Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received FDA approval for the cobas® HBV and cobas® HCV viral load tests, the first assays approved by the United States Food and Drug Administration (FDA) for use on the cobas® 6800 and cobas® 8800 Systems. The fully automated systems offer the fastest time to results, the highest throughput and the longest walk-away time available among automated molecular platforms, providing laboratories both improved operating efficiency and flexibility to adapt to changing testing needs. The new tests are the next generation of Roche's viral load tests, which clinicians use to manage the treatment of patients chronically infected with hepatitis B or hepatitis C virus.

On October 8, 2011, I said goodbye to my loved ones and didn’t know if I would ever see them again. 15 hours later I was in the ICU having become the 11th person in the United Kingdom to undergo an intestinal transplant at The Churchill Hospital, Oxford.

As part of transplant I had an ileostomy. This is where part of the intestine is brought to the outside of your body and your bodily waste is collected in a pouch known as an ostomy pouch. You lose control of the very thing you take for granted. On top of that, everyone wants access to output data and the only way of doing this is manually emptying into a jug. There had to be an alternative.

MedImmune, the biologics research and development arm of AstraZeneca, recently joined the Human Vaccines Project to develop vaccines and immunotherapies for infectious diseases and cancer, according to a press release.

The Human Vaccines Project aims to accelerate vaccine development by deciphering the human immune system with the support of leading academic research centers, governments and nonprofit groups.

Entrepreneur Office Hours: Get Answers Now! Two Locations: College Park and Baltimore  

Free, Open Entrepreneur Office Hours for University of Maryland Students, Faculty and Staff, and Regional Entrepreneurs with Bio or Tech-Based Startups or Ideas  

Get answers now from experienced entrepreneurs and legal/business professionals on how to build a successful startup company. Receive free and impartial advice, brainstorm business strategies, investigate funding opportunities and learn about the vast resources available to entrepreneurs.

The California Life Sciences Institute (CLSI), the non-profit partner of the California Life Sciences Association (CLSA), today formally joined forces with the Bay Area BioEconomy Initiative (BAB), a non-profit organization committed to strengthening the life science economy of the San Francisco Bay Area by fostering innovation and collaboration.

Founded in 2013, under the leadership of Tony Coles, Una Ryan, and Matthew Hudes, BAB has worked with industry, universities, investors, medical centers, health insurers and payors, high-tech companies and government to advance several key strategic imperatives to support the Bay Area life sciences industry. As a result, BAB has emerged as a new model for cross-disciplinary collaborations.

Even more than usual, fragmented and redundant digital healthcare innovation threatens to frustrate the innovation ecosystem. Dave Francis of RBC Securities put it well: “There are a lot of zombie digital health start-ups that get $1.5 million and a customer from a regional health system, and go no further.” He spoke at the October, 2015 Health 2.0 Conference.

The start-ups whose pitches I attended at Health 2.0 illustrate this point well. Out of about 35 pitches that I attended, close to half were pursuing markets that I know several other companies are also pursuing, including a dozen or so that overlapped with other companies presenting at the conference, e.g.:

PURPOSE: 65% of registration proceeds will go towards the ROAR campaign to renovate vacant & abandon Baltimore homes for families, in need.

WHEN: Tuesday, October 20, 2015 | 6:30pm-8:30pm

WHERE: Johns Hopkins East, 1101 East 33rd Street, Baltimore, Maryland 21218 | 3rd Floor Conference Room.

PRESENTER: Dr. Jayfus Tucker Doswell | President/CEO Juxtopia

When it comes to capturing venture capital funding Maryland tops the region in both deals and dollars.

In a ranking of all 50 states and D.C., Maryland ranked No. 11 in venture capital funding in the third quarter of 2015. It ranked No. 7 in its share of nationwide deals during the same time.

The U.S. Department of Commerce’s Commercial Service is coordinating participation in the Hannover Messe, the world’s largest Industrial Trade Fair, to be held in April 25-29, 2016 in Hannover, Germany. This year, the United States is the official partner country for the first time and therefore will offer substantial visibility to U.S. based exhibitors who participate in any of the five trade shows, including one for Research and Technology, as well as an Investment Pavilion.

The Research & Technology trade show would be a great platform for U.S. Exhibitors, including Large and Start-up Companies, Academia, Technical Institutions, and Labs, to present their research activities in these fields .

AstraZeneca and Peregrine are expanding their ongoing onco-immunotherapy pact to allow for a Phase II trial of an experimental lung cancer combination treatment.  

The companies said they will test a combination of Peregrine’s phosphatidylserine-targeted immune-activator bavituximab and AZ’ anti-PD-L1 immune checkpoint inhibitor durvalumab (MEDI4736) in a global Phase II study in patients with previously treated squamous or non-squamous non-small cell lung cancer. 

M Square, the University of Maryland Research Park, won this year’s Association of University Research Parks’ Outstanding Research Park award.

The award ceremony took place earlier this month during the AURP Annual Awards of Excellence at the Buffalo Niagara Medical Campus in New York.

Silver Spring-based United Therapeutics Corp. on Thursday announced its board had authorized the repurchase of up to an additional $500 million worth of its common stock, for as long as a year, starting Jan. 1. Purchases may be made in the open market or in privately negotiated transactions from time to time as determined by the ...

An entrepreneur as well as a scientist, Kunal Parikh has spent years developing drug-delivery platforms to improve patient treatment. He plans to spend the next year pursuing patents for these technologies; submitting his research for publication in scholarly journals; visiting hospitals and manufacturing plants to conduct implementation research; and continuing to lead and mentor the team of scientists, engineers, and clinicians who work alongside him.

One year doesn't seem like enough time.

The kind of opportunity that technology and energy markets once offered is beckoning investors to property near biotech clusters. Emerging from the recession, technology and energy markets commanded the attention of commercial real-estate investors that wanted to tap into improving occupancy and rental rates largely absent elsewhere.

A similar dynamic is germinating in biotech clusters, which are typically marked by a high concentration of life-science companies near academic research institutions.

Trade-Ideas LLC identified Sucampo Pharmaceuticals ( SCMP) as a "dead cat bounce" (down big yesterday but up big today) candidate. In addition to specific proprietary factors, Trade-Ideas identified Sucampo Pharmaceuticals as such a stock due to the following factors:

Join us Nov. 19 for the 16th annual Bioscience Day at the University of Maryland, where we'll explore "Systems Biology: Advancing Life Sciences and Medicine."

Registration is free and lunch is provided.

Johns Hopkins researchers on Thursday unveiled a new medical research app that could help them better detect and manage epileptic seizures. The free app, called EpiWatch, is designed for the Apple Watch and iPhones. The app will collect data from patients before, during and after a seizure. Researchers are hopeful that after collecting data for one or two years, they will be able to develop an app that can detect most seizure types and generate an alert to call for help, if needed.

Malvern, Pennsylvania-based Galera Therapeutics, a biotech company focused on treating cancer patients, has closed $37 million in Series B funding. Novo Ventures led the round with participation from previous backers New Enterprise Associates, Novartis Venture Fund, Correlation Ventures and Galera Angels. In conjunction with the funding, Dr. Thomas Dyrberg, a managing partner of Novo Ventures, has been added to Galera’s board of directors.

People can lose their hearing for a variety of reasons, from age to loud noises, but there’s one thing they all have in common. There are no drugs to help them. Several companies have formed in recent years to address this gap, and now there’s another coming to the party a bit late, but with deep pockets—a new startup called Decibel Therapeutics, which is embarking on a broad effort to figure out what makes us go deaf in the first place.

Brian Stansky is the new director of Johns Hopkins’ incubator program for startups, according to a letter sent to colleagues from Christy Wyskiel, senior advisor to the president of Johns Hopkins on entrepreneurship and tech transfer. Nina Urban was appointed as associate director of the program.

Stansky served as interim director of the program for the last two months. He previously worked for 13 years as managing director at Integral Capital Partners, and oversaw health, sciences and media/telecom portfolios at T. Rowe Price.

Join REDI on October 22nd from 8:00-10:00am for the second edition of the Commercial Broker Breakfast (CBB). The CBB event combines networking and a mini trade show that includes local architects, bankers, contractors, interior designers, and other related vendors.

This year's event is highlighted by a discussion with Benjamin Wu, Deputy Secretary for the Maryland Department of Commerce.

AstraZeneca's ($AZN) MedImmune is joining the likes of Vanderbilt University and GlaxoSmithKline ($GSK) as a member of the Human Vaccines Project, the company announced Tuesday.

The public-private partnership, incubated at the International AIDS Vaccine Initiative (IAVI), aims to accelerate the development of vaccines and immunotherapies against major infectious diseases and cancers "by decoding the human immune system."

Resveratrol for the win: Red wine drinkers had better levels of HDL cholesterol, better sleep and lower cardiometabolic risk factors

Why Two Minutes of Lost Footage From 'The Civil War' Documentary… Promoted Why You Should Be Getting Your Wine Online Recommended by Alcohol is the Goldilocks of the nutrition world. Too much can be destructive to your health, raising your blood pressure and your risk of developing several kinds of cancer. Too little may hold you back from some of the benefits that moderate drinkers enjoy, like lower incidence of cardiovascular disease, mortality and type-2 diabetes.

Large pharmaceutical companies are often on the lookout for small strategic acquisitions of companies that have a promising pipeline candidate in their portfolio. Sometimes, acquiring a company with a promising early-stage candidate makes sense instead of developing a product from scratch, which involves a lot of time.

Swiss oncology major Roche RHHBY is all set to acquire a privately held biotechnology company, Adheron Therapeutics. Based in Berkeley, CA, Adheron has developed a revolutionary technology that disrupts cell adhesion to treat a variety of inflammatory and autoimmune diseases, such as rheumatoid arthritis (RA) and fibrotic diseases through a cell surface protein called Cadherin-11.

23andMe has raised a substantial $115 million in a series E round led by Fidelity Management and Research Company, with participation from new investors Casdin Capital, WuXi Healthcare Ventures, and Xfund, as well as existing investors such as Google Ventures.

The personal genomics and biotechnology company was founded in 2006 by Linda Avey and Anne Wojcicki, wife of Google cofounder Sergey Brin. The Mountain View, Calif.-based company had already raised $126 million prior to today’s announcement, and boasts a slew of big-name investors, including Google, Google Ventures, Sergey Brin, and Yuri Milner.

The Association of Public and Land-grant Universities (APLU) today named six public research institutions as finalists for its third annual Innovation & Economic Prosperity (IEP) University Awards. The winners will be announced on November 17 at the association’s annual meeting in Indianapolis. The finalists — Auburn University, Clemson University, Ohio University, University of Illinois, University of Maryland, and University of Minnesota — are competing for four different awards that recognize different components of economic engagement. The award categories include talent, innovation, place, and connections.

In a move that takes concierge medicine to a whole new level, human genome pioneer J. Craig Venter on Tuesday unveiled a venture that combines whole genome sequencing with advanced clinical technologies to provide comprehensive health exams for self-paying customers.

The venture, called Health Nucleus, was formed as part of Human Longevity Inc., also known as HLI, the company Venter founded 19 months ago (with an initial $70 million in venture funding) to provide whole genome sequencing and other diagnostic services.

MedImmune is the newest member of the Human Vaccines Project, which will help to accelerate the research and development of vaccines and immunotherapies for infectious disease and cancer.

Incubated at the International AIDS Vaccine Initiative (IAVI), the Human Vaccines Project is an ambitious new public-private partnership seeking to transform the future of global disease prevention and treatment by solving the primary scientific obstacles impeding the research and development of new vaccines and immunotherapies. Endorsed by 35 leading vaccine scientists, the Project brings together top academic research centers, and government, non-profit and industry research and development efforts into a global consortium.

A $300 million worldwide licensing agreement announced last week between Immunomic Therapeutics and Astellas Pharma to develop treatment for a wide range of allergic diseases, including peanut allergies, is the largest deal ever to come out of Johns Hopkins Technology Ventures, the patent, licensing, and technology commercialization arm of the university.

The agreement, first announced Thursday night, centers on the LAMP-vax technology, which was originally developed by Thomas August, Drew Pardoll, and others at the Johns Hopkins University School of Medicine and licensed in 2006 to Immunomic Therapeutics, a biotech company based in Hershey, Pennsylvania.

Can aging be slowed by using gene therapy to make permanent changes to a person’s DNA?

One Seattle-area woman says she has tried exactly that. Her claim has entangled some high-profile American academics in a strange tale of do-it-yourself medicine that involves plane flights to Latin America, an L.A. film crew, and what’s purported to be the first attempt to use gene therapy to forestall normal aging.

DNA doesn't just coil in the iconic double helix immortalized in every high school biology textbook. It also loops into a menagerie of fantastical shapes, new research finds.

By revealing the hidden shape of DNA, the new insights could provide a more detailed look at the workings of drugs such as chemotherapeutic agents, which interact with DNA.

Attracting mid- to large-sized medical device companies through established innovation hubs is the biggest key to growing Baltimore into a major medical device technology sector, according to a report released today by the Maryland Technology Enterprise Institute (Mtech).

"Baltimore already has many of the pieces in place to support innovation hubs and a thriving medical device community," said Martha Connolly, director of Mtech Baltimore. "This study is important because we believe Baltimore is well-positioned to be a leading center for medical devices. The expertise of the University System of Maryland and Johns Hopkins University in engineering and medicine provide great capabilities for this sector." 

WHEN: Tuesday, October 20, 2015 | 6:30pm-8:30pm WHERE: Johns Hopkins East, 1101 East 33rd Street, Baltimore, Maryland 21218 | 3rd Floor Conference Room.

Learn how to secure National Institutes of Health SBIR/STTRs for your high-tech bio-innovation.

Dr. Doswell lead JUICE Money wins for high-tech minority companies and HBCUs such as: 3 NIH SBIR/STTR grant awards in 2015.

• 3 NIH SBIR/STTR grant awards in 2015.
• 1 DOD RIF grant award in 2015.
• 1 CASIS grant award for testing innovation onboard the International Space Station in 2015.
• 1 Maryland Innovation Initiative (MII) Phase II award for Morgan State University in 2015.
• 1 Maryland Space Grant Consortium Award for Morgan State University in 2015.
• Secured Maryland TEDO awards.
• Secured a Maryland Industrial Partnerships (MIPS) award
• Secured NSF STTR Phase I/II awards.
• Helped fund the Robotics Technician Program at Baltimore City Community College

Nominations are now being accepted for the 2016 FLC awards. One of the most coveted honors in the technology transfer field, the FLC awards have been presented to over 200 federal laboratories since their inception in 1984. To reflect the diversity in scope and number of technology transfer efforts undertaken by federal laboratories and their partners, seven categories of awards will be presented.

CareFirst BlueCross BlueShield will award $3 million to nonprofits or government organizations to develop new programs using telemedicine to improve health care access in the Maryland, Northern Virginia and D.C.

CareFirst’s request for proposals is looking for innovative programs that can address gaps in access to telemedicine services. The money will be awarded to programs over the next three years.