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Boehringer Ingelheim GMBH

www.boehringer-ingelheim.com

Latest From Boehringer Ingelheim GMBH

Pediatric Exclusivity For ‘Deemed’ Biologics Needs Clarity, Industry Tells US FDA

Draft guidance says unexpired pediatric exclusivity would continue to apply to a deemed 351(a) BLA on March 23, 2020, but industry says differences in how pediatric exclusivity operates under the statutory frameworks governing drugs and biologics could result in the loss of some marketing protection.

Biosimilars Biologics

Insulin Maker Lilly Seeks US FDA Assurances On ‘Authorized Biologics’

Sponsor of an NDA-approved protein product subject to March 2020 ‘transition provisions’ should be able to seek biosimilar licensure of that same product without surrendering its ‘deemed’ 351(a) approval, company says, also requesting that FDA clarify parameters for ‘branded biosimilars.’

Biologics Biosimilars

Deal Watch: Roivant Spins Out Arvelle, Licenses Epilepsy Candidate From SK Biopharma

Already having launched several portfolio companies, Roivant goes a step further by spinning out CNS specialist Arvelle from Axovant. BI and IBM will incorporate blockchain technology in clinical trials, while AbbVie licenses multiple myeloma candidate from TeneoBio.

Business Strategies Commercial

Old Dog, New Tricks: Label Expansions Invigorate Diabetic Nephropathy Market

With four new entrants readying to be prescribed in the next four years, the market for diabetic nephropathy is looking more buoyant than ever. However, competition from GLP-1 agonists and eventually from generics could put a dampener on proceedings.

 

Metabolic Disorders Renal
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