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News Breaks
May 21, 2014
09:01 EDTHALO, BAXBaxter provides U.S. regulatory update on HyQvia
Baxter International (BAX) and Halozyme Therapeutics (HALO) announced that the U.S. Food and Drug Administration has extended the PDUFA date for its review of the Biologics License Application for HYQVIA, the company’s investigational subcutaneous treatment for patients with primary immunodeficiency. The FDA is requiring additional time to review supplemental data that Baxter provided as part of the ongoing BLA process for HyQvia approval. The PDUFA date has been extended by three months, which is the standard extension period. As part of the FDA’s extended review of the HyQvia BLA amendment, Baxter now expects to participate in a Blood Products Advisory Committee meeting, which the agency has scheduled for July 31.HyQvia was approved by the European Commission for EU member states in 2013 and is available in several European countries, including Germany, Netherlands, Sweden, Norway, Denmark, Ireland and Italy.
News For BAX;HALO From The Last 14 Days
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July 31, 2015
07:58 EDTHALOHalozyme and Eisai partner to investigate eribulin and PEGPH20 in breast cancer
Halozyme and Eisai Co. have signed a clinical collaboration agreement to evaluate Eisai's agent eribulin mesylate - brand name: Halaven - in combination with Halozyme's investigational drug PEGPH20 in first line HER2-negative metastatic breast cancer. The companies will jointly share the costs of a phase 1b/2 clinical trial to assess whether or not eribulin, in combination with PEGPH20, can improve overall response rate as compared with eribulin alone as a therapy in women with advanced breast cancer. In hyaluronan-rich triple-negative breast preclinical animal models, the addition of PEGPH20 to eribulin showed a significantly higher tumor growth inhibition and overall tumor regression when compared to eribulin alone. Eribulin is not indicated for first-line therapy for patients with HER2-negative metastatic breast cancer.
July 30, 2015
10:00 EDTBAXOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: Altria Group (MO) downgraded to Outperform from Buy at CLSA... Baxter (BAX) downgraded to Market Perform from Outperform at Leerink... Changyou.com (CYOU) downgraded to Hold from Buy at Summit Research... Depomed (DEPO) downgraded to Neutral from Buy at Janney Capital... Euronet (EEFT) downgraded to Neutral from Buy at Monness Crespi... Foundation Medicine (FMI) downgraded to Market Perform at JMP Securities... Garmin (GRMN) downgraded to Underweight from Neutral at JPMorgan... Golden Star Resources (GSS) downgraded to Hold at Canaccord... Grainger (GWW) downgraded on negative catalysts at RBC Capital... Henry Schein (HSIC) downgraded to Hold from Buy at Evercore ISI... LINN Energy (LINE) downgraded to Market Perform from Outperform at Raymond James... LifeLock (LOCK) downgraded to Neutral from Buy at BofA/Merrill... LinnCo (LNCO) downgraded to Market Perform from Outperform at Raymond James... Manitowoc (MTW) downgraded to Hold from Buy at BB&T... PACCAR (PCAR) downgraded to Equal Weight on peak cycle concerns at Morgan Stanley... PG&E (PCG) downgraded to Neutral from Outperform at Credit Suisse... Pacer (PACR) downgraded to Equal Weight from Overweight at Morgan Stanley... Penn Virginia (PVA) downgraded to Sector Perform from Outperform at Scotia... Shutterfly (SFLY) downgraded to Market Perform at Raymond James... Terex (TEX) downgraded to Hold from Buy at BB&T... Total System (TSS) downgraded to Neutral at Baird... Whiting Petroleum (WLL) downgraded to Equal Weight from Overweight at Stephens... Whole Foods (WFM) downgraded to Equal Weight from Overweight at Morgan Stanley.
08:23 EDTBAXBaxter downgraded to Market Perform on 'lofty' valuation at Leerink
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07:07 EDTBAXBaxter downgraded to Market Perform from Outperform at Leerink
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July 29, 2015
16:30 EDTBAXBaxter sees Q3 EPS ex-items of 29c-31c, consensus 27c
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16:29 EDTBAXBaxter reports Q2 adjusted EPS $1.00, consensus 95c
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July 21, 2015
07:59 EDTBAXBioMarin gene therapy an overhang for Baxalta, says JPMorgan
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July 20, 2015
14:55 EDTBAXBaxter recalls two lots of IV solutions due to possible particulate matter
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