Vtesse, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted its drug candidate, VTS-270 for treatment of Niemann-Pick Type C1 Disease (NPC), Breakthrough Therapy designation status. Both the FDA and the European Medicines Agency (EMA) had previously granted Orphan Drug status to VTS-270, which is currently in a pivotal Phase 2b/3 clinical trial.

David Narrow, who graduated from Johns Hopkins University in 2013 with a master's degree in biomedical engineering, has been named one of Forbes magazine's "30 Under 30" notable entrepreneurs in the health care industry.

Narrow, 25, is the CEO of Sonavex, a company that works to improve outcomes for surgical patients by providing clinicians cutting-edge visualization through the use of imaging technology. Sonavex is presently based in North Baltimore and is part of FastForward at Johns Hopkins Technology Ventures, a business accelerator program that supports startup companies.

Accelerator Corporation, a leading life science investment and management firm, today announced the Series A financing of Petra Pharma Corporation to develop small molecule inhibitors for the treatment of cancer and metabolic diseases in alliance with Weill Cornell Medicine. The investors participating in the $48 million Series A investment in Petra Pharma include Accelerator New York's investment syndicate partners: AbbVie, Alexandria Venture Investments, ARCH Venture Partners, Eli Lilly and Company, Harris & Harris Group, Inc., Innovate NY Fund, Johnson & Johnson Innovation – JJDC, Inc., The Partnership Fund for New York City, Pfizer Venture Investments, Watson Fund and WuXi PharmaTech.

Under Armour’s partnership with IBM Watson is the latest in a series of announcements from the consumer health and fitness business that illustrate how the company is thinking about big data applications not only to provide timely, helpful insights on athletic training to a customer base of 180 million but also how to get them to buy more gear.

Nat Turner and Zach Weinberg are young, successful and ambitious. The pair formerly started an ad tech company that Google acquired for $81 million, Invite Media, and for the past two years they've been tackling a much bigger problem: cancer.

Turner and Weinberg launched Flatiron Health after seeing family and friends battle the brutal disease. Flatiron Health is taking a data-driven approach to cancer. It analyzes the results of cancer treatments and turns the information and findings it gathers into software solutions the medical community can subscribe to. Now they've raised $175 million from pharmaceutical giant Roche, which will also be purchasing some of Flatiron Health's software, The New York Times' Katie Benner reports.

A cancer startup just raised millions in a funding round led by a pharmaceutical giant.

That could be the sign of bigger things to come.

Billions of dollars have been made from cancer drugs that inhibit the ubiquitin-proteasome system, otherwise known as the cellular garbage dump. By turning off the cell’s garbage disposal system, these drugs enable proteins to build up to a point where malignant cells commit suicide.

Medigene AG (Frankfurt Stock Exchange: MDG1) announced today that the Supervisory Board has resolved important changes and additions to the senior management team to better align the organisational structure with the strategic goals of the company in immuno-oncology and to expand Medigene's presence in the United States. The Supervisory Board has appointed Prof Dolores Schendel as the new Chief Executive Officer of the company, with effect from 1 February 2016. Prof Schendel joined Medigene's Executive Board as Chief Scientific Officer in May 2014. She was co-founder of Trianta Immunotherapy GmbH (now Medigene Immunotherapies GmbH), which was acquired by Medigene at the beginning of 2014 and whose platforms are the basis of Medigene's scientific strategy.

Germantown startup NextCure Inc. has raised $67 million in Series A financing for a plan to commercialize the work of a scientist credited with discovering a key pathway for how cancer drugs harness the immune system, it was announced Wednesday.

Many articles these days talk about reasons why companies should consider innovation as a core discipline.    A quick Google search on “why innovate” produces 23,600,000 results.  There is a plethora of opinions regarding innovation and why it is important.  Competition is usually one of the reasons but not the only one, especially when looking how the world will be in the near future.  Innovation becomes a critical survival skill when looking at predictions for how we will live, work, and communicate as early as 2020.

At the end of every year, Edge reaches out to the smartest people on the planet and asks them a single question in an attempt to find the ideas and concepts that are changing the world of science. This year’s two-part question was: “What do you consider the most interesting recent [scientific] news? What makes it important?”

Baltimore, by a curious mixture of geographic positioning, educated talent, proximity to pork, and determined capital, is poised to become a crucial part of the East Coast technology cluster.

"BioIT Solutions of Silver Spring, Maryland has been selected as one of the 50 Most Valuable Tech Companies by Insights Success magazine in their December issue. We are the only company in the list focused on the biotechnology industry."

Do you work in Greater Washington and love your employer? Then you probably work at a federal agency. We asked Glassdoor, a job-recruiting site that allows employees to anonymously grade their company and their CEO, to crunch the numbers to find out who the most-liked employers are in Greater Washington. We recently compiled a list of most-liked CEOs, too.

The crisis in soaring drug prices has produced not merely a new class of public enemies to skewer -- step forward, Martin Shkreli! -- but the best evidence yet that the nation's healthcare regulatory priorities are out of whack.

AT&T next month will open a center focused on digital health innovations within the Texas Medical Center's state-of-the-art Innovation Institute, the communications giant announced on Tuesday.

Tuesday, January 12, 2016 2:00 pm

When developing a new drug or technology, innovators are generally focused on achieving regulatory approval. But often they don’t spend enough time considering how the product will be paid for once it is approved. This NHLBI Small Biz Hangout will focus on basic components of reimbursement that every innovator needs to understand—coverage, coding, and payment. Attendees will hear guidance on how to implement an effective reimbursement strategy while their product is still in development.

What is technology transfer / business development and what are the career opportunities in the field? What are the skills required and how does one acquire them? How can an scientist start a non-traditional career such as this? These are the questions to be answered in this presentation from two former bench scientists from the National Cancer Institute.

Barbara Crews, assistant executive director for community relations at the Johns Hopkins University Montgomery County Campus, has been appointed to an executive committee position with the Gaithersburg-Germantown Chamber of Commerce board of directors.

Crews will serve a yearlong term as vice chair for member recruitment and retention. In this role, she will help the chamber recruit new members and retain existing ones. She will help existing members get the most out of their memberships by engaging them in chamber activities.

Facebook has been making tentative steps in the health tech realm. I’m not referring to Mark Zuckerberg’s philanthropic ambitions. But the social media network has demonstrated an interest in some diverse areas from genomic testing to public health. There’s even more going on with its Internet.org division but the company has been pretty tight-lipped about new developments on this front with most information on healthcare projects coming from entrepreneurs rather than the technology company. Here are a few areas that could grow in 2016.

Medical technology is slated to be a $40 billion market in India by 2025. But it’s largely ignored, says Siraj Dhanani, founder of InnAccel, India’s first medical technology incubator.

“It’s a market that’s suboptimally served, and there are global models for med-tech innovation that can be successfully implemented in India,” he says, seated in his Bangalore office.

The 2015 return of 12.3% for the NASDAQ Biotechnology Index ETF makes the biotech sector one of the market's best-performing baskets this year, and the returns of the five best biotech stocks in the space were downright mind-boggling. All five of these biotech companies boast billion-dollar market caps, and each has seen its shares post eye-popping returns of nearly 200% or more this year. Let's find out why.

Here are three things we can agree on. Some predictions are good. Some predictions are bad. Most predictions are wrong.

Stephanie Baum, Meghana Keshavan and I spent the last fews days spouting off on the kind of deals we think should happen in healthcare in 2016. Afterward, we polled the full MedCity News reporting staff and incorporated feedback from social media to rank these healthcare M&A predictions from completely loony tunes and to actually having some merit.

As the year draws to a close, I want to reflect on FDA’s many accomplishments in these previous 12 months, the last nine of which it has been my pleasure to serve as Acting Commissioner. FDA has broad responsibilities – indeed, we are tasked with overseeing products that account for about 20 cents of the consumer dollar — so we work on a wide range of topics in any given year. In this and two additional blog posts over the coming days I’ll cover some of our key accomplishments in 2015. Each blog will examine a different area of FDA’s work. This first post will focus on medical product innovation – our role in making safe, effective and innovative products available to patients who need them.

Older adults can be the focus of emerging digital health firms.   Kudos to Aging 2.0 and its effort to find an attract startups that can help older adults.  So much of the Digital Health landscape acts, just like Apple, agnostic about age, avoiding the chance to shape a market message for products that clearly could benefit (and in Apple's case, do benefit) older adults. Even more striking is the percentage of health care costs that are actually spent on older adults.  For other age-indifferent health-related see Connected Health Symposium and mHealth Summit for too many examples. But Aging 2.0 has a different agenda than these -- welcoming the messaging about age and inviting companies that these other events might (or might not) welcome in LivePitch events. Here are a few of the companies in the Digital Health space pitching for pilots at Aging 2.0. Material is from the companies' websites: 

Most people would agree that it would be better to prevent cancer, if we could, than to treat it once it developed. Yet economic incentives encourage researchers to focus on treatment rather than prevention.

The way the patent system interacts with the Food and Drug Administration’s drug approval process skews what kinds of cancer clinical trials are run. There’s more money to be made investing in drugs that will extend cancer patients’ lives by a few months than in drugs that would prevent cancer in the first place.

Bethesda-based Northwest Biotherapeutics Inc. is raising $12.6 million in new funding as part of a direct offering to health care-focused investors, according to a company announcement.

We are at the beginning of a transformation in human health, treating diseases in ways that we could only speculate about in the recent past. While biology isn’t quite engineering (yet), biotech has become a technology-based, high-growth, high-wage space, all while working to cure cancer. Doing well by doing good. It is more than a business.

As we look back on the medtech developments of 2015 there’s definitely a sense that we’re living through revolutionary times. Nearly every day exciting and fascinating technologies are being unveiled by small and large companies, universities, and even tiny independent groups. Empowered by high-powered computers, 3D printers, and other technologies, researchers, scientists, and engineers are coming up with novel solutions to age-old medical problems. Everything from treating gunshot wounds to how fetuses inside the womb are monitored is going through change thanks to technologies developed by thousands of independent minds around the world.

Biologists often emphasize how little anyone really knows about the brain, the genome, and the mechanisms behind effective drugs. But this year their tune changed as diverse technologies–gene editing, stem cells, cloning, and DNA databases–coalesced into an immensely powerful toolkit for manipulating life. The message in 2015 seemed to be: “We can do anything.”

The Executive Director is a full-time, benefited position which serves as CEO of the organization, reports to the Board of Directors, and is responsible for all operational aspects of organization including facilities, staff, day-to-day business and financial functions.  The position also requires providing entrepreneurial support and advice to FITCI clients.  The position requires normal weekday core hours and participation at evening/ and some weekend events.  The salary is negotiable.

Like many CEOs, Peter Greenleaf knows that disagreements will inevitably arise among smart, driven executives. He says the best leaders serve as aligners who bring people together to pursue a shared vision, even if they hold different views on how to get there.

Emergent Biosolutions has announced the selection of its spin-off company’s board of directors. The spin-off company, Aptevo Therapeutics Inc., was announced by the Emergent in August. According to an earlier report from Bio Prep Watch, the company will be focused on therapeutics development in oncology and hematology. 

Maryland-based Emergent BioSolutions Inc. (NYSE: EBS) will spin out cancer research group Aptevo Therapeutics into its own publicly traded company to be based in Seattle, the company announced this week. The tax-free spinoff will happen in mid 2016, the company said.

The Food and Drug Administration granted marketing approval to AstraZeneca’s gout medicine Zurampic. Zurampic was approved as combination therapy with a xanthine oxidase inhibitors (XOIs) for the treatment of hyperuricemia — an excess of uric acid in the blood — associated with gout in patients who have responded to XOIs alone.