Neurology/Psychiatric

Neuren and Acadia’s trofinetide wins FDA rare pediatric disease designation for Rett syndrome as phase III testing advances

March 10, 2020

PERTH, Australia – The FDA granted Melbourne-based Neuren Pharmaceuticals Ltd. and San Diego, California-based Acadia Pharmaceuticals Inc. a rare pediatric disease designation for trofinetide for treatment of Rett syndrome, a rare neurodevelopmental congenital central nervous system disorder.

A sleigh full of approvals

FDA brings good tidings, with new drugs for breast cancer, insomnia, schizophrenia and migraine

December 24, 2019

By Michael Fitzhugh

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Four new U.S. drug approvals, one accelerated for need, have handed a string of year-end victories to five drugmakers, marking an unusually active start to a week full of global holiday celebrations. Daiichi Sankyo Co. Ltd., Astrazeneca plc, Eisai Inc., Intra-Cellular Therapies Inc. and Allergan plc all secured new approvals from the agency.

China grants conditional approval to Green Valley's GV-971 for Alzheimer's disease

November 6, 2019

By Elise Mak

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BEIJING – Chinese drug regulators granted conditional approval to Shanghai Green Valley (Group) Co. Ltd.'s marine-derived oligosaccharide, GV-971, to treat Alzheimer's disease (AD), but required further trials to prove the drug's efficacy after marketing.

Sulfide stress as new target?

Schizophrenia biomarker can be detected in human hair

November 6, 2019

By John Fox

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A subtype of schizophrenia is related to abnormally high brain levels of hydrogen sulfide (H2S), which has important implications for the development of new treatments, according to a study by researchers at the RIKEN Center for Brain Science (CBS) in Japan.

Enabler of inebilizumab: Mitsubishi pact for Viela gets firm $30M up front

October 16, 2019

By Randy Osborne

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Days after going public, Viela Bio Inc. nailed down a deal with Mitsubishi Tanabe Pharma Corp. to develop and commercialize Viela’s humanized anti-CD19 monoclonal antibody, inebilizumab, in nine Asia regions for the rare disease called neuromyelitis optica spectrum disorder (NMOSD), as well as other potential future indications.

South Korea’s Chong Kun Dang invests in startup Biorchestra targeting AD

October 16, 2019

By Jihyun Kim

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HONG KONG – South Korean pharmaceutical company Chong Kun Dang Holdings recently invested KRW5 billion (US$4.1 million) in Biorchestra Co. Ltd., a Korean startup based in Daejeon that aims to develop Alzheimer’s dementia treatment based on microRNA.