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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
Amgen's (AMGN) Xgeva Gets EU Approval for Expanded Label
by Zacks Equity Research
Amgen (AMGN) gets EU approval to expand the label of its key drug, Xgeva to include patients with multiple myeloma.
Amgen's Blincyto Gets FDA Nod for Minimum Residual Disease
by Zacks Equity Research
Amgen's (AMGN) leukemia drug, Blincyto is the first approved drug for the treatment of minimal residual disease in the United States.
The Zacks Analyst Blog Highlights: Verona, Squibb, Protagonist and Amgen
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Verona, Squibb, Protagonist and Amgen
Biotech Stock Roundup: PTGX Down, VRNA Up, AMGN's Repatha Gets Positive Opinion
by Zacks Equity Research
The biotech sector was in focus last week with Protagonist's stock plunging on news of discontinuation of a phase IIb study and Verona Pharma stock surging on positive top-line data from COPD study among others.
Merck, Eisai Get Japanese Nod for Lenvima Label Expansion
by Zacks Equity Research
Merck (MRK) and partner Eisai receive approval in Japan for Lenvima for the first line treatment of patients with unresectable hepatocellular carcinoma (HCC).
Amgen's Repatha Gains CHMP Nod to Include Outcomes Data
by Zacks Equity Research
Amgen (AMGN) gets CHMP's positive opinion to incorporate a new indication into the European label of its PCSK9 inhibitor, Repatha.
Novartis Gets Positive CHMP Opinion on Biosimilar Remicade
by Zacks Equity Research
The CHMP gave a positive opinion to Novartis (NVS) proposed biosimilar of Remicade for all of the branded drug's indications. A decision from the EMA is expected shortly.
Radius Health Down on Negative CHMP Opinion for Lead Drug
by Zacks Equity Research
Shares of Radius Health (RDUS) declined after the company's application for lead drug, abaloparatide-SC, was given a negative opinion by the CHMP in Europe.
The Zacks Analyst Blog Highlights: Amgen, FedEx, Thermo Fisher, Sherwin-Williams and Ameriprise
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Amgen, FedEx, Thermo Fisher, Sherwin-Williams and Ameriprise
Roche's (RHHBY) Lucentis 0.3 mg PFS Receives FDA Approval
by Zacks Equity Research
Roche's (RHHBY) opthalmology drug, Lucentis 0.3 mg prefilled syringe (PFS) is a new method of administering medicine for all forms of diabetic retinopathy.
Radius Health Announces Positive Data on Lead Drug Tymlos
by Zacks Equity Research
Radius Health (RDUS) announces positive results from the extended study, ACTIVExtend on its drug Tymlos whcih is approved for the treatment of postmenopausal women with high risk osteoporosis for fracture.
Merck's Keytruda Gets Priority Review for Cervical Cancer
by Zacks Equity Research
Merck's (MRK) sBLA for Keytruda to expand its label for the treatment of advanced cervical cancer gets acceptance for priority review by the FDA.
Is Amgen Inc. (AMGN) a Great Stock 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.
Regeneron and Sanofi Announce Positive Data on Praluent
by Zacks Equity Research
Regeneron (REGN) & Sanofi's Praluent achieves the primary endpoint in the ODYSSEY OUTCOMES trial as the drug reduces the overall risk of MACE by 15%.
Merck to Pay $300M Upfront to Co-Develop Eisai's Cancer Drug
by Zacks Equity Research
Merck (MRK) is going to pay $300 million upfront to Japan's Eisai to jointly develop and commercialize the latter's pipeline candidate Lenvima.
Spectrum (SPPI) Q4 Loss Widens Y/Y, Sales Miss, Stock Falls
by Zacks Equity Research
Spectrum (SPPI) reports narrower-than-expected loss in the fourth quarter, while it misses on revenues. Rolontis successful in phase III study.
Pharmaceutical Industry Outlook - March 2018
by Zacks Equity Research
The year 2017 was rewarding for pharma and biotech stocks, with the sector witnessing some positive developments that led to a much-awaited recovery.
Radius (RDUS) Q4 Loss Wider Than Expected on Higher Expenses
by Zacks Equity Research
Radius Health (RDUS) reported a wider-than-expected loss in the fourth quarter due to higher operating expenses related to the commercialization of Tymlos.
Amgen (AMGN) Gets CHMP Nod to Expand EU Label of Neulasta
by Zacks Equity Research
Amgen (AMGN) gains positive opinion from the CHMP to update the label of Neulasta to include Neulasta Onpro Kit, an innovative delivery system.
Biotech Stock Round Up: Celgene Suffers Setback, Gilead Teams Up with Sangamo
by Zacks Equity Research
The major news in the biotech sector in the last five trading sessions include the FDA's refusal to file letter for Celgene Corporation's (CELG) ozanimod while Gilead Sciences, Inc.'s (GILD) announced an agreement with Sangamo Therapeutics.
Radius Health (RDUS) to Disappoint Investors in Q4 Earnings?
by Zacks Equity Research
Investors are expected to focus on the uptake of the lead drug, Tymlos when Radius Health (RDUS) reports its fourth-quarter results.
Ligand (LGND) Q4 Earnings & Revenues Top, 2018 View Solid
by Zacks Equity Research
Ligand's (LGND) earnings and revenues beat estimates. The top line also rises year over year owing to higher royalty benefits. The company provides a strong 2018 guidance.
The Zacks Analyst Blog Highlights: Amgen, TOTAL, Marriott, PG&E and Vertex
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Amgen, TOTAL, Marriott, PG&E and Vertex
Novartis Psoriasis Drug Cosentyx Positive in SCALP Study
by Zacks Equity Research
Novartis (NVS) announces positive results from the phase III study on multi-blockbuster drug Cosentyx for the treatment of moderate-to-severe scalp psoriasis.
Roche (RHHBY) to Acquire Flatiron Health for $1.9 Billion
by Zacks Equity Research
Roche (RHHBY) announces that it will acquire Flatiron Health to accelerate development and delivery of breakthrough drugs for cancer patients.