22:14 , Mar 29, 2019 |  BC Extra  |  Company News

Luye submits NDA for schizophrenia, bipolar disorder therapy

Luye submitted an NDA to FDA for Rykindo risperidone extended-release microspheres (LY03004) to treat schizophrenia and bipolar disorder. Luye Pharma Group Ltd. (HKSE:2186) hopes to launch the injectable formulation of the generic risperidone in the...
19:11 , Oct 26, 2018 |  BC Week In Review  |  Clinical News

Lundbeck’s Lu AF35700 misses schizophrenia endpoint

The first Phase III trial from H. Lundbeck A/S (CSE:LUN) to read out since CEO Deborah Dunsire took the helm last month has missed its primary endpoint. Lundbeck reported that Lu AF35700 missed the primary...
23:01 , Oct 25, 2018 |  BC Extra  |  Clinical News

Lundbeck’s Lu AF35700 misses schizophrenia endpoint

The first Phase III trial from H. Lundbeck A/S (CSE:LUN) to read out since CEO Deborah Dunsire took the helm last month has missed its primary endpoint. Lundbeck slid DKK108.90 (27%) to DKK300 on Thursday...
01:14 , Oct 6, 2018 |  BioCentury  |  Finance

Large cap comeback

The biotech sector continued to be a stock pickers’ market through 3Q18 as there was a near even split between global biotech stocks that gained and lost value in the quarter. While 1H18 saw investors...
17:49 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

FDA approves once-monthly schizophrenia drug from Durect, Indivior

Durect Corp. (NASDAQ:DRRX) and Indivior plc (LSE:INDV) said FDA approved Perseris risperidone (RBP-7000) to treat schizophrenia in adults. The approval triggered a $5 million milestone payment to Durect from Indivior. The companies said Perseris is...
16:44 , Jul 30, 2018 |  BC Extra  |  Company News

FDA approves once-monthly schizophrenia drug from Durect, Indivior

Durect Corp. (NASDAQ:DRRX) and Indivior plc (LSE:INDV) said FDA approved Perseris risperidone (RBP-7000) to treat schizophrenia in adults. The approval triggered a $5 million milestone payment to Durect from Indivior. The companies said Perseris is...
21:33 , May 11, 2018 |  BioCentury  |  Finance

Seroquel stepping stone

The $538 million acquisition by Luye Pharma Group Ltd. (HKSE:2186) of Seroquel quetiapine fumarate from AstraZeneca plc (LSE:AZN; NYSE:AZN) will lay the commercial groundwork in new emerging markets for the Chinese pharma’s internal CNS pipeline....
17:56 , May 11, 2018 |  BC Week In Review  |  Company News

Luye acquires AstraZeneca antipsychoitic for $538M

AstraZeneca plc (NYSE:AZN; LSE:AZN) granted Luye Pharma Group Ltd. (HKSE:2186) territorial rights to antipsychotic drug Seroquel quetiapine fumarate and its extended release formulation, Seroquel XL. Luye received rights in 51 countries and regions including China,...
16:13 , May 7, 2018 |  BC Extra  |  Company News

Luye paying AZ $538M for antipsychotic

AstraZeneca plc (NYSE:AZN; LSE:AZN) granted Luye Pharma Group Ltd. (HKSE:2186) territorial rights to antipsychotic drug Seroquel quetiapine fumarate and its extended release formulation, Seroquel XL. Luye received rights in 51 countries and regions including China,...
19:46 , Dec 15, 2017 |  BC Week In Review  |  Clinical News

FDA accepts NDA for Indivior's sustained-release risperidone

Indivior plc (LSE:INDV) said FDA accepted for review an NDA for RBP-7000 to treat schizophrenia. The PDUFA date is July 28. In September, Indivior gained rights to IP for RBP-7000 from Durect Corp. (NASDAQ:DRRX) for...