Newsletter | January 7, 2016

01.07.16 -- Momenta Pharmaceuticals: Sizing Up Biosimilar Challenges & Opportunities

Biosimilar Development
 
Featured Editorial
Momenta Pharmaceuticals: How To Unlock The "Black Box" Of Biosimilars
By Anna Rose Welch, Editor, Biosimilar Development   By Anna Rose Welch, Editor, Biosimilar Development
Complex drugs (including biologics) were once considered a black box filled with inexplicable structures and incomprehensible variabilities. However, as Momenta’s Craig Wheeler describes, when it comes to tackling the complexity of biosimilars, it comes down to having the “right lens” to succeed scientifically and commercially.
The BPCIA After Amgen v. Sandoz
By Gary Levin and Ron Kern, BakerHostetler   By Gary Levin and Ron Kern, BakerHostetler
The Federal Circuit’s recent decision to not rehear the Amgen Inc. v. Sandoz, Inc. case leaves open several important issues under the BPCIA. Whether or not the Supreme Court reviews the issues from the final Federal Circuit decision, other important questions about the BPCIA remain to be addressed.
The Next Generation Of Drug-Delivery Devices
Phillips-Medisize   Phillips-Medisize
An exciting trend in drug delivery is underway: the movement toward smaller, smarter, wirelessly connected electronic devices that allow patient-administered therapy. Inspired by the technological advancements driving the consumer electronics market, new methods for drug delivery show great promise for all stakeholders.
News Headlines
Baxalta, Momenta Announce HUMIRA Biosimilar Met Primary Endpoint In Pharmacokinetic Study
FDA Approves Basaglar, First FDA-Approved Follow-On Insulin Glargine Treatment
Statement By Chip Davis, President And CEO, GPhA, Regarding BsUFA Reauthorization
Blockbuster Launches And Limited Impact Of U.S. Biosimilar Entrants Sustain Biopharma's Momentum In 2016
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