BioSpace News Archive

Deals

Charles River Laboratories Acquires SAMDI Tech

Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it has acquired SAMDI Tech, Inc , a leading provider of high-quality, label-free high-throughput screening (HTS) solutions for drug discovery research.

January 30, 2023
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4 min read
FDA

Stemline Therapeutics Receives U.S. FDA Approval for ORSERDUTM (elacestrant) as the First and Only Treatment Specifically Indicated for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer

Stemline Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved ORSERDU for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

January 30, 2023
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9 min read
FDA

Xeris Biopharma Announces FDA Grants Orphan-drug Exclusivity for Recorlev®

Xeris Biopharma Holdings, Inc. today announced that the Food and Drug Administration (FDA) granted its subsidiary Xeris Pharmaceuticals, Inc., orphan-drug exclusivity (ODE) for Recorlev® (levoketoconazole) for the treatment of adult patients with endogenous Cushing’s syndrome for whom surgery is not an option or has not been curative.

January 30, 2023
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13 min read
Bio NC

Asensus Surgical to Host Investor Day on February 21, 2023

Asensus Surgical, Inc. today announced that the Company will host an Investor Day on Tuesday, February 21, 2023 in New York City.

January 30, 2023
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1 min read
Drug Development

Vera Therapeutics Releases 36 Week Interim Analysis of Phase 2b Clinical Trial of Atacicept for the Treatment of IgA Nephropathy

Vera Therapeutics, Inc. today announced results from a prespecified per-protocol (PP) analysis of the Phase 2b ORIGIN clinical trial of atacicept in patients with IgA nephropathy (IgAN) following announcement of topline results on January 3, 2023.

January 30, 2023
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11 min read
First Wave BioPharma to Present at the BIO CEO & Investor Conference

First Wave BioPharma, Inc. announced James Sapirstein, Chairman, President and CEO, will present at the BIO CEO & Investor Conference being held February 6-9, 2023, at the Marriott Marquis in New York City.

January 30, 2023
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3 min read
Drug Development

Aptose Initiates Dosing of Tuspetinib in APTIVATE Expansion Trial in Patients with Acute Myeloid Leukemia

Aptose Biosciences Inc. today announced the 120 mg monotherapy dosing of patients in the APTIVATE Phase 1/2 clinical trial of tuspetinib.

January 30, 2023
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6 min read
Deals

Tonix Pharmaceuticals Regains Compliance with Nasdaq Minimum Bid Price Requirement - January 30, 2023

Tonix Pharmaceuticals Holding Corp. announced today that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market.

January 30, 2023
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4 min read
Drug Development

Equilibre Biopharmaceuticals Announces Positive Topline Results from Phase 2 Clinical Trial of EQU-001 (NCT05063877) for Safety, Tolerability and Preliminary Efficacy as Adjunctive Therapy for Focal Seizures in Adults with Epilepsy

Equilibre Biopharmaceuticals Corp. today reported positive topline results from the Phase 2 clinical trial evaluating the clinical safety, tolerability, and preliminary efficacy of EQU-001 – a novel anti-inflammatory anti-seizure medication - administered as once-daily oral adjunctive therapy for focal seizures in adults with epilepsy.

January 30, 2023
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9 min read
Philips sees some improvement in Q4 2022 and takes firm actions to address operational challenges in an uncertain environment

2022 has been a very difficult year for Philips and our stakeholders, and we are taking firm actions to improve our execution and step up performance with urgency.

January 30, 2023
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15 min read