FDAnews Drug Daily Bulletin

The FDA currently can approve drugs for either prescription or OTC use, but a third "behind-the-counter" (BTC) alternative has gained notice in recent weeks, as lawmakers seek ways to prevent the abuse of common OTC drugs and drugmakers run into hurdles trying to switch their Rx products to OTC status.

The SEC has issued Merck a formal notice informing the drugmaker that it is launching a full investigation into the recall of painkiller Vioxx.

A federal appeals court recently voted to invalidate Merck's patent on its blockbuster osteoporosis treatment Fosamax, clearing the way for generic firms to hone in on the multibillion dollar market for the drug.

GlaxoSmithKline's (GSK) long-running feud with the IRS heated up when the tax agency slapped the company with a nearly $2 billion bill for back taxes allegedly owed by legacy company Glaxo Wellcome.

Japan's largest drugmaker, Takeda Pharmaceutical, will acquire Syrrx, a privately held California biotechnology company working on treatments for cancer and diabetes, for roughly US$270 million in cash.

Beyond Genomics has announced its name change to BG Medicine. The company also announced the appointment of Pieter Muntendam as its new president to lead the company's business operations and strategy.

Barrier Therapeutics, a pharmaceutical company developing products in the field of dermatology, has announced the acquisition of the U.S. and Canadian rights to Solage (mequinol 2 percent, tretinoin 0.01 percent) Topical Solution from Moreland Enterprises.

The Institute for the Study of Aging (ISOA), a biomedical venture philanthropy created to catalyze and fund drug discovery research for Alzheimer's disease, recently awarded a two-year program-related investment to NeuroMolecular Pharmaceuticals (NeuroMolecular).

Tripos, a leading provider of drug discovery chemistry and informatics products and services, and BioTie Therapies, a Finnish biotech company, have announced a partnership to enhance BioTie's drug discovery efforts, which include innovative medicines for the treatment of dependence disorders, inflammatory diseases and thrombosis.

The University of Pittsburgh Medical Center will make a $1 million, in-kind investment in ZelleRX to develop cancer treatments.

JDS Pharmaceuticals and Synthon Pharmaceuticals have entered into a co-promotion agreement for Lithobid (lithium carbonate), a leading brand of twice daily lithium carbonate for the treatment of bipolar disorder.