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Drug Channels News Roundup, June 2021: Amazon's Latest, Patients vs. Accumulators, Generics & Biosimilars, 340B Games, and a Hospital Road trip

Drug Channels

As you declare your vaccinated independence, celebrate with these Drug Channels fireworks: Amazon’s teeny step toward pharmacy disruption How patients view copay accumulators My $0.02 on generic and biosimilar trends Some hospitals seem to be gaming their 340B eligibility Plus, tips on effective hospital marketing.

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

Drug Channels

New sections cover: pharmacies’ administration of—and profits from—COVID-19 vaccines; smaller PBMs; PBM purchasing groups and GPOs; 340b split-billing software vendors; and shakeout and consolidation within retail pharmacy. We also present a more unified outlook for specialty drugs, including specialty generics and biosimilars.

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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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New MS PATHS Data at ECTRIMS 2021 Confirm Biogen’s Disease-Modifying Therapies Do Not Reduce Antibody Response to COVID-19 Vaccines in People with Multiple Sclerosis

The Pharma Data

Biogen today announced results of a new analysis of immune response to the COVID-19 vaccine among people with multiple sclerosis (MS). Germany and Spain, researchers evaluated blood samples from 322 participants 28-90 days after their last COVID-19 vaccine dose. Using data from the MS PATHS network in 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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FDA Action Alert: MacroGenics and Amgen

The Pharma Data

Food and Drug Administration (FDA) ’s focus appears to be on Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines, as the year wraps up there are still some PDUFA dates on the agency’s calendar. Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. Although much of the U.S. Read on for this week’s.

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Navigating FDA User Fee Updates for Fiscal Year 2023

thought leadership

Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs (including small molecules, vaccines, cell and gene therapy products, biologics, etc.), Generic Drugs, Biosimilars, and Medical Devices.

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