Month: November 2019

ONO Reports Submission of MAA to MHLW for Tirabrutinib Hydrochloride

Shots: ONO has submitted manufacturing and marketing approval application to MHLW for the treatment of WM an LPL in Japan The application is based on P-II ONO-4059-05 study assessing Tirabrutinib in 27 patients with untreated recurrent or refractory WM and LPL. Additionally, ONO has applied for the manufacturing and marketing approval of Tirabrutinib to treat […]Read More

Top Biosimilar Companies with Approved and Pipeline Products in the

Biosimilars are the key alternatives for expensive Biologics therapies and saving millions of dollars of patients spent in the treatment of multiple diseases. Hence physicians are likely to adopt biosimilars “a reference product to biologics” possessing similar therapeutic properties in terms of potency, safety, and efficacy to original biologic products. The companies are focusing on […]Read More

AstraZeneca Collaborates with JVP to Invest in Digital Health Program

Shots: AstraZeneca launches its digital health program, BeyondBio with the initial investment of $2.8M AstraZeneca in collaborates with JVP to support Israeli start-up companies by providing direct access to databases and leading academic research institutes in digital health with an aim to find technological solutions in the medical sphere The digital health program is operated […]Read More

AstraZeneca Reports the US FDA Acceptance of sBLA and Granted

Shots: The sBLA is based P-III CASPIAN study assessing Imfinzi + SOC (etoposide with either cisplatin or carboplatin)/ Imfinzi + tremelimumab + CT vs CT as monothx. in patients with previously untreated extensive-stage SCLC in 200+ centers across 23 countries The P-III CASPIAN study demonstrated improvement in OS (13.0 cs 10.3 mos.) with a reduction […]Read More

WuXi ATU and GeneMedicine Collaborate to Develop and Manufacture Oncolytic

Shots: WuXi ATU to provide overall process development, viral bank manufacturing, viral stock characterization and cGMP commercial manufacturing and IND filing services via its Oncolytic Virus CDMO platform, to accelerate the development and commercialization of Gene Medicine’s oncolytic virus products The collaboration allows GeneMedicine to advance its pipeline products from the clinical stage to commercialization […]Read More

Roche’s Kadcyla (trastuzumab emtansine) Receives Health Canada’s Approval for The

Shots: The approval is based on P-III KATHERINE study assessing Kadcyla vs Herceptin as adjuvant therapy in people with HER2+ eBC with pathological residual invasive disease in the breast and/or axillary lymph nodes following neoadjuvant taxane and Herceptin-based treatment The P-III KATHERINE study results: reduction in the risk of residual invasive BC recurrence or death […]Read More

Avion Signs an Exclusive License Agreement with ImmuPharma to Develop

Shots: Immuphrama to receive $70M milestones including $5M as regulatory & $65M as commercialization milestones and up to 17% royalties on pre-specified annual US sales targets. ImmuPharma retains all rights to commercialize Lupuzor outside the US and receives an additional $5M on approval of Lupuzor for each additional indication (Ex- Lupus) Avion to get an […]Read More

Octavus Consulting Collaborates with IBCI for Delivering of Professional Educational

Shots: The IBCI educational programs will focus on providing perspectives on Business & Competitive Intelligence role in every industry for professionals from all domains in India. Additionally, IBCI has already provided 50 types of programs for 7000+ highly qualified professionals from every domain Octavus Consulting with its team expertise in Competitive Intelligence and Product Strategies […]Read More

JW Pharma Acquires C&C Research Laboratories a Joint Venture with

Shots: JWP to acquire all stock of Chugai in C&C by 31 Dec 2019. C&C will be a wholly-owned subsidiary of JWP and will continue its R&D with independent management. Additionally, JWP and Chugai will cooperate on novel therapies developed by C&C The collaboration follows the succeeding of C&C in developing candidates for the treatment […]Read More