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- Read more about Ibrutinib: indication of added benefit in one of three therapeutic indications
Ibrutinib is a drug for the treatment of rare diseases. It has been approved for the treatment of adults with chronic lymphocytic leukaemia (CLL) or with relapsed or refractory mantle cell lymphoma (MCL) since 2014, and since 2015 also for the treatment of adults with Waldenström macroglobulinaemia. Regarding the treatment of patients with CLL or MCL, the Federal Joint Committee (G-BA) already conducted a benefit assessment and made a decision in 2015.
- Read more about NIH-funded study of Avastin and Lucentis examines their effects at five years
In a study of nearly 650 people with the eye disease age-related macular degeneration (AMD), half still had vision 20/40 or better, typically good enough to drive or to read standard print, after five years of treatment with anti-VEGF drugs that are injected into the eye. The authors of the study, funded by the National Eye Institute (NEI) at the National Institutes of Health, say those outcomes would have been unimaginable about 10 years ago, prior to the drugs’ availability.
- Read more about EMA committee recommends approval of AstraZeneca's CAZ AVI
AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder.
- Read more about Flamel Technologies Receives FDA Approval of Akovaz™
Flamel Technologies announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s New Drug Application (NDA) for Akovaz™ (ephedrine sulfate), a drug administered parenterally as a pressor agent to address clinically important hypotension in surgical settings.
- Read more about Oncurious begins phase I/IIa study with TB-403 to treat medulloblastoma
Oncurious NV, an emerging oncology company focused on the development of innovative orphan drugs for the treatment of pediatric cancers, announces it has initiated a Phase I/IIa study that will evaluate the safety and tolerability and explore the preliminary efficacy of TB-403 for the treatment of relapsed or refractory medulloblastoma, a rare, life-threatening brain tumor that mainly affects children.
- Read more about Teva Announces FDA Approval of ProAir RespiClick® (albuterol sulfate) Inhalation Powder
Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration (FDA) has approved ProAir RespiClick^® (albuterol sulfate) Inhalation Powder for the treatment or prevention of bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB)
- Read more about Study shows how different people respond to aspirin an important cardioprotective drug
Researchers have learned new information about how different people respond to aspirin, a globally prescribed drug in cardioprotection. The research team, led by scientists at Cardiff University in the United Kingdom and including representatives from the University of Alabama at Birmingham and the University of Colorado, identified more than 5,600 lipids or fats in blood platelets and gained new insights into how these cells respond to aspirin.
- Read more about New drug more effective in treating atrial fibrillation
Vernakalant, a new drug for treating recent-onset atrial fibrillation, has proved to be considerably more effective than Ibutilide, an established drug in this indication. It was able to normalize patients’ heart rhythm more rapidly and with fewer side-effects ocurring. This was revealed by a study conducted at the Department of Emergency Medicine at Medical University of Vienna/General Hospital that has recently been published in "Europace", a journal of the European Society of Cardiology.
- Read more about FDA Approves ACADIA Pharmaceuticals’ NUPLAZID™ (pimavanserin)
ACADIA Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved NUPLAZID (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. In 2014, the FDA designated NUPLAZID as a Breakthrough Therapy for this condition.

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- Read more about FDA approves first generic Crestor
The U.S. Food and Drug Administration today approved the first generic version of Crestor (rosuvastatin calcium) tablets for the following uses: in combination with diet for the treatment of high triglycerides (hypertriglyceridemia) in adults; in combination with diet for treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia), a disorder associated with improper breakdown of cholesterol and triglycerides; either alone or in combination with other cholesterol treatment(s) for adult patients with homozygous familial hypercholesterolemia, a disorder associated with high low-density lipoprotein (LDL) cholesterol.