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.

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.

Drugmaker says racism is not caused by Ambien

Sanofi on Side Effects

Drugmaker says racism is not caused by Ambien

The fact that Roseanne Barr made waves by tweeting a negative slur about a member of the Obama administration and then blaming a sleep drug for the lapse is old news. The well-crafted response of the company that makes the drug is a public relations move well worth repeating.

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.

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?”

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.

Shire and Takeda Achieve Merger

Roller Coaster Ride

Japan-based drugmaker Takeda tentatively agreed to buy Ireland-based rare disease biopharma company Shire for 46 billion pounds ($64 billion) in one of the largest pharma deals to date, Reuters reported. According to the story, “Takeda has offered the equivalent of 49 pounds in cash and stock for each share of Shire, almost 25 percent more than Tuesday's closing price. Shire Plc said Wednesday that it is prepared to recommend the deal to shareholders, pending agreement on other terms.”

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

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.

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.

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.