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5/25/2016

Two hypertension treatments from Novartis were bought by PDL BioPharma with an equity investment from Noden Pharma. Under the terms of the agreement, PDL will pay $110 million upfront, $89 million a year after the deal closes and milestone fees of as much as $95 million. The acquisition includes Tekturna, or aliskiren, and Tekturna HCT, or aliskiren and hydrochlorothiazide.

5/25/2016

Most antibiotics kill beneficial bacteria along with harmful pathogens, and a mouse study found that broad-spectrum treatments significantly changed gut microbiomes, thinned the colon mucosa and reduced immune cell counts. A second study showed that mice treated with broad-spectrum antibiotics had fewer Ly6Chi monocytes in their bone marrow, blood and brains, and they did not perform well on memory tests. Meanwhile, St. Jude Children's Research Hospital is testing a drug that targets only staphylococcus. The microbiomes of mice treated with the experimental agent were more stable and rebounded more rapidly than the microbiomes of mice treated with standard antibiotics.

5/25/2016

Seqirus' Flucelvax Quadrivalent, a four-strain inactivated influenza vaccine, has been approved by the FDA. The cell culture-derived vaccine is indicated for patients who are at least 4 years old.

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Drug Store News
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Flucelvax Quadrivalent, Seqirus
5/25/2016

Allergan's new-drug application for its oxymetazoline HCl cream has been accepted for review by the FDA as a treatment for rosacea-associated persistent facial erythema in adults. A decision from the agency is expected in the first half of 2017.

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Allergan, Erythema, oxymetazoline
5/25/2016

Purdue Pharma agreed to dismiss patent infringement claims against Egalet's Oxaydo, or oxycodone HCl, which is indicated for use in managing acute and chronic pain that is moderate to severe. The settlement involved no further legal action or financial obligations.

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Purdue Pharma, Egalet
5/25/2016

The remaining patent on UCB's epilepsy drug Vimpat, which is scheduled to expire in March 2022, will be reviewed by the US Patent and Trademark Office. The USPTO agreed to the review after it found that Argentum Pharmaceuticals, the generic-drug-maker challenging UCB's patent, could prove that some of UCB's patent claims are "unpatentable." A decision could come in a year.

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Reuters
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UCB, UCB, Argentum Pharmaceuticals, USPTO
5/25/2016

The California Department of Food and Agriculture has issued its second recall involving Organic Pastures Dairy's raw milk and cream after detecting salmonella in follow-up product testing. The latest recall covers products with a code date of June 1, 2016.

5/25/2016

An FDA panel has voted in favor of approving St. Jude Medical's Amplatzer PFO Occluder, an implantable wire-mesh device designed for preventing recurring ischemic strokes in patients with patent foramen ovale and a history of at least one unexplained stroke. The panel found that the device is safe, that its benefits outweigh the risks of use and that it is effective for its intended use.

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St. Jude Medical
5/25/2016

The FDA has given Interventional Spine clearance for its 8-degree Lumbar Lordotic Opticage Expandable Intervertebral Body Fusion Device, an addition to the company's Opticage Expandable Interbody Fusion product line. The device, which can be implanted using transforaminal, posterior or lateral methods, is indicated to be used with autogenous bone graft to treat degenerative disc disease at one or two contiguous levels from L2 to S1.

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BeckersSpine.com, FDAnews
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Interventional Spine, FDA, 8-degree
5/25/2016

JP Laboratories' Maharashtra plant and Krebs Biochemicals & Industries' Andhra Pradesh facility in India were cited by the Italian Medicines Agency over multiple good manufacturing practice violations. The regulator advised European regulatory bodies to ban the use and importation of drugs manufactured in the facilities.

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FDAnews