Pharma News

Swedish Orphan Biovitrum AB (Sobi) announced that the Food and Drug Administration (FDA) has approved a higher strength 20 mg capsule of Orfadin® (nitisinone) for the treatment of Hereditary Tyrosinaemia type-1 (HT-1). HT-1 is a rare genetic disease that affects infants and children. It is progressive and may result in liver and kidney complications and can be fatal if untreated.

Today leading experts on infectious disease and urinary tract infections (UTIs) will gather in London to discuss the alarming state of antibiotic resistance, and present findings from a landmark study that conclusively shows that cranberries can be a nutritional approach to reducing symptomatic UTIs, and as a result, may be a useful strategy to decrease worldwide use of antibiotics.

 Dioxins are environmental pollutants that stay in the body for long periods of time because they can accumulate in fat tissue. They are mainly by-products of combustion and industrial processes. Long-term exposure to dioxins has been suspected to have a host of toxicities, causing health issues such as cancer and impairment of the immune system and the developing nervous system.

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The dangers of arterial thrombosis - the formation of blood clots that can block arteries and cause illness or death - can escalate through a vicious cycle of coagulation and inflammation. But microRNAs - single-stranded, non-coding small RNAs that can tamp down signaling from specific genes - may be able to break this cycle. In previous studies, researchers from Brigham and Women's Hospital found that microRNA-181b (miR-181b) could regulate acute and chronic vascular inflammation. In a new study published online this week in The FASEB Journal, the research team investigated the role of miR-181b in blocking the development of arterial thrombosis. The new findings have implications for heart attacks, stroke and peripheral artery disease.

Blood safety researchers say it is highly likely that the mosquito-borne Zika virus can be transmitted through blood transfusions and are calling for an evidence-based approach to protecting the blood supply from the threat of Zika virus according to a commentary in the journal Transfusion.

Fungal infections can be devastating to human health, killing approximately 150 people every hour, resulting in over a million deaths every year, more than malaria and tuberculosis combined.

Abbott, a global healthcare company, announced the results of the IMPACT clinical trial, which demonstrated that the FreeStyle Libre system met its primary endpoint of a reduction in time spent in hypoglycemia (low glucose levels, defined as <70 mg/dL1) for people with type 1 diabetes. People in the trial who used Abbott's FreeStyle Libre sensor and reader system spent 38 percent less time in hypoglycemia, as compared to people who managed their glucose with traditional self-monitoring of blood glucose (SMBG) systems (pricking a finger to draw a drop of blood that is added to a test strip inserted into a glucose meter). Data were presented at the American Diabetes Association's 76th Scientific Sessions.

Ajanta Pharma Limited, announced the launch of memantine hydrochloride tablets in the US market through its wholly owned subsidiary Ajanta Pharma USA Inc. Memantine hydrochloride is an anti-dementia drug and is a bioequivalent generic version of Namenda.

Shire plc, a leading global biotechnology company, has agreed to license global rights to all indications for PF-00547659 from Pfizer Inc.  PF-00547659 is an investigational biologic being evaluated for the treatment of moderate-to-severe inflammatory bowel disease (IBD). PF-00547659 has been evaluated in more than 700 patients in phase 1 and 2 trials, and phase 3 trials are expected to begin after consultation with global health authorities. Closing of the transaction is subject to HSR approval. Terms of the deal were not disclosed.

Amgen announced that the Arthritis Advisory Committee of the US Food and Drug Administration (FDA) will review data supporting the company's Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira (adalimumab).