BioSpace News Archive

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• 

  FDA

  Eli Lilly and AbCellera Win EUA for COVID-19 Antibody Treatment

  Bamlanivimab, an intravenous treatment, should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

  November 10, 2020

   · 

  3 min read

   · 

  Alex Keown
• 

  Business

  Affimed Joins Forces with Roivant in Fight Against Cancer

  Affimed receives $60 million up front with potential for up to $2 billion more in partnership deal with Roivant Sciences.

  November 10, 2020

   · 

  2 min read

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  Kate Goodwin
• 

  Drug Development

  Does Talaris’ Investigational Cell Therapy Have Potential to Be a ‘Pipeline in a Product’?

  Talaris Chief Executive Officer Scott Requadt sees FCR001, the company’s investigational cell therapy, as a potential pipeline in a product (an experimental treatment that could have multiple uses across a number of indications).

  November 10, 2020

   · 

  4 min read

   · 

  Alex Keown
• 

  Drug Development

  CureVac’s COVID-19 Vaccine Candidate Shows Positive Results in Phase I

  The interim analysis demonstrated that two doses of the vaccine ranging from 2 micrograms to 12 micrograms per dose, given 28 days apart, were safe, with no vaccine-related serious adverse events.

  November 10, 2020

   · 

  3 min read

   · 

  Mark Terry
• 

  Job Trends

  The Future Looks Bright for mRNA-based Vaccines

  It isn’t often that a contestant pulls ahead in a major contest and their competitor wins too, but Moderna – along with other COVID-19 vaccine contenders – will take it.

  November 10, 2020

   · 

  2 min read

   · 

  Heather McKenzie
• 

  Drug Development

  Sinovac, Merck and Other Companies Pause Some Clinical Programs

  Here’s a look at recent clinical trial pauses around the biopharma industry.

  November 10, 2020

   · 

  3 min read

   · 

  Alex Keown
• 

  Axovant Changes Name to Sio Gene Therapies, Adding to List of Biopharma Company Rebrands

  Clinical-stage gene therapy company Axovant Gene Therapies is changing its name to Sio Gene Therapies, a move that will likely further distance the company from disappointing results of its Alzheimer’s candidate just three years ago.

  November 10, 2020

   · 

  3 min read

   · 

  Brandon May
• 

  Drug Development

  Could Keytruda/Lenvima Combo Help Treat Advanced Renal Cell Carcinoma?

  Merck and Eisai announced today that they have new investigational data demonstrating positive top-line results from the Phase III KEYNOTE-581/CLEAR trial (Study 307).

  November 10, 2020

   · 

  3 min read

   · 

  Krystle Vermes
• 

  Business

  BIO Chairman: FDA Vaccine Reviews Too Complex and Costly for States to Replicate

  Several states have pledged to review COVID-19 vaccines themselves, after FDA emergency use authorizations, to ensure safety and efficacy. A robust review, however, is unlikely.

  November 10, 2020

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  4 min read

   · 

  Gail Dutton
• 

  Drug Development

  Amgen and AstraZeneca’s Tezepelumab Looking to Be First-in-Class Asthma Treatment

  Amgen and AstraZeneca announced that their Phase III NAVIGATOR trial of Tezepelumab hit the primary endpoint in severe asthma.

  November 10, 2020

   · 

  3 min read

   · 

  Mark Terry