Tags : Bluebird Bio

Pharma

Bluebird bio to Spin Off its Oncology Business into Independent

Shots: Bluebird plans to separate its severe genetic disease & oncology businesses into differentiated and independent publicly traded companies. The company will retain focus on SGD and will launch its oncology business (“Oncology Newco”) as a new entity The spinoff is expected to result in two independent, publicly traded companies by the end of 2021 […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (May 11-15, 2020)

1. Janssen to Present Updated Results of JNJ-4528 in P-Ib/II CARTITUDE-1 Study for Multiple Myeloma at ASCO 2020 Published: May 14, 2020 | Tags: Janssen, Update, Results, JNJ-4528, P-Ib/II, CARTITUDE-1, Study, Multiple Myeloma, ASCO 2. Samsung Bioepis Reports Results of Ontruzant (biosimilar, trastuzumab) in P-III Follow-up Study (SB3-G31-BC-E) for Early or Locally Advanced HER2-Positive Breast Cancer […]Read More

Biotech

BMS and bluebird bio to Resubmit the BLA for Idecabtagene

Shots: Shots: The companies receive the US FDA’s Refusal to File letter regarding the BLA for idecabtagene vicleucel for patients with heavily pre-treated r/r MM, which was submitted in Mar’2020 Upon preliminary review, the US FDA determined that the Chemistry, Manufacturing and Control module of the BLA requires further detail to complete the review Ide-cel […]Read More

Insights+

PharmaShots’ Key Highlights of Fourth Quarter 2019

1. Pfizer Launched its Zirabev (biosimilar, bevacizumab) in the US by the year end 2019 Date – Oct 01, 2019 Product – Zirabev (biosimilar, bevacizumab) The biosimilar was launched in the US on Dec 31, 2019 following the settlement between Genentech and Pfizer granting all global rights of the product to the Pfizer. In Sept […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (November 11-15, 2019)

Roche’s Kadcyla (trastuzumab emtansine) Receives CHMP’s Recommendation for Approval as an Adjuvant Treatment for Patients with HER2+ eBC with Residual Invasive Disease After Neoadjuvant Treatment Published: Nov 15, 2019 | Tags: Roche, Kadcyla, trastuzumab emtansine, Receives, CHMP, Recommendation, Approval, Adjuvant, Treatment, HER2+ Early Breast Cancer 2. Stanford Medicine Reports Results of Apple Heart Study for Detecting […]Read More

Biotech

Bluebird Bio Collaborates with Forty Seven to Evaluate Antibody Conditioning

Shots: The collaboration will lead to evaluation of Forty Seven’s FSI-174 + magrolimab in combination with Bluebird’s ex vivo lentiviral vector hematopoietic stem cell (LVV HSC) gene therapy platform The focus of the collaboration is to develop gene therapy with reduced toxicity and will initially target diseases having the potential to be corrected with transplantation […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (October 07-11, 2019)

OraSure Technologies’ Rapid Diagnostic OraQuick Ebola Rapid Antigen Test Receives the US FDA Marketing Approval for Detection of Ebola Virus Antigens Published: Oct 10, 2019 | Tags: Diagnostic, Oraquick Ebola Rapid Antigen Test, Orasure Technologies, Rapid, Receives, The US FDA, Marketing, Approval, Detection, Ebola Virus Antigens 2. Alnylam Reports Submission of MAA to Brazilian Health Regulatory […]Read More

Biotech

Bluebird Bio Signs a Three-Year Research Collaboration with Novo Nordisk

Shots: Bluebird Bio to utilize its mRNA-based megaTAL technology providing a specific and efficient way to silence, edit or insert genetic components combining Novo Nordisk’s deep expertise in hemophilia research and therapeutics  The focus of the collaboration is to identify gene therapy candidates for people with severe genetic diseases with initial interest of correcting FVIII-clotting […]Read More

Regulatory

Bluebird Bio’s Zynteglo Receives CHMP’s Positive Opinion for Conditional Marketing

Shots: The positive opinion is based on P-I/II HGB-205 & Northstar (HGB-204) and P-III Northstar-2 (HGB-207) & Northstar-3 (HGB-212) studies assessing Zynteglo in patients with transfusion-dependent β-thalassemia (TDT) who do not have β0/β0 genotype aged 12 yrs. and older Collective data from studies: 80% achieved transfusion independence with median duration of 38 mos.; @6mos. median […]Read More