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Clinical Trials

Set Alert for Clinical Trials

Novavax’s COVID-19 Vaccine Boost From First Phase I Data

A first look at the clinical data for Novavax’s COVID-19 vaccine suggests it can produce strong antibody responses while being well tolerated.

Companies Coronavirus COVID-19

Coronavirus Update: Lilly Initiates 2,400-Patient Nursing Home Trial

Dozens of specially outfitted RVs will roll out to long-term care facilities in the US to test the prophylactic and symptom-reducing potential of the antibody Lilly is developing with AbCellera.

Coronavirus COVID-19 Clinical Trials

Morphosys/Incyte’s Monjuvi Wins Early US FDA Approval In Second-Line DLBCL

Monjuvi’s good efficacy and safety profile should enable its broad adoption in the second line DLBCL space and help it compete well against rival CAR-T therapies, analysts said.

Approvals Cancer

Progress In Pharma’s Slow Battle Against Respiratory Syncytial Virus

Pfizer is up against AstraZeneca and Sanofi in developing competing approaches to tackling the unmet need in respiratory syncytial virus (RSV). But earlier failures mean all players will need much more data to sway regulators.

Commercial Clinical Trials

CymaBay’s Stalled Seladelpar Back In Play For PBC

Weeks after lifting of an FDA clinical hold, CymaBay says it will resume development of its PPAR agonist in primary biliary cholangitis. It will initiate a new Phase III trial but also use data from a terminated Phase III study.

Clinical Trials Drug Approval Standards

Coronavirus Update: Russia Plans First Vaccinations In October

Concern and skepticism about Russia's rapid vaccine roll out. Meanwhile Japan is latest to reach deal with Pfizer/BioNTech.

Coronavirus COVID-19 Vaccines

Novo Nordisk Q2 Preview: Focus On Rybelsus, Ozempic And Payors

Novo Nordisk’s 6 August Q2 update will be scrutinized for clues on its plans for semaglutide in obesity, sales data for diabetes drugs Rybelsus and Ozempic, and likely M&A.

Clinical Trials M & A

US Studies Hold The Key To COVID-19 Vaccines Race

US demands for 30,000 subject studies and harmonized protocols mean a robust result could arrive soon – but recruitment could still be a challenge.  

Commercial Companies

AZ Outlines COVID-19 Plans With Strong Q2 Update

AstraZeneca used its robust Q2 update to express hopes that Phase III data from of its COVID-19 vaccine candidate this year could provide it with a regulatory pathway. It is also entering a mAb combination into the clinic as a promising approach against COVID-19.

Clinical Trials Commercial
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