On July 28, the FDA approved the country’s first interchangeable biosimilar product. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with, its reference product Lantus (insulin glargine).
Under...more
Federal Rule of Civil Procedure 26(a)(2) requires retained expert witnesses to provide an expert report which gives “a complete statement of all opinions the witness will express and the basis and reasons for them.” Fed. R....more
It is not often that a federal district court limits an expert witness’s proffered testimony on the ground that the expert is not qualified to offer it, and it is also uncommon for a court to exclude expert testimony on the...more
On December 8, 2020, the Second Circuit Court of Appeals affirmed the Southern District of New York’s granting of summary judgment in favor of Bayer — and resulting closure of all cases against Bayer — in the Mirena...more
On December 9, 2020, the Department of Health and Human Services (HHS) Secretary Alex Azar issued a new notice of declaration under the Public Readiness and Emergency Preparedness (PREP) Act (the Declaration) to provide...more
On December 3, 2020, the U.S. Department of Health and Human Services (HHS) amended its Public Readiness and Emergency Preparedness Act (PREP Act) Declaration for Medical Countermeasures Against COVID-19 in order to clarify...more
The Pennsylvania Superior Court, the state’s mid-level appellate court, recently held in Kornfeind v. New Werner Holding Co., 2020 PA Super 266, that Pennsylvania’s “borrowing statute” applies only to foreign statutes of...more
The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics...more
On June 15, 2020, the U.S. Food & Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) that permitted emergency distribution of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) from the...more
6/22/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Drug Treatment ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Off-Label Use ,
Pharmaceutical Industry ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Revocation ,
Secretary of HHS
Over the last seven weeks, industry participants contributing to the COVID-19 pandemic response efforts have looked to the Public Readiness and Emergency Preparedness Act (the PREP Act), 42 U.S.C. § 247d-6d, for critical...more
The Food and Drug Administration’s (FDA) recent draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and Answers,” offers insight and...more