Category: Regulations
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Biosimilar Shown Effective for Rheumatoid Arthritis
4 February 2015. A biologic therapy for rheumatoid arthritis was shown to work as well as an approved name-brand biologic treatment in a late-stage clinical trial, according to findings released by biotechnology company Amgen. The study found Amgen’s biologic code-named ABP501 performed as well as adalimumab, marketed as Humira by AbbVie, in relieving symptoms of…
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Lung Cancer Antibody Given FDA Breakthrough Tag
2 February 2015. An experimental engineered antibody for treating lung cancer received a breakthrough designation from the U.S. Food and Drug Administration. Genentech, a biotechnology subsidiary of drug maker Roche, says breakthrough status was granted for its cancer immunotherapy code-named MPDL3280A to treat programmed death-ligand 1 or PD-L1 positive non-small cell lung cancer whose disease…
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Trial to Test Drug to Delay Early-Onset Alzheimer’s
28 January 2015. A clinical trial is planned to test a current drug for epilepsy as a way to delay the early onset of Alzheimer’s disease. The late-stage trial undertaken by AgeneBio Inc., a start-up pharmaceutical company in Baltimore, is funded by a $900,000 grant from Alzheimer’s Drug Discovery Foundation. The trial aims to address…
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Trial Shows Drug Reduces Depression in One Day
27 January 2015. A clinical trial testing a new drug to treat major depressive disorder shows the drug improved symptoms in patients after a single dose within one day. The intermediate-stage trial was conducted by Naurex Inc., a biopharmaceutical company in Evanston, Illinois and a spin-off from Northwestern University. Naurex develops drugs for diseases of…
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Mobile Heart Monitor Algorithm Approved in Europe
22 January 2015. An algorithm analyzing signals to detect atrial fibrillation from a heart monitor built into mobile devices received regulatory approval in Europe. AliveCor, a developer of heart monitoring systems for mobile devices, says the company received the Conformité Européene or CE mark for the algorithm that analyzes heart monitoring signals in its AliveECG…
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FDA Approves Novartis Psoriasis Drug
21 January 2015. U.S. Food and Drug Administration approved the biologic drug secukinumab for adults with moderate to severe plaque psoriasis, a common skin disorder. Secukinumab, an antibody designed specifically to address the condition, is marketed by the pharmaceutical company Novartis under the brand name Cosentyx. Plaque psoriasis is the most common type of psoriasis, an…
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Trial Testing Gene Therapy for Rare Eye Disorder
20 January 2015. An early-stage clinical trial is underway testing a gene-repair therapy for choroideremia, a rare progressive genetic eye disorder that leads to blindness. The trial, conducted at Children’s Hospital of Philadelphia began enrolling its first patients, according to Spark Therapeutics, also of Philadelphia, the biotechnology company leading the study. Choroideremia is associated with…
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FDA Issues Draft Wellness Device Guidance
19 January 2015. The U.S. Food and Drug Administration on Friday released draft guidance defining low-risk general wellness devices that the agency intends to exclude from regulatory oversight. The 8-page document, published on the FDA Web site, will be open for comment for 90 days beginning tomorrow. FDA says it prepared the document to answers…
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FDA Approves Nerve Pathway Device for Obesity
14 January 2015. U.S. Food and Drug Administration today approved a device blocking nerve signals between the brain and stomach to help obese people who have not responded to other weight-loss methods control their appetites and lose weight. The Maestro Rechargeable system approved by FDA is made by medical device maker EnteroMedics Inc. in St.…
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Trial Testing RNA Therapy for Duchenne Muscular Dystrophy
Update: 15 January 2015. Comments on the article are offered at the end of the main text. 14 January 2015. A clinical trial is underway testing safety and effectiveness of synthetic RNA treatments for Duchenne muscular dystrophy, a genetic disease affecting primarily males. The treatments are developed by Sarepta Therapeutics Inc., a biotechnology company in…