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Home » Newsletters » BioWorld

BioWorld

Aug. 21, 2017

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Other news to note

Medivir AB, of Stockholm, licensed the exclusive rights to develop, manufacture and commercialize its nucleotide polymerase inhibitor for hepatitis C, MIV-802, in Greater China to Ascletis Inc., of Hangzhou, China. Read More

In the clinic

Medivir AB, of Stockholm, enrolled the first patient in a phase I/II study of the Smac mimetic birinapant in combination with the anti-PD-1 therapy Keytruda (pembrolizumab), marketed by Merck & Co. Inc., of Kenilworth, N.J. Read More

Bench Press: BioWorld looks at translational medicine

Researchers from the Dutch VU University Medical Center have adapted the mathematical algorithms that are used to describe the behaviors of schooling fish and swarming birds to identify RNA biomarkers in blood samples that were capable of diagnosing early and late stage non-small-cell lung cancer (NSCLC), and distinguishing such patients from patients with inflammatory conditions. Read More

Appointments and advancements

Grail Inc., of Menlo Park, Calif., named Bill Rastetter CEO, Ken Drazan president, and Jeff Huber vice chairman of the board. Read More

Financings

Jazz Pharmaceuticals plc, of Dublin, said, through its wholly owned subsidiary Jazz Investments I Ltd., is offering $500 million aggregate principal amount of 1.5 percent exchangeable senior notes due 2024 in a private offering to qualified institutional buyers. Read More

Can cannabinoids earn respect? New-generation candidates are not just blowing smoke

The legal, regulatory and marketing hurdles faced by companies with commercial cannabinoids have not deterred new entrants seeking to build better mousetraps. Although many companies in the field continue to rely on the cannabis plant as the starting point for their R&D efforts, some have turned to what they consider next-generation drug development to overcome concerns about pharmacokinetic consistency. Read More

FDA's oversight of post-approval studies of drugs granted accelerated approval in question

LONDON – An analysis of 38 post-approval clinical trials ordered by the FDA to provide evidence of efficacy of 22 drugs granted accelerated approval from 2009 to 2013 shows only half of the studies had been completed by April 2017.  Read More

SUSTAIN response: Novo good show rocks diabetes; pundits weigh Lilly impact

The type 2 diabetes win with once-weekly glucagon-like peptide-1 (GLP-1) agonist semaglutide by Novo Nordisk A/S in SUSTAIN 7 put pressure of the kind not expected by some analysts on Eli Lilly and Co., whose dulaglutide in the same class – commercialized as Trulicity – came up short in the experiment. Read More

Nuclear factor controlling brown fat gene identified

A study reported Aug. 14, 2017 in Nature Cell Biology has identified a nuclear factor involved in brown fat metabolism that contributes to the pathophysiology of obesity in humans, which could lead to the development of new brown fat-targeted anti-obesity therapies. Read More

Alzeca sets sights on early MRI-based Alzheimer's testing with $11M series A

Alzeca Biosciences Inc., a small developer of imaging agents intended to aid early diagnosis of Alzheimer's disease and other neurodegenerative disorders, has closed an $11 million series A financing backed by private investors. Read More

China cracks down on penalties for falsifying drug application data

HONG KONG – Chinese regulators have clarified the legal consequences of data falsification in new drug and medical device applications, alarming the industry – both applicants for registration and research institutions – by raising falsification to the level of a criminal law violation. Read More

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