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...
20:47 , Jun 12, 2018 |  BC Extra  |  Politics & Policy

BIO chair outraged by nude dancer party

An industry party held during the BIO annual meeting in Boston has been excoriated by the trade organization for featuring nude or partially clothed female dancers. The trade organization’s chairman called on the party’s sponsors to...
23:09 , Apr 6, 2018 |  BioCentury  |  Finance

Fundamentally driven

Continued struggles by the mega-cap bellwethers and the resurgence of volatility in global equity markets were the major themes of 1Q18, whipsawing biotech stocks throughout the quarter but leaving index values little changed on the...
20:47 , Feb 16, 2018 |  BC Week In Review  |  Clinical News

FDA approves second generic of thrice-weekly Copaxone

The Sandoz Ltd. unit of Novartis AG (NYSE:NVS; SIX:NOVN) and partner Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) said FDA approved an ANDA for thrice-weekly 40 mg/mL Glatopa glatiramer acetate injection as a generic version of multiple sclerosis...
22:52 , Feb 13, 2018 |  BC Extra  |  Company News

FDA approves second generic of thrice-weekly Copaxone

The Sandoz Ltd. unit of Novartis AG (NYSE:NVS; SIX:NOVN) and partner Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) said FDA approved an ANDA for thrice-weekly 40 mg/mL Glatopa glatiramer acetate injection as a generic version of multiple sclerosis...
00:37 , Jan 31, 2018 |  BC Extra  |  Company News

Pfizer to invest $5B in U.S. manufacturing

In its earnings release Tuesday, Pfizer Inc. (NYSE:PFE) announced plans to invest $5 billion over five years in U.S. capital projects in the wake of the new U.S. tax code. The pharma also said FDA...
17:35 , Jan 12, 2018 |  BC Week In Review  |  Clinical News

Momenta reports Phase I data for anti-FCRN mAb

Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) said its immune-mediated disease candidate M281 was safe and showed proof of mechanism in a Phase I trial in healthy volunteers. M281 is a human IgG1 mAb against neonatal Fc receptor...
23:59 , Jan 5, 2018 |  BC Extra  |  Clinical News

Momenta gains on Phase I data for anti-FCRN mAb

Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) added $2.80 (19%) to $17.55 on Friday after reporting that its immune-mediated disease candidate M281 was safe and showed proof of mechanism in a Phase I trial in healthy volunteers. M281...
06:30 , Nov 3, 2017 |  BC Week In Review  |  Clinical News

Biosimilar Orencia from Momenta and Mylan misses in PK trial

Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) and Mylan N.V. (NASDAQ:MYL; Tel Aviv:MYL) said their proposed biosimilar of Orencia abatacept, M834, missed the primary pharmacokinetic endpoints compared to U.S.- and EU-sourced Orencia in a Phase I trial in...
17:50 , Nov 2, 2017 |  BC Innovations  |  Product R&D

Sweet specificity

Siamab Therapeutics Inc. is gearing up to compete in the small but active space of companies targeting sugar groups that are up-regulated in cancer. So far, its technology has produced a lead therapeutic, a deal...