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FDA clears second Remicade biosimilarIn what is expected to produce hefty saving for rheumatoid arthritis patients and the healthcare system, FDA approved the second biosimilar to Remicade (Johnson & Johnson).
FDA: Limit codeine and tramadol use in kidsFDA said this week that it is restricting the use of codeine and tramadol medicines in children. The drug’s labels will now include a contraindication that codeine should not be used to treat pain or cough, and that tramadol should not be used to treat pain, in children younger than 12 years.
Potential blockbuster arthritis drug delayedCiting safety concerns, FDA delayed approval of a new blockbuster drug to treat rheumatoid arthritis.
Novel drug approved for Huntington's symptomFDA recently approved deutetrabenazine (Austedo, Teva Pharmaceuticals) to treat chorea associated with Huntington’s disease (HD). The medication is only the second product approved to treat HD, and is the first deuterated product approved by FDA.
Drug prolongs IPF life expectancy: StudyTwo recent studies demonstrate that pirfenidone (Esbriet, Genentech) prolongs life expectancy by 2.47 years for IPF patients and that Esbriet and nintedanib (Ofev, Boehringer Ingelheim) reduce the decline in lung function.
Major EpiPen recall issuedMeridian Medical Technologies, Mylan's manufacturing partner for the EpiPen Auto-Injector, expanded a voluntary recall of the EpiPen and EpiPen Jr. epinephrine auto-Injectors to now include additional lots distributed in the United States and other markets.
First drug for rare skin cancer wins approvalFDA approved the first treatment for metastatic Merkel cell carcinoma (MCC), a rare, aggressive skin cancer.
New Parkinson's drug, 2 others approvedFDA approved safinamide (Xadago, Newron Pharmaceuticals) tablets as an add-on treatment for patients with Parkinson’s disease. FDA also approved new treatments for classical Hodgkin lymphoma and pemphigus vulgaris, a rare, life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.
Gottlieb FDA nomination praisedPharmaceutical manufacturers and some consumer groups praised President Donald Trump’s nomination of Dr. Scott Gottlieb as the new FDA commissioner.
HIV dual therapy shows promiseA dual-drug regiment to treat HIV could soon be a reality, according to results presented at the recent Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.

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