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Zacks News
Should You Pick Up Novartis (NVS) Before Q2 Earnings?
by Mitchell Moore
Novartis AG (NVS) gained 1.1% so far in trading this week. Plus, the Swiss multinational pharmaceutical company has been on a tear since the end of April, up 18.2%. Now let's see what investors should expect heading into its Q2 2019 earnings release on Thursday.
Is a Beat in the Cards for Novartis' (NVS) Q2 Earnings?
by Ekta Bagri
Investors will focus on regular top- and bottom-line numbers along with pipeline updates when Novartis (NVS) reports second-quarter results.
Novartis' (NVS) Crizanlizumab Gets Priority Review From FDA
by Zacks Equity Research
The FDA accepts Novartis' (NVS) BLA for crizanlizumab and grants Priority Review to the same to prevent pain crises in patients with sickle cell disease.
Eton's Ophthalmic Solution Candidate Gets CRL, Shares Fall
by Zacks Equity Research
Eton's (ETON) partner receives complete response letter for a regulatory application seeking approval of its pipeline candidate, EM-100, as a treatment for ocular itching.
J&J Falls Amid Reports of Criminal Probe Into Talcum Powder
by Zacks Equity Research
The U.S. Justice Department is reportedly pursuing a criminal investigation as to whether J&J (JNJ) lied about the possible cancer risk associated with its talcum powder.
Amgen & Novartis' Alzheimer Studies End in Another Failure
by Zacks Equity Research
Amgen (AMGN) and Novartis (NVS) discontinue two Alzheimer's disease studies. Alzheimer's has always been a highly challenging area with many studies failing.
Aimmune Down on Negative ICER Review on Allergy Candidate
by Zacks Equity Research
Aimmune's (AIMT) peanut allergy candidate AR101 attracts negative review from ICER, stating risks outweighs benefits in patients. AR101 is under review and a decision is expected by January 2020.
Amneal (AMRX) Down on Guidance Update & Restructuring Plan
by Zacks Equity Research
Amneal (AMRX) slumps on news of budget cut and reduction in annual guidance.
Glaxo's Two-Drug HIV Pill Dovato on Par with Three-Drug Pill
by Zacks Equity Research
Glaxo's (GSK) phase III study, evaluating the efficacy of switching to Dovato from a three-drug TAF based regimen, meets the primary endpoint.
Jazz (JAZZ) Acquires Early-Stage Precision Oncology Asset
by Zacks Equity Research
Jazz (JAZZ) acquired Redx Pharma's early stage pan-RAF inhibitor program for developing potential treatment for cancer with RAF and RAS mutations.
Novo Nordisk Reports Encouraging Data From Hemophilia Studies
by Zacks Equity Research
Novo Nordisk (NVO) reports data on Concizumab and Refixia for the treatment of hemophilia.
Bayer-J&J Announce Positive Xarelto Data in Children with VTE
by Zacks Equity Research
Bayer's (BAYRY) Xarelto, in the phase III EINSTEIN-Jr study in pediatric patients, shows a similar low risk of VTE or blood clots compared to current standard anticoagulation therapy.
Roche Reveals New Hemlibra Data, Extends Spark Merger Deadline
by Zacks Equity Research
Roche (RHHBY) presents new positive data on Hemlibra, reinforcing its efficacy and safety. Moreover, the deadline of the impending merger with Spark has been extended.
Aerie Completes Enrollment Under Rhopressa Study in Japan
by Zacks Equity Research
Aerie (AERI) completes enrollment in mid-stage study on Rhopressa in Japan much ahead of schedule.
Incyte Out-Licenses INCMGA0012 Rights in China to Zai Lab
by Zacks Equity Research
Incyte (INCY) inks a licensing deal with Zai Lab to develop and commercialize INCMGA0012 for hematology and oncology indications in Greater China.
Puma Biotech Submits sNDA for Breast Cancer Drug Nerlynx
by Zacks Equity Research
Puma Biotech (PBYI) files an sNDA for the nod of Nerlynx in combination with Xeloda to treat patients with HER2-positive metastatic breast cancer, having failed two or more prior lines of treatments.
Alnylam Submits MAA in Europe for RNAi Therapeutic Givosiran
by Zacks Equity Research
Alnylam (ALNY) submits Marketing Authorization Application to the EMA for givosiran in development for the treatment of acute hepatic porphyria.
AstraZeneca Gets CHMP Nod for Forxiga/Fasenra Expanded Label
by Zacks Equity Research
AstraZeneca (AZN) gets positive CHMP opinion for self-administration option for Fasenra and the Fasenra pen and to include outcomes data on Forxiga???s label.
Roche's Tecentriq Gets CHMP Recommendation for Breast Cancer
by Zacks Equity Research
Roche (RHHBY) announced that its immuno-oncology drug, Tecentriq, was recommended for approval by the CHMP for triple-negative breast cancer.
Atara Reports Initial Data for Multiple Sclerosis Candidate
by Zacks Equity Research
Atara (ATRA) announces initial ATA188 phase I safety results for patients with progressive MS.
Amgen's Osteoporosis Drug Evenity Gets Adverse CHMP View
by Zacks Equity Research
The CHMP provides an unfavorable feedback to Amgen's (AMGN) marketing application for Evenity to treat severe osteoporosis in postmenopausal women with risk of fracture.
FDA Accepts Sanofi's BLA for Meningitis Vaccine to Review
by Zacks Equity Research
The FDA accepts for review Sanofi's (SNY) BLA for MenQuadfi, a meningococcal vaccine candidate, presently under development to prevent meningococcal meningitis.
Dova Receives Approval for Doptelet in Europe, Stock Up
by Zacks Equity Research
Dova Pharmaceuticals (DOVA) announces approval of its thrombocytopenia drug, Doptelet, in Europe for patients with chronic liver disease.
Bayer Sets Up Special Committee to Tackle Glyphosate Lawsuits
by Zacks Equity Research
Activist investor, Elliott Advisors, discloses a 1.1-billion-euro ($1.3 billion) stake in Bayer (BAYRY). It forms a new committee and hires U.S. lawyer Beisner to fight its glyphosate litigations.
Is Allergan a Good Deal for AbbVie?
by Sejuti Banerjea
AbbVie is dishing out $63 billion in stock and cash for Allergan, provided it gets regulatory approval.