Insights+

Top 20

ViewPoints

Latest News

Clinical Trials

Biogen’s Gosuranemab (BIIB092) Fails to Meet its Primary Endpoint in P-II TANGO Study for Alzheimer Disease

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,

COVID-19 Pharma

Atea Pharma Secures $50M Milestone Payment with Roche in the Development of AT-527 for COVID-19

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

Regulatory

Blueprint Medicines’ Ayvakit (avapritinib) Receives FDA’s Approval to Treat Patients with Advanced Systemic Mastocytosis

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

Clinical Trials COVID-19

CureVac Report Results of CVnCoV in Second Interim Analysis of P-llb/lll HERALD Trial to Treat COVID-19

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

Regulatory

MannKind and United Therapeutics Reports the US FDA’s Acceptance of NDA for Priority Review of Tyvaso DPI to Treat PAH and PH-ILD

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

Clinical Trials COVID-19

Pfizer Presents Results of Tofacitinib in STOP-COVID Study for Patients Hospitalized with COVID-19 Pneumonia at NEJM

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

Biotech Clinical Trials

Lundbeck Presents Results of Vyepti (eptinezumab-jjmr) in RELIEF Study for Preventive Treatment of Migraine at JAMA

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

Clinical Trials COVID-19

Organicell Reports Results of Expanded Access Trial for Zofin to Treat Mild to Moderate COVID-19

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

Clinical Trials COVID-19

Regeneron Reports Results of REGEN-COV (casirivimab and imdevimab) in P-III RECOVERY Trial for COVID-19 Patients

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