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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
Lilly's Emgality Gets FDA Priority Review for Cluster Headache
by Zacks Equity Research
Eli Lilly's (LLY) supplemental biologics license application for its migraine drug, Emgality, wins a priority review from the FDA for treating episodic cluster headache in adults.
Ligand Sells Promacta Rights for $827M, Updates '19 View
by Zacks Equity Research
Ligand Pharmaceuticals (LGND) announces sale of all rights to Novartis' Promacta, including royalty payments on global sales, to Royalty Pharma.
Merck Gets CHMP Nod for Six-Week Dosing Option of Keytruda
by Zacks Equity Research
Merck (MRK) gets CHMP recommendation for a six-week dosing schedule of Keytruda across all current monotherapy indications.
AbbVie Gets CHMP Nod for Psoriasis Candidate Risankizumab
by Zacks Equity Research
AbbVie (ABBV) gets positive opinion of the CHMP recommending marketing approval for risankizumab for the treatment of moderate-to-severe plaque psoriasis.
Radius (RDUS) Posts Narrower Q4 Loss on Robust Tymlos Sales
by Zacks Equity Research
Radius Health (RDUS) posts narrower-than-expected Q4 loss as Tymlos sales gain traction and capture additional market share.
Spectrum (SPPI) Misses Earnings Estimates in Q4, Tops Sales
by Zacks Equity Research
Spectrum Pharma (SPPI) misses bottom-line estimates in the fourth quarter but beats on revenues.
Sanofi/Regeneron Disagree With Jury Verdict in Amgen's Favor
by Zacks Equity Research
Sanofi (SNY) and partner Regeneron (REGN) disagree with a jury verdict in favor of Amgen upholding the validity of two patents related to Repatha.
Roche (RHHBY) to Acquire Spark Therapeutics for $4.8 Billion
by Zacks Equity Research
Roche (RHHBY) to acquire Philadelphia-based gene therapy company, Spark Therapeutics, Inc. (ONCE) at a price of $114.50 per share in an all-cash transaction.
Amgen Starts Phase III Enrollment for Heart Failure Drug
by Zacks Equity Research
Amgen (AMGN) and partners started enrollment for the second phase III study of omecamtiv mecarbil, which is being developed for the potential treatment of heart failure with reduced ejection fraction.
The Zacks Analyst Blog Highlights: Walmart, Amgen, Honda, TransCanada and TransUnion
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Walmart, Amgen, Honda, TransCanada and TransUnion
Merck Gets Priority Review for Keytruda in Third-Line SCLC
by Zacks Equity Research
Merck's (MRK) sBLA looking for approval of Keytruda monotherapy for the third-line treatment of small cell lung cancer, a difficult-to-treat cancer, gets FDA's priority review.
AbbVie's RA Candidate Upadacitinib Gets FDA Priority Review
by Zacks Equity Research
AbbVie's (ABBV) new drug application for its late-stage candidate, upadacitinib, gets a priority review status from the FDA for treating rheumatoid arthritis in adult patients.
Merck's Keytruda Fails to Meet Endpoint in Liver Cancer Study
by Zacks Equity Research
Merck's (MRK) Keytruda fails a phase III study in second-line advanced hepatocellular carcinoma (HCC). It gets FDA approval for the adjuvant treatment of patients with high-risk stage III melanoma.
Top Analyst Reports for Walmart, Amgen and Honda
by Mark Vickery
Today's Research Daily features new research reports on 16 major stocks, including Walmart (WMT), Amgen (AMGN) and Honda (HMC).
Roche's (RHHBY) BLA for Lymphoma Drug Gets Priority Review
by Zacks Equity Research
The FDA accepts Roche's (RHHBY) BLA for polatuzumab vedotin and NDAs for entrectinib, and grants Priority Review status to the applications.
Merck Gets Priority Review for Keytruda Combo in Kidney Cancer
by Zacks Equity Research
Merck's (MRK) sBLA looking for approval of Keytruda plus Pfizer's Inlyta for the first-line treatment of the most common type of kidney cancer gets FDA's priority review.
Despite M&A Spree, Biotech ETFs Slide on Mixed Earnings
by Sanghamitra Saha
Biotech stocks came up with mixed earnings and weighed on the related ETFs in the key reporting season.
Teva (TEVA) Q4 Earnings Miss,'19 View Weak, Shares Down
by Zacks Equity Research
Teva's (TEVA) fourth-quarter earnings miss estimates while sales marginally beat expectations. Guidance for 2019 is lower than expected.
Key Takeaways from Eli Lilly's (LLY) Q4 Earnings Report
by Zacks Equity Research
Here are the key takeaways from Eli Lilly's (LLY) fourth-quarter earnings conference call.
Merck's Keytruda Gets FDA Priority Review for Head/Neck Cancer
by Zacks Equity Research
Merck's (MRK) supplemental biologics license application for Keytruda receives a priority review from the FDA for the first-line treatment of patients with recurrent/metastatic head and neck cancer.
AbbVie Buys Rights to Novel Immunotherapy for Multiple Myeloma
by Zacks Equity Research
AbbVie (ABBV) enters a global strategic transaction agreement with privately-held Teneobio to develop and commercialize the latter's pre-clinical immunotherapy candidate, TNB-383B, as a multiple myeloma treatment.
Sanofi/Regeneron Cut Price of PCSK9 Inhibitor Praluent by 60%
by Zacks Equity Research
Sanofi (SNY) and Regeneron (REGN) announce a 60% cut in the U.S. list price of their cholesterol lowering drug, Praluent to improve access and affordability of the product.
Ligand (LGND) Beats on Q4 Earnings & Sales, Raises '19 View
by Zacks Equity Research
Ligand (LGND) beats earnings and sales estimates for the fourth quarter of 2018 and raises 2019 guidance.
Lilly (LLY) Lags Q4 Earnings, Lowers 2019 View, Stock Down
by Zacks Equity Research
Eli Lilly (LLY) misses estimates for earnings but beats the same for sales. The company lowers its previously issued guidance for earnings and sales. Stock drops in pre-market trading.
Roche Submits sBLA to FDA for Label Expansion of Kadcyla
by Zacks Equity Research
Roche (RHHBY) submits sBLA for Kadcyla to the FDA for adjuvant treatment of patients with HER2-positive early breast cancer with residual disease after neoadjuvant treatment.