June 2016

The results of a study presented today at the European League Against Rheumatism Annual Congress (EULAR 2016) found a doubled risk of pre-malignant cervical changes, and potentially also an increased risk of cervical cancer, among women with Systemic Lupus Erythematosus (SLE) compared to the general female population. The highest risks were found in women with SLE who were treated with immunosuppressant drugs. These findings highlight the importance of regular cervical screening in all women with SLE, regardless of whether the increased risk is due to disease severity or treatment.

About 80 percent of patients with moderate to severe psoriasis saw their disease completely or almost completely cleared with a new drug called ixekizumab, according to three large, long-term clinical trials led by Northwestern Medicine.

Researchers at the University of California San Diego School of Medicine, with colleagues in Pennsylvania and China, report that not only are there distinct differences in key cellular processes and molecular signatures between rheumatoid arthritis (RA) and osteoarthritis (OA) but, more surprisingly, there are joint-specific differences in RA. The findings help explain, in part, why drugs treating RA vary in effect  why, for example, a treatment that might work in arthritic knees isn't effective in an arthritic hip and provide a potential new template for precisely targeting treatment for each and every ailing joint.

The eighth annual Dealmakers' Intentions Study from inVentiv Health Consulting (formerly Campbell Alliance), concludes that after a chart-topping year, life sciences dealmaking will return to historic norms or slightly higher. The survey of biopharmaceutical dealmakers points to the rise of acquisitions with earn-outs and identifies top opportunities for buyers and sellers.

The Anticoagulants-Market Insights & Drugs Sales Forecast (VTE & AF) -2020report provides an overview of the disease, epidemiology and global market trends for the seven major markets ie: United States, EU5 (France, Germany, Italy, Spain, UK) and Japan. According to DelveInsight, Global Anticoagulants (VTE & AF) Therapeutics Market was around $11.4 billion in 2015 and is estimated to reach $17.2 billion by 2020 growing at a CAGR of 8.59% from 2015 to 2020.

Biogen reported top-line results from the Phase 2 SYNERGY study evaluating opicinumab (anti-LINGO-1), an investigational, fully human monoclonal antibody being developed as a potential neuroreparative therapy in people with relapsing forms of multiple sclerosis (RMS). In the study, opicinumab missed the primary endpoint, a multicomponent measure evaluating improvement of physical function, cognitive function, and disability. However, evidence of a clinical effect with a complex, unexpected dose-response was observed.

 Remedy Pharmaceuticals, a privately-held pharmaceutical company focused on bringing life-saving hospital-based treatment to people affected by central nervous system (CNS) related edema, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational drug, CIRARA, for the treatment of Large Hemispheric Infarctions (LHI).

Ironwood pharmaceutical Inc. And Allergan Plc announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for the 72 mcg dose of linaclotide for use in the treatment of adults with chronic idiopathic constipation (CIC).

Relmada Therapeutics, Inc. (RLMD), a clinical-stage company developing novel therapies for the treatment of chronic pain, announced that d-Methadone (dextromethadone, REL-1017), a N-methyl-d-aspartate (NMDA) receptor antagonist in development as a treatment for both depression and chronic neuropathic pain, has received Orphan Drug designation from the US Food and Drug Administration (FDA) for the management of postherpetic neuralgia. Postherpetic neuralgia (PHN) is a painful neuropathic condition resulting from an outbreak of the herpes zoster virus, otherwise known as shingles.

The Phase 3 clinical study confirmed the efficacy, safety and immunogenicity of MYL-1401O, the proposed biosimilar trastuzumab co-developed by Biocon and Mylan, in comparison to branded trastuzumab.