Gottlieb proposes plan to simplify FDA structure

Reorganizing FDA

Dr. Scott Gottlieb, who became the 23rd Commissioner of the Food and Drug Agency (FDA) on May 11, 2017, is proposing “to flatten out FDA’s structure by having the Center directors report directly to him, instead of through a level of “directorates” between the commissioner and Center staff,” as reported by Jill Wechsle of Pharmaceutical Executive. The objective is “to give more authority to the agency’s six product regulatory Centers and to the Office of Regulatory Affairs (ORA) and will ensure that the commissioner remains in close contact with the Center leadership,” according to Gottlieb in an email to FDA staff this week.


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Market surge creates opportunities and challenges

Biopharma in China

The sophistication of drug production in China has come a long way in a short time, offering both opportunities and challenges for Chinese and Western pharma and biotech companies, according to an article by Peter Young in Pharmaceutical Executive. In recent memory, China was “principally a low cost, low quality producer of pharmaceutical intermediates and fine chemicals,” according to Young, but the country cleaned up its manufacturing practices, developed more sophisticated medicines, conducted clinical trials, improved its regulatory system and developed “a more diversified, modern system of providing patient care.”

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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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Shkreli seems to be sharing biotech tips from prison

Voice Behind the Wall

Does a prison sentence for securities fraud silence somebody who still thinks he has a lot to say? Martin Shkreli, the former pharmaceutical executive who was sentenced to serve seven years for securities fraud, may be blogging biopharma tips from prison, according to Amirah Al Idrus of Fierce Biotech.

In the combative, "insolent" tone that he used outside of the prison walls, somebody who sounds like Shkreli is writing a blog using TRULINCS, a limited e-mail system employed by corrections systems. He sends the posts to a friend, who then publishes them. In the first of these posts, disseminated July 1, Shkreli said, "I’ll be discussing biopharmaceuticals and other topics. I am not recommending any stocks or making investment advice. This is merely me 'thinking out loud'."

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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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FDA Publicly Shames IQVIA

Gottlieb takes IQVIA to task on Twitter for inaccurate opioid sales data

FDA Commissioner Scott Gottlieb, M.D., has publicly reprimanded IQVIA, a global provider of advanced analytics, technology solutions, and contract research services to the life sciences industry, for providing inaccurate sales data on opioids, including fentanyl.

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FDA's Gottlieb urges more clinical trial participation by women

Female Factor

In a speech acknowledging National Women’s Health Week, Food and Drug Commissioner Scott Gottlieb reiterated the “importance of making sure women are appropriately represented in clinical trials,” according to a blog by Michael Causey on the Association of Clinical Research Professionals (ACRP) website. He commended the U.S. Food and Drug Administration’s (FDA’s) Office of Women’s Health (OWH) and acknowledged that it provided more than $40 million for 371 projects to “inform the FDA’s work about issues specific to women’s health and sex differences” at an agency event May 16 on “The Great Debate: What is Enough…Women in Clinical Trials?”

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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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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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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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