BioSpace News Archive

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• 

  RSV

  Merck Challenges AstraZeneca, Sanofi With Phase IIb/III Data for RSV Antibody

  Merck’s clesrovimab lowered the risk of medically attended lower respiratory infections associated with RSV infection when used in infants, according to topline results announced Tuesday.

  July 23, 2024

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  2 min read

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  Tristan Manalac
• 

  Drug Development

  GSK’s Dovato Matches Efficacy of Gilead’s Biktarvy in Head-to-Head HIV Trial

  In the largest study of its kind, GSK’s two-drug regimen Dovato demonstrated non-inferior efficacy compared to Gilead Sciences’ three-drug regimen Biktarvy for the treatment of HIV-1.

  July 23, 2024

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  2 min read

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  Kate Goodwin
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  Mergers & acquisitions

  Agilent Pays $925M to Buy CDMO Biovectra to Boost Biologics, CRISPR Capabilities

  The acquisition of the contract development and manufacturing organization will allow Agilent Technologies to provide a one-stop source for gene-editing services for its customers.

  July 23, 2024

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  2 min read

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  Tristan Manalac
• 

  Regulatory

  SEC Hits Allarity With Wells Notice, Flags Alleged Violations in FDA Meeting

  Allarity Therapeutics announced Monday that the Securities and Exchange Commission has made a preliminary determination recommending an enforcement action against the company for alleged violations of federal securities laws.

  July 23, 2024

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  2 min read

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  Tristan Manalac
• 

  Gene therapy

  HHS Issues Negative Opinion on Bluebird’s Fertility Support Program for Gene Therapies

  The Department of Health and Human Services’ Office of the Inspector General found that bluebird bio’s fertility support program for its gene therapies could potentially violate federal anti-kickback statutes.

  July 23, 2024

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  2 min read

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  Tristan Manalac
• Business

  STERIS to Host a Conference Call for Fiscal 2025 First Quarter Financial Results on August 7, 2024

  July 23, 2024

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  7 min read
• Business

  Aquestive Therapeutics to Report Second Quarter 2024 Financial Results and Recent Business Highlights on August 6 and Host Conference Call on August 7 at 8:00 a.m. ET

  July 23, 2024

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  3 min read
• FDA

  Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Foam to the FDA for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over

  July 23, 2024

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  9 min read
• Press Releases

  Jaguar Health Reports Phase 3 OnTarget Trial Results for its Cancer Supportive Care Drug Crofelemer

  July 23, 2024

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  10 min read
• Press Releases

  Astrana Health, Inc. Schedules 2024 Second Quarter Financial Results Release and Conference Call

  July 23, 2024

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  2 min read