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Zacks News
Roche's (RHHBY) sBLA for Asthma Drug Xolair Accepted by FDA
by Zacks Equity Research
The FDA accepts Roche's (RHHBY) allergic asthma drug Xolair's sBLA for the treatment of nasal polyps in adult patients aged 18 years or above with inadequate response to intranasal corticosteroids.
Week Begins with Biotech Mergers
by Zacks Equity Research
Week Begins with Biotech Mergers
Merger Monday, Biotech Edition: MRK, SNY, ARQL, THOR & More
by Mark Vickery
Large-cap pharmaceutical companies are putting their assets to work in the biotech space, particularly in cancer treatment (oncology).
Blueprint's (BPMC) Systemic Mastocytosis Study Data Impresses
by Zacks Equity Research
Blueprint Medicines (BPMC) posts favorable initial data from the part 1 of phase II PIONEER study on avapritinib for the treatment of patients with indolent systemic mastocytosis. Stock rises.
J&J Presents Data on CAR-T Therapy Drug and Imbruvica at ASH
by Zacks Equity Research
J&J's (JNJ) initial data on CAR-T therapy candidate JNJ-68284528 from an early-stage study shows promising response rate.
Bristol-Myers' (BMY) Lymphoma Drug Meets Goals in Key Study
by Zacks Equity Research
Bristol-Myers' (BMY) TRANSCEND NHL 001 study on CAR T-cell therapy drug meets endpoints.
Biogen Up on New Data on Alzheimer's Candidate Aducanumab
by Zacks Equity Research
Biogen (BIIB) divulges new positive data on Alzheimer's candidate, aducanumab at CTAD. Stock rises.
Pharma Stock Roundup: FDA Updates for RHHBY, AZN, MRK, No Asbestos in Talc Says JNJ
by Kinjel Shah
The FDA approves Roche's (RHHBY) Tecentriq for expanded use. It grants priority review status to AstraZeneca (AZN) & Merck's (MRK) supplemental applications.
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.
4 Solid Gene Therapy Buyout Bets Post Audentes-Astellas Deal
by Ekta Bagri
Gene therapy continues to draw attention with the recent spate of deals and acquisitions. We list four stocks with promising candidates in their pipelines that make attractive acquisition targets.
J&J Stock Witnesses Volatility in '19: What to Expect in 2020
by Zacks Equity Research
Here we discuss the ups and downs of J&J's (JNJ) stock this year.
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.
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.
Pfizer/Astellas Xtandi Gets Nod in China for Prostate Cancer (Revised)
by Zacks Equity Research
Pfizer (PFE)/Astellas' Xtandi gets approval in China to treat metastatic castration-resistant prostate cancer (CRPC).
Epizyme Announces FDA Committee Review of Tazemetostat NDA
by Zacks Equity Research
Epizyme (EPZM) announces that the FDA committee will review its NDA for lead candidate, tazemetostat, on Dec 18.
Mylan (MYL) Launches Herceptin Biosimilar Ogivri in the US
by Zacks Equity Research
Mylan (MYL) launches Ogivri, a biosimilar of Roche's blockbuster breast cancer drug, Herceptin (trastuzumab), in the United States.
Biogen's Shares Down on Rating Downgrade by Baird Analyst
by Zacks Equity Research
Biogen's (BIIB) shares decline following a rating downgrade by an analyst at Robert W. Baird on concerns related to approval of Alzheimer's disease candidate, aducanumab.
Puma Biotech Expands Pierre Fabre License to Add Countries
by Zacks Equity Research
Puma Biotech (PBYI) stretches its license deal with Pierre Fabre, granting the latter commercial rights to Nerlynx in new countries across Europe and parts of Africa. Stock rallies.
Large-Cap Pharmaceuticals Industry Prospects Bright for 2020
by Kinjel Shah
The Zacks Large Cap Pharmaceuticals industry ranks in the top 13% of more than 250 Zacks industries.
Digital Diabetes Management Gains Momentum: 3 Stocks in Focus
by Trina Mukherjee
With digital diabetes management space rapidly gaining momentum, patients with diabetes can look forward to better and improved outcomes.
ChemoCentryx Up on Encouraging Rare Disease Candidate Data
by Zacks Equity Research
ChemoCentryx (CCXI) announces positive data pivotal study evaluating its lead candidate, avacopan, in patients with ANCA vasculitis, a rare disease affecting small blood vessels.
Pfizer/Astellas Xtandi Gets Nod in China for Prostate Cancer
by Zacks Equity Research
Pfizer (PFE)/Astellas' Xtandi gets approval in China to treat metastatic castration-resistant prostate cancer (CRPC).
Roche's NDA for SMA Drug Risdiplam Gets Priority Review
by Zacks Equity Research
The FDA accepts Roche's (RHHBY) NDA for risdiplam under a priority review to treat spinal muscular atrophy. A verdict is pending on May 24, 2020.
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.