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Zacks News
AstraZeneca's Lynparza Gets China Nod in First-Line Setting
by Zacks Equity Research
AstraZeneca's (AZN) Lynparza receives approval in China for first-line maintenance treatment of advanced ovarian cancer with BRCA-mutation.
Aurinia's Lupus Candidate Succeeds in Pivotal Study, Stock Up
by Zacks Equity Research
Aurinia's (AUPH) lupus candidate, voclosporin, met primary endpoint of renal response rate in a late-stage study. An NDA is expected in the first half of 2020.
Immunomedics Resubmits Application for Breast Cancer Drug
by Zacks Equity Research
Immunomedics (IMMU) resubmits BLA to the FDA for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer, who have received at least two prior therapies.
Biogen's Lupus Candidate Meets Endpoint in Phase II Study
by Zacks Equity Research
Biogen (BIIB) posts favorable top-line results from a phase II study evaluating BIIB059 for treating cutaneous and systemic lupus erythematosus. The study tastes success by achieving its main goal.
AstraZeneca Sells Schizophrenia Drug Rights in US and Canada
by Zacks Equity Research
AstraZeneca (AZN) divests commercial rights to its schizophrenia and bipolar disorder medicines Seroquel/Seroquel XR in the United States and Canada to Cheplapharm Arzneimittel GmbH.
Roche's Tecentriq-Chemo Combo Gets FDA Nod in First-Line NSCLC
by Zacks Equity Research
Roche (RHHBY) obtains FDA approval for Tecentriq in combination with chemotherapy for the first-line treatment of adults with metastatic NSCLC.
AstraZeneca's (AZN) Imfinzi Gets FDA Priority Tag for SCLC
by Zacks Equity Research
AstraZeneca's (AZN) Imfinzi, if approved for extensive-stage small cell lung cancer, can cater to a broader lung cancer patient population, which can bring in additional sales.
Here's Why Merck's (MRK) Shares Are Up This Year
by Zacks Equity Research
Merck's (MRK) shares are up 11.7% this year so far on strong performance and positive regulatory updates on its PD-1 inhibitor Keytruda.
Pharma Stock Roundup: FDA Nod to NVS' & AZN's Drugs, BMY-CELG Merger Closes
by Kinjel Shah
The FDA approves Novartis' (NVS) sickle cell disease candidate Adakveo and AstraZeneca's (AZN) Calquence for chronic lymphocytic leukemia. Bristol-Myers (BMY) completes $74 billion-buyout of Celgene.
AstraZeneca Gets FDA Nod for Calquence Line Extension in CLL
by Zacks Equity Research
The FDA approves AstraZeneca's (AZN) Calquence to treat CLL patients, based on positive data from two phase III studies.
Amarin's Shares Down on Underperform Rating by Oppenheimer
by Zacks Equity Research
Amarin's (AMRN) shares decline as the independent advisory firm, Oppenheimer, initiates coverage with an Underperform rating on the back of concerns related to its marketed drug, Vascepa.
Alkermes Submits NDA to FDA for Schizophrenia & Bipolar I Drug
by Zacks Equity Research
Alkermes (ALKS) submits NDA to the FDA seeking approval of ALKS 3831 for the treatment of schizophrenia and bipolar I disorder.
Roche Gets CHMP Opinion for Breast Cancer & Lymphoma Drugs
by Zacks Equity Research
Roche's (RHHBY) breast cancer candidate and lymphona candidate get positive CHMP opinion. The company inks a deal to acquire Promedior, Inc.
Here's Why AstraZeneca's (AZN) Shares Are Up Year to Date
by Zacks Equity Research
AstraZeneca's (AZN) stock is on an upward trajectory this year. Let us take a look at the reasons for the same.
AstraZeneca/Merck's Selumetinib NDA Gets FDA Priority Status
by Zacks Equity Research
The FDA grants priority review to AstraZeneca (AZN) and Merck's NDA for MEK 1/2 inhibitor, selumetinib. Additionally, Qtrilmet tablets to treat type-II diabetes get approval in the EU.
Pharma Stock Roundup: MRK, GSK, ABBV, LLY's Pipeline & Regulatory Updates
by Kinjel Shah
Merck (MRK) gets approval in Europe for Ebola vaccine. Roche, Glaxo (GSK) & Pfizer (PFE) provide pipeline updates.
Glaxo's Nucala Meets Goal in Rare Inflammatory Disorder Study
by Zacks Equity Research
GlaxoSmithKline's (GSK) late-stage study evaluating Nucala succeeds in reducing flares in patients with Hypereosinophilic Syndrome.
AVEO Pharmaceuticals (AVEO) Q3 Earnings & Revenues Top Mark
by Zacks Equity Research
AVEO Pharmaceuticals (AVEO) rides high on both earnings and revenue beat in the third quarter. Shares rise.
Inovio's (INO) Q3 Loss In Line, Sales Lag, VGX-3100 in Focus
by Zacks Equity Research
Inovio's (INO) loss in the third quarter meets estimates while revenues miss the same. Lead vaccine candidate VGX-3100 is in focus.
Pfizer-Merck KGaA's Bavencio Fails in 2nd Gastric Cancer Study
by Zacks Equity Research
Pfizer (PFE) and Merck KGaA's Bavencio misses the primary goal in a late-stage study evaluating it as the first-line maintenance therapy for patients with metastatic HER2-negative gastric cancer.
Pharma Stock Roundup: AGN, NVO Q3 Earnings, FDA Nod to SNY & NVS' Products
by Kinjel Shah
Novo Nordisk (NVO) and Allergan (AGN) release Q3 results. FDA approves Sanofi's quadrivalent flu vaccine for older adults and Novartis' long-acting biosimilar version of Amgen's Neulasta.
Ironwood (IRWD) Beats on Q3 Earnings & Revenues, Ups '19 View
by Zacks Equity Research
Ironwood (IRWD) witnesses strong demand for Linzess in the third quarter as well.
BMY or AZN: Which Is the Better Value Stock Right Now?
by Zacks Equity Research
BMY vs. AZN: Which Stock Is the Better Value Option?
Mylan (MYL) to Report Q3 Earnings: What's in the Offing?
by Zacks Equity Research
Investors will look forward to regular top and bottom-line numbers, when Mylan (MYL) reports Q3 results along with updates on merger with Upjohn.
Merck (MRK) Beats on Q3 Earnings & Sales, Raises '19 View
by Zacks Equity Research
Merck (MRK) beats estimates for earnings as well as sales in third-quarter 2019. Blockbuster cancer drug, Keytruda continues its robust performance on strong demand. Shares up.