Timing
|
Medicine/vaccine
|
Trial (indication, presentation)
|
Event
|
H1
2023
|
daprodustat
|
ASCEND
(anaemia of chronic kidney disease)
|
Regulatory
decision
(EU)
|
Jemperli
|
RUBY
(1L endometrial cancer)
|
Regulatory
submission
(US)
|
momelotinib
|
MOMENTUM
(myelofibrosis with anaemia)
|
Regulatory
decision (US)
|
RSV
older adult vaccine candidate
|
RSV,
older adults aged
60+
years
|
Regulatory
decision (US)
|
Shingrix
|
Shingles,
at-risk adults aged 18+ years
|
Regulatory
decision (JP)
|
H2
2023
|
bepirovirsen
|
B-Together
(hepatitis B virus)
|
Phase
IIb data readout
|
Nucala
|
Nasal
polyposis
|
Regulatory
submission
(CN,
JP)
|
Blenrep
|
DREAMM-7
(2L+ multiple myeloma)
|
Phase
III data readout
|
Blenrep
|
DREAMM-8
(2L+ multiple myeloma)
|
Phase
III data readout
|
Blenrep
|
DREAMM-7
(2L+ multiple myeloma)
|
Regulatory
submission
(US,
EU)
|
Blenrep
|
DREAMM-8
(2L+ multiple myeloma)
|
Regulatory
submission
(US,
EU)
|
Jemperli
|
RUBY
(1L endometrial cancer)
|
Regulatory
decision
(US)
|
Zejula
|
FIRST
(1L maintenance ovarian cancer)
|
Phase
III data readout
|
cabotegravir
|
Pre-exposure
prophylaxis, long-acting injectable
|
Regulatory
decision (EU)
|
Vocabria
|
HIV
|
Regulatory
decision (CN)
|
gepotidacin
|
EAGLE-1
(urogenital gonorrhoea)
|
Phase
III data readout
|
gepotidacin
|
EAGLE-2/3
(uncomplicated urinary tract infection)
|
Regulatory
submission (EU)
|
MenABCWY
(gen 2)
vaccine
candidate
|
Meningitis
ABCWY
|
Phase
II data readout
|
RSV
older adult vaccine candidate
|
RSV,
older adults aged
60+
years
|
Regulatory
decision
(EU,
JP)
|
RSV
older adult vaccine candidate
|
RSV,
older adults aged
50-59
years
|
Phase
III data readout
|
RSV
older adult vaccine candidate
|
RSV,
older adults aged
50-59
years
|
Regulatory
submission
(US,
EU, JP)
|
SKYCovione COVID-19 vaccine
|
COVID-19
|
Regulatory
decision (EU)
|
2024
|
linerixibat
|
GLISTEN
(cholestatic pruritus in primary biliary cholangitis)
|
Phase
III data readout
|
linerixibat
|
GLISTEN
(cholestatic pruritus in primary biliary cholangitis)
|
Regulatory
submission
(US,
EU)
|
Nucala
|
Severe
asthma
|
Regulatory
decision (CN)
|
Nucala
|
Nasal
polyposis
|
Regulatory
decision (JP)
|
Nucala
|
MATINEE
(chronic obstructive pulmonary disease)
|
Phase
III data readout
|
Nucala
|
MATINEE
(chronic obstructive pulmonary disease)
|
Regulatory
submission
(US,
EU, CN, JP)
|
Blenrep
|
DREAMM-7
(2L+ multiple myeloma)
|
Regulatory
decision
(US,
EU)
|
Blenrep
|
DREAMM-8
(2L+ multiple myeloma)
|
Regulatory
decision
(US,
EU)
|
cobolimab
|
COSTAR
(non-small cell lung cancer)
|
Phase
III data readout
|
Jemperli
|
RUBY
(1L dMMR/MSI-H endometrial cancer)
|
Regulatory
decision (EU)
|
Jemperli
|
RUBY
part 2 (1L endometrial cancer)
|
Phase
III data readout
|
Jemperli
|
RUBY
part 2 (1L endometrial cancer)
|
Regulatory
submission
(US,
EU)
|
momelotinib
|
MOMENTUM
(myelofibrosis with anaemia)
|
Regulatory
decision (EU)
|
Zejula
|
ZEAL
(1L maintenance NSCLC)
|
Phase
III data readout
|
gepotidacin
|
EAGLE-2/3
(uncomplicated urinary tract infection)
|
Regulatory
decision
(US,
EU)
|
gepotidacin
|
EAGLE-2/3
(uncomplicated urinary tract infection)
|
Regulatory
submission
(JP)
|
gepotidacin
|
EAGLE-1
(urogenital gonorrhoea)
|
Regulatory
submission
(US)
|
MenABCWY
(gen 1)
vaccine
candidate
|
Meningitis
ABCWY
|
Regulatory
submission (US)
|
RSV
older adult vaccine candidate
|
RSV,
older adults aged
50-59
years
|
Regulatory
decision
(US,
EU, JP)
|