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clinical trials
This Week at FDA: Generic drug approvals continue downward trend, new guidance on clinical trial diversity coming
RAPS.org
Fri, 01/21/22 - 11:01 am
FDA
regulatory
clinical trials
clinical trial diversity
generics
Exact Sciences posts positive data on Cologuard 2.0 ahead of readouts on rival tests
Medtech Dive
Thu, 01/20/22 - 10:55 am
diagnostics
Medtech
EXACT Sciences
Cologuard 2.0
clinical trials
colon cancer
CROs embracing tech to decentralize trials and speed enrollment as regulators show support 'with their feet'
Fierce Biotech
Thu, 01/20/22 - 10:48 am
CROs
clinical trials
decentralized clinical trials
With $825M SPAC merger, ProKidney sets stage for phase 3 trial of kidney disease cell therapy
Fierce Biotech
Tue, 01/18/22 - 11:58 pm
ProKidney
SPACs
cell therapy
clinical trials
kidney disease
Europe launches initiative to transform clinical trials
Biopharma Reporter
Tue, 01/18/22 - 10:41 am
Europe
clinical trials
Rewind: Roche returns to phase 2 after seeing post hoc signal in failed pivotal Huntington's trial
Fierce Biotech
Tue, 01/18/22 - 10:30 am
Roche
Ionis Pharmaceuticals
tominersen
Huntington's disease
clinical trials
Tiny biotech hammered as lead drug fails a key PhII study
Endpoints
Tue, 01/18/22 - 10:28 am
Sensorion
clinical trials
France
arazasetron
hearing loss
FDA approval, global partnership on the agenda at Mithra as phase 3 menopause trials hit goals—with one blemish
Fierce Biotech
Fri, 01/14/22 - 11:18 am
Mithra
clinical trials
menopause
FDA
hot flashes
EMA sets out plan to accelerate clinical trials, reduce administrative burden
Fierce Biotech
Fri, 01/14/22 - 11:16 am
EMA
Europe
clinical trials
CRO owner pleads guilty to obstructing FDA investigation into falsified clinical trial data
Endpoints
Thu, 01/13/22 - 11:01 am
legal
CROs
GSK
clinical trials
falsified data
For Biogen's Aduhelm, narrow coverage from CMS 'could effectively spell the end': analyst
Fierce Pharma
Wed, 01/12/22 - 11:01 am
CMS
Biogen
Aduhelm
Medicare
clinical trials
Alzheimer's disease
Chasing Roche, Merck unveils adjuvant lung cancer data for Keytruda
Pharmaforum
Tue, 01/11/22 - 11:28 am
Merck
Roche
Keytruda
clinical trials
non-small cell lung cancer
Tecentriq
Novartis snaps up the rights to a Covid-19 antiviral after seeing mid-stage results. So where are the data?
Endpoints
Mon, 01/10/22 - 11:31 pm
Novartis
Molecular Partners
clinical trials
COVID-19
antivirals
ensovibep
BioMarin's hemophilia A gene therapy hits goal in phase 3, teeing up FDA filing despite durability doubts
Fierce Biotech
Mon, 01/10/22 - 11:32 am
Biomarin
hemophilia A
gene therapy
valrox
clinical trials
Where Will Cassava Sciences Be in 1 Year?
Motley Fool
Fri, 01/7/22 - 10:45 am
Cassava Sciences
Simulfilam
clinical trials
Alzheimer's disease
Aligos says stop right now to lead hep B med after fruitless phase 1 data
Fierce Biotech
Thu, 01/6/22 - 11:56 pm
Aligos Therapeutics
hepatitis B
clinical trials
Ultragenyx granted go-ahead to up doses for Angelman antisense therapy that stalled after safety issues
Fierce Biotech
Wed, 01/5/22 - 10:32 pm
Ultragenyx
GeneTx Biotherapeutics
Angelman Syndrome
clinical trials
antisense
GTX-102
Annexon becomes the latest group to provide a confusing update in Huntington's disease
EP Vantage
Wed, 01/5/22 - 10:45 am
Annexon Biosciences
Huntington's disease
clinical trials
ANX005
mRNA Epstein-Barr Virus Vaccine Candidate Launches Phase 1 Study
Precision Vaccines
Wed, 01/5/22 - 10:20 am
Moderna Therapeutics
vaccines
EBV
MRNA
clinical trials
mRNA-1189
Avrobio halts PhII study for Fabry disease in another setback, shuttering lead program
Endpoints
Tue, 01/4/22 - 10:49 am
Fabry disease
clinical trials
Avrobio
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