01:40 , Aug 18, 2018 |  BioCentury  |  Regulation

Pediatric push

FDA has endorsed extrapolation of therapeutic efficacy from adults to children for new drugs to treat partial onset seizures in a draft guidance and is now discussing in public meetings whether the approach can be...
18:22 , Jul 26, 2018 |  BC Innovations  |  Translation in Brief

A plasticity problem

New research from the University of Bordeaux suggests the synaptic pathology underlying Alzheimer’s disease is driven by aberrant activation of CAMK2 by β-amyloid oligomers. The findings may point to the missing link in how β-amyloid...
01:46 , May 5, 2018 |  BioCentury  |  Product Development

Rebuilding Biogen’s brain

Biogen Inc. is still a long way from a full rebuild of its pipeline, with an Alzheimer’s disease-laden Phase III lineup that needs to diversify. But there’s progress in the early- to mid-stage programs where...
15:22 , May 4, 2018 |  BC Week In Review  |  Company News

Accelerator launches Proniras to develop anticonvulsant

Accelerator Life Science Partners (Seattle, Wash.) launched newco Proniras Corp. (Seattle, Wash.) to develop tezampanel (LY293558) to treat nerve agent-induced seizures. Proniras has received an $89.5 million award from HHS’s Biomedical Advanced Research and Development...
19:57 , May 3, 2018 |  BC Innovations  |  Translation in Brief

New Therapeutic Targets and Biomarkers: April 2018

New Therapeutic Targets and Biomarkers: April 2018 Select top therapeutic targets and biomarkers covered by BioCentury or added to the BCIQ database during April 2018. Therapeutic targets are defined as any protein, gene or other...
21:16 , Apr 24, 2018 |  BC Extra  |  Company News

Biogen looks to ex-U.S. markets for growth

Biogen Inc. (NASDAQ:BIIB) perceives greater long-term growth opportunities than anticipated in the EU and emerging markets, the company's CEO Michel Vounatsos said on its earnings call Tuesday, while noting that the U.S. market remains its...
16:44 , Mar 16, 2018 |  BC Week In Review  |  Company News

Biogen scoops up neuropsychiatry candidate from Pfizer

Biogen Inc. (NASDAQ:BIIB) will acquire neuropsychiatry candidate PF-04958242 from Pfizer Inc. (NYSE:PFE) for $75 million up front. The pharma is eligible for $515 million in milestones, plus tiered royalties ranging from the low to mid...
18:23 , Mar 12, 2018 |  BC Extra  |  Company News

Biogen scoops up neuropsychiatry candidate from Pfizer

Biogen Inc. (NASDAQ:BIIB) will acquire neuropsychiatry candidate PF-04958242 from Pfizer Inc. (NYSE:PFE) for $75 million up front. The pharma is eligible for $515 million in milestones, plus tiered royalties ranging from the low to mid...
17:01 , Aug 10, 2017 |  BC Week In Review  |  Clinical News

FDA approves Eisai's seizure drug Fycompa for monotherapy use

FDA approved an sNDA from Eisai Co. Ltd. (Tokyo:4523) for Fycompa perampanel (E2007) as monotherapy to treat partial-onset seizures with or without secondarily generalized seizures in epileptics ages ≥12. Fycompa was already approved as an...
20:19 , Dec 15, 2016 |  BC Innovations  |  Translation in Brief

Fore score

Cerecor Inc. (NASDAQ:CERC) has picked up a forebrain-selective anti-epileptic compound from Eli Lilly and Co. (NYSE:LLY) that could treat seizures by blocking AMPA glutamate receptor (GRIA; GLUR) without the dose-limiting motor side effects associated with...