FDA Policy/General

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Biogen has agreed to purchase Pfizer’s PF-04958242, a first-in-class, Phase 2b-ready drug being evaluating to treat several neurological and psychiatric diseases, including schizophrenia. Biogen is paying $75 million upfront for the compound, and the agreement could include up to $515 million in developmental and commercial milestones.

Laborie Medical Technologies has agreed to pay $214 million to acquire Cogentix Medical. The transaction would give Laborie to Cogentix Medical’s Urgent PC Neuromodulation System, a non-drug, non-surgical treatment for overactive bladder and associated symptoms of urinary urgency, urinary frequency and urge incontinence.

Seattle Genetics has acquired Cascadian Therapeutics and its tucatinib, an investigational oral tyrosine kinase inhibitor that is highly selective for HER2, a growth factor receptor overexpressed in multiple cancers, including breast, colorectal, ovarian and gastric. Tucatinib is currently being evaluated in a pivotal trial called HER2CLIMB for patients with HER2-positive metastatic breast cancer, including patients with or without brain metastases.

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