BioCentury | May 22, 2020
Product Development

May 21 Quick Takes: EC approves Zolgensma for SMA; plus Sunovion, Kadmon, Sorrento, tafasitamab, Zentalis’ new JV

Immediate access to Zolgensma in France The European Commission conditionally approved Zolgensma onasemnogene abeparvovec from Novartis AG (NYSE:NVS; SIX:NOVN) to treat spinal muscular atrophy in babies and young children who have SMA Type 1 or...
BioCentury | Apr 29, 2020
Product Development

April 28 Quick Takes: Syndax gains on leukemia data; plus Supernus, Neurocrine, Avadel, Insilico-Astellas, Innovent-Lilly, Chimerix

AACR data propel Syndax shares Syndax Pharmaceuticals Inc. (NASDAQ:SNDX) rose $7.99 (69%) to $19.50 on Tuesday after presenting initial data from the Phase I/II AUGMENT-101 trial of SNDX-5613 that showed responses in two out of...
BioCentury | Apr 6, 2019
Finance

Everybody up

Biotech stocks were off to a strong start in 1Q19, with 71% of companies tracked by BioCentury seeing market cap growth in the quarter. Across all market cap bands, biotechs saw a median gain of...
BioCentury | Feb 1, 2019
Clinical News

FDA wants more info on Sunovion Parkinson’s therapy

Sunovion Pharmaceuticals Inc. said late Jan. 30 that FDA issued a complete response letter for its NDA for apomorphine sublingual film (APL-130277) to treat "off" episodes in Parkinson’s disease patients. The subsidiary of Sumitomo Dainippon...
BioCentury | Jan 31, 2019
Company News

FDA wants more info on Sunovion Parkinson’s therapy

Sunovion Pharmaceuticals Inc. said late Wednesday that FDA issued a complete response letter for its NDA for apomorphine sublingual film (APL-130277) to treat "off" episodes in Parkinson’s disease patients. The subsidiary of Sumitomo Dainippon Pharma...
BioCentury | Jan 17, 2019
Regulation

Products on shutdown standby

Products on shutdown standby On Jan. 14, FDA said it has reserves to continue drug reviews for five more weeks if the government shutdown continues. There are at least six PDUFA dates for new products...
BioCentury | Jan 5, 2019
Finance

Ready to launch

The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record year...
BioCentury | Jan 4, 2019
Clinical News

FDA approves Acorda's Inbrija for Parkinson's

FDA approved Inbrija levodopa inhalation powder from Acorda Therapeutics Inc. (NASDAQ:ACOR) to treat "off" periods in Parkinson's disease patients receiving carbidopa/levodopa. The approval comes after multiple delays and gives Acorda a new product to bring...
BioCentury | Dec 24, 2018
Company News

FDA approves Acorda's Inbrija for Parkinson's

Acorda Therapeutics Inc. (NASDAQ:ACOR) said FDA approved its Inbrija levodopa inhalation powder to treat "off" periods in Parkinson's disease patients receiving carbidopa/levodopa. The approval comes after multiple delays and gives Acorda a new product to...
BioCentury | Sep 10, 2018
Distillery Therapeutics

Cancer

INDICATION: Lung cancer Patient sample and mouse studies suggest promoting the expression of KIF16B, SELENOW and TESK2 could help prevent brain metastasis in lung cancer. In patients, low expression of KIF16B, SELENOW and TESK2 in...
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