Articles By Estel Grace Masangkay
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AstraZeneca, Pharmacyclics, And J&J Join Forces On Immuno-Oncology Trials
11/6/2014
AstraZeneca, Pharmacyclics, and Johnson & Johnson company Janssen Research & Development announced that the companies have inked a clinical trial partnership deal to investigate the safety and efficacy of AZ’s MEDI4736 in combination with Imbruvica (ibrutinib), co-developed by Janssen and Pharmacyclics.
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Ultragenyx Snags EU Orphan Status For XLH Drug KRN23
11/4/2014
Biopharmaceutical company Ultragenyx Pharmaceutical announced that it has received Orphan Medicinal Product Designation from the European Commission for its investigational drug KRN23 (or UX023) for the treatment of rare metabolic bone disease, X-linked hypophosphatemia (XLH).
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FDA Approves AstraZeneca’s Xigduo For T2D
11/4/2014
AstraZeneca announced that it has secured approval from the U.S. Food and Drug Administration (FDA) for its once-daily Xigduo XR for the treatment of adult patients with Type 2 diabetes.
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U.K.’s NICE Backs J&J And Bayer’s Blood Thinner Xarelto
11/3/2014
In a draft guidance published for consultation, UK’s National Institute for Health and Care Excellence (NICE) announced that it has given a positive opinion for coverage of Xarelto (rivaroxaban) for patients who have had a heart attack.
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Pfizer’s Vaccine For Meningitis B Gets FDA Accelerated Approval
11/3/2014
Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved Trumenba as the first licensed vaccine in the U.S. for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals from 10 through 25 years old.
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3rd Potential Ebola Vaccine To Enter Human Trials
11/3/2014
An Ebola vaccine candidate developed by the Public Health Agency of Canada is set to enter human clinical trials, The Guardian reports.
- Ariad’s Cancer Drug Iclusig Backed By CHMP 10/31/2014
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Merck Scores 2nd FDA Breakthrough Status For Keytruda
10/30/2014
Merck announced that it has received a second Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for Keytruda (pembrolizumab) — this time as a treatment for advanced non-small cell lung cancer (NSCLC).
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AstraZeneca’s Lynparza For Ovarian Cancer Backed By CHMP
10/30/2014
AstraZeneca reported that it has received the positive opinion of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the marketing authorization of Lynparza (olaparib) as monotherapy and maintenance treatment of advanced ovarian cancer in adult patients.
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Akebia Posts Topline Phase 2B Trial Results Of CKD Drug
10/30/2014
Akebia Therapeutics, a biopharmaceutical company developing treatments for kidney disease based on hypoxia inducible factor (HIF) biology, reported positive topline results from the Phase 2B trial of AKB-6548 in non-dialysis patients with anemia caused by chronic kidney disease (CKD).