FDA Policy/General

Since Our Last Issue ...

Mylan has signed an agreement with the Medicines Patent Pool (MPP) to expand access to chronic hepatitis C medicines in developing countries. The agreement licenses Mylan to produce and market a generic version of Bristol-Myers Squibb’s Daklinza (daclatasvir) Tablets, 30 mg and 60 mg, for distribution in 112 low- and middle-income countries. Daclatasvir Tablets, 30 mg and 60 mg, are indicated for use with sofosbuvir, with or without ribavirin, for treating patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection in the U.S. and genotype 1, 3 and 4 in Europe. The license allows Mylan to develop fixed-dose combinations that offer the potential to treat all of the six major genotypes of HCV.

Sun Pharma has signed definitive agreements to acquire an 85% stake in Russia-based JSC Biosintez for $24 million. Sun would also assume a debt of about $36 million as part of the transaction. Biosintez focuses on the hospital segment, and it had annual revenues of about $52 million for 2015.

Navidea Biopharmaceuticals has entered into a definitive asset purchase agreement with Cardinal Health for Cardinal to purchase Navidea’s Lymphoseek product for lymphatic mapping, lymph node biopsy and diagnosing metastatic spread to lymph nodes. Navidea will receive $80 million at closing, plus the opportunity to earn up to $230 million more based on certain milestones through 2026.

Edwards Lifesciences has agreed to acquire Valtech Cardio, a privately held company based in Israel and developer of the Cardioband System for transcatheter repair of the mitral and tricuspid valves. The purchase price is $340 million in stock and cash. Prior to the transaction close, Valtech will spin off its early-stage transseptal mitral valve replacement technology program. Edwards will retain an option to acquire that program and its associated intellectual property.

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

Read more

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