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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
Roche Reports Positive Data from Tecentriq Combination Study
by Zacks Equity Research
Roche reported positive data from a combination study of Tecentriq and Avastin in metastatic renal cell carcinoma patients.
3 Stocks in Focus as Biotech M&A Hopes for 2018 Rise
by Arpita Dutt
With tax reform on the horizon, the biotech sector is expected to witness a surge in M&A deals. Here is a look at Juno (JUNO) and two other biotech stocks that could be on the acquisition radar.
Sanofi Begins Combo Studies on Multiple Myeloma Candidate
by Zacks Equity Research
Sanofi (SNY) starts two new phase III studies evaluating isatuximab in combination with other cancer medicines for the treatment of multiple myeloma, a rare blood cancer.
Roche's Avastin Gets Full FDA Approval for Brain Cancer
by Zacks Equity Research
Roche (RHHBY) announced that the FDA converted accelerated approval for Avastin to full approval for the patients previously treated for aggressive form of brain cancer.
AbbVie/J&J's Imbruvica Succeeds in Combo Study with Rituxan
by Zacks Equity Research
AbbVie (ABBV) J&J's combination study evaluating Imbruvica in Waldenstrom's macroglobulinemia (WM), a rare form of non-Hodgkin's lymphoma, meets primary endpoint.
Biotech Stock Roundup: FDA Nod for Amgen PCSK9 Inhibitor, Revance Up on RT002 Data
by Arpita Dutt
Data presentations and regulatory updates were the key highlights this week with companies like AbbVie (ABBV) and Clovis providing data on their pipeline candidates.
AbbVie Psoriasis Candidate Succeeds in 4th Phase III Study
by Zacks Equity Research
AbbVie (ABBV) announces data from a phase III study on risankizumab, which shows that a significant portion of plaque psoriasis patients treated with risankizumab achieved high levels of skin clearance.
Mylan Up on FDA Approval & Amazon's Rumored Pharmacy Interest
by Zacks Equity Research
Mylan (MYL) receives approval for its biosimilar of breast cancer drug, Herceptin. Amazon is reportedly in talks with Mylan and another generic manufacturer about a potential entry in distribution of drugs.
Amgen's PCSK9 Inhibitor Gets FDA Nod for Stroke Prevention
by Zacks Equity Research
Amgen (AMGN) announced FDA approval of its regulatory application seeking approval to expand Repatha's label to prevent heart attacks and strokes in patients with established cardiovascular disease.
AbbVie Stock Up More Than 30% So Far in 2H17: Here's Why
by Zacks Equity Research
AbbVie's (ABBV) shares have gained 32.1% so far in the second half of the year supported by a series of positive news in the past few months.
5 Biotech and Pharma Stocks with FDA Catalysts this December
by Arpita Dutt
As we enter the last month of the year, here is a look at some pharma and biotech companies including Amgen (AMGN) that await a decision from the FDA for label expansions or new drugs.
Biotech Stock Roundup: Regeneron Down on Eylea Data, Biogen-Alkermes in MS Deal
by Arpita Dutt
While there were not too many updates this week, companies like Regeneron (REGN) and Biogen were in the news related to their pipeline.
Nektar (NKTR) Stock Up More than 300% This Year: Here's Why
by Zacks Equity Research
Nektar's (NKTR) shares skyrocket in the year so far on a robust pipeline including several study initiations and strategic collaborations.
Will New Drug Approvals Boost Novartis (NVS) Portfolio?
by Zacks Equity Research
Novartis (NVS) is facing stiff generic competition for key drugs. Nevertheless, we expect approval of new drugs to boost its portfolio.
J&J Seeks Darzalex's Label Expansion in First-Line Setting
by Zacks Equity Research
Johnson & Johnson (JNJ) has submitted regulatory applications in the United States and EU for label expansion of Darzalex as first-line therapy for multiple myeloma.
Amgen (AMGN) Unveils Auto Injector Device for Enbrel in US
by Zacks Equity Research
Amgen launched its Enbrel Mini with AutoTouch, a new auto injector device for Enbrel in the United States.
AstraZeneca's (AZN) Asthma Drug Benralizumab Approved by FDA
by Zacks Equity Research
AstraZeneca (AZN) received FDA approval for benralizumab for treating severe eosinophilic asthma.
Biotech Stock Roundup: Dynavax Vaccine Gets FDA Nod, Loxo Inks Deal with Bayer
by Arpita Dutt
Regulatory actions and licensing and collaboration agreements were the key highlights this week with companies like Loxo Oncology (LOXO) remaining in the limelight.
Novartis (NVS) Arm's Biosimilars Study Results Encourage
by Zacks Equity Research
Novartis (NVS) generic arm, Sandoz, reported positive data from two phase III studies evaluating biosimilars of Humira and MabThera respectively.
Amgen Gets Positive CHMP Opinion to Expand Nplate's Label
by Zacks Equity Research
Amgen (AMGN) received positive CHMP opinion to expand Nplate's label to include pediatric patients and also for the marketing application of Avastin biosimilar.
Ligand (LGND) Q3 Earnings & Revenues Top, 2017 View Raised
by Zacks Equity Research
Ligand's (LGND) earnings and revenues beat estimates. Total revenues also rise year over year on the back of higher royalty benefits. The company ups its guidance for 2017.
Radius Health (RDUS) Earnings Miss in Q3, Tymlos in Focus
by Zacks Equity Research
Radius Health (RDUS) reported a wider-than-expected loss in third-quarter as expenses grew significantly for the commercialization of Tymlos.
Sanofi (SNY) Q3 Earnings In Line, Sales Lag, Diabetes Weak
by Zacks Equity Research
Sanofi's (SNY) Q3 results were mixed as it reported in-line earnings and missed sales expectations. Meanwhile, the outlook for the Diabetes franchise remains weak.
Pfizer (PFE) Beats on Q3 Earnings, Raises 2017 EPS View
by Zacks Equity Research
Pfizer (PFE) beat expectations for earnings while delivering in-line revenues in Q3. It raised its adjusted earnings guidance while tightening revenue expectations for 2017.
The Zacks Analyst Blog Highlights: Amgen, Comcast, McDonald's, Waste Management and BB&T
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Amgen, Comcast, McDonald's, Waste Management and BB&T