BioSpace News Archive

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  Policy

  More Mandates Expected as FDA Gears Up for Full Approval of COVID-19 Vaccines

  As COVID-19 vaccines near full approval by the U.S. FDA, Dr. Anthony Fauci expects several organizations across the country, including businesses and schools, will issue their own vaccine mandates before people can enter their establishments.

  August 9, 2021

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  3 min read

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  Brandon May
• 

  Drug Development

  Notch Up Another Win for Enhertu, This One in Metastatic Breast Cancer

  The clinical study compared Enhertu to Kadcyla in HER2+ metastatic breast cancer patients who previously received trastuzumab.

  August 9, 2021

   · 

  3 min read

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  Mark Terry
• 

  Drug Development

  Ovoca Bio’s “Female Viagra” Nasal Spray Inching Closer to Market

  Called “female Viagra” in the media, Ovoca Bio’s BP-101 (Libicore) nasal spray therapy for low libidos in premenopausal women is undergoing Phase II trials.

  August 9, 2021

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  4 min read

   · 

  Gail Dutton
• 

  Deals

  Philip Morris Bolsters ‘Beyond Nicotine’ Strategy with OtiTopic Acquisition

  The acquisition of OtiTopic will boost the company’s new strategy and potentially address a significant unmet medical need in more than 83 million people in the U.S. with myocardial infarction.

  August 9, 2021

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  2 min read

   · 

  Alex Keown
• 

  Business

  Voyager Pipeline Transformation Takes Shape, Focused On Maximizing Novel AAV Capsids

  Voyager’s primary focus will be on developing gene therapies for Huntington’s disease, Amyotrophic Lateral Sclerosis (ALS), and pre-clinical research in spinal muscular atrophy and diseases linked to GBA1 mutations.

  August 9, 2021

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  3 min read

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  Heather McKenzie
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  Policy

  Spectrum Pharma’s Rolontis Denied in Neutropenia Due to Manufacturing Issues

  The company indicated they plan to meet with the FDA to determine the next course of action.

  August 9, 2021

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  2 min read

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  Mark Terry
• 

  Drug Development

  Sanofi Secures FDA Nod in Late-Onset Pompe Disease

  Sanofi has announced that the U.S. FDA approved its new treatment for children one year of age or older diagnosed with late-onset Pompe disease.

  August 9, 2021

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  2 min read

   · 

  Vanessa Doctor, RN
• 

  Business

  Mission and AbbVie Reach Second Milestone in Alzheimer’s, Parkinson’s Drug Research

  Mission Therapeutics and AbbVie announced their DUB inhibitor collaboration back in 2018.

  August 9, 2021

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  2 min read

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  Brandon May
• 

  Business

  Seagen Strikes $2.6 Billion ADC Deal with China’s RemeGen

  Seagen forged an exclusive licensing agreement with China’s RemeGen Co., Ltd, to develop and commercialize disitamab vedotin, a novel HER2-targeted ADC.

  August 9, 2021

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  2 min read

   · 

  Alex Keown
• 

  Drug Development

  Bluebird bio Takes Hit with FDA Clinical Hold on Gene Therapy

  The hold is related to a report of a SUSAR of myelodysplastic syndrome in a patient treated with eli-cel, also known as Lenti-D, in a Phase III clinical trial.

  August 9, 2021

   · 

  2 min read

   · 

  Alex Keown