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Home » Authors » Tamra Sami

Articles by Tamra Sami

Daewoong_4-28.jpg

Vitalli Bio launches with $477M licensing deal with Daewoong for phase I-ready autoimmune disease candidate

April 28, 2023
By Tamra Sami
Daewoong Pharmaceutical Co. Ltd. has out-licensed its phase I-ready autoimmune disease candidate, DWP-213388, to new spinout company Vitalli Bio in a deal worth up to $477 million.
Read More
World map with connecting lines

Pharmaessentia raises $462M in GDR offering to expand global footprint

April 27, 2023
By Tamra Sami
Pharmaessentia Corp. raised $462.7 million in a global depositary receipt (GDR) offering on the Luxembourg Stock Exchange that marks the largest global health care GDR offering so far this year. The capital raise “reflects confidence in the market opportunity for our approved product and the potential of our pipeline,” said Pharmaessentia founder and CEO Ko-Chung Lin.
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3D dollar sign
Newco news

Albatroz launches with $3M in seed funding to tackle new target for solid tumors and arthritis

April 26, 2023
By Tamra Sami
Albatroz Therapeutics Pte Ltd. has secured $3 million in seed funding to develop therapeutic antibodies against a new target that degrades the extracellular matrix, a key contributor to cancer and arthritis.
Read More
Technegas illustration

US FDA resets review clock for Cyclopharm’s Technegas for pulmonary embolism

April 25, 2023
By Tamra Sami
After receiving a U.S. FDA complete response letter nearly two years ago, Cyclopharm Ltd. said the agency has accepted its response and reset the clock for the NDA review of its Technegas combination product for pulmonary embolisms, with a new PDUFA date set for Sept. 29.
Read More

Hastening China expansion: CBC and Mubadala co-lead $315M funding round for Hasten

April 25, 2023
By Tamra Sami
China’s Hasten Biopharmaceutical Co. Ltd. will look for bolt-on acquisitions to deepen its pipeline following a funding round of $315 million that was co-led by Asia’s largest health care-dedicated investment firm, CBC Group of Singapore, and Abu Dhabi sovereign wealth fund, Mubadala Investment Co.
Read More
Postponed stamp on calendar

FDA pushes back PDUFA date for Daiichi Sankyo’s quizartinib

April 25, 2023
By Tamra Sami
Daiichi Sankyo Co Ltd. has experienced yet another setback with its quizartinib NDA submission, as the U.S. FDA has now extended the review period by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies.
Read More
Map of Australia with pills, vials and syringe

Australia begins first overhaul of its health technology assessment process in 30 years

April 25, 2023
By Tamra Sami
Australia’s Department of Health is seeking input from the public on the country’s health technology assessment process that informs decisions about what drugs or devices should be reimbursed and under what circumstances a therapy should be subsidized and at what cost to the taxpayer.
Read More
Technegas illustration

US FDA resets review clock for Cyclopharm’s Technegas for pulmonary embolism

April 25, 2023
By Tamra Sami
After receiving a U.S. FDA complete response letter nearly two years ago, Cyclopharm Ltd. said the agency has accepted its response and reset the clock for the NDA review of its Technegas combination product for pulmonary embolisms, with a new PDUFA date set for Sept. 29.
Read More
Technegas illustration

US FDA resets review clock for Cyclopharm’s Technegas for pulmonary embolism

April 24, 2023
By Tamra Sami
After receiving a U.S. FDA complete response letter nearly two years ago, Cyclopharm Ltd. said the agency has accepted its response and reset the clock for the NDA review of its Technegas combination product for pulmonary embolisms, with a new PDUFA date set for Sept. 29.
Read More
Postponed stamp on calendar

FDA pushes back PDUFA date for Daiichi Sankyo’s quizartinib

April 21, 2023
By Tamra Sami
Daiichi Sankyo Co Ltd. has experienced yet another setback with its quizartinib NDA submission, as the U.S. FDA has now extended the review period by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies. No additional efficacy or safety data has been requested.
Read More
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