Drugs

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New York has reached an agreement with Endo Pharmaceuticals over its marketing of long-acting opioid, Opana ER. The agreement requires Endo to “cease all misrepresentations regarding the properties of Opana ER, to describe accurately the risk of addiction to Opana ER, and to summarize studies regarding Opana ER on its Web site,” according to a release from NY Attorney General Eric T. Schneiderman. “

The Justice Department says that Olympus Corp. of the Americas, the nation’s largest distributor of endoscopes and related equipment, will pay $623.2 million to resolve criminal charges and civil claims relating to a scheme to pay kickbacks to doctors and hospitals. A company subsidiary also will pay $22.8 million to resolve criminal charges relating to the Foreign Corrupt Practices Act in Latin America. A department news release says that a criminal complaint filed in New Jersey federal court charged the company with conspiracy to violate the anti-kickback statute. Olympus has entered into a three-year deferred prosecution agreement that will allow it to avoid conviction if it complies with reform and compliance provisions in the agreement, the department says.

Xencor, Inc. has begun dosing in a Phase 2 trial of XmAb5871 in patients with IgG4-related disease and also in a Phase 2 trial of XmAb5871 in patients with Systemic Lupus Erythematosus (SLE). According to president and CEO Bassil Dahiyat, XmAb5871 has potent, reversible B-cell inhibition and promising treatment effect demonstrated in a Phase 1b/2a study of patients with rheumatoid arthritis, and previous ex vivo results with XmAb5871 showing inhibition of SLE patient B-cell activation and humoral immunity.

AbbVie and Boehringer Ingelheim will enter into a global collaboration to develop and commercialize BI 655066, an anti-IL-23 monoclonal biologic antibody in Phase 3 development for psoriasis. The companies says they are also evaluating this biologic therapy in Crohn’s disease, psoriatic arthritis and asthma. Abbvie will gain rights to the anti-IL-23 antibody and an anti-CD-40 antibody, BI 655064, currently in Phase 1 development, according to the company, and Boehringer Ingelheim will retain responsibility for further development of BI 655064.

Citius Pharmaceuticals has entered into a non-binding letter of intent to acquire all of the outstanding shares of Leonard Meron Biosciences including Leonard’s lead drug candidate, Mino-Lok, an antibiotic lock solution used to treat patients with catheter-related bloodstream infections.

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