Pharma News

Janssen Research & Development, LLC (Janssen) announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food & Drug Administration (FDA) seeking a new indication for INVOKANA® (canagliflozin) to reduce the risk of major adverse cardiovascular events (MACE), composed of cardiovascular (CV) death, myocardial infarction and stroke, in adults with type 2 diabetes who have established CV disease or are at risk for CV disease. The application also applies to INVOKANA®’s fixed-dose combinations, INVOKAMET® and INVOKAMET® XR, and is based on findings from the landmark CANVAS clinical trial program, which were presented at a special symposium at the American Diabetes Association 77th Scientific Sessions in June 2017 and simultaneously published in The New England Journal of Medicine.

Users of statins, widely prescribed for prevention of cardiac disease, have a 27% lower risk of contracting a Staphylococcus aureus (S. aureus) bloodstream infection outside of a hospital, according to a new study in Mayo Clinic Proceedings. Researchers report that statin use, especially among elderly patients with preexisting chronic conditions such as diabetes, kidney, or liver disease, may be protective against this serious bloodstream infection. As the western world's population is aging and more people live with chronic medical conditions, any potential preventive effect of statins could have important clinical implications.

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 Ministry of Health and Family Welfare, Government of India signed a Letter of Intent with the Norwegian Ministry of Foreign Affairs, Government of Norway to extend the cooperation within health sector through the Norway India Partnership Initiative (NIPI) for a period of three years starting from 2018, here today. Shri C K Mishra, Secretary (HFW) and His Excellency, Mr. Nils Ragnar Kamsvag, Ambassador of Norway signed this Letter of Intent. Shri Manoj Jhalani, Additional Secretary & Mission Director (AS&MD), Ms. Vandana Gurnani, JS (RCH), Dr. Tore Godal, Special Adviser to Prime Minister of Norway, Dr Maha-noor Khan, Ministry of Foreign Affairs, Norway were also present during the signing ceremony.

Fibrocell Science, Inc a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today reported interim results in its Phase 1/2 clinical trial of FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).

While immune cells called neutrophils are known to act as infantry in the body’s war on germs, a National Institutes of Health-funded study suggests they can act as medics as well. By studying rodents, researchers showed that instead of attacking germs, some neutrophils may help heal the brain after an intracerebral hemorrhage, a form of stroke caused by ruptured blood vessels. The study suggests that two neutrophil-related proteins may play critical roles in protecting the brain from stroke-induced damage and could be used as treatments for intracerebral hemorrhage.

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics and injectable epinephrine products to American consumers.

Researchers at the Department of Clinical Medicine at the University of Bergen (UiB) have discovered that medical treatment against diabetes reduces the risk of getting Parkinson´s disease by 35 per cent.

Scientists at The Scripps Research Institute (TSRI) have made a discovery that could speed efforts to develop a successful HIV vaccine.

The scientists found that on the HIV envelope protein, at a site important for viral function, a small group of sugar molecules, known as glycans, serves as a key “anchor” for antibodies that can broadly neutralize the virus. Future candidate vaccines are therefore likely to include this glycan cluster among their specific viral targets in order to maximize the chances of stimulating an effective antibody response.

Konica Minolta, Inc. and Boston-based Invicro LLC (“Invicro”) announced that they have concluded an agreement whereby Konica Minolta will acquire Invicro, a leading provider of imaging services and software for research and drug development.

BioCryst Pharmaceuticals, Inc a biotechnology company focused on the development and commercialization of treatments for rare and infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for RAPIVAB (peramivir injection), an intravenous (i.v.) neuraminidase inhibitor, extending its availability for the treatment of acute uncomplicated influenza to pediatric patients 2 years and older who have been symptomatic for no more than two days. The pediatric approval was based on the interim analysis of an ongoing pediatric clinical study. Those results will be presented at the upcoming ID Week 2017 meeting in San Diego.