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Pink Sheet

Moderna COVID-19 Vaccine: Booster Study Hits Only One Of Two Immunogenicity Endpoints

By Sue Sutter 13 Oct 2021

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Immune responses to a single booster dose of mRNA-1273 would be considered successfully bridged to the two-dose primary series if each of two immunobridging criteria were met, but the mRNA vaccine missed the prespecified success criteria for seroresponse rate, the FDA said.

Medtech Insight

Digital Health Roundup, August/September 2021: Record Digital Health Funding Q1-3 Of $21.3Bn, AAOS Highlights, Regulatory Updates

By Marion Webb 12 Oct 2021

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In this roundup of developments in digital health, we highlight the key news and announcements from August and September.

Pink Sheet

CureVac Pulls Covid Vaccine From European Review Process

By Francesca Bruce 12 Oct 2021

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The company behind the CVnCOV COVID-19 vaccine candidate says the decision to withdraw from regulatory review is strategic. The EMA says outstanding issues affecting the benefit-risk balance remained to be answered at the time of withdrawal.

Medtech Insight

Medtech Companies Face Challenges And Choices When Going Public

By Barnaby Pickering 12 Oct 2021

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In a panel discussion at The Medtech Conference, hosted by AdvaMed, CEOs discussed the challenges, benefits and technicalities surrounding an IPO.

HBW Insight

Influencer Biz Getting Dicier; Instagram Celeb, His Manager And Attorney Talk Shop

By Ryan Nelson 08 Oct 2021

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At NAD 2021, Adam Waheed, an award-winning content creator with more than 17m social media followers, addressed challenges and legal risks that have escalated in recent years as influencer marketing opportunity exploded in the US and abroad.

Scrip

IPO Update: Average Return Turns Negative For Newly Public Biopharma Firms

By Mandy Jackson 05 Oct 2021

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With 88 initial public offerings in the US through the end of the third quarter of 2021, the biopharma industry is two IPOs ahead of the full-year 2020 total, but with an average return of -4% momentum may slow.

Scrip

Quick Listen: Scrip’s Five Must-Know Things

By Ian Haydock 04 Oct 2021

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In this week's podcast edition of Five Must-Know Things: the prospects for Merck’s Acceleron acquisition; the pandemic and biotech capital in-flow; an interview with Menarini’s CEO; upcoming endocrine and metabolic product disorders; and an interview with Novartis Pharma’s president.

Scrip

Merck’s Oral Antiviral Data In COVID-19 May Change Pandemic Outlook

By Joseph Haas 01 Oct 2021

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Merck/Ridgeback’s ribonucleoside analog shows nearly 50% reduction of risk for hospitalization or death in Phase III study. Firms will seek EUA in US; a contract is in place for 1.7 million courses of therapy.

Scrip

Sanofi’s Uses Latecomer COVID Data To Highlight Bigger mRNA Strategy

28 Sep 2021

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The French drug maker isn’t moving its mRNA COVID-19 vaccine into Phase III, instead focusing on a GSK-partnered protein SARS-CoV-2 vaccine and applying mRNA technology elsewhere.

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