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Farooq

January

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Early results from randomized trials are sometimes published before the trial is completed. The results of such interim publications may generate a great deal of interest in the medical community because the findings often hold a great deal of promise for new and effective therapies. However, in an article recently published in JAMA, Dartmouth researchers compared the consistency and prominence of interim publications with the final publications.

Researchers at the Institute of Industrial Science (IIS), the University of Tokyo, CNRS and INSERM, report a new organ-on-a-chip technology for the study of blood vessel formation and drugs targeting this event. The technology recreates a human blood vessel and shows how new capillaries grow from a single vessel (parent vessel) in response to proper biochemical signaling cues.

Novartis AG (NYSE: NVS) announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and Drug Administration (FDA) approval of its new drug application (NDA) for Lutathera® (lutetium Lu 177 dotatate*) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors, in adults.

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Sanofi and Ablynx, a biopharmaceutical company engaged in the discovery and development of Nanobodies®, entered into a definitive agreement under which Sanofi will offer to acquire all of the outstanding ordinary shares, including shares represented by American Depositary Shares (ADSs), warrants and convertible bonds of Ablynx at a price per Ablynx share of €45 in cash, which represents an aggregate equity value of approximately €3.9 billion.

The U.S. Food and Drug Administration today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs.

New research published by the Journal of the Royal Society of Medicine exposes the extent of redactions in protocols for industry-sponsored randomised drug trials. Trial protocols are needed for a proper assessment of the veracity of drug trial reports. The researchers, from the Nordic Cochrane Centre in Copenhagen, found widespread redactions in the protocols for commercially sponsored trials they received from research ethics committees in Denmark.

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In both cell cultures and mouse models, a drug used to treat Hepatitis C effectively protected and rescued neural cells infected by the Zika virus – and blocked transmission of the virus to mouse fetuses. Writing in the current online issue of the journal Scientific Reports, researchers at University of California San Diego School of Medicine, with colleagues in Brazil and elsewhere, say their findings support further investigation of using the repurposed drug as a potential treatment for Zika-infected adults, including pregnant women.

Pfizer Inc. has announced that REFLECTIONS B3281006, a comparative safety and efficacy study of PF-05280586 versus MabThera® (rituximab-EU), met its primary endpoint. PF-05280586 is being developed by Pfizer as a potential biosimilar to Rituxan® (rituximab-US) / MabThera® (1). The trial demonstrated equivalence in overall response rate (ORR) for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma.

More patients could be eligible for critical treatments to remove or dissolve blood clots that cause strokes, according to a new treatment guideline issued by the American Heart Association/American Stroke Association. The guideline, based on the most recent science available, was published in the Association's journal Stroke, and released during the American Stroke Association's International Stroke Conference 2018, the premier global meeting for researchers and clinicians dedicated to the prevention and treatment of stroke.

More patients could be eligible for critical treatments to remove or dissolve blood clots that cause strokes, according to a new treatment guideline issued by the American Heart Association/American Stroke Association. The guideline, based on the most recent science available, was published in the Association's journal Stroke, and released during the American Stroke Association's International Stroke Conference 2018, the premier global meeting for researchers and clinicians dedicated to the prevention and treatment of stroke.