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Zacks News
What's in Store for Immune Design (IMDZ) in Q4 Earnings?
by Zacks Equity Research
Immune Design Corp (IMDZ) is scheduled to report fourth-quarter 2016 results after the market closes on Mar 7.
Pharma Stock Roundup: Mylan, Endo Report 4Q Results, FDA Nod for AZN Diabetes Drug
by Arpita Dutt
Quite a few companies including AstraZeneca (AZN) provided pipeline/regulatory updates this week.
Mylan (MYL) Beats on Q4 Earnings, Stock Up on Strong View
by Zacks Equity Research
Shares of Mylan N.V.'s (MYL) were up 7.2% after the company beat expectations in the fourth-quarter 2016 and provided a strong outlook for 2017 amid challenging conditions.
Kite Pharma (KITE) Posts Q4 Loss; Up on Positive Cancer Data
by Zacks Equity Research
Kite Pharma, Inc. (KITE) reported narrower-than-expected loss in the fourth quarter of 2016.
Exelixis (EXEL) Reports Q4 Earnings, Revenues Beat Y/Y
by Zacks Equity Research
Exelixis, Inc.(EXEL) posted fourth-quarter 2016 earnings of 12 cents, compared with loss of 18 cents per share in the year ago quarter.
Mylan's Proposed Biosimailar for Cancer Under Review in U.S.
by Zacks Equity Research
Mylan N.V. (MYL) and Biocon Ltd. announced that the FDA has accepted their biologics license application for a biosimilar version of Amgen's (AMGN) Neulasta (pegfilgrastim) - MYL-1401H.
Prothena (PRTA) Reports Wider-than-Expected Loss in Q4
by Zacks Equity Research
Prothena's wider-than-expected loss in the fourth quarter was disappointing.
Can Prothena (PRTA) Pull a Surprise This Earnings Season?
by Zacks Equity Research
Prothena Corporation plc (PRTA) is scheduled to report fourth-quarter 2016 results on Feb 14 after the market closes.
Allergan (AGN) Tops Q4 Earnings; 2017 Sales View Upbeat
by Kinjel Shah
Allergan plc's (AGN) fourth-quarter 2016 earnings came in at $3.90 per share, beating the Zacks Consensus Estimate of $3.79 by 2.9%.
Bristol-Myers' Injectable Opdivo Gets FDA Approval for mUC
by Zacks Equity Research
Bristol-Myers Squibb Company (BMY) announced that the FDA has approved an injectable form of immuno-oncology drug Opdivo
Roche (RHHBY) Beats on Earnings in 2016, Misses on Sales
by Zacks Equity Research
Roche beat on earnings but missed on sales in 2016 due to decline in sales of Lucentis, Pegasys, Avastin and Tarceva.
SanofiRegeneron Sarilumab Approved in Canada for Arthritis
by Zacks Equity Research
Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced that their pipeline candidate, sarilumab, has been approved in Canada for the treatment of adult patients with moderate-to-severely active rheumatoid arthritis (RA).
Pfizer (PFE) Gets Positive CHMP Opinion for Arthritis Drug
by Zacks Equity Research
Pfizer Inc. (PFE) announced that Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion for the company's marketing authorisation application (MAA) for its rheumatoid arthritis (RA) drug, Xeljanz.
Roche (RHHBY) Arthritis Drug Actemra sBLA Accepted by FDA
by Zacks Equity Research
Roche's (RHHBY) supplemental Biologics License Application (sBLA) for arthritis drug, Actemra, accepted for review by the FDA for giant cell arteritis (GCA).
BioLineRx (BLRX) Starts Cancer Study on BL-8040+Keytruda
by Zacks Equity Research
BioLineRx (BLRX) announced the initiation of a second phase IIa study on BL-8040 in combination with Keytruda for the treatment of pancreatic cancer.
Merck KGaA Expands Distribution Deal with Roche (revised)
by Zacks Equity Research
Germany-based Merck KGaA announced that it has expanded the distribution alliance with Roche Holding AG (RHHBY).
Pharma Stock Roundup: Trump Targets Pharma Again, Merck Up on Keytruda News
by Arpita Dutt
The sector was once again slammed by president-elect Donald Trump's comments this week regarding drug pricing.
Mylan/Biocon's Herceptin Biosimilar under Review in the U.S.
by Zacks Equity Research
Mylan (MYL) and Biocon Ltd. announced that the FDA had accepted the BLA for their biosimilar version of Herceptin (trastuzumab), MYL-1401O.
by Zacks Equity Research
Roche Gets Priority Review for Immunotherapy Drug Tecentriq
by Zacks Equity Research
Roche Holding AG's (RHHBY) Genentech announced that the FDA has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for cancer immunotherapy, Tecentriq.
The FDA Approved Fewer Drugs in 2016: Here's Why
by Arpita Dutt
Was there any specific reason for the significantly lower number of drug approvals in 2016 compared to 2015?
Roche's (RHHBY) Lucentis Gets FDA Nod for Fifth Indication
by Zacks Equity Research
Roche Holding AG (RHHBY) announced today that the FDA has approved a label expansion of ophthalmology drug Lucentis- fifth indication.
Mylan/Biocon's Herceptin Biosimilar Phase III Data Published
by Zacks Equity Research
Mylan (MYL) and partner Biocon's biosimilar version of Herceptin phase III data published in JAMA.
Roche (RHHBY) Hemophilia A Drug Positive in Phase III
by Zacks Equity Research
Roche (RHHBY) announced that the phase III study, HAVEN 1, met its primary endpoint.
Pharma Stock Roundup: J&J Back in Talks with Actelion, Teva Settles Corruption Probe
by Arpita Dutt
J&J (JNJ) and Actelion are back in the limelight with the companies in exclusive talks regarding a possible deal.