FDA Policy/General

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AMAG Pharmaceuticals has entered into a licensing agreement with Palatin Technologies for the exclusive North American commercial rights to Rekynda (bremelanotide), an investigational product developed for on-demand treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women.

Phoenix Life Sciences has executed a letter of intent to acquire Phoenix Bio Pharmaceuticals, a privately held company with a focus on intellectual property (IP). The current IP portfolio comprises condition-specific formulations, multiple proprietary compounds, extraction technology, and delivery systems for medical cannabis products.

Parexel International has entered into a definitive agreement to acquire The Medical Affairs Company, a provider of outsourced medical affairs services to the pharmaceutical, biotechnology, and medical device industries.

LabCorp is reportedly in negotiations to purchase Pharmaceutical Product Development (PPD), a global contract research organization operating in over 50 countries. The purchase price is rumored to be $8 billion and would include the purchase of debt.PPD was bought by two private equity firms, Carlyle and Hellman & Friedman, for $3.9 billion in 2011.

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