18:38 , Aug 10, 2018 |  BC Week In Review  |  Clinical News

Second Vertex drug caught in CF standoff

NICE's suspension of its review of Symkevi tezacaftor/ivacaftor on Aug. 9 marks the latest delay of access in England and Wales to cystic fibrosis drugs from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX). NICE suspended its review after the...
21:23 , Aug 9, 2018 |  BC Extra  |  Company News

Second Vertex drug caught in CF standoff

NICE's suspension of its review of Symkevi tezacaftor/ivacaftor on Thursday marks the latest delay of access in England and Wales to cystic fibrosis drugs from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX). NICE suspended its review after the...
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 the...
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 the...
23:21 , Jul 13, 2018 |  BioCentury  |  Finance

Pause for politics

The near record-setting pace of 1H18 capital markets activity isn’t likely to be replicated this half, but that won’t be because of changes to sector fundamentals. Instead, it’s likely the consequence of macroeconomic and geopolitical...
03:05 , Jun 30, 2018 |  BioCentury  |  Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with the...
22:56 , Jun 25, 2018 |  BC Extra  |  Company News

CHMP interactions delaying Coherus biosimilar timeline

Coherus Biosciences Inc. (NASDAQ:CHRS) lost $1.80 (10%) to $15.40 on Monday after it disclosed that EMA's CHMP will require further interactions with the company in order to issue an opinion on its pending MAA for...
20:59 , Jun 22, 2018 |  BioCentury  |  Finance

Bountiful, not bubbly

A compressed calendar, rather than investor overexuberance, accounts for one of the busiest weeks for IPO pricings in the sector’s history. Seven NASDAQ IPOs were completed during the week ending June 22, raising a total of...
18:20 , Jun 15, 2018 |  BC Week In Review  |  Company News

Denovo gains IP from Stanford to develop lead program for new indication

Denovo Biopharma LLC (San Diego, Calif.) received exclusive, worldwide rights to IP from the Stanford University School of Medicine (Stanford, Calif.) that the biotech said will allow it to develop lead program enzastaurin (DB102) for...
06:03 , Jun 14, 2018 |  BioCentury  |  Finance

Gene therapies in Sync

With the launch of a pair of new start-ups, Syncona Ltd. (LSE:SYNC) has invested in a CNS play and a new ophthalmic approach, bringing the U.K. firm’s gene therapy portfolio to five. Syncona invested $23 million...