Articles By Estel Grace Masangkay
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Bayer Wins 2 FDA QIDP Designations For Inhaled Drugs
11/26/2014
Bayer announced that it has received two Qualified Infectious Disease Product (QIDP) designations from the U.S. Food and Drug Administration (FDA) for two of its inhaled investigational drugs, Amikacin Inhale and Ciprofloxacin Dry Powder for Inhalation (DPI).
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Sanofi, Regeneron Present Alirocumab Data At AHA
11/25/2014
Pharma partners Sanofi and Regeneron announced results from six late-stage trials of alirocumab, an investigational drug being developed for its potential to lower down low-density lipoprotein (LDL) cholesterol.
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Novartis' Cosentyx For Plaque Psoriasis Backed By CHMP
11/25/2014
Novartis announced that it has received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Cosentyx (secukinumab) as first-line systemic therapy for the treatment of moderate-to-severe plaque psoriasis in adults in the EU.
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Lilly Posts New Jardiance Data In Diabetes At AHA 2014
11/25/2014
Eli Lilly & Co. on behalf of its partner Boehringer Ingelheim presented new data from a retrospective analysis of clinical trials showing that Jardiance (empagliflozin) reduced average blood sugar, body weight, and several markers of abdominal fat in adults with Type 2 diabetes.
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Synergy Posts Topline Phase 2 Data For OIC Drug
11/24/2014
Synergy Pharmaceuticals reported positive data from its Phase 2 trial investigating SP-333 in patients with opioid-induced constipation (OIC).
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Pfizer Launches Trumenba Vaccine For Meningitis B In U.S.
11/24/2014
Pfizer announced the launch of Trumenba (meningococcal group B vaccine) for those 10 to 25 years of age infected with meningitis caused by Neisseria meningitidis serogroup B.
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Janssen Files New Application For Simponi For Nr-AxSpA In EU
11/24/2014
Johnson & Johnson company Janssen Biologics announced that it has filed a Type II Variation application with the European Medicines Agency (EMA) for the approval of Simponi (golimumab) as treatment for severe, active, non-radiographic axial spondyloarthritis (nr-AxSpA).
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Roche's Avastin Given Green Light For Ovarian Cancer By FDA
11/21/2014
Women with platinum-resistant recurrent ovarian cancer have another treatment option available in the form of Avastin plus chemotherapy, Roche announced earlier this week following the combination’s approval from the U.S. Food and Drug Administration (FDA).
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Clovis Links With GSK For Cancer Drug Combo Trial
11/21/2014
Biopharmaceutical firm Clovis Oncology announced that it has signed up with GlaxoSmithKline to conduct a clinical trial that will investigate the combination of rociletinib and trametinib as treatment for patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC).
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The Medicines Co. Posts Positive Phase 1 Data For CAD Drug
11/20/2014
The Medicines Company presented positive data from a new Phase 1 study investigating its lipid-modifying agent MDCO-216 as treatment for reducing atherosclerotic disease.