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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
269 Results
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Drug Development
Pharnext Announces a New Financing Through a Convertible Bond Program for a Total Amount up to €81 Million Gross to Extend its Cash Runway and to Continue to Fund its Pivotal Phase III Study
Pharnext Announces a New Financing Through a Convertible Bond Program for a Total Amount up to €81 Million Gross to Extend its Cash Runway and to Continue to Fund its Pivotal Phase III Study of PXT3003, the PREMIER trial, in Charcot-Marie-Tooth Disease Type 1A
June 7, 2021
·
17 min read
Biotech Beach
Agendia’s MammaPrint® Test is the First to Demonstrate the Ability to Predict Benefit from Extended Endocrine Treatment in NSABP B-42 Trial
MammaPrint was the only test to predict significant 36% and 52% reductions in DFS and BCFI events, respectively, for patients treated with extended endocrine therapy
June 7, 2021
·
5 min read
Drug Development
C4 Therapeutics Presents Pre-clinical Data on CFT8919, A Selective Degrader of EGFR L858R, at Keystone Symposium on Targeted Protein Degradation
Pre-clinical Data Support Plans to Advance CFT8919 to Clinical Development with IND Submission Expected in mid-2022 and Clinical Trial Initiation Expected by YE 2022
June 7, 2021
·
7 min read
Deals
Cerecor Enters Into $35 Million Debt Financing Agreement With Horizon Technology Finance
Cerecor Inc., a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases, announced that it has entered into a debt financing agreement led by Horizon Technology Finance Corporation to provide up to $35.0 million in term loans.
June 7, 2021
·
6 min read
Drug Development
BeyondSpring Announces Three Presentations Highlighting Positive Clinical Outcome Data from the Phase 3 Program of Plinabulin in Combination with Pegfilgrastim for the Prevention of Chemotherapy-Induced Neutropenia at the ASCO Annual Meeting
Data demonstrate that combination of plinabulin and pegfilgrastim offers superior benefit for reducing the incidence and severity of febrile neutropenia (FN) and hospitalization, with better quality-of-life (QoL), compared to pegfilgrastim alone
June 7, 2021
·
9 min read
Drug Development
IN8bio Completes Treatment of First Cohort in Phase 1 Clinical Trial with Gamma Delta T-Cell Therapy in Patients with Newly Diagnosed Glioblastoma Multiforme
Single-dose administration of IN8bio’s genetically modified gamma delta T-cells in lymphodepleted glioblastoma multiforme (GBM) patients was well tolerated
June 7, 2021
·
7 min read
Policy
Celltrion Healthcare launches Remsima™ SC, the world’s first subcutaneous formulation of infliximab in Canada, for the treatment of people with rheumatoid arthritis
Celltrion Healthcare Canada Limited announced the launch of Remsima™ SC, the world’s first subcutaneous formulation of infliximab in Canada for the treatment of adult patients with rheumatoid arthritis.
June 7, 2021
·
5 min read
Business
Gamida Cell Announces Appointment of Senior Vice President, Global Operations and Manufacturing and Provides Commercial Manufacturing Update
Gamida Cell Ltd., an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, announced the appointment of Vladimir Melnikov as senior vice president, global operations and manufacturing.
June 7, 2021
·
6 min read
Drug Development
Aurinia Announces Additional Analysis of its AURORA 1 Phase 3 Study Data Presented at ERA-EDTA 2021 Congress
New examination of AURORA 1 Phase 3 data demonstrates increased renal response rates with LUPKYNIS™ (voclosporin) used in combination with MMF and low-dose steroids in patients with lupus nephritis regardless of target urine protein creatinine ratio (UPCR)
June 7, 2021
·
11 min read
Business
OpGen Submits Updated 510(k) Summary to FDA and Successfully Completes Move to New Headquarters in Maryland
OpGen, Inc., a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, announced that it has submitted an updated 510 summary document to the U.S. FDA for its Acuitas AMR Gene Panel for Isolates.
June 7, 2021
·
4 min read
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