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Pharma Press Releases

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Lonza Announces Agreement to Manufacture AstraZeneca's COVID-19 Long-Acting Antibody Combination

Saturday, October 31, 2020

Lonza announced today that the company has signed an agreement with AstraZeneca to manufacture AZD a combination of two longacting antibodies LAABs for the potential prevention and treatment of COVID AZD is currently in Phase I clinical studies and A...

Genmab and ADC Therapeutics Announce Expanded Agreement for Camidanlumab Tesirine (Cami)

Saturday, October 31, 2020

Genmab A S and ADC Therapeutics SAannounced that they have entered into an amended agreement that will allow ADC Therapeutics to develop and commercialize CamidanlumabTesirin Cami will continue

FDA Grants Rafael Pharmaceuticals Orphan Drug Designation for CPI-613® (devimistat) for Treatment of Soft Tissue Sarcoma

Friday, October 30, 2020

Rafael Pharmaceuticals Inc Rafael or the Company a leader in the growing field of cancer metabolismbased therapeutics announced today that the US Food and Drug Administration FDA granted Orphan Drug Designation for CPI devimistat for the treatment of...

FDA Accepts for Priority Review Libtayo® (cemiplimab-rwlc) for Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ≥50%

Friday, October 30, 2020

Regeneron Pharmaceuticals Inc announced that the US Food and Drug Administration FDA has accepted for priority review the supplemental Biologics License Application sBLA for PD inhibitor Libtayo cemiplimabrwlc to treat patients with firstline locally...

SomaLogic Announces New Collaboration with FDA to Advance Biosimilar Development

Thursday, October 29, 2020

SomaLogic Inc announced an agreement with the US Food and Drug Administration FDAs Division of Applied Regulatory Science to evaluate the utility of largescale analysis of proteins proteomics for the identification of biomarkers that may be useful in...

Novartis expands Kymriah® manufacturing footprint with first-ever approved site for commercial CAR-T cell therapy manufacturing in Asia

Friday, October 30, 2020

Novartis announced the receipt of marketing authorization from Japans Ministry of Health Labor and Welfare MHLW for Foundation for Biomedical Research and Innovation at Kobe FBRI to manufacture and supply commercial Kymriah tisagenlecleucel for patie...

Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer

Friday, October 30, 2020

Roche announced US Food and Drug Administration FDA approval of expanded claims for the cobas EGFR Mutation Test v as a companion diagnostic CDx for a broad group of therapies in the treatment of nonsmall cell lung cancer NSCLC

Equillium Receives FDA Clearance of COVID-19 IND for Phase 3 Trial

Thursday, October 29, 2020

Equillium Inc a clinicalstage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders announced that it has received a Study May Proceed letter from the US Food and Drug Administration FDA to begin a Phase c...

Pelican BioThermal Announces Asia Award Win for Excellence

Thursday, October 29, 2020

Pelican BioThermal the global name in temperature controlled packaging was announced as winner of the Bioprocessing Excellence in Passive Packaging Solutions in Korea at a leading Asia awards ceremony celebrating excellence within the biopharma indus...

Thermo Fisher Scientific Extends Collaboration to Advance Biopharmaceutical Discovery and Development

Friday, October 30, 2020

Thermo Fisher Scientific the world leader in serving science and Symphogen an affiliate of and the antibody center of excellence within the international pharmaceutical company Servier announce the extension of a strategic collaboration to deliver in...