20:41 , Oct 5, 2018 |  BC Week In Review  |  Company News

Momenta cutting biosimilar programs, headcount

Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) said it plans to terminate five biosimilar development programs under its 2016 co-development deal with Mylan N.V. (NASDAQ:MYL) and reduce headcount by about 50% to focus on its novel pipeline. The...
23:34 , Oct 3, 2018 |  BC Extra  |  Politics & Policy

Phage display founders win Nobel for chemistry

The 2018 Nobel Prize for Chemistry was awarded to three scientists for their work on directed evolution of proteins and enzymes, which led to the development of human antibody-based therapeutics. The first, Humira adalimumab from...
23:52 , Oct 1, 2018 |  BC Extra  |  Company News

Momenta cutting biosimilar programs, headcount

Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) said it plans to terminate five biosimilar development programs under its 2016 co-development deal with Mylan N.V. (NASDAQ:MYL) and reduce headcount by about 50% to focus on its novel pipeline. The...
20:38 , Sep 21, 2018 |  BioCentury  |  Politics, Policy & Law

Filling the rebate void

HHS’s proposal to eliminate drug rebates should have the intended consequence of increasing transparency into drug pricing in the short term. But the long view is that value-based pricing or alternative co-pay agreements will do...
17:06 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

CHMP positive on patisiran, Symkevi, Humira and Neulasta biosimilars

EMA's CHMP recommended a number of approvals July 26, including Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), Symkevi tezacaftor/ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), a handful of cancer therapies and three biosimilars. The committee recommended...
22:08 , Jul 27, 2018 |  BC Extra  |  Company News

CHMP positive on patisiran, Symkevi, Humira and Neulasta biosimilars

EMA's CHMP recommended a number of approvals Friday, including Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), Symkevi tezacaftor/ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), a handful of cancer therapies and three biosimilars. The committee recommended approval...
21:26 , Jul 27, 2018 |  BioCentury  |  Regulation

Biosimilar barriers

A coming showdown over anticompetitive contracting practices, coupled with an impending wave of patent expirations, could result in a wave of biosimilar approvals and launches in the U.S. over the next year, according to biosimilars...
02:23 , Jun 30, 2018 |  BioCentury  |  Product Development

Defining access potential - before it’s too late

We see it everywhere: confirmation bias. Innovators believe in a drug, find the evidence to support its value, and dismiss or ignore the facts challenging their preferred story. But confirmation bias is particularly problematic thanks...
17:50 , Jun 29, 2018 |  BioCentury  |  Regulation

Biosimilars do-over

As part of an initiative to stimulate biosimilar competition, FDA is planning a do-over of draft guidance on statistical methods for demonstrating biosimilarity to a reference product. The agency announced on June 21 it was...
18:29 , Jun 8, 2018 |  BC Week In Review  |  Clinical News

CHMP recommendations include Aimovig, orphan candidates

Among a host of positive recommendations announced on June 1, EMA's CHMP backed approval of migraine therapy Aimovig erenumab and Orphan Drug designees Tegsedi inotersen for hereditary transthyretin (TTR) amyloidosis and Myalepta metreleptin for leptin...