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M. Nielsen Hobbs

Executive Editor

Washington DC
M. Nielsen Hobbs has more than 20 years of experience covering the pharmaceutical industry, and writes frequently about the intersection of business, regulation, science and politics. Before joining the “The Pink Sheet” he worked for Congressional Quarterly. Hobbs enjoys discussing BB-8 almost as much as he enjoys talking about 351(k).
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Latest From M. Nielsen Hobbs

Generic Association CEO Davis Jumps To Wholesalers Group

Association for Accessible Medicines’ interim leader is General Counsel Jeffrey Francer; Chip Davis’ four-and-half year tenure included a total rebrand of the association, a significant legislative victory with the CREATES act – and an abrupt departure for the Healthcare Distribution Alliance.

Biosimilars Generic Drugs

Predicting The User Fee Reauthorization Schedule

PDUFA and GDUFA negotiations are expected to begin first, as they usually take the longest to complete, and will be followed by BsUFA talks.

User Fees Review Pathway

Medicaid Demo’s Formularies Include Protections For HIV, Behavioral Health Drugs

Healthy Adult Opportunity initiative (don’t call it block grants) adopts some, but not all, of Medicare Part D’s protected classes, allowing states to exclude some drugs from coverage in the expansion Medicaid population to drive additional savings.

Medicaid Reimbursement

Coronavirus Not Impacting Rx Manufacturing Supply Chain – Yet

US FDA’s drug shortage team continues to check in with sponsors, but so far the infections and quarantines have not impacted drug production.

Manufacturing Infectious Diseases

Orphan Exclusivity For Gene Therapies Hinges On Two Big Factors

US FDA draft guidance says that ‘minor differences’ in transgenes and/or vectors won’t be enough for orphan exclusivity, but agency will consider ‘additional features of the final product’ in making the determination.

Gene Therapy Rare Diseases

US FDA’s Precision Medicine Efforts Turn Towards Adverse Events

Next PrecisionFDA challenge aims to detect ‘adverse event anomalies’ including manufacturer-specific patterns and drug-drug interactions.

Drug Safety Personalized Medicine
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