BioSpace News Archive

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  Policy

  Biogen Officially Weighs in On Medicare Draft Guidance for Aduhelm

  CMS issued a draft decision for Biogen’s Alzheimer’s drug and said it would only cover the cost of Aduhelm and any required scans “if they are enrolled in qualifying clinical trials.”

  February 11, 2022

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  4 min read

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  Mark Terry
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  Drug Development

  Study: COVID-19 Infection Can Attack Placenta, Increasing Risk of Stillbirth

  New research published this week gives a greater understanding of why the CDC warned of an increased risk of stillbirth for women infected by SARS-CoV-2 during pregnancy in November.

  February 11, 2022

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  3 min read

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  Kate Goodwin
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  Drug Development

  Pfizer-BioNTech COVID-19 Vaccine for Kids Under 5: What We Know

  On Feb. 15, the FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to discuss an amended EUA for the Pfizer-BioNTech vaccine in the under 5 age group.

  February 11, 2022

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  3 min read

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  Mark Terry
• 

  Drug Development

  2-Year Data from Genentech AMD/DME Drugs Reinforce Relief

  New two-year data from Phase III studies of Susvimo and Vabysmo reinforce the two drugs’ potential to improve the quality of life of patients diagnosed with DME and nAMD.

  February 11, 2022

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  2 min read

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  Vanessa Doctor, RN
• 

  Drug Development

  The Show Will Go On for Cassava after FDA Denies Citizen Petition

  Shares of Cassava Sciences are up more than 5% in premarket trading after the FDA denied a Citizen Petition filed last year to suspend the company’s Alzheimer’s clinical trials.

  February 11, 2022

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  3 min read

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  Alex Keown
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  Drug Development

  COVID-19 Update: Potential Link Between mRNA Vaccines and Menstrual Disorders

  The EMA’s safety committee has announced that they are reviewing reports of menstrual disorders after people received COVID-19 vaccinations from Pfizer-BioNTech and Moderna.

  February 11, 2022

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  2 min read

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  Hayley Shasteen
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  Business

  Fujifilm Launches $60 Million VC Fund for Early-Stage Biotech

  The fund will be used to target partnerships with promising early-stage biotechnology to enhance Fujifilm’s life sciences portfolio.

  February 11, 2022

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  3 min read

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  Hannah Chudleigh
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  Drug Development

  Curevo Nets $60M for Adjuvant-Saving Shingles Vaccine

  Curevo, a clinical-stage biotechnology company, is developing safe and highly-effective vaccines to fight infectious diseases such as shingles.

  February 11, 2022

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  2 min read

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  Claudia Beezhold
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  Drug Development

  Pfizer Postpones EUA in Kids Under 5, will Wait for Full Data

  Pfizer indicated it will wait for the full data on a three-dose series of the vaccine for that population, believing it “may provide a higher level of protection in this age group.

  February 11, 2022

   · 

  4 min read

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  Mark Terry
• 

  Drug Development

  Positive Data in Hand, Novavax Eyes Adolescent COVID-19 Vaccine Approval

  The promising results from the pediatric expansion are what fuels Novavax’s next move to apply for regulatory approval for the 12-to-17-year age group by the first quarter of 2022.

  February 11, 2022

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  2 min read

   · 

  Vanessa Doctor, RN