FDA Policy/General

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Dr. Reddy’s Laboratories and XenoPort have entered into a license agreement that grants Dr. Reddy’s exclusive U.S. rights for developing and commercializing XenoPort’s clinical-stage oral new chemical entity XP23829 for treating moderate-to-severe chronic plaque psoriasis. The therapy is also being considered for treating patients with relapsing forms of multiple sclerosis.

Shire reported positive results from a Phase 3 safety and efficacy study, SHP465-305 SHP465 (triple-bead mixed amphetamine salts - MAS) in children and adolescents aged 6-17 years with Attention-Deficit/Hyperactivity Disorder (ADHD). According to the company, the primary efficacy analysis of study 305 demonstrated that SHP465, administered as a daily morning dose, was superior to placebo on the change from baseline in ADHD-RS-IV (ADHD rating scale) total score, suggesting a significant improvement in ADHD symptoms. It says SHP465 was also superior to placebo in the key secondary efficacy analysis on the clinical global impression improvement scale.

Citius Pharmaceuticals has completed the acquisition of late-stage specialty pharmaceutical company Leonard-Meron Biosciences (LMB). LMB’s Mino-Lok, is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections. The company says the patent-protected solution is now entering Phase 3 trials and contains minocycline, edetate (disodium EDTA), and ethyl alcohol, which act to break down bacterial biofilm, eradicate the bacteria, and provide anti-clotting properties.

Oxford BioTherapeutics (OBT), a company developing a range of Antibody Drug Conjugates (ADC) for treating cancer, and Nerviano Medical Sciences have signed a license agreement that will allow OBT to utilize Nerviano’s novel payload (drug-linker) technology to expand its ADC development portfolio. According to Nerviano, the technology of new DNA intercalating agents is based on a proprietary thienoindole scaffold, characterized both by potent antitumor activity and by physicochemical properties that are highly compatible with deployment as antibody payloads.

According to Pfizer, the U.S. Federal Trade Commission is seeking more information on its pending merger between Pfizer and Allergan, announced last November. The company says the inquiry was expected and it anticipates to complete the merger in the second half of 2016.

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