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Zacks News
5 Winning Stocks to Beat September Blues
by Tirthankar Chakraborty
Investing in stocks that have traditionally given consistent returns during the weakest month of the year seems judicious.
Teva Austedo Gets FDA Nod for Label Expansion in Dyskinesia
by Zacks Equity Research
Teva Pharmaceutical (TEVA) announced that the FDA has approved the label expansion of Austedo to include tardive dyskinesia in adults. Shares are up since announcement.
Lilly/Incyte to Re-File Baricitinib NDA Faster Than Expected
by Zacks Equity Research
Lilly (LLY) and Incyte announced that they will re-submit the new drug application (NDA) for their rheumatoid arthritis (RA) drug, baricitinib much faster than previously expected.
Roche's (RHHBY) Actemra Gets FDA Nod for Label Expansion
by Zacks Equity Research
Roche Holding AG's (RHHBY) drug Actemra got FDA approval for label expansion.
BioMarin's Pegvaliase BLA Granted Priority Review by the FDA
by Zacks Equity Research
BioMarin Pharmaceutical (BMRN) announced that the FDA has accepted and granted priority review to the BLA for phenylketonuria candidate, Pegvaliase with a decision expected in February 2018.
Advanced Accelerator Gets Action Date for Lutathera from FDA
by Zacks Equity Research
The FDA granted an action date for Lutathera after the company resubmitted the New Drug Application (NDA) for the candidate.
Novo Nordisk's Tresiba Gets Canadian Nod
by Zacks Equity Research
Novo Nordisk's (NVO) Tresiba is approved by Health Canada for the once-daily treatment of adults with diabetes mellitus to improve glycemic control.
Amgen Presents New Repatha Analysis from FOURIER Study
by Zacks Equity Research
Amgen's (AMGN) new analysis from FOURIER study on Repatha showed that there was a strong progressive relationship between lower levels of bad cholesterol and a lower risk of cardiovascular events rates.
The Zacks Analyst Blog Highlights: Toyota Motor, NVIDIA and Regeneron
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Toyota Motor, NVIDIA and Regeneron
Strength Seen in Adaptimmune Therapeutics (ADAP): Stock Soars 15.2%
by Zacks Equity Research
Adaptimmune Therapeutics plc (ADAP) was a big mover last session, as the company saw its shares rise over 15% on the day.
Kamada (KMDA) Gets FDA Approval for Rabies Vaccine
by Zacks Equity Research
Kamada Ltd. (KMDA) and partner Kedrion Biopharma and announced that FDA has approved Kedrab [rabies immune globulin (Human)] for post-exposure prophylaxis against rabies infection.
Time for the Facts: Global Week Ahead
by John Blank
"Fostering a Dynamic Global Economy" was the main central banker theme at the Jackson Hole summit. Have the world's major central bankers been paying attention to the pedestrian facts?
AstraZeneca's Faslodex Gets FDA Nod in First-Line Setting
by Zacks Equity Research
AstraZeneca (AZN) drug Faslodex receives FDA approval for a label extension for Faslodex in the first-line monotherapy setting for the treatment of advanced breast cancer.
Will Endo (ENDP) Continue to Disappoint Investors in 2017?
by Zacks Equity Research
Endo (ENDP) a global specialty pharmaceutical company focused on branded and generic pharmaceuticals, is under significant pressure due to intensifying consortium pricing pressures and additional competitive entrants and product discontinuations.
Vertex's Cystic Fibrosis Combo Gets Priority Review in U.S.
by Zacks Equity Research
Vertex Pharmaceuticals' (VRTX) regulatory applications for tezacaftor/ivacaftor (Kalydeco) combination have been accepted by the FDA and EMA for review.
Pfizer's Ibrance in First-Line Combo Breast Cancer Study
by Zacks Equity Research
Pfizer, Inc. (PFE) and six international cancer research groups are collaborating on a combination study to explore the use of Ibrance for first-line treatment of advanced breast cancer.
Are Glaxo's Successful New Drugs Enough to Drive Growth?
by Zacks Equity Research
Despite the success of new products, GlaxoSmithKline plc (GSK) believes that its overall performance has been weaker than it would have liked.
Alkermes Initiates Rolling Submission of Depression Drug
by Zacks Equity Research
Alkermes (ALKS) initiated the rolling submission of a New Drug Application (NDA) to the FDA for pipeline candidate ALKS 5461 for major depressive disorder.
4 Biotech Stocks to Add to your Portfolio Post Q2 Earnings
by Arpita Dutt
Here is a look at four biotech stocks including Gilead (GILD) that topped estimates in Q2 and are witnessing upward estimate revisions for the current year.
Alexion's (ALXN) Soliris' Label Expansion Approved in Europe
by Zacks Equity Research
Alexion Pharmaceuticals (ALXN) announced that the European Commission (EC) approved a label expansion of lead drug Soliris which should further boost sales.
Why Regeneron Pharmaceuticals, Inc. (REGN) Might Be a Diamond in the Rough
by Zacks Equity Research
Investors might have overlooked the Zacks #1 Rank Regeneron Pharmaceuticals, Inc. (REGN) stock that has seen solid estimate revision in past one month but that is not reflected in its price performance.
Pfizer's (PFE) Besponsa Gets FDA Nod with a Boxed Warning
by Zacks Equity Research
Pfizer, Inc.'s (PFE) leukemia candidate, Besponsa received FDA approval, though with a boxed warning on the label.
Seattle Genetics' Adcetris Granted Priority Review by FDA
by Zacks Equity Research
Seattle Genetics, Inc.'s (SGEN) supplemental Biologics License Application for Adcetris in patients with cutaneous T-cell lymphoma has been accepted by the FDA and granted priority review.
Novo Nordisk's Semaglutide Shows Remarkable Results in Study
by Zacks Equity Research
Novo Nordisk (NVO) pipeline candidate shows superior glucose control and weight loss in study in diabetes patients compared with Eli Lilly and Co's Trulicity (dulaglutide).
Regeneron's (REGN) RSV Drug Suptavumab Fails NURSERY Trial
by Zacks Equity Research
Regeneron Pharmaceuticals, Inc. (REGN) announced disappointing results from a phase III study, NURSERY Pre-term on suptavumab .