Worldwide Blockbusters’ Movements during Sep., 2013


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Worldwide Blockbusters’ Movements during Sep., 2013

On Sep. 23, 2013, Ablynx landed $840M AbbVie deal on next-gen Humira successor. Based on this, AbbVie has whipped out the checkbook to close a partnership with Belgian antibody specialist Ablynx on one of its lead programs, paying $175 million upfront and promising up to $665 million more in milestones in exchange for a next-gen approach to rheumatoid arthritis that could eventually succeed Humira.

On Sep. 23, 2013, Roche won bragging rights to the FDA's new breakthrough therapy designation for its ALK inhibitor alectinib, a non-small cell lung cancer drug which will be featured at an upcoming presentation at the European Cancer Congress in Amsterdam at the end of this month. This is Roche's ($RHHBY) second BTD (its first went to the Phase III chronic lymphocytic leukemia drug obinutuzumab), which puts the pharma giant in league with Novartis ($NVS) and Johnson & Johnson ( $JNJ).

On Sep. 23, 2013, five years after Merck was handed a rejection for sugammadex, the FDA has come back with another complete response letter stiff-arming the pharma giant's latest attempt to get marketing authorization for the anesthesia drug.

On Sep. 23, 2013, Cambridge, MA-based Alnylam Pharmaceuticals ($ALNY) said it garnered positive interim data from a Phase I study of ALN-TTRsc, an RNAi therapy targeting the transthyretin gene for the treatment of TTR-mediated amyloidosis.

On Sep. 20, 2013, A European Union regulator recommended approval of 11 new drugs for a range of diseases such as HIV, breast cancer and diabetes. And the nods could lead to final approvals from the European Commission in the coming months. Many of the drugs have already gained FDA approvals, yet the European Medicines Agency noted that the 11 recommendations for approval from its Committee for Medicinal Products for Human Use (CHMP) mark the most nods in a single meeting this year.

Article Link: Worldwide Blockbusters’ Movements during Sep., 2013

Tags: Drug Development,  Antibody,  Cancer,  FDA

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