FDA Policy/General

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Alvogen has signed a definitive agreement to acquire Omega Bittner, a Russia-based pharmaceutical firm owned by Perrigo. Omega Bittner markets over-the-counter products in Russia, including Lactacyd, Aflubin and Paranit. Alvogen says the acquisition supports its strategy to gain more exposure to Russia’s high growth market. It will also create greater scale and diversity across its portfolio and sales channels.

RedHill Biopharma has entered into a commercialization agreement with ParaPRO, an Indiana-based specialty pharmaceutical company, granting RedHill the exclusive rights to promote esomeprazole strontium delayed-release capsules to gastroenterologists in certain U.S. territories. The prescription proton pump inhibitor is indicated for adults for treating gastroesophageal reflux disease.

Clear orthodontic corrective device maker ClearCorrect has agreed to be acquired by Straumann Holding for about $150 million. ClearCorrect says the acquisition will allow it to improve and expand the global reach of its Flex and Unlimited treatments.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome