20:06 , Apr 24, 2019 |  BC Extra  |  Financial News

Why Satsuma investors see room for another migraine therapy

While a new class of drugs has captured most of the attention around migraine treatments, Satsuma's investors believe there's room in the marketplace for a new formulation of an old drug. Satsuma Pharmaceuticals Inc. (South...
21:59 , Apr 22, 2019 |  BC Extra  |  Company News

FDA accepts BLA for Alder's migraine therapy for infusion

Alder said FDA accepted a BLA for eptinezumab to prevent migraine. The company, which submitted the BLA on Feb. 21, said it expects to receive a PDUFA date within 74 days following the submission. If...
00:06 , Apr 6, 2019 |  BioCentury  |  Finance

Big caps under pressure

Biogen’s fall in the wake of its decision to discontinue late-stage trials of Alzheimer’s therapy aducanumab is yet another reminder that large caps are in dire need of new pipeline products, and could serve as...
21:35 , Mar 18, 2019 |  BC Extra  |  Company News

Biohaven spends $105M for faster review of oral CGRP inhibitor

Biohaven bought a $105 million Priority Review voucher from GW Pharmaceuticals to expedite the entry of its oral migraine therapy into the CGRP inhibitor market. It plans to use the voucher on an NDA for...
01:33 , Mar 1, 2019 |  BC Week In Review  |  Clinical News

Alder submits BLA for migraine therapy, raises $130M in follow-on

After submitting its first BLA to FDA on Feb. 22, Alder BioPharmaceuticals Inc. (NASDAQ:ALDR) raised $130 million in a bumped-up follow-on late Feb. 27. Alder submitted the BLA for eptinezumab, a mAb against calcitonin-related gene...
23:45 , Feb 13, 2019 |  BC Extra  |  Company News

Teva down after predicting a 'trough' year ahead

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) lost $1.49 to $17.63 on NYSE Wednesday when the company reported a decrease in 4Q18 generics sales and introduced 2019 guidance that was lower than the Street had...
18:55 , Feb 7, 2019 |  BC Week In Review  |  Clinical News

CHMP recommendations include Ajovy, Vizimpro, Humira biosimilars

EMA's CHMP recommended a basket of approvals and label extensions on Feb. 1, including Ajovy fremanezumab, Vizimpro dacomitinib and two Humira biosimilars. CHMP also backed an expanded label for Forxiga dapagliflozin to include Type I...
21:12 , Feb 1, 2019 |  BC Extra  |  Company News

CHMP recommendations include Ajovy, Vizimpro, Humira biosimilars

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including Ajovy fremanezumab, Vizimpro dacomitinib and two Humira biosimilars. CHMP also backed an expanded label for Forxiga dapagliflozin to include Type I diabetes....
00:27 , Jan 30, 2019 |  BC Extra  |  Company News

Amgen's guidance comes up short, but migraine drug sales show promise

Amgen Inc. (NASDAQ:AMGN) reported 4Q18 and 2018 earnings that beat consensus estimates on Tuesday but the bellwether’s 2019 guidance fell shy of analyst expectations. The company said it expects 2019 non-GAAP EPS of $13.10-$14.30, below...
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...