19:52 , Jan 17, 2019 |  BioCentury  |  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...
02:49 , Jan 5, 2019 |  BioCentury  |  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...
18:18 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

Aerie's Roclatan under FDA review with March PDUFA

Aerie Pharmaceuticals Inc. (NASDAQ:AERI) said FDA accepted for review an NDA for Roclatan netarsudil/latanoprost to reduce intraocular pressure (IOP) in glaucoma or ocular hypertension. The PDUFA date is March 14, 2019. Roclatan met its primary...
21:06 , Apr 6, 2018 |  BioCentury  |  Finance

Smid-cap smorgasbord

While the biggest milestone of the second quarter came early and turned out to be a disappointment, investors still have plenty to look forward to in immuno-oncology. In addition, specialist investors’ current strategy of overweighting...
19:42 , Jan 26, 2018 |  BC Week In Review  |  Financial News

Follow-on roundup: Ultragenyx, Adamas, Rocket

Rare disease company Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) raised $250 million on Jan. 23 through the sale of 4.4 million shares at $57 in a bumped-up follow-on underwritten by J.P. Morgan, BofA Merrill Lynch, Goldman Sachs...
22:56 , Jan 24, 2018 |  BC Extra  |  Financial News

Follow-on roundup

At least six companies priced follow-ons, raising more than $600 million total. Rare disease company Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) raised $250 million on Tuesday through the sale of 4.4 million shares at $57 in a...
23:25 , Jan 9, 2018 |  BioCentury  |  Finance

Stars in China

A major clinical flop and a spate of weak earnings reports by U.S. large cap biotechs reverberated throughout the sector in the fourth quarter, breaking a three-quarter-long streak of outperformance. Across all market cap bands,...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
18:41 , Dec 22, 2017 |  BC Week In Review  |  Clinical News

FDA approves Aerie's Rhopressa to lower IOP

FDA approved Rhopressa netarsudil 0.02% from Aerie Pharmaceuticals Inc. (NASDAQ:AERI) to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The company plans to launch the drug in 2Q18. The approval...
21:38 , Dec 19, 2017 |  BC Extra  |  Company News

FDA approves Aerie's Rhopressa

FDA approved Rhopressa netarsudil 0.02% from Aerie Pharmaceuticals Inc. (NASDAQ:AERI) to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The company plans to launch the drug in 2Q18. The approval...