpoint in P-II TANGO Study for Alzheimer Disease
Tuba Khan
June 17, 2021
Shots: The P-II TANGO study evaluating the safety & efficacy of gosuranemab vs PBO in 654 patients aged 50–80 yrs with MCI due to AD or with mild AD for 78 wks across 97 sites,
Atea Pharma Secures $50M Milestone Payment with Roche in the Development of AT-527 for COVID-19
Tuba Khan
June 17, 2021
Shots: Atea Pharma achieved a milestone related to the development of AT-527 and is expecting to receive a related payment of $50M under its license agreement with Roche. The company believes that AT-527 is suitable
Blueprint Medicines’ Ayvakit (avapritinib) Receives FDA’s Approval to Treat Patients with Advanced Systemic Mastocytosis
Tuba Khan
June 17, 2021
Shots: The full FDA approval is based on data from 2 clinical trials i.e., P-I EXPLORER & P-II PATHFINDER trial evaluating the efficacy of Ayvakit (200 mg, PO, qd) in 53 adults with advanced SM
CureVac Report Results of CVnCoV in Second Interim Analysis of P-llb/lll HERALD Trial to Treat COVID-19
Tuba Khan
June 17, 2021
Shots: The P-llb/lll HERALD trial evaluating the safety & efficacy of CVnCoV in 40,000 with COVID-19 across 10 countries in Latin America & EU which conducted with Bayer, at least 13 variants circulating within the
MannKind and United Therapeutics Reports the US FDA’s Acceptance of NDA for Priority Review of Tyvaso DPI to Treat PAH and PH-ILD
Tuba Khan
June 17, 2021
Shots: The NDA is based on data from the BREEZE study evaluating Tyvaso DPI in 51 patients with PAH transitioning from Tyvaso inhalation solution which demonstrates the safety & tolerability of Tyvaso DPI Additionally, a
Pfizer Presents Results of Tofacitinib in STOP-COVID Study for Patients Hospitalized with COVID-19 Pneumonia at NEJM
Tuba Khan
June 17, 2021
Shots: The STOP-COVID study was conducted with a research collaboration b/w Pfizer & an ARO in Brazil, evaluating the efficacy & safety of tofacitinib (10mg, bid) + SoC vs PBO + SoC in a ratio
Lundbeck Presents Results of Vyepti (eptinezumab-jjmr) in RELIEF Study for Preventive Treatment of Migraine at JAMA
Tuba Khan
June 16, 2021
Shots: The RELIEF study evaluating the efficacy & safety of VYEPTI (100mg, 30-minute IV infusion) vs PBO in a ratio (1:1) in 480 patients with migraine, administered within 1-6 hrs of migraine attack The study
Organicell Reports Results of Expanded Access Trial for Zofin to Treat Mild to Moderate COVID-19
Tuba Khan
June 16, 2021
Shots: The company reported the results of an expanded access trial for Zofin in patients with COVID-19 which was conducted in Houston, TX The trial met EPs for safety & efficacy i.e., improved pulmonary opacities
Regeneron Reports Results of REGEN-COV (casirivimab and imdevimab) in P-III RECOVERY Trial for COVID-19 Patients
Tuba Khan
June 16, 2021
Shots: The P-III RECOVERY trial evaluating REGEN-COV (8,000 mg) vs usual care alone in seronegative patients with COVID-19 demonstrates 20% reduction in risk of death in patients failing to exhibit a natural antibody response The
