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Zacks News
Roche's NDA for SMA Drug Gets Expanded Review From FDA
by Zacks Equity Research
The FDA stretches the review timeline of Roche's (RHHBY) NDA for risdiplam by three months, which is being evaluated to treat spinal muscular atrophy. A decision is now pending on Aug 24, 2020.
Alnylam (ALNY) Completes Rolling Submission of Lumasiran NDA
by Zacks Equity Research
Alnylam (ALNY) completes rolling submission of the NDA for lumasiran seeking approval for kidney disease, primary hyperoxaluria type 1. The EMA accepts MAA for lumasiran for the same indication.
Large-Cap Pharma Stocks to Benefit in Post-Pandemic Market
by Kinjel Shah
The Zacks Large Cap Pharmaceuticals industry ranks in the top 13% of more than 250 Zacks industries.
Biotech Stocks, ETFs to Gain on COVID-19 Vaccine & Drug Progress
by Sweta Jaiswal, FRM
The race to introduce a vaccine and drug for COVID-19 is creating near-term opportunities, making the biotech sector a lucrative space for investments.
Immunomedics Up as Breast Cancer Drug Study Shows Efficacy
by Zacks Equity Research
Immunomedics (IMMU) soars as the phase III study on breast cancer drug shows efficacy and will be subsequently halted.
The Zacks Analyst Blog Highlights: Johnson & Johnson, Merck & Co, Novartis, PayPal and IBM
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Johnson & Johnson, Merck & Co, Novartis, PayPal and IBM
Bristol Myers/Acceleron's Reblozyl Label Expansion Gets FDA Nod
by Zacks Equity Research
Bristol Myers (BMY) and Acceleron received FDA nod for the label expansion of Reblozyl for MDS patients who require RBC transfusions, failing an erythropoiesis stimulating agent.
Top Stock Reports for J&J, Merck, Novartis & Others
by Sheraz Mian
Today's Research Daily features new research reports on 16 major stocks, including Johnson & Johnson (JNJ), Merck (MRK) and Novartis (NVS).
Pharma Coronavirus Efforts Continue, Amgen & Incyte Join In
by Kinjel Shah
Amgen (AMGN) signs a deal with Adaptive Biotechnologies to discover antibodies to prevent/treat COVID-19. Incyte/Novartis (NVS) plan to initiate study on Jakafi for COVID-19- associated cytokine storm.
Novartis Terminates Sale of Sandoz Dermatology Business
by Zacks Equity Research
Novartis (NVS) terminates sale of Sandoz US generic oral solids and dermatology businesses to Aurobindo Pharma USA Inc.
NVS vs. NVO: Which Stock Should Value Investors Buy Now?
by Zacks Equity Research
NVS vs. NVO: Which Stock Is the Better Value Option?
The Zacks Analyst Blog Highlights: Novartis, Teva, Gilead and AbbVie
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Novartis, Teva, Gilead and AbbVie
Lilly's Taltz Gets FDA Nod for Plaque Psoriasis in Children
by Zacks Equity Research
The FDA approves Eli Lilly's (LLY) sBLA for Taltz injection to treat pediatric patients with moderate to severe plaque psoriasis. Stock up.
COVID-19 Claiming Lives But Therapeutics Could Be on the Way
by Sejuti Banerjea
The WHO's Solidarity testing project could be good news for the world.
Novartis Reports Data on Inclisiran, CHMP Positive on Zolgensma
by Zacks Equity Research
Novartis (NVS) announces pipeline updates on inclisiran and regulatory updates on Cosentyx and Zolgensma.
Jazz's (JAZZ) Xyrem Follow-On Candidate NDA Gets FDA Acceptance
by Zacks Equity Research
The FDA accepts Jazz's (JAZZ) regulatory application seeking approval for JZP-258, a low sodium formulation of Xyrem in the United States.
Novartis to Donate Generic Hydroxychloroquine for Coronavirus
by Zacks Equity Research
Novartis (NVS) will donate 130 million doses of generic hydroxychloroquine for COVID-19 treatment.
Aduro's (ADRO) Earnings & Revenues Miss Estimates in Q4
by Zacks Equity Research
Aduro (ADRO) incurs wider-than-expected loss in Q4. Revenues too fall short of the mark.
Puma Biotech's (PBYI) Nerlynx Aids Growth Despite Competition
by Zacks Equity Research
Puma Biotech (PBYI) focuses on improving sales of its only marketed drug Nerlynx, which is approved for treating breast cancer. High dependence on Nerlynx for growth remains a woe.
AMAG Sees High Feraheme Sales, To Sell Women Healthcare Drugs
by Zacks Equity Research
AMAG (AMAG) plans to divest two of its women healthcare drugs, Intrarosa and Vyleesi. Its marketed drug, Feraheme, achieves record sales in 2019.
J&J Files MAA for Multiple Sclerosis Drug Ponesimod in Europe
by Zacks Equity Research
Ponesimod's regulatory application in Europe is based on data from the head-to-head OPTIMUM phase III study comparing it to Sanofi's (SNY) MS drug, Aubagio
Alnylam's Givlaari Gets Approval in Europe for Rare Disease
by Zacks Equity Research
Alnylam's (ALNY) second RNAi-based therapeutics, Givlaari receives approval in Europe for treating acute hepatic porphyria, becoming the first and only approved therapy for the indication.
The Zacks Analyst Blog Highlights: Merck, Novartis, Mondelez International, ServiceNow and General Dynamics
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Merck, Novartis, Mondelez International, ServiceNow and General Dynamics
Roche's Esbriet Gets FDA Breakthrough Tag for New Indication
by Zacks Equity Research
Roche (RHHBY) gets Breakthrough Therapy status from the FDA for Esbriet in adults with unclassifiable interstitial lung disease.
Gilead to Buy Immuno-Oncology Company Forty Seven for $4.9B
by Zacks Equity Research
Gilead (GILD) looks to strengthen its immuno-oncology research and development portfolio with the acquisition of Forty Seven.