Course5i prides itself in enabling #LifeSciences organizations with insights, #analytics and #AI to drive strategic decisions. Enabling better health outcomes.
The #FDA has approved #Jardiance 10 mg tablets for the treatment of adults with #chronic kidney disease in the US based on the #Phase 3 EMPA-KIDNEY trial. https://t.co/dUUagw4Wq2
The #FDA has accepted the NDA filing for #Verona Pharma’s ($VRNA) #ensifentrine for the maintenance treatment of #COPD and assigned a PDUFA target action date of June 26, 2024. https://t.co/S3kMaUdFcT
#Viatris ($VTRS) announced the launch of #Breyna, the first #FDA approved generic version of #Symbicort in the US for patients with #asthma and #COPD, in partnership with #Kindeva. https://t.co/FTVLNB49To
#CuriumPharma received marketing authorization from EC for PYLCLARI for detection of PSMA+ lesions with PET in #prostatecancer; strengthening its position in the PET radiopharmaceutical space
https://t.co/zNOwvmIeCT
#PSMA#diagnostics#radiopharma
$GSK (#GSK) Q2’23 key #respiratory highlights - #Trelegy global sales: £611 M (+30% CER); #Trelegy#US sales: £461 M (+28% CER). The #Phase 3 readout and regulatory submission of #Nucala in #COPD in H2’24. https://t.co/qaFFrMwH3T
#Lupin receives approval from the #FDA for generic #Spiriva. This is the first generic approval for #Spiriva HandiHaler in the US, and is also the first DPI approval from #India for the US. https://t.co/LBYiW3PTtl
#Astellas to pay #Cullgen $35M upfront for discovery of multiple protein degraders. Cullgen will also receive additional $85M upon Astellas’ exercise of the license option - strengthening Astellas position in degradation space
#proteindegradation
https://t.co/vEhAOSPYXI
$ARVN ARV-766 (AR #degrader) showed initial efficacy in heavily pre-treated, post-NHA mCRPC including pts with AR L702H mut.; 42% PSA50 rate in pts with AR LBD mut; Expansion into early line pre-NHA setting planned in H2’23 - targeting specific small subset of pts
#prostatecancer
$BGNE presented robust efficacy data showing ORR 57.6% from Ph1b AdvanTIG-105 trial evaluating ociperlimab + tislelizumab + chemo in HER2- St. IV GC/GEJC. Responses were maintained regardless of PD-L1 TAP score
#ASCO2023 # ASCO23 #cancer#tigit
#Roche’s anti-TIGIT #tiragolumab + atezo & bevacizumab showed impressive efficacy with ORR 42.5% per RECIST v1.1 & 55% per HCC modified RECIST in Morpheus-liver study. Roche to evaluate the combo in Ph3 IMbrave152/SKYSCRAPER-14 global trial. #ASCO23#ASCO2023#cancer
#Hengrui's TGF-βRII/ PD-L1, SHR-1701 + EZH2i SHR-2554 shows promising ORR of 61.3% in Ph1 study for STs, lymphoma; Noteworthy ORR of 100% was observed in r/r cHL pts that warrants further evaluation - brings new hopes in the TGF-β space
#ASCO23#ASCO2023#Cancer
$AZN TIGIT x PD-1 BsAb #rilvegostomig fails to impress in CPI refractory NSCLC pts (ORR: 3.9%), once again raising questions on potential of TIGIT as a target in lung cancer; AZ plans pivotal Ph3 trial initiation in 2023 in undisclosed indication.
#ASCO23#ASCO2023#cancer
#ASCO23: CLDN18.2 continues being a hot target: $ELEV SYSA1801 showed preliminary activity (47.1% ORR) in China-based Ph1 trial for GC pts with tolerable toxicity profile; data from larger patient pool warranted. Plans to initiate Ph1 trial in the US in H2'23
#gastriccancer
Major breakthrough in Lower risk MDS treatment landscape. Evolution from ESAs to targeted therapies- Luspatercept to become SOC in 1L (EPO<500); imetelstat in 2L and 1L (EPO> 500) $GERN $BMY #ASCO2023
ASCO'23: The annual meeting will take place from June 2- June 6 in Chicago (in person & online). The team at Course5i curated a list of presentations highlighting the development in ADC’s, BITE's, OV's to shed more light on the evolving approaches to treat cancer. #ASCO23#cancer
#AstraZeneca’s ($AZN) has announced the discontinuation of the #brazikumab#IBD development program. The brazikumab’s development timeline was impacted by delays that could not be mitigated following global events. https://t.co/CUwbOTXktJ
$MRTX Mirati’s Ph3 SAPPHIRE study for sitravatinib + OPDIVO vs. docetaxel in 2L/3L NSCLC failed to meet its primary endpoint of OS at the final analysis
#lungcancer
https://t.co/r2EuN0oYrc
$GLD acquired XinThera to strengthen its early-stage portfolio in oncology & inflammation; Gains rights to develop ongoing PARP1 & MK2 inhibitors and plans to discover new therapies in future
https://t.co/HyuFpfPNKw