17:25 , Sep 28, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP on Sept. 21 recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta...
21:45 , Sep 21, 2018 |  BC Extra  |  Company News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP Friday recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta Therapeutics (NASDAQ:SRPT)...
17:21 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

Takeda's Alunbrig meets in Phase III for first-line NSCLC

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said first-line treatment with Alunbrig brigatinib met the primary endpoint of improving independent review committee (IRC)-assessed progression-free survival (PFS) vs. Xalkori crizotinib in the Phase III ALTA-1L trial to treat...
22:55 , May 11, 2018 |  BioCentury  |  Strategy

Takeda hits the gas

Takeda Pharmaceutical Co. Ltd.’s proposed acquisition of Shire plc is an acceleration of -- not a departure from -- CEO Christophe Weber’s stated strategy to build a top-tier global pharma, according to management. On May...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
23:40 , Jul 7, 2017 |  BioCentury  |  Finance

Onward and upward

The top three market cap tiers continued to outperform smaller caps in 2Q17, led by companies valued between $1 billion and $9.9 billion. Companies valued below $1 billion failed to carry over their momentum from...
00:45 , Jun 24, 2017 |  BioCentury  |  Strategy

Takeda’s modality operandi

Takeda Pharmaceutical Co. Ltd. is moving beyond its traditional small molecule approach into new modalities with the goal of delivering therapeutics that provide a step change for patients. To get there, Takeda is using a...
21:58 , May 26, 2017 |  BC Extra  |  Company News

FDA expands Zykadia's label to first-line NSCLC

FDA granted regular approval to Zykadia ceritinib from Novartis AG (NYSE:NVS; SIX:NOVN) for the first-line treatment of metastatic non-small cell lung cancer in anaplastic lymphoma kinase (ALK)-positive patients. The small molecule ALK inhibitor had accelerated...
16:06 , May 4, 2017 |  BC Week In Review  |  Clinical News

FDA approves Takeda's Alunbrig

FDA granted accelerated approval to Alunbrig brigatinib (AP26113) from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) to treat metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) in patients who have progressed on, or are intolerant...
22:26 , Apr 28, 2017 |  BC Extra  |  Company News

FDA approves Takeda's Alunbrig

FDA granted accelerated approval to Alunbrig brigatinib from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) to treat metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) in patients who have progressed on or are intolerant to...