Course5 Life Sciences
@Course5_LifeSci
Course5i prides itself in enabling #LifeSciences organizations with insights, #analytics and #AI to drive strategic decisions. Enabling better health outcomes.
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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. investor.lilly.com/news-releases/…
The #FDA has accepted the NDA filing for #Verona Pharma’s ($VRNA) #ensifentrine for the maintenance treatment of #COPD and assigned a PDUFA target action date of June 26, 2024. veronapharma.com/media/verona-p…
#Viatris ($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. newsroom.viatris.com/2023-07-31-Via…
#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 curiumpharma.com/2023/07/28/pyl… #PSMA #diagnostics #radiopharma
#AstraZeneca ($AZN) Q2’23 key #respiratory highlights - #Symbicort US sales: $200 M (-10% CER); #Breztri US sales: $84 M (+57% CER). The #Phase 3 readout of #Breztri in #asthma in H2’24. astrazeneca.com/content/dam/az…
$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. gsk.com/media/10423/q2…
#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. lupin.com/lupin-receives…
lupin.com
Lupin Receives Approval from U.S. FDA for Tiotropium Dry Powder Inhaler
Lupin Receives Approval from U.S. FDA for Tiotropium Dry Powder Inhaler
#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 astellas.com/en/news/27931
$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. astrazeneca.com/media-centre/p…
$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 ir.mirati.com/press-releases…
$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 investors.gilead.com/news/news-deta…
Continuing with disappointment in MF $INCY announces discontinuation of LIMBER-313 for parsaclisib in 1L- removing parsaclisib from its pipeline. LCM plan for ruxolitinib in MF adversely affected #Myelofibrosis
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