BioSpace News Archive

Policy

SURGLASSES received FDA 510(k) Clearance for Caduceus S

SURGLASSES announced that Caduceus S AR Spine Navigation System has received 510 clearance from the U.S. Food and Drug Administration and is ready to launch its products into the US market in the first quarter of 2023.

December 20, 2022
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2 min read
Ribbon Biolabs Reaches Key Milestone with Automation of InfiniSynthTM Platform for Commercial-scale, Unlimited Length DNA Synthesis

Ribbon Biolabs, the DNA synthesis company, announced the successful implementation of their innovative InfiniSynthTM platform for the automated assembly of sequence-agnostic and long DNA.

December 20, 2022
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3 min read
Lone Star Bio

NanOlogy Publishes Results From a Clinical Trial of Intracystic LSAM-PTX in Mucinous Pancreatic Cysts

NanOlogy LLC, a clinical-stage interventional oncology drug company, announced publication of a research article entitled Early Phase Trial of Intracystic Injection of Large Surface Area Microparticle Paclitaxel for Treatment of Mucinous Pancreatic Cysts in Endoscopy International Open.

December 20, 2022
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3 min read
BioMidwest

OneOncology Partners Add Practices and Physicians to National Platform

OneOncology, the national platform for independent oncology practices, announced recent significant practice growth and new physician hires across the platform.

December 20, 2022
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3 min read
Business

Seagen, Astellas and Merck Announce FDA Acceptance of sBLAs for PADCEV® with KEYTRUDA® for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

Seagen, Astellas and Merck Announce FDA Acceptance of sBLAs for PADCEV ® (enfortumab vedotin-ejfv) with KEYTRUDA ® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer.

December 20, 2022
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59 min read
Quest Analytics Achieves HITRUST Risk-based, 2-year Certification for Quest Enterprise Services (QES) to Manage Risk, Improve Security Posture and Meet Compliance Requirements

Quest Analytics today announced that Quest Enterprise Services (QES) has earned Certified status for information security by HITRUST.

December 20, 2022
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2 min read
Drug Development

BioLineRx Announces Results from Phase 1/2a Study of Investigational Anti-Tumor Vaccine AGI-134 in Metastatic Solid Tumors

BioLineRx Ltd. today announced results from the Phase 1/2a study of intratumoral cancer vaccine candidate, AGI-134, designed to evaluate the safety and biological activity of AGI-134 in patients with unresectable metastatic solid tumors.

December 20, 2022
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9 min read
Genetown

Ginkgo Bioworks and the Ministry of Health of the Republic of Botswana Announce Plans to Develop and Implement New Biosecurity Capabilities in Botswana

Ginkgo Bioworks today announced that they have entered into a Memorandum of Understanding (“MoU”) with the intent of developing and implementing new biosecurity capabilities in Botswana.

December 20, 2022
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6 min read
Drug Development

Kira Pharmaceuticals Announces Clearance to Initiate Phase 2 Evaluation of KP104 in IgA Nephropathy (IgAN) and Complement 3 Glomerulopathy (C3G) in China and Australia

Kira Pharmaceuticals, a global biotechnology company pioneering transformational complement therapies to treat immune-mediated diseases, announced today that the Chinese National Medical Products Administration ( NMPA ) and the Australian Therapeutic Goods Administration ( TGA ) have approved initiation of Phase 2 studies.

December 20, 2022
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5 min read
Business

Invitae Completes Selected Assets Sale of its Next Generation Sequencing (NGS) research assays to Integrated DNA Technologies, Inc.

Invitae today announced that it has completed a transaction with Integrated DNA Technologies, Inc. (IDT), which includes the sale of Next Generation Sequencing (NGS) research assays under the trademarked name Archer®, also known as the Research Use Only (RUO) kitted solutions.

December 20, 2022
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4 min read