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Zacks News
Thousand Oaks, CA-based Amgen is one of the biggest biotech companies in the world, with a strong presence in the oncology/hematology, cardiovascular disease, neuroscience, inflammation, bone health and nephrology markets. The company used advances in cellular and molecular biology to develop two of the biotech industry’s earliest and most successful drugs, Epogen (anemia) and Neupogen (white blood cell stimulant). Amgen successfully launched two next-generation products, Aranesp and Neulasta. Meanwhile, the acquisition of Immunex Corporation gave Amgen access to the multi-blockbuster drug, Enbrel. However, all these older drugs are facing declining sales due to biosimilar or branded competition, which is being somewhat offset by its newer blockbuster drugs like Prolia/Xgeva
Biotech Stock Roundup: AXON Soars, Amgen Drugs Get FDA, EC Nod
by Zacks Equity Research
Key areas of focus in the biotech space include regulatory approvals and licensing/acquisition deals.
Allergan's Second Anti-CGRP Drug Positive in Mid-Stage Study
by Zacks Equity Research
Allergan's (AGN) anti-CGRP candidate, atogepant, successful in mid-stage study, following positive data readouts from two phase III studies on another anti-CGRP candidate, ubrogepant.
Amgen Gets FDA Nod to Add ASPIRE Data on Kyprolis Label
by Zacks Equity Research
Amgen (AMGN) gets FDA approval to add overall survival data from the phase III ASPIRE study on the label of its multiple myeloma drug, Kyprolis.
Amgen's (AMGN) Prolia Gets Label Expansion Approval in Europe
by Zacks Equity Research
Amgen (AMGN) announces approval for its regulatory application seeking label expansion for Prolia in Europe.
Roche Rituxan Label Expanded by FDA for Pemphigus Vulgaris
by Zacks Equity Research
Roche (RHHBY) obtains FDA approval for the label expansion of Rituxan for the treatment of adults with pemphigus vulgaris.
Mylan (MYL) Gets FDA Approval for Biosimilar of Neulasta
by Zacks Equity Research
Mylan (MYL) and partner Biocon get a significant boost with the FDA approval for Fulphila, a biosimilar of Amgen's Neulasta.
Merck Presents Positive Melanoma Data on Keytruda at ASCO
by Zacks Equity Research
Merck (MRK) presents encouraging data from two pivotal advanced melanoma studies on its PD-L1 inhibitor, Keytruda.
Novartis Announces Positive Data on Kisqali and Tasigna
by Zacks Equity Research
Novartis (NVS) announces positive data on breast cancer drug Kisqali and oncology drug Tasigna at the ASCO.
Eli Lilly's Olumiant Gets FDA Nod for Rheumatoid Arthritis
by Zacks Equity Research
Eli Lilly (LLY) and its partner Incyte announce approval of their arthritis drug, Olumiant, in the United States. The drug will be available at two-fifth of the price of leading RA drugs.
Merck's (MRK) Keytruda Lung Cancer Data in Focus at ASCO
by Zacks Equity Research
Merck (MRK) presents data from several cancer studies of its PD-L1 inhibitor, Keytruda at ASCO including two key lung cancer trials.
FDA Confirms September Action Date for Teva's Migraine Drug
by Zacks Equity Research
Teva (TEVA) confirms that FDA has extended the goal date of the Biologics License Application (BLA) for fremanezumab to September from mid-June.
Novartis Gets Approval for Remicade Biosimilar in Europe
by Zacks Equity Research
Novartis' (NVS) Sandoz wins approval for a biosimilar version of Remicade in Europe, which should further strengthen its biosimilars portfolio.
Why Is Amgen (AMGN) Up 3.7% Since Its Last Earnings Report?
by Zacks Equity Research
Amgen (AMGN) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Merck's Keytruda Shows Survival Benefit in Squamous NSCLC
by Zacks Equity Research
Merck's (MRK) Keytruda in combination with chemotherapy demonstrates better OS and PFS in first-line metastatic squamous NSCLC compared to chemotherapy alone.
Biotech Stock Roundup: FDA Gives Nod to Amgen's Drugs, EU Approves Exelixis' Cabometyx
by Zacks Equity Research
Label expansion of a few prominent drugs along with pipeline updates were the key areas of focus for investors in the biotech space.
Allergan Stock Down Since Q1 Earnings Report: Here's Why
by Zacks Equity Research
Though Allergan (AGN) boasts a solid underlying business, its stock is down. Here we discuss why.
Amgen's Label Expansion Application for Prolia Gets FDA Nod
by Zacks Equity Research
Amgen (AMGN) announces FDA approval for its regulatory application seeking label expansion for Prolia.
Roche (RHHBY) Announces Positive Data on Hemophilia Drug
by Zacks Equity Research
Roche (RHHBY) announces positive data from two phase III studies on hemophilia drug Hemlibra which has further strengthened its hemophilia portfolio.
Company News For May 21, 2018
by Zacks Equity Research
Companies in the news are: PYPL,AMGN,TTD,CBS
Migraine Space in Focus as AMGN/NVS' Aimovig Gets FDA Nod
by Zacks Equity Research
Migraine is one of the top 10 causes of years lived with disability globally. With Aimovig receiving FDA approval for treatment of migraine, investors' attention is on future regulatory decisions.
Amgen's Migraine Drug Aimovig Gets FDA Approval, Shares Up
by Zacks Equity Research
Amgen's (AMGN) preventive treatment for migraine, Aimovig, gets approval in the United States.
Amgen's (AMGN) Repatha Gains EU Nod to Include Outcomes Data
by Zacks Equity Research
Amgen (AMGN) gets European Commission's approval to incorporate a new indication into the European label of its PCSK9 inhibitor, Repatha.
Pfizer Gets FDA Nod for Amgen, J&J's Anemia Drug Biosimilar
by Zacks Equity Research
Pfizer's (PFE) Retacrit, a biosimilar of Amgen's Epogen and J&J's Procrit gets FDA approval. The drug will be available for the treatment of anemia.
Eli Lilly's Cluster Headache Candidate Succeeds in Phase III
by Zacks Equity Research
Eli Lilly's (LLY) galcanezumab meets the primary endpoint in a late-stage study evaluating it for the prevention of episodic cluster headache.
Radius Health (RDUS) Incurs Narrower-Than-Expected Q1 Loss
by Zacks Equity Research
Radius Health (RDUS) narrower-than-expected loss in the first quarter was encouraging as sales of lead drug Tymlos pick up amid competition.