FDAnews Drug Daily Bulletin

In a field with multi-billion dollar potential, Roche is more than doubling the size of its Phase II/III clinical trial for what it considers the most advanced monoclonal antibody (mAb) in development to treat early Alzheimer’s disease (AD).

While an impending update to the U.S. Pharmacopeia’s (USP) reference standard for heparin sodium will sharpen the drug’s monograph, there is no substitute for solid supplier quality control to prevent contaminants in heparin and other active pharmaceutical ingredients (API), FDA officials say.

The FDA has OKed Pfizer’s Bosulif, a once-daily pill to treat chronic myelogenous leukemia (CML), marking the pharma giant’s third new oncology drug approval in a little more than a year.

Heart attack survivors should be wary about taking a common group of painkillers known as non-steroidal anti-inflammatory drugs, say Danish researchers reporting in the journal Circulation this week, because the drugs could increase longer term risk of a second heart attack, or even death.

Israeli biotechnology firm Atox Bio said the FDA has granted fast track designation to AB103, its product in development for the treatment of necrotizing soft tissue infections, also known as flesh-eating bacteria.

Johnson & Johnson settled a lawsuit on the first day of a trial over claims its antipsychotic drug Risperdal (risperidone) caused a male plaintiff to grow breast tissue, one of his lawyers told a state judge in Philadelphia.

The stock of Cambridge biotech Zalicus took a 33 percent dive Monday after the company announced it is stopping trials of Synavive, which it had hoped would improve on drugs now on the market to treat rheumatoid arthritis.

AstraZeneca’s MedImmune unit is joining with a Chinese pharmaceutical outsourcing company to develop an experimental treatment for autoimmune and inflammatory diseases, deepening the British drug developer’s presence in the world’s second-largest economy.

Cancer drugmaker Geron said it would halt the study of its experimental drug, imetelstat, as a treatment for breast cancer and the drug was also unlikely to move forward in trials for advanced non-small cell lung cancer, causing the company’s shares to shed nearly half their value.