FDA Policy/General

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Palatin Technologies has entered into a collaboration and license agreement with Shanghai Fosun Pharmaceutical Industrial Development Co. to develop and commercialize bremelanotide for female sexual dysfunction (FSD) indications. Bremelanotide is an investigational product designed for on-demand treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. Under the agreement, Palatin will receive an upfront payment of $5 million and $7.5 million based on certain regulatory milestones.

Natus Medical has agreed to acquire certain neurosurgery business assets from Integra LifeSciences for $47.5 million. As part of the transaction, Natus will acquire the global Camino ICP monitoring product line, including its San Diego manufacturing facility, from Integra. The transaction also includes the U.S. rights relating to Integra’s fixed pressure shunts, as well as U.S. rights to Codman’s Duraform dural graft implant, standard EVD catheters and CSF collection systems.

Merck has agreed to acquire Rigontec, a firm focused on accessing the retinoic acid-inducible gene I (RIG-I) pathway as an approach in cancer immunotherapy to induce both immediate and long-term anti-tumor immunity. Rigontec’s lead candidate, RGT100, is currently in Phase 1 development evaluating treatment in patients with various tumors. Under the terms of the agreement, Merck will pay $150 million upfront and will provide another $453 million in milestone payments.

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