BioSpace News Archive

CRISPR-Cas9 genome editing enzyme, 3d illustration

Patient Death Likely from Virus Used to Deliver Gene-Editing Therapy: NEJM Study

The New England Journal of Medicine study suggests that the 2022 death of a Duchenne muscular dystrophy patient was due to an adverse effect of recombinant AAV used to deliver the gene therapy.

September 28, 2023

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2 min read

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Tristan Manalac

Pictured: J&J sign and office in Ontario/i

Drug Development

J&J’s Rybrevant in Combo with Lazertinib Clears Phase III in NSCLC

Non-small cell lung cancer patients treated with the drug combination saw a statistically significant and clinically meaningful improvement in progression-free survival compared to AstraZeneca’s osimertinib.

September 28, 2023

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2 min read

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Tristan Manalac

Pictured: Roche tower in Basel, Switzerland

Business

Roche Doubles Down on Alzheimer’s, Huntington’s with $60M Ionis Partnership

The companies, which have been partners for a decade on various research programs, are pooling their efforts in two early-stage programs for Alzheimer’s and Huntington’s diseases using RNA-targeting medicines.

September 28, 2023

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2 min read

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Connor Lynch

Pictured: Person applies eye drops/iStock, megaflo

FDA

FDA Approves Viatris, Ocuphire’s Eye Drops to Reverse Pupil Dilation

The companies on Wednesday secured the regulator’s approval for their eye drop Ryzvumi for the reversal of pharmacologically-induced mydriasis, as Viatris looks to add $1 billion in sales by 2028.

September 28, 2023

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2 min read

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Tristan Manalac

Right and left sides of the brain/iStock, Warrenra

Drug Development

Karuna Submits Highly Anticipated NDA for KarXT in Schizophrenia

If approved by the FDA, Karuna Therapeutics’ investigational agonist of muscarinic acetylcholine 1 receptors M1 and M4 would provide the first new mechanism of action for schizophrenia patients in decades.

September 28, 2023

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3 min read

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Heather McKenzie

Pictured: Tinfoil crumpled into the shape of a hum

Drug Development

Parkinson’s Research Buoyed by Alzheimer’s Advances

After a groundbreaking year in the Alzheimer’s space, Parkinson’s disease researchers express renewed hope based on a greater biological understanding of neurodegeneration.

September 28, 2023

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6 min read

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Maddie Bender

Pictured: FDA sign at Washington D.C. headquarters

Policy

FDA Action Alert: Amgen, Alnylam and BMS

The FDA will kick off October with an advisory committee meeting for Amgen’s Lumakras and target action dates for Alnylam’s patisiran and Bristol Myers Squibb’s Opdivo.

September 28, 2023

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4 min read

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Tristan Manalac

Hemogenyx Pharmaceuticals PLC Announces Half-Year Report - September 28, 2023

Hemogenyx Pharmaceuticals plc, the Standard Listed biopharmaceutical group developing therapies designed to transform blood disease treatment, announces its unaudited interim results for the six-month period ended 30 June 2023.

September 28, 2023

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9 min read

Lone Star Bio

Lexicon to Present Post Hoc Analysis of Scored Clinical Trial at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2023

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that a new analysis of clinical trial data for INPEFA® (sotagliflozin) will be presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting, October 6-9, 2023 in Cleveland, Ohio.

September 28, 2023

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10 min read

Pharm Country

Nusano to Participate in October 2023 Investor Conferences

Nusano, Inc., a company reshaping the production of cancer-fighting radioisotopes, announced that senior management will participate in the following investor conferences in October.

September 28, 2023

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1 min read