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Zacks News
4 FDA Decisions to Watch Out for in Feb 2017
by Arpita Dutt
So far this year, the FDA has approved one drug. Will the pace of drug approvals pick up in February?
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.
Amgen Wins Favorable CHMP Opinion for Humira Biosimilar
by Zacks Equity Research
Amgen (AMGN) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion on the company's marketing authorization application (MAA) for ABP 501.
Will Amgen (AMGN) Keep the Earnings Streak Alive in Q4?
by Zacks Equity Research
We expect biotech major Amgen Inc. (AMGN) to beat expectations when it reports fourth-quarter 2016 and full-year results on Feb 2.
Biogen (BIIB) Q4 Earnings Top Estimates; '17 Sales View Soft
by Zacks Equity Research
Biogen Inc. (BIIB), a well-known name in the multiple sclerosis (MS) market, reported mixed fourth-quarter 2016.
Novartis (NVS) Beats Q4 Earnings, Might Spin-Off Alcon
by Zacks Equity Research
Novartis' (NVS) fourth-quarter 2016 results were mixed with the company beating earnings estimates but missing on revenues. The company has been facing challenging conditions for the past few quarters.
Can Amgen (AMGN) Be a Top Choice for Value Investors?
by Zacks Equity Research
Let's see if Amgen Inc. (AMGN) stock is a good choice for value-oriented investors right now from multiple angles.
Coherus Offers Positive Phase III Data on Humira Biosimilar
by Zacks Equity Research
Coherus BioSciences, Inc. (CHRS) reported encouraging top-line data from an ongoing part 3, of a phase III study on its biosimilar version of AbbVie Inc.'s (ABBV) Humira (adalimumab), CHS-1420, for the treatment of patients with psoriasis.
Biotech Stock Roundup: ARIAD to be Acquired for $5.2B, Vertex Outlook Falls Short
by Arpita Dutt
Several licensing deals and agreements were announced this week including the $5.2 billion ARIAD (ARIA) acquisition.
Amgen: Phase III Data on Hyperparathyroidism Drug Published
by Zacks Equity Research
Amgen Inc. (AMGN) announced that data from three phase III studies on its pipeline candidate, Parsabiv (etelcalcetide), were published in the Journal of the American Medical Association (JAMA).
Merck: Keytruda+Chemo Gets Priority Review for Lung Cancer
by Zacks Equity Research
Merck & Co., Inc.'s (MRK) supplemental Biologics License Application (sBLA) for its anti-PD-1 therapy, Keytruda, has been accepted under priority review by the FDA.
Kite Pharma Inks Deals for CAR T Cell Drug in Japan, China
by Zacks Equity Research
Kite Pharma (KITE) announced that it has entered into a strategic partnership with Daiichi Sankyo to develop and commercialize axicabtagene ciloleucel (KTE-C19) in Japan.
Amgen Inks Multiple Deals, Offers Update on Repatha Lawsuit
by Zacks Equity Research
Amgen Inc. (AMGN) announced a new six-year sourcing and supply agreement with DaVita Inc. (DVA) to supply Epogen and Aranesp to meet the latter???s requirements.
Pfizer's Humira Biosimilar Meets Primary Endpoint in Study (Revised)
by Zacks Equity Research
Pfizer, Inc. (PFE) announced positive top-line results from the comparative REFLECTIONS B538-02 study on its investigational compound, PF-06410293, a potential biosimilar to AbbVie Inc.'s (ABBV) Humira.
Pfizer's Humira Biosimilar Meets Primary Endpoint in Study
by Zacks Equity Research
Pfizer, Inc. (PFE) announced positive top-line results from the comparative REFLECTIONS B538-02 study on its investigational compound, PF-06410293, a potential biosimilar of Humira approved for the treatment of patients with rheumatoid arthritis.
Amgen's Repatha Wins Over Sanofi & Regeneron's Praluent
by Zacks Equity Research
The U.S. District Court in Delaware granted Amgen, Inc. (AMGN) permanent injunction against infringement by Sanofi and Regeneron of two patents owned by the former for Repatha.
The Zacks Analyst Blog Highlights: Comcast, Amgen, General Mills, Target and Ford
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Comcast, Amgen, General Mills, Target and Ford
Biotech Stock Roundup: Inotek Plunges on Pipeline Setback, Kite Files IND for Study Initiation
by Arpita Dutt
Although this was a relatively slow week for the biotech sector, Inotek (ITEK) made it to the headlines on disappointing data on its lead pipeline drug.
Kite Pharma (KITE) to Move Cancer Candidate into Phase I
by Zacks Equity Research
Kite Pharma, Inc. (KITE) announced that it has filed a Investigational New Drug (IND) application with the FDA to initiate phase I studies on KITE-718, a TCR candidate targeting MAGE in a solid tumor.
Stock Research Reports for Comcast, Amgen & General Mills
by Sheraz Mian
Today's Research Daily features new research reports on 16 major stocks, including Comcast (CMCSA), Amgen (AMGN) and General Mills (GIS).
Merck (MRK) Does Well in 2016: Reasons for Outperformance
by Zacks Equity Research
Merck & Co. Inc.'s (MRK) share price is up 12.1%, so far this year.
Ligand (LGND) Signs Licensing Deals with Ono and Novartis
by Zacks Equity Research
Ligand Pharmaceuticals announced that it has entered into a worldwide license agreement with Ono Pharmaceutical under which Ono will use its OmniAb platform for the discovery of fully human mono- and bispecific antibodies.
Bristol-Myers, PsiOxus Ink Deal for Oncolytic Virus Therapy
by Zacks Equity Research
Bristol-Myers (BMY) inks a deal with PsiOxus for an early-stage oncolytic virus candidate, NG-348.
Amgen Files for Approval of Osteoporosis Drug in Japan
by Zacks Equity Research
Amgen Inc. (AMGN) and partner UCB SA (UCBJF) announced that they have submitted an application seeking marketing approval for its investigational monoclonal antibody romosozumab to Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
Merck Keytruda Gets CHMP Nod for First-Line Lung Cancer
by Zacks Equity Research
Merck & Co., Inc. (MRK) announced that its anti-PD-1 therapy, Keytruda, was rendered a positive opinion in the EU for the first-line treatment of metastatic lung cancer.