Pharma News

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.

 Japan based Tanaka Holdings has developed the world's first kit able to directly detect the ZIKA virus (ZIKV) in blood. The kit is capable of rapid ZIKV detection in just 10 to 15 minutes. Tanaka Kikinzoku Kogyo plans to supply samples for clinical evaluation with a view to collaboration with domestic and overseas medical manufacturers.

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A new study shows that it is possible to reduce the level of sugar in muffins without affecting their textural properties by replacing half of the sugar content with stevianna or inulin, which are plant-based sweeteners. Also, after individuals consumed sugar-replaced muffins, their glycemic response--or the concentration of glucose in the blood--was lower than when they consumed regular muffins.

In a pair of firsts, researchers at Case Western Reserve University and Massachusetts Institute of Technology have shown that the drug candidate phenanthriplatin can be more effective than an approved drug in vivo, and that a plant-virus-based carrier successfully delivers a drug in vivo.

Evidence of DNA "scrunching" may one day lead to a new class of drugs against viruses, according to a research team from the Perelman School of Medicine at the University of Pennsylvania, the Georgia Institute of Technology, and Columbia University. The team is led by Stephen C. Harvey, PhD, an adjunct professor in the department of Biochemistry and Biophysics at Penn. The scientists report in The Journal of Physical Chemistry B that DNA may go through a repetitive cycle of contraction and elongation, or as they put it, "scrunching," to generate the forces required to drive the DNA into a virus during replication. A better understanding of viral reproduction could be the basis of new ways to fight infectious pathogens.