Breath test detects cancer markers

Early and Effective

After his wife died of colon cancer at 36 in 2014, Billy Boyle, 39, became a man on a mission. Boyle, who had been doing research on how volatile organic compounds (VOCs) could be used to diagnose complications from chemical warfare, applied the idea to a breath test that could detect cancer-linked chemicals at very early stages.

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Study shows that female scientists’ career length compares favorably with that of men – once they get their first grant

Gender Issues

An analysis published this week by L. A. Hechtman et al. in Proceedings of the National Academy of Sciences shows that the career trajectory of women scientists is nearly as long as that of their male counterparts, once they attain a US National Institutes of Health (NIH) grant. The story, reported in Nature News by Holly Else, indicates that women are nearly as successful as men at garnering additional awards from the agency.

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Artificial intelligence system projects future symptoms

Predicting Progression of Alzheimer’s

Alzheimer’s disease, the sixth leading cause of death in the US, kills more senior citizens than breast cancer and prostate cancer combined. The disease affects millions of people annually, says the Alzheimer’s Association. If diagnosed early, as much as $7.9 trillion in medical and care costs could be saved, according to an article by Kyle Wiggers in Venture Beat.

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Sen. Patty Murray reprimands BIO and PhRMA about gender diversity

Silent on Sexism?

Sen. Patty Murray, D-Wash., the top Democrat on the Senate Health, Education, Labor and Pensions Committee, is furious. After an industry party that objectified women, Murray sent letters to the Biotechnology Innovation Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA) about their efforts to combat workplace harassment at their member companies, according to an article by Amirah Al Idrus in Fierce Biotech.

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Google, Amazon, Facebook, and Apple Spur Life Science Growth

Leading the Way with Strategic Partnerships

Frost & Sullivan, which analyzes markets to help investors, corporate leaders and governments navigate economic changes and identify disruptive technologies and companies, as well as Mega Trends and new business models, predicts that data monetization, direct-to-consumer and eCommerce business models will create growth opportunities in life sciences.

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FDA approves first medicine made from marijuana in US

Help without High

On Monday the US Food and Drug Administration (FDA) approved the country’s first medication derived from marijuana. GW Pharmaceuticals’ Epidiolex, is a drug administered as an oil to treat two kinds of epilepsy, Dravet or Lennox-Gastaut syndromes.

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Amazon health care company announces CEO

Nameless but in the News

The new health care company launched by Amazon, Berkshire Hathaway, and JPMorgan Chase continues to remain nameless, but now it has a prominent CEO. On Wednesday the companies announced that Dr. Atul Gawande, a surgeon at Brigham and Women’s Hospital in Boston who teaches at Harvard’s medical and public health schools, will become the chief executive officer of the new organization July 9, reported Andrew Joseph in STAT.

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President signs act to help terminally ill patients seek drugs

Right to Try

Giving a measure of hope to people with serious illnesses, President Donald Trump signed the "Right to Try Act" at the end of May. The measure would enable terminally ill patients to gain access to drug treatments that are not yet completely approved by the Food and Drug Administration.

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FDA guidance makes genetic risk assessments exempt from premarket approval

GHR Guidance

As of June 5, the Food & Drug Administration (FDA) officially made genetic risk assessments exempt from 501(k) premarket approval, as long as the company providing the test has gone through a one-time premarket review of its testing apparatus and at least one test, as reported by Jonah Comstock in Mobile Health News. Officially published in the Federal Registry, the notice finalized a guidance that was originally proposed in November 2017.

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Bristol-Myers Squibb and Flatiron announce collaboration

Real-World Data for Regulatory Submissions

Pharma giant Bristol-Myers Squibb (BMS) and Flatiron Health, a market leader in oncology-specific electronic health record software and the curation of regulatory-grade real-world data for cancer research and real-world evidence (RWE) generation, inked a three-year agreement to create a joint scientific advisory board designed to use real-world evidence in regulatory submissions, according to an article by Conor Hale in Fierce Biotech.

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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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