AstraZeneca, Amgen asthma drug tezepelumab secures FDA breakthrough designation
September 9, 2018 No Comment
UK biopharma company AstraZeneca and Amgen have secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for their asthma drug tezepelumab. The FDA breakthrough therapy designation for tezepelumab is for the treatment of patients with severe asthma, without an eosinophilic phenotype, who are administered inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids […]
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The European Commission (EC) has approved an expanded indication for Amgen blood cancer drug BLINCYTO (blinatumomab) as monotherapy for the treatment of certain form of acute lymphoblastic leukemia (ALL) in pediatric patients aged one year or older. The pediatric approval of BLINCYTO is for the treatment of patients with Philadelphia chromosome-negative (Ph-) CD19 positive B-cell […]
Continue reading …Nivestym FDA approval : Pfizer’s Amgen neutropenia drug Neupogen biosimilar gets FDA nod
July 21, 2018 No Comment
Nivestym FDA approval : Pfizer has bagged approval from the US Food and Drug Administration (FDA) for Nivestym (filgrastim-aafi) – a biosimilar to Neupogen (filgrastim) for all eligible indications of the reference Amgen neutropenia drug. Filgrastim is indicated in the US for neutropenia treatment among others. Neutropenia or low blood neutrophils, is a condition in […]
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Amgen and UCB have resubmitted the biologics license application (BLA) of their investigational osteoporosis drug EVENITY (romosozumab) to the US Food and Drug Administration (FDA) for treatment of osteoporosis in postmenopausal women at high risk for fracture. A bone-forming monoclonal antibody, EVENITY is said to increase bone formation and simultaneously decrease bone resorption, in order […]
Continue reading …Amgen cholesterol drug Repatha bags FDA approval for preventing heart attack and stroke
December 9, 2017 No Comment
Repatha FDA approval news : Repatha (evolocumab), the Amgen cholesterol drug has bagged the approval from the US Food and Drug Administration (FDA) for the prevention of heart attacks, strokes and coronary revascularizations in heart disease patients. The Amgen cholesterol injection is a human monoclonal antibody which has been designed to block the activities of […]
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Amgen cholesterol injection Repatha (evolocumab) has been demonstrated to have cut heart attack and stroke risk by 20% in a phase 3 cardiovascular outcomes study featuring 27,564 patients with heart diseases. Amgen Cholesterol Trial for Repatha Cholesterol Injection During the trial, it was proven that by maximum reduction of low-density lipoprotein cholesterol (LDL-C) levels (bad cholesterol) […]
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American biopharma company Amgen’s Parsabiv drug has been approved by the European Commission for treating secondary hyperparathyroidism. Secondary Hyperparathyroidism (sHPT) is a serious and chronic condition that affects millions of people throughout the world who are undergoing dialysis. Etelcalcetide branded as Parsabiv is intended to be used in adult patients with chronic renal disease, on […]
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Business News Today
- TASI acquires German inspection systems manufacturer Cassel Messtechnik
- ALX Oncology raises $105m to advance clinical development of ALX148
- ImmunogenX enrolls patients for Solutions for Celiac trial of Latiglutenase
- McDermott wins contract for six crude oil storage tanks in Texas
- Badin IV South Block, Pakistan : Petroleum Exploration, Jura Energy begin commercial production
- Google wraps up $2.6bn acquisition of data platform company Looker
- ABG buys majority stake in spirits distribution company Indie Brands
- Arthur J. Gallagher acquires Illinois-based Affiliated Benefit Consultants
- Pinpoint Therapeutics secures funds for developing autophagy inhibitors for cancer
- Antios Therapeutics begins phase 1 trial for ATI-2173, a chronic hepatitis B candidate
