Regulators flag safety warnings ahead of Astellas drug panel; Breast cancer vaccine in AACR spotlight; Setback for Actelion;

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> Regulators at the FDA have red-flagged signs of high blood pressure seen in trials of Astellas' mirabegron, an experimental therapy for overactive bladder. In a review of the drug prepared in advance of an FDA panel discussion, staffers also noted a series of hypersensitivity issues, including rash and anemia. "Although the safety results from the clinical trials database appear generally reasonable, the special safety concerns, especially the increases in blood pressure and pulse" will need to be studied, the agency noted in its report. Report

> GSK says it has the late-stage data needed to gain an approval for albiglutide, its weekly GLP-1 diabetes treatment. Seven of 8 late-stage studies have delivered data, setting the stage for a filing. The drug flunked a head-to-head study with Victoza last fall, though, raising doubts about its future commercial success. Report

> Investigators are reporting early-stage success with a new breast cancer vaccine, AE37, designed to prevent a recurrence of the disease. Story

> In a fresh setback for Actelion ($ATLN), the Swiss biotech says it is dumping a late-stage asthma/allergy program after it failed two late-stage studies. Researchers will switch to a backup treatment in Phase I. Investors weren't likely to react too much to the news, though. All eyes are on the late-stage macitentan, the follow-up to Tracleer. Story

> India's Piramal says it expects to significantly increase its R&D budget on new cancer drugs. Story

> Ajinomoto Pharmaceuticals has won exclusive rights to develop and commercialize elobixibat in Japan, South Korea, Thailand, Indonesia, Vietnam and Taiwan. Release

@FiercePharma: Bayer fails to block class-action status for 8 women's sex-discrimination claims--Bloomberg. News | Follow @FiercePharma

> Barred OTC drugmaker calls FDA oversight 'absurd'. Story

> Eisai discount doesn't sway NICE on Halaven. Article

Medical Devices News

@FierceMedDev: Good news for battle-worn company? Olympus Gets Alliance Offers From Sony, Fujifilm, Terumo. News | Follow @FierceMedDev

> Maquet, Siemens team up for hybrid OR. More

> Biomet looks to score DePuy's trauma biz for $280M. Story

> Latest Illumina rejection stings Roche. News

> MHRA urges docs to avoid some metal hips. Article

Manufacturing News

> Traditional meds pose tough challenge to manufacturing. Item

> Gerresheimer completes BRIC positioning with India acquisition. More

> Ranbaxy shipping generic Lipitor from new Indian plant. Story

Biotech Research News

> Deadly mushroom defeats human pancreatic cancer in mice. Report

> Cadre of scientists compile volumes of data on cancer cell weaknesses. News

> Study: DNA sequencing dubious as disease prevention tool. More

> Stanford CD47 breakthrough fights tumors in multiple cancers. Story

> New drug blocks brain cancer advance, making chemo kill easier. Article

And Finally... New research underscores the need for vitamin D for patients in intensive care. Story