FDA goes after sales of e-cigs to minors

Crackdown on Juul Labs

Juul Labs, a San Francisco-based maker of e-cigarettes since 2015, has become a focus of Food and Drug Administration (FDA) enforcement efforts after dozens of undercover illegal sales to supposed minors were made by retailers caught in “compliance checks,” according to Kate Zernike and Sheila Kaplan on the website www.mobilenytimes.com.

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Clinical Research Challenges: Current model is too slow, too costly

An industry expert says the current model for conducting clinical research is “failing patients who live in a mobile world and will not sustain itself if clinical trials take years to recruit,” writes Melissa Fassbender in Outsourcing-Pharma.com.

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Veeva joins six big CROs to expedite clinical trial development

Coming Together

Contract research organizations (CROs) play a critical role in supporting drug development. Clinical outsourcing is projected to increase to 50 percent by 2020. As sponsors conduct an increasing number of trials with multiple CROs, the development of pre-competitive industry standards will assist in bringing more consistency to trial management and addressing the complexity of trial oversight to make drug development processes more efficient and cost-effective.

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Clinical trials can be fake – and dangerous – too

Worse than Fake News

From 2013 to 2016, more than two dozen people who thought they were participating in a clinical trial to obtain a vaccine for herpes. The participants, from the Caribbean island of St. Kitts and in the state of Illinois, had no idea that the Southern Illinois University (SIU) professor had never gotten approval for the so-called clinical trials from the U.S. Food and Drug Administration (FDA), a safety panel or the government of St. Kitts and Nevis. Participants had side effects such as dizziness, aches and ringing in the ears, although nobody had life-threatening issues.

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Lilly invests in Sigilon diabetes cell therapies

“Living Therapeutics”

Eli Lilly - a global healthcare leader founded more than a century ago – is paying $63 million up front to license islet cell encapsulation technology from Sigilon Therapeutics, a Cambridge, Massachusetts-based, privately-held biopharmaceutical company focused on discovering and developing "living therapeutics" with its Afibromer™ technology product platform. Sigilon, which is using the technology for Type 1 diabetes, could garner an additional $410 million in milestones and royalties, according to an article by Amirah Al Idrus in Fierce Biotech.

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Facebook wanted hospitals to share data about vulnerable patients

Patient Benefits vs. Privacy Concerns

It might have been a mission with merit, but its value is obscured when contemplating the potential for problems. Those problems have actually become a reality.

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New funding helps company to bring clinical studies to more doctors

Inclusiveness with Elligo

A new round of funding will go a long way to enable Elligo Health Research to fulfill its stated mission of providing “physicians and their patients the opportunity to participate in clinical trials using advanced health care informatics.” According to the company’s website, “Improved access to physicians and patients means sponsors reach trial enrollment goals faster, and new products are accelerated to market, benefiting patients everywhere…We accomplish this by being the preeminent provider of clinical research infrastructure (CRI) services and technologies. As a CRI provider, we bring together and empower sponsors, clinicians, patients and CROs to improve clinical trial access and efficiency.”

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GSK buys Novartis out of joint venture

$13 Billion Deal

GlaxoSmithKline (GSK) is buying Novartis out of the consumer healthcare joint venture the two companies had. The $13 billion buyout will give GSK full control of products such as Sensodyne toothpaste, Panadol headache tablets, muscle gel Voltaren, and Nicotinell anti-smoking patches. Under the terms of the 2014 deal to pool their consumer assets, Novartis had the right so sell its 36.5 percent stake to Glaxo. The transaction should be complete in the second quarter of 2018, subject to necessary approvals.

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Clinical Trial Registries Show Many Mistakes

Tracking Trials

A review of 10,492 clinical trials that are registered on both the United States government’s ClinicalTrials.gov registry and the European Union’s Clinical Trials Register (EUCTR) found that 16.2 percent had differing statuses on the two sites, and 33.9 percent of trials shown as “completed” on ClinicalTrials.gov were only “ongoing” on EUCTR, reported Melissa Fassbender in OutsourcingPharma.com.

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Researchers suggest ways to renew commitment to biomedical research funding

Competitive Edge

“Yesterday’s triumphs may pale beside the promise of tomorrow’s breakthroughs — if pressures on research funding don’t threaten the future of biomedical research,” said researchers Jeffrey A. Bluestone, David Beier and Laurie H. Glimcher in an article called “The NIH is in danger of losing its edge in creating biomedical innovations” in STAT.

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Delayed reporting leads to shaming by tracking

Scrutiny for Sponsors

There are consequences when clinical trial sponsors fail to report study results on time to clinicaltrials.gov. A new online tracker developed by the clinical trial transparency advocacy project AllTrials publicly shames these sponsors by putting them under public scrutiny,

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Sequoia, Google, Tencent invest $15M in China AI biotech startup XtalPi

AI Answers

A new round of funding will give XtalPi, a computation-driven Chinese startup, a chance to provide applications of artificial intelligence for drug research and development. Leading the charge in the $15 million series B round of finance are high-profile technology investors Sequoia China, Google and Chinese internet giant Tencent, according to an article by Angus Liu in Fierce Biotech.

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Blockchain Use Will Improve Clinical Trials

The huge amounts of data created in clinical trials make it increasingly hard to share the information safely, keep it from being compromised, protect subject privacy and increase subject recruitment.

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Nebula enables use of cryptocurrency for genome sequencing

Efficient Data Acquisition

Will new technologies be able to break down the barriers to genome sequencing for large numbers of people? George Church, described in an article by Nick Paul Taylor in Fierce Biotech as a “prolific startup creator,” thinks so.

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Major companies partner to control drug costs

Three very large companies, Berkshire Hathaway, Amazon and JPMorgan Chase bank, have agreed to jointly address the costs of prescription drugs for their combined 1.1 million employees, reported Ben Popken and Lucy Bayly on NBC News. The partners will create a new company to provide drugs “…at a reasonable cost.” An event of this size could have an impact on all of medical economics.

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