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Weekly Drug News Round Up - July 9, 2014

Beleodaq Approved for Rare Form of Non-Hodgkin Lymphoma (NHL)

In 2014, the National Cancer Institute estimates that 18,990 will die Americans will die from NHL Read More...

Peripheral T-cell lymphoma (PTCL) is a rare and fast-growing type of type of non-Hodgkin lymphoma (NHL), a cancer of the lymph tissue that contains infection-fighting white blood cells. The U.S. Food and Drug Administration (FDA) has approved Beleodaq (belinostat) for the treatment of patients with PTCL, to be used when other treatments fail. In studies, 25.8 percent of 129 patients had their cancer disappear (complete response) or shrink (partial response) after treatment. The most common side effects seen with Beleodaq use were nausea, fatigue, fever, low red blood cells, and vomiting. Folotyn (pralatrexate) and Istodax (romidepsin) are other drugs approved since 2009 for PTCL.

FDA Gives Thumbs Up to Anacor’s Kerydin for Toenail Fungus

Onychomycosis is a nail and nailbed fungal infection that affects approximately 35 million people Read More...

This week, the U.S. Food and Drug Administration approved Kerydin (tavaborole) topical 5 percent solution, the first oxaborole antifungal approved for the topical fungal treatment of the toenails (onychomycosis). Kerydin is approved to treat Trichophyton rubrum or Trichophyton mentagrophytes fungal infections. Kerydin is an alcohol-based solution applied with a dropper to the infected toenail once daily for 48 weeks. In clinical trials, 6.5 to 9.1 percent of patients reached the primary endpoint of complete cure after one year. Common side effects with Kerydin included application site exfoliation, ingrown toenail, application site erythema and dermatitis (redness and swelling).

New Inhaled Asthma Agent May Replace Injectable Xolair: Study

However, one expert noted that the drug has yet to prove itself against moderate to severe asthma Read More...

A protein called immunoglobulin type E (IgE) plays a key role in allergies. IgE binds to allergens upon first exposure, and then triggers the allergic response upon re-exposure that may lead to an allergy or possibly an asthma attack. An inhaled investigational drug, quilizumab by Genentech, targets the cells that produce IgE, and may be effective for mild allergies and asthma symptoms, according to an industry-sponsored study. Omalizumab (Xolair), an injectable drug also by Genentech, is the only other IgE-targeted agent for asthma. Experts say quilizumab could replace omalizumab if studies are positive because it is more convenient and longer lasting.

Micardis Now in Generic Version from Several Manufacturers 

Generic drugs are chemically identical to their branded counterparts, and can save major prescription dollars Read More...

Several generic manufacturers, including Mylan, Torrent, Alembic, and Glenmark Generics have launched telmisartan tablets in the 20, 40 and 80-milligram strengths. Telmisartan is the generic version of Boehringer Ingelheim's Micardis Tablets. Telmisartan is an angiotensin II receptor blocker (ARB) used for high blood pressure (hypertension) and reduction of cardiovascular events in patients unable to take ACE inhibitors. Watson Labs first received approval for telmisartan tablets in January of 2014.

Opdivo: World's First Anti-PD-1 Immuno-Oncology Antibody Approved in Japan

According to EvaluatePharma, this novel class of drugs may have a value of over $14 billion by the year 2020 Read More...

Opdivo (nivolumab) is a human anti-human PD-1 (programmed death-1) monoclonal antibody from Ono Pharmaceuticals, the first drug approved worldwide that targets PD-1. Nivolumab and other PD-1 and PD-L1 monoclonal antibodies increase the ability of the body’s own immune system to recognize cancer cells and eliminate them. Many of these antibodies are currently in early to late phase research in the U.S. and have broad application to treat multiple types of cancer such as lung, breast, skin, and kidney cancer. The Biologics License Application (BLA) for pembrolizumab by Merck has been filed with action expected by late October 2014, possibly making it the first anti-PD-1 therapy approved in the U.S. Other programmed death-1 pathway agents under research include nivolumab by Bristol-Myers Squibb (in the U.S.), RG7446 by Roche and MEDI4736 by AstraZeneca and MedImmune.