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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
Key FDA Events to Watch Out for in Jul 2017
by Arpita Dutt
Will the FDA follow the advice of its advisory panel and give its nod to Puma's (PBYI) neratinib?
Teva's (TEVA) Filing for Biosimilar Rituxan Accepted by FDA
by Zacks Equity Research
Teva Pharmaceutical Industries Ltd. (TEVA) and Korean partner Celltrion, Inc., announced that the FDA has accepted for review their Biologics License Application (BLA) for CT-P10, a proposed biosimilar to Roche Holding AG's (RHHBY) Rituxan (rituximab).
Amgen's Colorectal Cancer Drug Gets FDA Nod to Expand Label
by Zacks Equity Research
Amgen, Inc. (AMGN) announced that the FDA has approved a label expansion of its colorectal cancer drug, Vectibix.
Pricing, Competition Remain Headwinds for Pharma in 2017
by Arpita Dutt
Fears regarding the drug pricing issue have waned, it will nevertheless remain a headwind in the near term.
Alder's Shares Dip Despite Positive Migraine Trial Results
by Zacks Equity Research
Alder Biopharmaceuticals, Inc.'s (ALDR) shares plummeted almost 28% despite the announcement of positive top line results from phase III study, evaluating its lead pipeline candidate eptinezumab for prevention of frequent episodic migraine.
Novartis' Erelzi, Biosimilar of Enbrel Approved In Europe
by Zacks Equity Research
Novartis AG (NVS) announced that the European Commission (EC) has approved Erelzi ??? the biosimilar version of Enbrel.
Amgen Gets Positive CHMP Opinion for Mimpara Label Expansion
by Zacks Equity Research
Amgen announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has rendered a positive opinion recommending marketing approval of a pediatric formulation of Mimpara for the treatment of secondary hyperparathyroidism
Roche's (RHHBY) Combination Cancer Remedy Wins FDA Approval
by Zacks Equity Research
Roche (RHHBY) announced that the FDA has granted approval to the subcutaneous injection of its marketed lymphoma drug MabThera/Rituxan as Rituxan Hycela for the treatment of adults with different types of blood cancers.
Allergan Continues to Focus on Acquisitions and Branded Unit
by Zacks Equity Research
We issued an updated research report on Allergan plc (AGN) on Jun 23.
Merck's Keytruda on a Roll: Can it Retain the Momentum?
by Zacks Equity Research
As demand for immuno-oncology drugs and their combinations rises, Merck & Co., Inc.'s (MRK) anti-PD-1 therapy, Keytruda, is being touted as a significant top-line driver for this Kenilworth, NJ based pharma giant.
Ligand Gets Milestone Payment on Partner Drug FDA Approval
by Zacks Equity Research
Ligand Pharmaceuticals Incorporated (LGND) announced receipt of a milestone payment of $1.5 million after its partner Melinta Therapeutics' pipeline candidate Baxdela (delafloxacin) was approved by the FDA.
Novartis Migraine Drug Accepted, AMD Positive in Phase III
by Zacks Equity Research
Novartis (NVS) announced that the EMA accepted its application for migraine candidate AMG 334.
Small Cancer Biotech Space in Focus, 3 Stocks Up 100% & More
by Zacks Equity Research
The oncology space has always been keenly watched by investors interested in the pharma/biotech sector.
Amgen's Xgeva Myeloma Label Expansion sBLA Accepted by FDA
by Zacks Equity Research
Amgen Inc. (AMGN) announced that the FDA has accepted its supplemental Biologics License Application (sBLA) to expand the label of its key drug, Xgeva.
AbbVie (ABBV) Stock Hits 52-Week High: More Room to Run?
by Zacks Equity Research
AbbVie Inc. (ABBV) shares hit a 52-week high of $71.12 on Friday before eventually closing at $71.05.
Nektar (NKTR) Stock Rallied Almost 50% This Year: Here's Why
by Zacks Equity Research
Shares of Nektar Therapeutics (NKTR) are up almost 48% this year so far, outperforming the Zacks classified Medical-Drugs industry's registered increase of 3.6% during this period.
Is Amgen (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.
Novartis (NVS) Announced Positive Data on Psoriasis Cosentyx
by Zacks Equity Research
Novartis AG (NVS) announced positive data on arthritis drug Cosentyx from two phase III studies.
Why Is ImmunoGen (IMGN) Stock Up 131% This Year?
by Zacks Equity Research
Shares of ImmunoGen, Inc. (IMGN) are massively up 130.9% this year so far, outperforming the the Zacks classified Medical-Drugs industry's registered 3.6% increase during this period.
Coherus Stock Plummets as FDA Rejects Neulasta Biosimilar
by Zacks Equity Research
Coherus Biosciences, Inc. (CHRS) shares declined nearly 24% in yesterday's trading as it announced that it has received a complete response letter (CRL) from the FDA for its biosimilar version of Amgen Inc's (AMGN) blockbuster drug, Neulasta.
Merck Stalls Enrolment in Two Myeloma Studies of Keytruda
by Zacks Equity Research
Merck & Co., Inc. (MRK) announced that it is pausing two late-stage studies evaluating its anti-PD-1 therapy, Keytruda, as a combination therapy for the treatment of multiple melanoma, a form of blood cancer.
Amgen's Multiple Myeloma Drug Receives NICE Recommendation
by Zacks Equity Research
Amgen Inc. (AMGN) announced that Kyprolis gained recommendation from National Institute for Health and Care Excellence (NICE) in combination with dexamethasone for the treatment of relapsed multiple myeloma.
Sanofi/Regeneron's Praluent Cuts Bad Cholesterol in Studies
by Zacks Equity Research
Sanofi (SNY) and partner Regeneron Pharmaceuticals, Inc. (REGN) announced that their PCSK9 inhibitor, Praluent significantly reduced bad cholesterol in two late-stage studies.
AbbVie (ABBV) Announced Positive Phase III RA Candidate Data
by Zacks Equity Research
AbbVie Inc. (ABBV) announced positive top-line results from a phase III study on rheumatoid arthritis candidate, upadacitinib (ABT-494).
Teva Migraine Candidate Succeeds in Second Phase III Study
by Zacks Equity Research
Teva announced that its experimental migraine prevention candidate, fremanezumab, met all the primary and secondary endpoints in a second late-stage study.