Shots: The P-III CANOPY-1 trial evaluates canakinumab (ACZ885) + pembrolizumab + platinum-based doublet CT vs PBO + pembrolizumab + CT in patients with LA or metastatic NSCLC The trial did not meet its 1EPs of OS and PFS and showed improvements in PFS & OS in pre-specified subgroups of patients based on the baseline inflammatory […]Read More
Bristol Myers Squibb’s Zeposia (ozanimod) Receives CHMP’s Positive Opinion for Adult Patients with Moderately to Severely Active Ulcerative Colitis Published: 15 Oct, 2021 | Tags: Bristol Myers Squibb, Zeposia, ozanimod, CHMP, Positive Opinion, Adult Patients with Moderately to Severely Active Ulcerative Colitis Gan & Lee Completes P-III Studies of GL-GLA for Patients with T1D & […]Read More
Shots: The US FDA has accepted the sBLA and EMA has validated the type-II variation application for Beovu (brolucizumab, 6mg) for the treatment of DME. Additionally, the PMDA has accepted an application for Beovu for the same indication The application is based on P-III KESTREL and KITE studies, which met their 1EPs of non-inferiority in […]Read More
AbbVie’s Rinvoq (upadacitinib) Receives the Health Canada Approval for the Treatment of Moderate to Severe Atopic Dermatitis Published: Oct 8, 2021 | Tags: AbbVie, Rinvoq, upadacitinib, Health Canada, Approval, Atopic Dermatitis Takeda Receives the US FDA Advisory Committee’s Recommendation for TAK-620 (maribavir) to Treat CMV Infection in Post-Transplant Recipients Published: Oct 8, 2021 | Tags: […]Read More
Shots: The NICE has recommended Novartis’ Adakveo (crizanlizumab) as a new treatment option to prevent recurrent sickle cell crises in patients aged ≥16 Additionally, patients will now have access to this treatment option on the NHS. The clinical evidence demonstrated that the people treated with crizanlizumab have significantly fewer sickle cell crises in a year […]Read More
BMS Reports EMA’s Validation of MAA for Relatlimab and Nivolumab as 1L Treatment for Unresectable or Metastatic Melanoma Published: Oct 1, 2021 | Tags: BMS, EMA, MAA, Relatlimab, Nivolumab, Metastatic Melanoma Merck and Ridgeback Report Interim Results of Molnupiravir in P-III MOVe-OUT Trial for the Treatment of COVID-19 Published: Oct 1, 2021 | Tags: Merck, […]Read More
Shots: The P-IIb study evaluates the efficacy & safety of remibrutinib vs PBO in 311 patients with CSU inadequately controlled by H1-antihistamines for 12wks. The results showed an improvement in UAS7 related to CFB @4 & 12wks. & rapid improvement as of 1wks., patients achieved UAS7=0 (complete absence of hives & itch) and UAS7≤6 (well-controlled […]Read More
The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular merger agreement to acquired First Wave Bio for ~$229M The key highlights of the big acquisition in this quarter includes Merck acquired Acceleron for ~$11.5B, Baxter acquired Hillrom for ~$10.5B, […]Read More
Shots: The P-IIb study evaluates ligelizumab (72/240mg) vs Xolair or PBO in patients with CSU with an inadequate control on antihistamines The results showed that proportion of patients achieved complete control of CSU symptoms @12 & 20wks. (44.1%/40.0% vs 23.5% & 0.0%) & (33.3%/34.1% vs 25.9% & 4.7%); CSU-free patients (38.1%/35.3% vs 18.8% & 0.0%) […]Read More
Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, Approval, MDR Gram-Negative Bacterial Infections GE Healthcare to Acquire BK Medical for ~ $1.45B Published: Sept 24, 2021 | Tags: GE Healthcare, Acquire, BK Medical, ~ $1.45B Roche Presents Results […]Read More
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