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Zacks News
Regeneron's sBLA for Eylea Accepted by FDA, Action Date Set
by Zacks Equity Research
Regeneron (REGN) announced that the FDA has accepted for review the company's supplemental Biologics License Application (sBLA) for Eylea with an action date of Aug 11, 2018.
Novartis Announces Positive Data on Sickle Cell Disease Drug
by Zacks Equity Research
Novartis (NVS) announced positive data from a phase II study, SUSTAIN, on pipeline candidate crizanlizumab which deferred the time to first sickle cell pain crisis (SCPC) in patients compared to placebo in key subgroups of adult patients with sickle cell.
Gilead (GILD) Posts Updated Data on CAR-T Therapy Yescarta
by Zacks Equity Research
Gilead (GILD) announced follow-up data from a phase II study, on its CAR-T therapy, Yescarta for treatment of refractory large B-cell lymphoma.
Novartis Reports Updated Results from Kymriah's JULIET Study
by Zacks Equity Research
Novartis (NVS) announced updated results from the JULIET study, which show Kymriah sustained complete responses at six months in adults with relapsed or refractory diffuse large B-cell lymphoma.
Here's Why Bluebird Bio (BLUE) Stock Skyrocketed Today
by Ryan McQueeney
Shares of Bluebird Bio (BLUE) were up nearly 20% in early morning trading Monday as investors responded to the company's announcement that its CAR-T candidate, bb2121, produced encouraging results in patients with a deadly blood cancer.
Incyte (INCY) Reports Phase III Follow-Up Data for Jakafi
by Zacks Equity Research
Incyte (INCY) announced new 208-week (4-year) follow-up data from the phase III RESPONSE study of Jakafi.
Puma (PBYI) Stock Up More than 200% This Year: Here's Why
by Zacks Equity Research
Puma's (PBYI) shares skyrocket in the year so far on the approval of its cancer drug Nerlynx in the United States coupled with strategic collaborations.
Gilead Sciences to Acquire Cell Design Labs for $567 Million
by Zacks Equity Research
Gilead Sciences, (GILD) and its subsidiary Kite announced that they have inked an agreement to acquire Cell Design Labs, for an upfront payment of $175 million.
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.
Lilly's (LLY) Taltz Gets Approval for Label Expansion in US
by Zacks Equity Research
Lilly (LLY) announced the label expansion of its psoriasis drug, Taltz, for the active psoriatic arthritis indication in the United States.
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.
How Will U.S. Tax Reform Impact Pharma/Biotech Industry?
by Zacks Equity Research
After certain modifications to the original plan over the past year, the tax reform bill is expected to be voted on by the Congress this week. Let's see how this vote will impact the pharma/biotech industry.
Regeneron's Stock Falls as Mid-Stage Eye Disease Studies Fail
by Zacks Equity Research
Regeneron Pharmaceuticals (REGN) announced that it will not advance two mid-stage studies evaluating the combination of nesvacumab of Eylea to phase III.
Teva's New CEO Re-Shuffles Senior Management, Stock Up 7%
by Zacks Equity Research
Teva (TEVA) announced several organizational changes in order to save costs and improve productivity.
The Zacks Analyst Blog Highlights: Johnson & Johnson, Novartis, GlaxoSmithKline and Roche
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Johnson & Johnson, Novartis, GlaxoSmithKline and Roche
Teva (TEVA) Stock Rises 5% on Reports of Massive Job Cuts
by Zacks Equity Research
Per an Israeli news release, Teva (TEVA) is expected to lay off 4000 employees
CAR-T Therapy Space 2017 Progress Report
by Zacks Equity Research
Given the vast potential of the CAR T therapy space and two recent approvals, biotech companies are leaving no stone unturned to develop their pipeline candidates.
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.
Parkinson's Space in Focus as Acorda Stops Tozadenant Trial
by Zacks Equity Research
Acorda scraps development of a key Parkinson's disease candidate, tozadenant. With the discontinuation, investors' focus once again shifts to the Parkinson's space.
Novartis (NVS) Receives EC Nod for Tasigna Label Expansion
by Zacks Equity Research
Novartis (NVS) oncology portfolio gets a boost with EC's approval for the label expansion of Tasigna for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia.
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.
Celgene CAR-T Therapy Gets Breakthrough Therapy Designation
by Zacks Equity Research
FDA grants Breakthrough Therapy Designation to Celgene's (CELG) chimeric antigen receptor T-cell (CAR-T) therapy candidate, bb2121.
Why is Alnylam's (ALNY) Stock Up More Than 200% this Year?
by Zacks Equity Research
Alnylam (ALNY) expects to achieve the profile of three marketed products by the end of 2020 and remains focused on development of its pipeline candidates.
Incyte (INCY) Initiates Essential Thrombocythemia Trial
by Zacks Equity Research
Incyte (INCY) announced that the first patient has been treated in the essential thrombocythemia trial on ruxolitinib. A potential label expansion of the drug will boost sales.
Roche (RHHBY) Receives FDA Clearance for Ventana MMR Test
by Zacks Equity Research
Roche's (RHHBY) diagnostic portfolio gets a further boost with FDA's clearance for Ventana tests.