Month: <span>August 2019</span>

Takeda Signs an Exclusive Multi-Target Research Agreement with Sosei Heptares

Shots: Sosei Heptares to receive $26M up front, R&D funding, $1.2B+ development & commercial milestones and royalties on sales of the licensed products. Takeda to get WW rights to develop & commercialize therapies for each target through specified pharmacological approaches in the collaboration The focus of the agreement is to develop multiple GPCR targets nominated […]Read More

Roche Reports Results of Tecentriq in P-III IMvigor130 Study for

Shots: The P-III IMvigor130 study involves assessing of Tecentriq + platinum-based CT vs platinum based-CT as monothx. in 1213 patients with metastatic urothelial carcinoma (mUC) prior not treated with systemic therapy The P-III IMvigor130 study resulted in meeting its 1EPs of PFS with the reduction in the risk of disease worsening or death, improved OS […]Read More

PharmaShots Weekly Snapshot (July 29– August 02, 2019)

1.AbbVie’s Maviret (glecaprevir/pibrentasvir) Receives European Commission Approval for Treatment-Naive Patients with Chronic Hepatitis C and Compensated Cirrhosis Published: Aug 02, 2019 | Tags: AbbVie, Maviret, glecaprevir, pibrentasvir, Receives, European Commission, Approval, Treatment-Naïve, Patients, Chronic Hepatitis C, Compensated, Cirrhosis 2.Thermo Fisher Enters into a Collaboration with Genome Canada and OICR to Develop NGS Assays for Cancer Published: Jul […]Read More

AbbVie’s Maviret (glecaprevir/pibrentasvir) Receives European Commission Approval for Treatment-Naive Patients

Shots: The marketing authorization is based on P-IIIb EXPEDITION-8 study assessing Maviret in 280 treatment-naive chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6) for 8wks. The P-IIIb EXPEDITION-8 study resulted in @8wks. 97.9% GT1, 2, 4, 5 & 6 patients achieved a sustained virologic response 12wks. (SVR12); no case of virologic failures […]Read More

Thermo Fisher Enters into a Collaboration with Genome Canada and

Shots: Thermo Fischer signs a 3yrs. collaboration with Genome Canada and the Ontario Institute for Cancer Research (OICR) to develop targeted next-generation sequencing-based assays and analysis software for $6M. Genome to fund $2M for development & validation which will split b/w Thermo Fischer and OICR  The partners will develop one assay for diagnosis of pancreatic […]Read More

Voluntis’ Oleena Digital Application Receives FDA’s Marketing Approval to Self-Manage

Shots: The US FDA has completed its regulatory review of Oleena software which is a Class II medical device facilitating oncology-related symptoms management and remote patient monitoring Oleena is embedded with clinical algorithms offerings real-time personalized insights and actionable recommendations to the patients for managing their own symptoms while monitoring remote patients will improve clinical […]Read More

Mylan and Biocon Launch Ogivri (biosimilar, trastuzumab) in Australia

Shots: Ogivri is the first biosimilar to Herceptin (trastuzumab) to be approved and launched in Australia for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer and will be available on the Pharmaceutical Benefits Scheme The TGA’s approval of Ogivri is based on data which demonstrated bio-similarity to Herceptin with no clinically meaningful differences […]Read More

Arcellx Signs a Development Evaluation and License Agreement with Pfenex

Shots: Pfenex to receive R&D funding along with $2.6M up to $18M as development, regulatory & commercial milestones and royalties on WW sales of products. Arcellx to get access to Pfenex expression technology platform to advance sparX proteins, activating, silencing & reprograming antigen- receptor complex T-cell based therapies Arcellx’s first sparX protein has completed its […]Read More

Nektar and BMS Receive the US FDA’s Breakthrough Designation for

Shots: The FDA’s BT designation is based on ongoing P-I/II PIVOT-02 study assessing the doublet therapy in patients with metastatic melanoma. FDA’s BT designation is to expedite the development of medicine targeting life-threatening diseases In Feb 2018, BMS signed a WW development and commercialization agreement with Nektar for its Bempegaldesleukin Nektar’s Bempegaldesleukin is a therapy […]Read More