FDA Policy/General

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AstraZeneca has withdrawn a marketing application filed with the European Medicines Agency (EMA) for ovarian cancer drug cediranib and its use in combination with platinum-based chemotherapy followed by maintenance monotherapy to treat adult patients with platinum-sensitive relapsed ovarian cancer. EMA reportedly had concerns about whether the drug’s potential side effects outweighed its benefits. The company says cediranib remains an important part of AstraZeneca’s ovarian cancer medicine pipeline and this decision does not affect the ongoing primary development program testing cediranib as a combination treatment with its existing and potential medicines.

Becton Dickinson is investing $100 million in its Holdrege, NE facility to expand capacity for its insulin syringe manufacturing operations. The investment will be used for new technology and manufacturing equipment to expand capacity for the company’s insulin syringes. BD already produces more than 2 billion insulin syringes each year,

Ligand Pharmaceuticals has licensed the rights to four drug development programs to Seelos Therapeutics, Inc., a newly formed biopharmaceutical company focused on central nervous system (CNS), respiratory and other disorders. Licensed programs include Ligand’s aplindore program for treating various CNS disorders, a CRTH2 antagonist program for treating respiratory disorders, a Captisol-enabled acetaminophen program for pain and fever management and an H3 receptor antagonist program for narcolepsy. Under the license agreement, Ligand could be entitled to over $150 million in milestone payments, and net sales royalties ranging from 4% to 10% for products.

Allergan has agreed to acquire Tobira Therapeutics for $1.7 billion. The deal gives Allergan several development programs for non-alcoholic steatohepatitis (NASH) and other liver diseases. NASH is a severe type of non-alcoholic fatty liver disease, which is characterized by a fat accumulation in the liver with no other apparent causes.

Natus Medical has entered into a definitive agreement with GN Store Nord A/S under which Natus will acquire the GN Otometrics for $145 million. With annual revenue of about $110 million, Otometrics makes hearing diagnostics and balance assessment equipment, disposables and software that are currently being sold in over 86 countries.

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