CLINICAL

FDA approves first targeted leukemia drug for certain patients, plus 2 moreLate last week, FDA approved a new drug to treat acute myeloid leukemia (AML), the first treatment for Batten disease, and expanded the use of a current drug to treat liver cancer.
New abuse-deterrent opioid availableA new abuse-deterrent painkiller - oxycodone hydrochloride (RoxyBond, Inspirion Delivery Services) - will be available soon after receiving FDA approval.
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.
Hep C drugs approved for kidsFDA approved supplemental applications for 2 primary hepatitis C medications to be used in children for the first time.
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.
First progressive MS drug carries high price tagWhile FDA just approved the first drug for primary progressive multiple sclerosis (PPMS), the drug’s price tag is controversial.
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.

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