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Novartis signs initial agreement with CureVac to manufacture COVID-19 vaccine candidate

The Pharma Data

Novartis announced today that it has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic. Preparations for the start of production, technology transfer and test runs are already underway.

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law Blog: Biosimilars

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

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Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. government fiscal year runs from October 1 – September 30. As AgencyIQ has previously discussed , developing biosimilars is an expensive process. As a reminder, the U.S.

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FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

The Pharma Data

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

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Available for Preorder: The 2022 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Drug Channels

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. Download a free report overview for more details.

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WORLD’S LARGEST BROWSABLE RESOURCE LINKING RARE PROTEIN-CODING GENETIC VARIANTS TO HUMAN HEALTH AND DISEASE

The Pharma Data

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Source link: [link].

Disease 52
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Collaboration between AbbVie, Biogen and Pfizer creates world’s largest browsable resource linking rare protein-coding genetic variants to human health and disease

The Pharma Data

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Source link: [link].

Disease 52