BioSpace News Archive

BioMidwest

cultivate(MD) Portfolio Company NSite Medical Announces FDA Clearance

cultivate(MD), a leader in medical device venture capital, is thrilled to announce that one of its portfolio companies, NSite Medical, has received FDA clearance for its groundbreaking AI-based scoliosis scanning application.

December 11, 2023
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3 min read
Cytovance Biologics and Alcami Unite to Deliver End-to-End Solutions for Biologics Developers

Cytovance Biologics has announced a strategic collaboration with fellow CDMO Alcami Corporation to expand its large molecule biologic manufacturing and sterile fill finish offering.

December 11, 2023
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3 min read
First Patient Dosed in U.S. Expanded Access Program for TLX250-CDx, Telix’s Breakthrough Kidney Cancer Imaging Agent

Telix Pharmaceuticals Limited today announces that the first patient has been dosed in a United States (U.S.) expanded access program (EAP, ClinicalTrials.gov ID: NCT06090331 ) for TLX250-CDx ( 89 Zr-DFO-girentuximab).

December 11, 2023
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6 min read
Genetown

Vapotherm Announces Notification to New York Stock Exchange of Intention to Voluntarily Delist Common Stock Application Pending to Transfer Shares to OTCQX

Vapotherm, Inc., announced its intention to voluntarily delist its common stock from The New York Stock Exchange and its filing of an application to have its common stock quoted on the OTCQX Marketplace.

December 11, 2023
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5 min read
Business

Merck and Moderna Initiate INTerpath-002, a Phase 3 Study Evaluating V940 (mRNA-4157) in Combination with KEYTRUDA® (pembrolizumab) for Adjuvant Treatment of Patients with Certain Types of Resected Non-Small Cell Lung Cancer

Merck & Co. and Moderna, Inc. (Nasdaq: MRNA), today announced the initiation of INTerpath-002, a pivotal Phase 3 randomized clinical trial evaluating V940 (mRNA-4157).

December 11, 2023
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56 min read
Pharm Country

NRx Pharmaceuticals to Participate in LifeSci Corporate Access Event

NRx Pharmaceuticals, Inc. today announced the Company will be participating in-person at the LifeSci Partners Corporate Access Event for three days from January 8th through the 10th in San Francisco.

December 11, 2023
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3 min read
Pharm Country

BD Signs World Economic Forum’s Zero Health Gaps Pledge

BD, a leading global medical technology company, announced it signed the World Economic Forum’s Zero Health Gaps Pledge, which reinforces the company’s longstanding commitment to help expand access and improve health equity in under-resourced communities around the world.

December 11, 2023
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4 min read
RoslinCT to manufacture first-ever US FDA approved CRISPR-based gene therapy CASGEVY™ (exagamglogene autotemcel)

RoslinCT to manufacture first-ever US FDA approved CRISPR-based gene therapy CASGEVY™ (exagamglogene autotemcel).

December 11, 2023
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4 min read
Genetown

EMPAVELI® (pegcetacoplan) Provided Long-Term Control of PNH in New Data Presented at ASH Annual Meeting

Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi today presented post hoc data that reinforce the long-term efficacy and safety of EMPAVELI® (pegcetacoplan) in adults with paroxysmal nocturnal hemoglobinuria (PNH) for up to three years.

December 11, 2023
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11 min read
Business

BioXcel Therapeutics Strengthens Clinical Development Leadership to Advance Late-Stage Programs

BioXcel Therapeutics, Inc. today announced a key executive promotion and a clinical advisor appointment as part of the Company’s strategic reprioritization focused on the advancement of its late-stage clinical programs and emerging pipeline candidates.

December 11, 2023
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10 min read