FDA Policy/General

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Waltham, Mass.-based Morphic Therapeutic says it has raised $51.5 million in a Series A venture financing to build on the shifting state of integrin receptors commonly found on the surface of about 90% of human cells from Tim Springer at Harvard Medical School. GlaxoSmithKline’s SR One venture group and Pfizer Venture Investment co-led the financing, along with Omega Funds, AbbVie Ventures, Tim Springer, Polaris Partners, Schrodinger and Shangpharma Investment Group.

KaloBios Pharmaceuticals, formerly run by Martin Shkreli, says it has emerged from bankruptcy and has acquired the rights to develop benznidazole for treating Chagas disease from Savant Neglected Diseases LLC for an upfront payment of $3 million, and warrants for Savant to buy 200,000 KaloBios common shares.

Leo Pharma has entered a strategic partnership with AstraZeneca and has acquired the global license to tralokinumab a potential new medicine, an anti-IL-13 monoclonal antibody that has completed a Phase 2b study for treating patients with atopic dermatitis and the exclusive license to brodalumab in Europe. The company says it will make an upfront payment to AstraZeneca of $115 million and will also pay up to $1 billion in commercially-related milestones and up to mid-teen tiered percentage royalties on product sales.

Australia’s Mayne Pharma Group has entered into an agreement to acquire 37 approved and five products with applications filed with FDA from Teva Pharmaceutical and Allergan for $652 million. The two companies were under pressure to divest to comply with FTC regulations in connection with Teva’s proposed acquisition of Allergan’s generic drug business.

Lannett is suing FDA in DC federal court over a 5/17 letter in which the agency rescinded its approval of the company’s ANDA for the oral cancer drug temozolomide (Merck’s Temodar). FDA says that the approval was “mistakenly granted.” At issue is the agency’s recent Warning Letter to China’s Chongqing Lummy Pharmaceutical Co., which was to provide the active pharmaceutical ingredient for Lannett’s generic Temodar. The letter details CGMP violations found in an inspection and notes that the firm is under an import alert.

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