BioSpace News Archive

Biotech Beach

TRACON Pharmaceuticals Announces Positive Results from the Independent Data Monitoring Committee Review of Interim Safety and Efficacy Data from the Ongoing ENVASARC Pivotal Trial

TRACON Pharmaceuticals today announced the Independent Data Monitoring Committee (IDMC) for the ongoing ENVASARC pivotal trial recommended continued accrual as planned in both cohort A of single agent envafolimab and cohort B of envafolimab given with Yervoy (ipilimumab).

December 27, 2021
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6 min read
FDA

Nobel Biocare Receives FDA 510(k) Clearance for the Nobel Biocare N1™ Implant System

Envista Holdings Corporation (NYSE: NVST) (“Envista”) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Nobel Biocare N1™ implant system.

December 27, 2021
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7 min read
Pharm Country

Sentinel Capital Partners Acquires TTG Imaging Solutions

Sentinel Capital Partners today announced its acquisition of TTG Imaging Solutions, a leading national provider of nuclear medicine and molecular imaging solutions.

December 27, 2021
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2 min read
Drug Development

Faraday Pharmaceuticals Announces Publication of Results from its Phase 2 Study of FDY-5301 for the Treatment of Reperfusion Injury Following a STEMI Heart AttackTo be Published in the International Journal of Cardiology

Faraday Pharmaceuticals, Inc. announced today the publication of results from its Phase 2 trial of FDY-5301 for the treatment of reperfusion injury following an ST-elevation myocardial infarction (STEMI) in the January 15, 2022 issue of the International Journal of Cardiology.

December 27, 2021
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3 min read
BioMidwest

PADAGIS ISSUES VOLUNTARY NATIONWIDE RECALL FOR NITROGLYCERIN LINGUAL SPRAY DUE TO A POSSIBLE DEFECTIVE DELIVERY SYSTEM

Padagis US LLC announced today it has issued a voluntary nationwide recall to the consumer/user level of the lots of Nitroglycerin Lingual Spray listed in the table below.

December 27, 2021
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3 min read
Drug Development

Regor Therapeutics Announces U.S. FDA Authorization to Conduct Regor’s First-in-Human Clinical Trial with the Next Generation Targeted Inhibitor RGT-419B for Oncology

On December 23, Regor Therapeutics, a clinical-stage biotech company, announced authorization from the US Food and Drug Administration to proceed with Regor’s Phase 1 clinical development plans for RGT-419B.

December 27, 2021
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3 min read
Business

Sutro Biopharma and Tasly Biopharmaceuticals Enter into Exclusive License Agreement for STRO-002 in Greater China

Partnership builds on the current progress and strength of ongoing clinical trials for STRO-002 in ovarian and endometrial cancer.

December 27, 2021
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8 min read
Drug Development

Kintor Pharma Provides Update on One of its Three Multi-Regional Phase 3 Trials of Proxalutamide for COVID-19

Kintor Pharmaceutical Limited today provided an update on its multi-regional study of proxalutamide for the treatment of COVID-19 infection (NCT04870606).

December 27, 2021
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4 min read
Business

VLP Therapeutics raises $21M Series A-1 for cancer treatment vaccine, infectious diseases vaccine R&D

US-based biotech company VLP Therapeutics, Inc. (VLPT) announced on December 27 that it has signed an agreement for an investment of US$21 million in a Series A-1 round.

December 27, 2021
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2 min read
FDA

Celularity Receives Fast Track Designation from U.S. FDA for its NK Cell Therapy CYNK-001 in Development for the Treatment of AML

Celularity Inc. today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, CYNK-001.

December 27, 2021
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5 min read