22:37 , May 29, 2019 |  BC Extra  |  Company News

CHMP against Emmaus' sickle cell therapy, Taiwan Liposome's doxorubicin

EMA's CHMP issued several opinions Wednesday, including a negative opinion for Emmaus' sickle cell disease therapy, and on re-examination, a negative recommendation for Taiwan Liposome's breast and ovarian cancer treatment. The agency recommended against approval...
23:57 , Apr 18, 2019 |  BC Extra  |  Preclinical News

Pig brain tech could spur stroke therapies, drug and target validation

While Wednesday's announcement that Yale researchers restored cell function in postmortem pig brains sheds no light on the feasibility of reviving consciousness, it does suggest new opportunities for stroke treatments, disease models and validation of...
00:01 , Aug 3, 2018 |  BC Innovations  |  Targets & Mechanisms

Oxitope’s oxidation play

A trio of papers from a UCSD group has found a connection between oxidized lipids and inflammation in atherosclerosis, osteoporosis and ischemia injury, breathing new life into the once popular “oxidation hypothesis” of atherosclerosis. The...
22:50 , Jan 5, 2018 |  BioCentury  |  Emerging Company Profile

Against radical pain

CerSci Therapeutics thinks that by neutralizing peroxynitrite and other free radicals it can treat acute pain and prevent it from becoming chronic, without the potential for abuse and addiction. CerSci was founded in 2014 to...
20:22 , Nov 3, 2017 |  BioCentury  |  Regulation

Frame work

A little over four years into its implementation, FDA’s structured benefit-risk framework appears to be meeting its objectives of creating transparency into its approval decisions. The agency began to incorporate the framework templates into its...
18:04 , Sep 1, 2017 |  BC Week In Review  |  Company News

Mitsubishi launches ALS drug Radicava in U.S.

Mitsubishi Tanabe Pharma Corp. (Tokyo:4508) launched Radicava edaravone in the U.S. to treat amyotrophic lateral sclerosis (ALS). The wholesale acquisition cost (WAC) of two 30 mg/100 mL IV infusion bags is $1,086. The recommended dose...
23:20 , Jul 11, 2017 |  BioCentury  |  Emerging Company Profile

Complementary ALS play

Alsonex Pty. Ltd. is targeting a central component of the complement cascade to quell neuroinflammation in amyotrophic lateral sclerosis without excessively dampening the immune system. That mechanism could slow disease progression and improve life expectancy...
19:53 , May 12, 2017 |  BC Week In Review  |  Clinical News

FDA approves ALS drug from Mitsubishi

FDA approved Radicava edaravone (MCI-186) from Mitsubishi Tanabe Pharma Corp. (Tokyo:4508) to treat amyotrophic lateral sclerosis (ALS). The company said Radicava will be available in early to mid-August at an annual price of about $145,000....
23:37 , May 5, 2017 |  BC Extra  |  Company News

FDA approves Mitsubishi's ALS drug

FDA approved Radicava edaravone from Mitsubishi Tanabe Pharma Corp. (Tokyo:4508) to treat amyotrophic lateral sclerosis. Mitsubishi said it is the first drug FDA has approved for ALS in more than 20 years. Mitsubishi Tanabe Pharma...
07:00 , Sep 5, 2016 |  BC Week In Review  |  Clinical News

Radicut edaravone regulatory update

FDA accepted an NDA from Mitsubishi for edavarone to treat amyotrophic lateral sclerosis. The PDUFA date is June 16, 2017. The IV cerebral neuroprotectant and free radical scavenger is marketed in Japan and South Korea...