20:04 , Feb 15, 2019 |  BC Week In Review  |  Company News

Mylan launches first U.S. generic of GSK's Advair

Mylan N.V. (NASDAQ:MYL) launched Wixela Inhub salmeterol/fluticasone, the first generic version of Advair Diskus, in the U.S. at a list price 70% less than the branded version. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) markets Advair Diskus. Both...
19:48 , Feb 15, 2019 |  BC Week In Review  |  Company News

ZappRx, Teva partner to increase patient access to specialty respiratory drugs

The Teva Respiratory LLC unit of Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) gained access to a digital platform from ZappRx Inc. (Boston, Mass.) to streamline prescription of Teva’s specialty respiratory medications. Financial terms were...
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...
22:27 , Feb 8, 2019 |  BioCentury  |  Finance

Earnings on deck

Earnings on deck At least 6 profitable biotechs and pharmas are slated to report earnings this week. (A) Premarket on U.S. exchange; during trading hours in Tel Aviv; (B) Premarket on U.S. exchange; during trading...
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....
01:15 , Feb 1, 2019 |  BC Week In Review  |  Clinical News

Mylan gets first FDA approval for an Advair generic

FDA approved Wixela Inhub salmeterol/fluticasone from Mylan N.V. (NASDAQ:MYL), the first generic version of Advair salmeterol/fluticasone from GlaxoSmithKline plc (NYSE:GSK; LSE:GSK), to treat asthma or chronic obstructive pulmonary disease (COPD). Mylan plans to launch the...
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...
00:38 , Jan 25, 2019 |  BC Week In Review  |  Clinical News

Samsung's Herceptin biosimilar gains U.S. approval

FDA approved a BLA for Ontruzant trastuzumab-dttb from Samsung Bioepis Co. Ltd. (Incheon, Korea), a biosimilar of Herceptin. The biosimilar is Samsung Bioepis' first approved in the U.S. to treat cancer. Ontruzant received approval for...
00:51 , Jan 23, 2019 |  BC Extra  |  Politics & Policy

SCOTUS upholds lower court's ruling in Helsinn patent case

Biotech companies seeking R&D partners should file patents early for their inventions, in light of the U.S. Supreme Court's unanimous decision Tuesday saying some private sales of inventions qualify as prior art in patent litigation....