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Biotech

Coave Signs an Exclusive License Agreement with Théa to Co-Development and Commercialize CTx-PDE6b for PDE6b Associated Retinitis Pigmentosa in EU

Shots: Coave to receive $11.7M up front & equity investment, ~ $76.5M as clinical development, regulatory & commercial milestones along with royalties on net sales of the product. Both companies will co-develop Coave’s CTx-PDE6b &

Clinical Trials

Coherus and Junshi Present Interim Results of Toripalimab in P-III JUPITER-06 Trial as 1L Treatment for Advanced Esophageal Squamous Cell Carcinoma at ESMO 2021

Shots: The P-III JUPITER-06 trial evaluates toripalimab + CT vs PBO + CT in a ratio (1:1) in 514 treatment-naive patients with advanced or metastatic ESCC The study met its co-primary 1EPs i.e., improvements in

Regulatory

AbbVie Submits Regulatory Applications to the US FDA and EMA for Rinvoq (upadacitinib) to Treat Active Ulcerative Colitis

Shots: The application is based on 2 P-III U-ACHIEVE & U-ACCOMPLISH induction studies & 1 U-ACHIEVE maintenance study evaluating upadacitinib (45mg, qd) as IT & (15/30 mg, qd) as MT vs PBO in patients with

Clinical Trials

Biogen Reports Mixed Results of Vixotrigine (BIIB074) in P-II CONVEY Study for the Treatment of Small Fiber Neuropathy

Shots: The P-II CONVEY withdrawal study evaluates efficacy & safety of vixotrigine (200/350 mg, bid) vs PBO in 265 patients with SFN for 12wks. The study met its 1EPs i.e., 200mg dose showed a reduction

Biotech

Clarus Signs an Exclusive WW License Agreement with McGill University to Develop and Commercialize its Technology for Rare Conditions Due to Coenzyme-Q10 Deficiencies

Shots: McGill to receive $350,000 up front, $10.5M as development and regulatory milestone & is also eligible for ~$30M as a commercial milestone. Clarus will develop and commercialize McGill’s technology targeted the conditions associated with

Clinical Trials

Boehringer Ingelheim Enters into a Clinical Collaboration with Amgen to Evaluate BI 1701963 + Lumakras (sotorasib) for Locally Advanced or Metastatic NSCLC

Shots: The companies collaborated to evaluate the synergistic effects of BI 1701963 (SOS1::pan-KRAS inhibitor) + Lumakras (KRAS G12C inhibitor) in a P-I trial for adult patients with LA or metastatic NSCLC The companies will jointly

Clinical Trials

BMS Reports Five-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -214 for the Treatment of Advanced or Metastatic Renal Cell Carcinoma

Shots: The P-III CheckMate -214 trial evaluates Opdivo (3mg/kg) + Yervoy (1mg/kg, q3w for 4 doses) vs sunitinib in 1096 patients with previously untreated advanced/mRCC Results: @median follow-up of 67.7mos., combination showed superior OS in

Clinical Trials

Amgen Presents Results of Lumakras (sotorasib) + Vectibix (panitumumab) in P-Ib/II CodeBreaK 101 study for KRAS G12C-Mutated Colorectal Cancer at ESMO21 2021

Shots: The P-Ib/II CodeBreaK 101 study evaluates Lumakras + Vectibix in 31 patients with KRAS G12C-mutated advanced CRC The results demonstrated ORR (27%) among 26 patients in the efficacy analysis, DCR (81%), 33% of patients

Regulatory

BioCryst’s Orladeyo (berotralstat) Receives NICE Recommendation as First Oral Therapy to Prevent HAE Attacks in the UK

Shots: The NICE recommendation is based on P-III APeX-2 trial evaluating Orladeyo vs PBO in adult & pediatric patients aged ≥12yrs. with HAE attacks The trial met its 1EPs i.e., reduction in HAE attacks @24wks.