BioSpace News Archive

Business

Genmab Announces Net Sales of DARZALEX® (daratumumab) for 2021

Genmab A/S (Nasdaq: GMAB) announced today that worldwide net trade sales of DARZALEX® (daratumumab) as reported by Johnson & Johnson were USD 6,023 million in 2021.

January 25, 2022
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5 min read
Business

Cingulate Appoints Curt Medeiros and Gregg Givens to Board of Directors

Following its initial public offering last month, Cingulate Inc. publicly announced today the appointments of Curt Medeiros and Gregg Givens to its Board of Directors. Officially, Medeiros and Givens joined Cingulate’s board in September.

January 25, 2022
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6 min read
Bio NC

Pfizer and BioNTech Initiate Study to Evaluate Omicron-Based COVID-19 Vaccine in Adults 18 to 55 Years of Age

Pfizer Inc. and BioNTech SE announced the initiation of a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate in healthy adults 18 through 55 years of age.

January 25, 2022
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19 min read
Business

ADARx Pharmaceuticals Expands Leadership Team

ADARx Pharmaceuticals, Inc. today announced the expansion of their leadership team through the appointment of Christopher D. Claeboe, Ph.D., MBA as VP, CMC and Manufacturing.

January 25, 2022
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1 min read
Pharm Country

OraSure Technologies, Inc. Expands HIV Oral Swab In-home Test into Europe

OraSure Technologies, Inc., a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced that it has launched its OraQuick® HIV Self-Test, an oral swab in-home test for HIV-1 and HIV-2, into Europe.

January 25, 2022
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7 min read
Drug Development

Athira Pharma Announces Initiation of Patient Dosing in SHAPE, a Phase 2 Clinical Trial of ATH-1017 for the Treatment of Parkinson’s Disease Dementia and Dementia with Lewy Bodies

Athira Pharma, Inc. today announced that patient dosing has begun in SHAPE, a Phase 2 clinical trial of ATH-1017 for the treatment of Parkinson’s disease dementia and Dementia with Lewy bodies. ATH-1017 is a small molecule designed to enhance the activity of Hepatocyte Growth Factor (HGF).

January 25, 2022
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6 min read
Business

Mindset Pharma Enters Manufacturing Agreement with Leading CDMO to Produce Pharmaceutical Grade Batches of Next-Generation Psilocybin Drug Candidate, MSP-1014

Mindset Pharma Inc. today announced that it has entered into a pharmaceutical manufacturing agreement with a leading contract development and manufacturing organization (CDMO) for the production of pharmaceutical grade batches of Mindset’s next-generation psilocybin drug candidate, MSP-1014.

January 25, 2022
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3 min read
Drug Development

Nanoscope Therapeutics Announces FDA Clearance of IND for MCO-010 Gene Therapy in Stargardt Macular Degeneration Patients

Nanoscope Therapeutics Inc. today announced it received IND clearance from the FDA to begin a Phase 2 trial of its Multi-Characteristic Opsin (MCO-010) ambient-light activatable optogenetic monotherapy.

January 25, 2022
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2 min read
FDA

Senhwa’s Pidnarulex Receives US FDA Fast Track Designation for the Treatment of Solid Tumors with BRCA1/2, PALB2 and other HR Gene Mutations

Senhwa Biosciences, Inc. announced today that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for Pidnarulex, a first-in-class G-quadruplex stabilizer, for the treatment of patients with breast and ovarian cancers BRCA1/2, PALB2, or other HRD mutations.

January 25, 2022
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3 min read
FDA

Nevro Responds to Competitor’s Announcement of FDA Approval for Painful Diabetic Neuropathy

Nevro Corp. today responded to Medtronic’s announcement of FDA approval for painful diabetic neuropathy (PDN).

January 25, 2022
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8 min read