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Janssen Gets Two Positive CHMP Opinions For Darzalex Subcutaneous Formulation Utilizing Enhanze


Janssen Gets Two Positive CHMP Opinions For Darzalex Subcutaneous Formulation Utilizing Enhanze
NEW BRUNSWICK (dpa-AFX) - Janssen Pharmaceutica received two positive opinions from the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA recommending to broaden the existing marketing authorization for the DARZALEX or daratumumab subcutaneous formulation, which uses ENHANZE technology, in two new indications, Halozyme Therapeutics Inc. (HALO) said in a statement.
One recommendation is for the use in combination with cyclophosphamide, bortezomib and dexamethasone, for the treatment of adult patients with newly diagnosed systemic light chain amyloidosis.
The second recommendation is for the use of daratumumab subcutaneous in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalido ....

Janssen Pharmaceutica , Committee For Medicinal Products Human , European Medicines Agency , Halozyme Therapeutics Inc , Medicinal Products , Human Use , Halozyme Therapeutics , குழு க்கு மருத்துவ ப்ராடக்ட்ஸ் மனிதன் , மருத்துவ ப்ராடக்ட்ஸ் , மனிதன் பயன்பாடு ,

F. Hoffmann-La Roche Ltd: Phase III prevention trial showed subcutaneous administration of investigational antibody cocktail casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections by 81%


F. Hoffmann-La Roche Ltd: Phase III prevention trial showed subcutaneous administration of investigational antibody cocktail casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections by 81%
Placebo
Risk reduction
13
1.2
4 copies/mL)
14
0.4

Individuals without any COVID-19 symptoms who lived in the same household as an individual who tested positive to SARS-CoV-2 within the prior four days
. Based on the seronegative modified Full Analysis Set population, which includes all randomized subjects without evidence of current or prior SARS-CoV-2 infection (i.e., a negative RT-qPCR test and a negative antibody test) at randomization.
Adverse events (AEs) occurred in 20% (n=265 out of 1,311) of REGEN-COV participants and 29% (n=379 out of 1,306) of placebo participants, and serious AEs occurred in 1% (n=10) of REGEN-COV participants and 1% (n=15) of placebo participants. There were 0 REGEN-COV participants and 4 placebo pa ....

United Kingdom , United States , Nathalie Meetz , Levi Garraway , Daniel Grotzky , Jon Kaspar Bayard , Karl Mahler , Sabine Borngr , Gerard Tobin , Bruno Eschli , Birgit Masjost , Lisa Tuomi , Actemra Roactemra , Loren Kalm , Patrick Barth , Karsten Kleine , National Institute Of Allergy , Us Department Of Health , Pharmaceuticals Industry , Committee For Medicinal Products Human Use , Biomedical Advanced Research , National Institutes Of Health , Human Services , Drug Administration , Head Of Global Product Development , Development Authority ,

Detailed text transcripts for TV channel - MSNBC - 20170418:04:06:00

Election. can they turn these gains into something tangible that can translate into winning and can they pick up new supporters along the way? last week in illinois democrats picked up a whole bunch of seats in small local races. in kansas last week, democrats fell short, but they were encouraged by a huge swing in that direction. there the democratic candidate only lost by seven points in a redder than red district that donald trump carried by 27 points. and yes, part of it is, midterm off-year elections are always hard on the party in the white house. no question momentum is on the democrats side. one of the good signs for democrats if subcutaneous if they appear to be enticing new and infrequent voters to the polls. prior to the kansas race, two republican strategists told mcclatchy the main problem is ....

Red District , Donald Trump , White House , Mcclatchy The Main , Nuclear Arms Race , Question Momentum ,

Detailed text transcripts for TV channel - MSNBC - 20170418:01:07:00

Points. d yes part of the is in midterm off year elections are always hard on the party in the white house. no question momentum is on the democrats side. one of the good signs for democrats if subcutaneous if they appear to be enticing new and infrequent voters to the polls. priority the kansas race, too republican strategists told mcclatchy the main problem is not the independents and moderate voters have swung en masse to democrats. the problem is the democratic second base so energize that voters who rarely pay attention to politics are suddenly engaged. one said that the gop realized there might be a problem when polling found that low propensity democratic voters were interested in the race. democrats will look to make gains in two special elections in the coming months, in south carolina and montana. the the biggest one is tomorrow in georgia s 6th congressional ....

White House , Question Momentum , Mcclatchy The Main , En Masse , Georgias 6th Congressional District , South Carolina ,