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Zacks News
Gilead (GILD) Application for HIV Drug Validated in EU
by Zacks Equity Research
Gilead Sciences, Inc. (GILD) announced that the company's Marketing Authorization Application for once-daily single tablet for the treatment of HIV-1 infection in adults has been fully validated by the European Medicines Agency.
Puma (PBYI) Ends Patient Enrollment in Phase III Cancer Trial
by Zacks Equity Research
Puma Biotechnology, Inc. (PBYI) announced that it has completed enrollment of patients in a phase III study to evaluate its lead pipeline candidate PB272 in combination with Xeloda for treatment of third-line HER2-positive metastatic breast cancer.
Amgen's Colorectal Cancer Drug Gets FDA Nod to Expand Label
by Zacks Equity Research
Amgen, Inc. (AMGN) announced that the FDA has approved a label expansion of its colorectal cancer drug, Vectibix.
Novartis Gets EC Nod for Lung Cancer Drug's Label Expansion
by Zacks Equity Research
Novartis AG (NVS) announced that the European Commission has approved a label expansion of lung cancer drug drug Zykadia.
Novartis' Erelzi, Biosimilar of Enbrel Approved In Europe
by Zacks Equity Research
Novartis AG (NVS) announced that the European Commission (EC) has approved Erelzi ??? the biosimilar version of Enbrel.
Novartis Cardiovascular Drug Positive, NSCLC Drug Approved
by Zacks Equity Research
Shares of Novartis AG (NVS) were up after the company announced positive top-line results from the global phase III study, CANTOSon cardiovascular drug.
Glaxo's (GSK) Shingles Candidate Phase III Data Positive
by Zacks Equity Research
GlaxoSmithKline plc (GSK) announced positive top-line results from a phase III revaccination study on its shingles vaccine candidate, Shingrix, in older patients.
Novartis Announces Positive Results for Cardiovascular Drug
by Zacks Equity Research
Novartis AG (NVS) announced top-line results from the global phase III study, CANTOS on cardiovascular drug.
Novartis (NVS) Biosimilar of MabThera Approved in the EU
by Zacks Equity Research
Novartis AG (NVS) announced that its generic arm, Sandoz, has received European Commission (EC) approval for Rixathon.
GlaxoSmithKline's Benlysta Positive in Continuation Trial
by Zacks Equity Research
GlaxoSmithKline plc (GSK) announced positive results from a phase II continuation study evaluating the efficacy and safety of its marketed drug, Benlysta, in combination with standard of care for treatment systemic lupus erythematosus (SLE).
Should Value Investors Pick GlaxoSmithKline (GSK) Stock Now?
by Zacks Equity Research
Let's put GlaxoSmithKline PLC (GSK) stock into this equation and find out if it is a good choice for value-oriented investors right now.
Puma (PBYI) Stock Surges as Neratinib Nears FDA Approval
by Zacks Equity Research
Puma's stock has significantly outperformed the Zacks classified Medical-Biomed/Genetics industry in the year so far after an FDA advisory committee recommended approval for neratinib in May this year.
Gilead (GILD) Submits NDA for HIV Combination Therapy Regimen
by Zacks Equity Research
Gilead Sciences, Inc. (GILD) announced that it has submitted a NDA to the FDA for an investigational HIV combination therapy regimen.
Novartis Presents Positive Data on CAR-T Cell Therapy Drug
by Zacks Equity Research
Novartis AG (NVS) announced data from an interim analysis from a phase II study on lymphoma candidate.
Inovio's HPV Immunotherapy Moves to Phase III, Stock Rises
by Zacks Equity Research
Inovio Pharmaceuticals, Inc (INO) initiated a pivotal phase III REVEAL study to evaluate the safety and efficacy of immunotherapy, VGX-3100 to treat cervical dysplasia caused by human papillomavirus.
Novartis' (NVS) Tasigna Receives Label Update Nod in EU
by Zacks Equity Research
Novartis AG (NVS) announced that the EC has approved the inclusion of Treatment-free Remission (TFR) data in the oncology drug Tasigna's label.
Merck's Cancer Drug Keytruda Positive in Clinical Studies
by Zacks Equity Research
Merck & Co., Inc. (MRK) announced positive data from a phase III study KEYNOTE-024, evaluating its anti-PD-1 therapy, Keytruda (pembrolizumab) for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC).
Novartis Presents Data on Tafinlar-Mekinist Combination
by Zacks Equity Research
Novartis AG (NVS) announced results from a phase II study, BRF113220, on the combination of Tafinlar and Mekinist at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO).
Gilead Single Tablet Regiment for HIV Good in Phase III
by Zacks Equity Research
Gilead Sciences, Inc. (GILD) reported positive results on four phase III studies evaluating bictegravir in combination with FTC/TAF as a single tablet regimen for HIV infection.
Pfizer's Trumenba Vaccine Approved by European Commission
by Zacks Equity Research
Pfizer Inc. (PFE) announced that its Trumenba vaccine received approval from the European Commission (EC) for active immunization of people aged 10 years and older for the prevention of invasive disease caused by Neisseria meningitidis serogroup B (MenB).
Merck's (MRK) Keytruda Gets FDA Nod for Solid Tumor Cancers
by Zacks Equity Research
Merck & Co., Inc. (MRK) announced that Keytruda, has received accelerated approval for the treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors .
Novartis' (NVS) Lung Cancer Drug Gets Positive CHMP Opinion
by Zacks Equity Research
Novartis (NVS) recently announced that the CHMP of the European Medicines Agency (EMA) has recommended the approval of a label expansion of Zykadia.
Merck's (MRK) Keytruda Gets FDA Nod for Two New Indications
by Zacks Equity Research
Merck & Co., Inc. (MRK) announced that the FDA has approved two new indications for Keytruda (pembrolizumab), the company's anti-PD-1 therapy.
Ionis (IONS) Stock Falls Despite Positive Inotersen Data
by Zacks Equity Research
Ionis Pharmaceuticals, Inc. (IONS) announced that the phase III study NEURO-TTR on inotersen (IONIS-TTRRx) in patients with familial amyloid polyneuropathy (FAP) met both primary endpoints.
Mylan (MYL) Beats on Q1 Earnings, Revenues Miss Estimates
by Zacks Equity Research
Mylan's (MYL) first-quarter results beat on earnings but missed the top line due to a decline in EpiPen sales.