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IN THE PIPELINE

FDA approves novel kidney disease drugAfter initially rejecting calcifediol (Rayaldee, Opko Health) for chronic kidney disease earlier this year because of manufacturing concerns, FDA approved the drug four months ahead of its new timeline. Rayaldee extended release capsules is the first drug to receive FDA approval for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.
New kidney warning on popular diabetes drugsSoon after FDA warned about a potential increased risk of foot and leg amputations with the use of the type 2 diabetes medication canagliflozin (Invokana and Invokamet, Janssen Biotech), the agency strengthened the existing warning about the risk of acute kidney injury with Invokana and Invokamet, as well as dapagliflozin (Farxiga and Xigduo XR, AstraZeneca).
First US cholera vaccine availableFDA approved the first US vaccine for cholera, Vaxchora, made by PaxVax Bermuda Ltd. in Hamilton, Bermuda. Vaxchora is the only single-dose vaccine for cholera currently licensed anywhere in the world.
Teva halts migraine patch sales over burnsTeva Pharmaceuticals is temporarily suspending sales and distribution of its sumatriptan iontophoretic transdermal system (Zecuity) patch for migraines, after FDA said it is investigating the risk of serious burns with the use of the patch.
FDA warns about OTC antacids, antidiarrheal medFDA is warning consumers about the risk of serious bleeding when using over-the-counter aspirin-containing antacid products to treat heartburn. The agency also issued a separate warning about loperamide (Imodium, Johnson & Johnson), saying that abuse or misuse of the product can cause serious heart problems that can lead to death.
New hypertension drug gets FDA approvalThe first and only fixed-dose combination of a beta blocker beta blocker (BB) and angiotensin II receptor blocker (ARB) for hypertension will be available in the US in the second half of the year. FDA approved nebivolol and valsartan (Byvalson, Allergan) 5 mg/80 mg tablets in early June.
FDA approves Zinbryta to treat multiple sclerosisFDA recently approved daclizumab (Zinbryta, Biogen and AbbVie), a once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS).
Top 5 facts about cancer drug costsThe global oncology market was worth $107 billion in 2015, and global annual cancer drug costs surged by 11.5% from 2011 to 2015, according to a new report.
First 4-strain flu vaccine availableFDA recently approved the first 4-strain, cell culture-derived, inactivated seasonal flu vaccine available in the United States. Flucelvax Quadrivalent influenza vaccine (Seqirus) helps protect against the 2 influenza A viruses and two B viruses recommended by the World Health Organization (WHO) and the FDA for the current influenza season.
New diabetes drug enters competitive marketIn a major new entry in the diabetes market, FDA just approved linagliptin and metformin hydrochloride extended-release tablets (Jentadueto XR, Boehringer Ingelheim and Eli Lilly and Company) to treat type 2 diabetes.