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 approval...
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 of...
18:54 , Jul 13, 2018 |  BC Week In Review  |  Company News

Celgene, Accord settle Revlimid patent litigation

Celgene Corp. (NASDAQ:CELG) granted Accord Healthcare Ltd. (Middlesex, U.K.) rights to market an authorized generic version of cancer and hematology drug Revlimid lenalidomide starting on Jan. 18, 2022, in the U.K., according to a SEC...
07:00 , Sep 28, 2015 |  BC Week In Review  |  Company News

Allergan, Accord Healthcare Ltd., Novartis, Takeda cancer news

The U.S. District Court for the District of Delaware ruled that the ANDAs submitted by Novartis’ Sandoz unit, Accord Healthcare and Actavis LLC (now known as Allergan) for a generic version of Velcade bortezomib...
07:00 , Aug 4, 2014 |  BC Week In Review  |  Clinical News

Accofil filgrastim regulatory update

EMA’s CHMP issued a positive opinion recommending approval of an MAA from Intas’ Accord Healthcare Ltd. subsidiary for Accofil filgrastim. The product is a biosimilar of Neupogen filgrastim, a recombinant methionyl human G-CSF marketed...
07:00 , Jul 15, 2013 |  BC Week In Review  |  Company News

Intas Pharmaceuticals Ltd, Roche cancer news

Roche granted Intas' Accord Healthcare Ltd. subsidiary rights to market a generic version of Roche's Xeloda capecitabine in the U.S. ahead of the Dec. 14, 2013, expiration of the patent covering Xeloda. The deal...
07:00 , Oct 10, 2011 |  BC Week In Review  |  Company News

Intas Pharmaceuticals, AstraZeneca, Handa Pharmaceuticals neurology, generics news

AstraZeneca settled a pair of suits filed in the U.S. District Court for the District of New Jersey regarding ANDAs for generic versions of antipsychotic drug Seroquel XR quetiapine. Under the settlements, AstraZeneca granted...
07:00 , Jul 25, 2011 |  BC Week In Review  |  Clinical News

Actos pioglitazone regulatory update

EMA's CHMP recommended updating the label for Actos pioglitazone from Takeda to include additional warnings about the risk of bladder cancer, but did not recommend withdrawing the diabetes drug. While the committee concluded there is...