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Zacks News
Glaxo's Benlysta Gets Positive CHMP Opinion for Use in Kids
by Zacks Equity Research
Glaxo's (GSK) SLE drug Benlysta gets a favorable CHMP opinion that recommends an approval for intravenous formulation in pediatric patients.
Merck's Two HIV Drugs Get FDA Approval for Expanded Use
by Zacks Equity Research
Merck's (MRK) new HIV drugs, Pifeltro and Delstrigo, get FDA nod for use in treatment-experienced adults living with HIV-1 who are virologically suppressed.
Trovagene's Onvansertib Shows Response in Phase Ib AML Study
by Zacks Equity Research
Trovagene (TROV) successfully completes a phase Ib study, evaluating onvansertib in combination with standard-of-care in AML patients. The regimen is well tolerated and safe.
Pharma Stock Roundup: FDA Approves Expanded Use of MRK/J&J's Drugs & Other Updates
by Kinjel Shah
FDA approves label expansion of Merck's (MRK) Keytruda and J&J's (JNJ) Erleada.
Biogen's New Study to Test Higher Dose of SMA Drug Spinraza
by Zacks Equity Research
Biogen (BIIB) starts a DEVOTE study to investigate whether a higher dose of Spinraza can provide greater efficacy for treating patients with spinal muscular atrophy.
Roche's Gazyva Now a Breakthrough Therapy for Lupus Nephritis
by Zacks Equity Research
Roche's (RHHBY) lymphoma drug, Gazyva, obtains Breakthrough Therapy designation in the United States for lupus nephritis.
J&J Files sBLA for Tremfya With FDA for Psoriatic Arthritis
by Zacks Equity Research
J&J's (JNJ) sBLA seeking approval for Tremfya for active psoriatic arthritis is based on data from the phase III DISCOVER 1 and 2 studies.
Biogen Stops Late-Stage Studies on Alzheimer's Candidate
by Zacks Equity Research
Biogen (BIIB) and its Japanese partner, Eisai receive another setback as they discontinue two late-stage studies evaluating elenbecestat in patients with Alzheimer's disease.
Roche's New Perjeta Combo Meets Goal in Breast Cancer Study
by Zacks Equity Research
Roche's (RHHBY) new fixed-dose combination of Perjeta and Herceptin meets the primary endpoint in the phase III study for treating patients with HER2-positive early breast cancer.
Pharma Stock Roundup: Pipeline/Regulatory Updates From GSK, PFE & Others
by Kinjel Shah
Glaxo's (GSK) Nucala gets FDA nod for use in kids. Pfizer (PFE), Allergan (AGN) & Roche (RHHBY) give regular pipeline/regulatory updates.
Renal Cell Carcinoma Space in Focus: Some Key Developments
by Ekta Bagri
The first-line RCC treatment landscape is gradually changing. Let's take a look at the recent events in this space.
Roche Reports Positive Data on Tecentriq & NMOSD Drug (Revised)
by Zacks Equity Research
Roche's (RHHBY) immuno-oncology drug, Tecentriq, meets the primary goal in a late-stage study in NSCLC patients. Also, the company reports positive data on its NMOSD drug in a phase III study.
Puma Biotech's sNDA for Nerlynx Combo Gets FDA Acceptance
by Zacks Equity Research
The FDA accepts for review Puma Biotech's (PBYI) sNDA that seeks an approval for Nerlynx in combination with Roche's Xeloda for treating third-line breast cancer.
Horizon (HZNP) Up 36.7% YTD: Pipeline Development in Focus
by Zacks Equity Research
Shares of Horizon Therapeutics (HZNP) have gained year to date, owing to its focus on label expansions and pipeline development.
Roche (RHHBY) Reports Positive Data on Tecentriq & MS Drug
by Zacks Equity Research
Roche's (RHHBY) immuno-oncology drug, Tecentriq, meets the primary goal in a late-stage study in NSCLC patients. Also, the company reports positive data on its MS drug in a phase III study.
Bristol-Myers' (BMY) Opdivo Shows Long-Term Survival Benefit
by Zacks Equity Research
Bristol-Myers' (BMY) Opdivo continues to experience long-term OS benefit as demonstrated by the long-term pooled efficacy and safety results in patients with previously-treated NSCLC.
4 Big Drugmakers Boasting Impressive Oncology Pipelines
by Kinjel Shah
We discuss four pharma giants, which possess the industry's strongest oncology pipeline portfolios.
Allergan's Filings for Abicipar Pegol Accepted in U.S/Europe
by Zacks Equity Research
The FDA is expected to give its decision on Allergan's (AGN) BLA for its anti-VEGF product, abicipar pegol in mid-2020, while the EMA's decision is expected in the second half of 2020.
Pfizer's Pneumococcal Vaccine Shows Potential in Infants
by Zacks Equity Research
Pfizer (PFE) announces positive preliminary data from mid-stage study evaluating its 20-valent pneumococcal conjugate vaccine in infants. Completes enrollment in late-stage studies on the vaccine in adults.
Lilly's RET Inhibitor Shrinks Tumors in Lung Cancer Study
by Zacks Equity Research
Lilly (LLY) presents data from the LIBRETTO-001 study on selpercatinib for the treatment of RET fusion-positive non-small cell lung cancer. The candidate as a monotherapy attains 68% ORR.
The Zacks Analyst Blog Highlights: Allergan, Merck, Roche, J&J and Bristol-Myers
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Allergan, Merck, Roche, J&J and Bristol-Myers
Pharma Stock Roundup: AGN's Opioid Settlement, Line Extension Nod in EU for MRK, JNJ Drugs
by Kinjel Shah
Allergan (AGN) settles with two Ohio plaintiffs for $5 million. Merck's (MRK) Keytruda, Roche's (RHHBY) Tecentriq and J&J's (JNJ) Stelara get EU approval for expanded use.
Bristol-Myers' (BMY) Opdivo Falls Flat in Brain Tumor Study
by Zacks Equity Research
Bristol-Myers (BMY) announces dismal results from a late-stage study on its immuno-oncology drug Opdivo for critical brain tumor.
Roche's Tecentriq Combo Gets EU Nod for Difficult Lung Cancer
by Zacks Premium Research
The latest EU nod makes Roche's (RHHBY) immuno-oncology drug -- Tecentriq -- the first and only cancer immunotherapy approved for the initial treatment of ES-SCLC in Europe.
Here's a Plan to End the Trade War: Zacks September Strategy
by John Blank
End tariffs unilaterally to restore global growth, whilst two sets of negotiations unwind issues. In light of this, when does the self-created U.S. trade war with China end? It likely ends no sooner than the U.S. Presidential election in November 2020.