News Archive

A week after the Congressional hearings discussed how the US Food and Drug Administration’s impending regulatory guidelines (expected by October) will impact mobile health apps, aspiring and current digital health entrepreneurs may be rethinking their path. In a report dubbed “FDA 101,” health startup accelerator Rock Health has compiled a handy report to help digital health entrepreneurs assess whether their mobile health apps would be classified as medical devices by the FDA and require 510(k) clearance.

Some of the pressure to clear the waters has come from technology developments that have simply outpaced the regulatory environment. Another is that provisions of health care reform call for making greater use ofremote monitoring, to reduce healthcare costs. Providers are pretty keen to reduce costs where they can as well. Remote monitoring would be particularly helpful when it comes to patients with chronic conditions, such as congestive heart failure or diabetes or both, so they can have shorter hospital stays and care managers can be alerted for any changes in their vital signs.

President Barack Obama’s top healthcare adviser acknowledged on Tuesday that costs could rise in the individual health insurance market, particularly for men and younger people, because of the landmark 2010 healthcare restructuring due to take effect next year.

U.S. Health and Human Services Secretary Kathleen Sebelius said definitive data on costs will not be available until later this year when private health plans become authorized to sell federally subsidized coverage on new state-based online marketplaces, known as exchanges.

Emergent BioSolutions, Inc., a global specialty pharmaceutical company, is generating fresh ideas from Michigan State University students at its Lansing location to improve operations.

Emergent BioSolutions, the Roscommon-based Lear Corp., the Saginaw-based Mistequay Group, Ltd. and approximately five other companies hosted more than 20 undergraduate and graduate business and engineering students on various projects. The initiative is the brainchild of Bill Demmer, the CEO of the Lansing-based Demmer Corp., who donated $5 million to the university to create the Marnie Demmer Center for Business Transformation in late 2011, MLive.com reports.

Sure, New Enterprise Associates is much, much bigger than most venture capital firms. And not all of their deals fall neatly into what we think of as traditional Series A-B-C venture.

NEA invests in private hospital systems in China. It does the occasional PIPE deal. It does big-ticket “growth” fundings that look a whole hell of a lot like private equity.

But NEA is definitely not a private equity firm, as it is here described in The Wall Street Journal.

Tech entrepreneurs will soon find a new home at Innovation Crossroads, the Eastern Shore’s first, full-service business incubator.

Gov. Martin O’Malley and the department of public works recently approved $1.2 million in funding from the Maryland Department of Business and Economic Development for construction of the incubator, the Dorchester County Council announced on Tuesday.

Innovation Crossroads is the planned anchor tenant of the newly constructed Cambridge-based Regional Technology Park.

Two announcements on Monday and Thursday of last week signaled a fundamental strategic and physical shift for biopharma giant AstraZeneca, including the establishment of a new corporate headquarters in a new UK location; the shift of small molecule and biologics R&D to three strategic centers around the world; and an eventual overall headcount reduction of 5,050 between now and the end of 2016.

On Monday, March 18, the company announced its intent to focus the R&D in three places, and to fully implement these plans by 2016:

Many of the changes in the healthcare industry outlined by the Affordable Care Act and HITECH Act call for shifting to healthcare IT for helping physician practices run more efficiently to helping guide clinical outcomes. But the shift from paper based to digital records isn’t just happening among providers. It is carrying over into other industries that healthcare intersects such as pharmaceuticals, medical devices and more robust collaborations with payers.

Andrew Khouri of Quaker Partners, who also mentors Blueprint Health accelerator companies, highlighted some needs in healthcare that are creating interesting investment opportunities and some investment trends at a recent event at the University City Science Center. Khouri acknowledged the “industry is in turmoil” because there’s uncertainty about how the changes will work in practice from the transformation of payment models to setting up health insurance exchanges. But there’s so much momentum to reduce costs and improve outcomes that there is a lot of opportunity.

The Series A crunch has left the realm of Bigfoot and Nessie and is entering the realm of truth, at least according to Fenwick & West.

The law firm released the results of its 2012 Seed Financing Survey today, which found that the number of startups obtaining Series A financing after a seed round declined significantly in 2012.

Why not explore what’s to gain from crowdfunding when there’s nothing to lose? MedStartr’s co-founder and CEO Alex Fair explains.

Alex Fair, Co-Founder & CEO of MedStartr Thinking about joining the crowd? We know, your mother probably told you not to get mixed up with the wrong kind. But according to MedStartr’s Alex Fair, there’s a lot right with the mob mentality growing among today’s entrepreneurs; crowd communities are creating equitable springboards for promising startups. That’s right, we’re talking about crowdfunding. After all, there is strength in numbers— especially from those that come with dollar signs.

A certain song has been running through my head the past few days. Lately, it strikes me as an anthem of sorts for biotech venture capital in 2013.

It’s Fleetwood Mac’s classic break-up song, “Go Your Own Way.”

Allow me to explain. Biotech venture capital has been going through a shakeout now for a couple years, which I’ve written about quite a bit. If you want to be charitable, there are maybe half as many venture firms investing in life sciences companies today as there were five to 10 years ago. There are maybe only a dozen firms left in the U.S. who can say with a straight face that they still are active investors in early-stage biotech startups. It may be harder now than it’s ever been to raise money for a new biotech idea.