A recent study analyzed inflammasome response, finding the POP1 PYRIN domain protein acts to decrease excessive inflammatory responses and prevent systemic inflammation. Researchers ultimately developed a drug based on POP1 and found it reduced inflammation in mice…
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U.S. Bans Another Indian Drug Plant over Production Quality
MUMBAI (Reuters)—The U.S. Food and Drug Administration (FDA) has banned imports from another India-based drug manufacturing plant over quality control concerns, making it the 10th site in the country this year to face such action. The FDA’s import alert on Mumbai-based Polydrug Laboratories Pvt Ltd’s Ambernath manufacturing plant comes two months after Canada banned the…
Peripheral Nerve Regeneration Insights
A recent investigation provides new details on how macrophages, endothelial cells and Schwann cells coordinate to heal peripheral nerve damage…
Pfizer Loses UK Patent Case over Use of Lyrica Drug for Pain
LONDON (Reuters)—Pfizer suffered a major setback in Britain on Thursday when the High Court in London ruled that claims of patent protection for the use of its $5 billion-a-year drug Lyrica as a pain treatment were invalid. Lyrica, known generically as pregabalin, was originally developed for epilepsy. However, further research showed it could also help patients…
Lupus Nephritis Therapies Compared, Plus Naming Guidance for Biosimilars
Comparing tacrolimus, mycophenolate mofetil and cyclophosphamide, tacrolimus was the most efficacious. Also, biosimilars may soon be easier to differentiate…
Small Grants Fund Physical Activity to Combat OA
To increase access to community-based physical activity for arthritis patients, the Osteoarthritis Action Alliance has awarded funding to three programs designed to implement evidence-based physical activity programs and osteoarthritis education in their communities…
Novartis Launches First U.S. Biosimilar Drug at 15% Discount
LONDON/ZURICH (Reuters)—Novartis kicked off a new era in U.S. medicine on Thursday with the launch of the first biosimilar copy of a biotechnology drug approved in the U.S., at a discount of 15% to the original. The Swiss drugmaker’s generics unit Sandoz said Zarxio, its form of Amgen’s white blood cell-boosting product Neupogen (filgrastim), would…
Resunab Fast Tracked to Treat Scleroderma, Plus, Infliximab Biosimilars in Europe
The FDA has fast-tracked the development of a drug to treat systemic sclerosis, or scleroderma; initial clinical trials started in June. Also, a major hospital group in France has selected the biosimilar infliximab to treat its patients with RA, Crohn’s disease and psoriasis…
FDA Warns of Severe Joint Pain Risk with DPP-4 Diabetes Drugs
(Reuters)—A class of diabetes drugs that include Merck & Co Inc.’s Januvia has been linked with severe joint pain, the U.S. Food and Drug Administration said on Friday. The FDA said it had identified 33 cases of severe joint pain in patients taking a class of drugs known as DPP-4 inhibitors between Oct. 16, 2006,…
FDA Proposes Adding Suffixes to Distinguish Biosimilar Drug Names
WASHINGTON (Reuters)—The U.S. Food and Drug Administration proposed on Thursday identifying cheaper versions of biologic drugs with a suffix to distinguish them from their more expensive, branded counterparts. The FDA said its draft guidance is designed to prevent the inadvertent substitution of non-interchangeable products and to make it easier to monitor and track usage once…
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