News Archive

The American Telemedicine Association (ATA) today released an update to two critical state policy reports which identified gaps in coverage and reimbursement, and physician practice standards and licensure.

“After ATA issued the State Telemedicine Gaps Reports last September, many state regulating bodies responded by looking at how their laws and regulations impact healthcare delivery in their state,” said Jonathan Linkous, CEO of ATA. “As a result of state actions across the nation, ATA reevaluated the indicators for each state and issued new reports.  As before, we anticipate that these reports will serve as an incentive to increase the utilization of telemedicine to improve the accessibility, affordability and quality of healthcare.”

With molecular diagnostics projected to grow to a $7.6 billion industry by 2017 (Kalorama) and surpass $8 billion by 2020 (Grand View Research), the field is seeing growing interest from both corporate giants and smaller specialized companies.

On the corporate side, the largest players include such familiar names as Roche, Qiagen, Becton Dickinson, and Abbott, as well as more recent arrivals such as Hologic, Grifols, and bioMérieux. Yet the past few years has also seen a growing number of smaller companies devoted to MDx by focusing on specific technologies or disease areas (especially cancer).

U.S approval of GlaxoSmithKline’s newest respiratory inhaler continues the global drugmaker’s shift from the blockbuster drug Advair to a suite of drugs that will be assembled at the British company’s Zebulon manufacturing site.

GSK said Thursday the company and business partner Theravance won approval from the Food and Drug Administration to market Breo Ellipta for asthma. The drug had been approved in 2013 for chronic obstructive pulmonary disease, but it failed to win approval for sale to minors as GSK officials had hoped.

Emergent BioSolutions Inc. (EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved IXINITY(R) [coagulation factor IX (recombinant)], an intravenous recombinant human coagulation factor IX therapeutic for the control and prevention of bleeding episodes and for perioperative management in adults and children, >=12 years of age, with Hemophilia B. Hemophilia B is a bleeding disorder caused by a mutation on the factor IX gene resulting in a deficiency of clotting factor IX in the blood, which controls bleeding.

Teachers’ unions provided a lot of the muscle to get the Affordable Care Act passed, but now they’re working to overturn one portion of the law that stands to affect their members: the law’s excise tax. 

The National Education Association on April 29 signaled its support for a bill introduced by Rep. Joe Courtney, D-Conn., that would repeal the tax, which goes into effect in 2018.

Having secured a funding boost for the National Institutes of Health in the 21st Century Cures legislation, House Democrats now say the Food and Drug Administration would be ill-equipped to handle the new burdens under the bill without more resources.

Rep. Frank Pallone (D-N.J.), the ranking member of the House Energy and Commerce Committee, raised the matter during a hearing Wednesday on the latest iteration of the legislative package, which is intended to accelerate the pace of innovation in medical drug and device development.

U.S. legislators recently released a discussion draft of the medical innovation bill known as the 21st Century Cures Initiative. The legislation aims to hasten the discovery, development, and delivery of new medical devices and drugs, particularly for the treatment of thousands of diseases for which there are no cures.

The proposals in the draft include ways to revamp how agencies such as the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) foster and regulate medical innovation in the U.S.

District investor group NextGen Angels has raised $1 million from 24 of its members to finance expanding to two more cities.

The local angel group, which currently boasts 85 members, has a similar presence in New York City and very recently set up a Boston location. CEO Dan Mindus told me Austin and Chicago are the next two cities on the list, with 10 more cities slated in the next 12 to 18 months. Those include Atlanta, Philadelphia, Seattle, Portland and San Diego.

Gaithersburg company to use funds to add staff and upgrade equipment to meet demand

Angela Graham, President and CEO, accepts check from DED’s Valerie Fremont and Gene Smith Quality Biological, Inc., an industry leader in manufactured ready-to-use biological research tools, has been awarded an EDF Grant by the Montgomery County Department of Economic Development (DED) to support the expansion of their fulfillment operations. The award, funded from the Montgomery County Economic Development Fund (EDF), will be used to upgrade and modernize equipment needed to meet requirements from local and regional customers. The company, headquartered in Gaithersburg, plans to add 10 new jobs as part of the expansion.

Bungalow Insurance won the $30,000 Perlman Grand Prize of the 2015 Wharton Business Plan Competition. The prize was awarded at the Wharton School’s annual Venture Finals on April 30, 2015, where student finalists received more than $128,000 in combined cash prizes and in-kind legal/accounting services.