U.S. health regulators on Friday said they have granted accelerated approval to Roche Holding's drug for advanced lung cancer in patients with a specific genetic mutation.

The drug, alectinib, to be sold under the brand name Alecensa, was approved to treat patients with advanced ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate, treatment with Pfizer's Xalkori.

Becton, Dickinson and Company (BDX), or BD, operated under three business segments until 2014. It then underwent organizational restructuring, effective October 1, 2015, to better align its business model to the strategic vision and goals of the company. Consequently, the company operates under two business segments: BD Medical and BD Life Sciences.

Sweden’s eHealth Agency (eHälsomyndigheten) selected woman-owned Get Real Health's electronic personal health patient engagement platform to help its citizens access and manage their own health data.

Get Real Health, a Montgomery County, Maryland health IT pioneer, is partnering with Swedish technology consulting company Capgemini Sverige AB to bring a complete patient engagement solution, called HälsaFörMig, to Sweden’s publicly owned Swedish eHealth Agency. Capgemini will run the service, while Get Real Health’s two core products, InstantPHR® and CHBase™ (Connected Health Base), will provide the consumer health data platform.

In terms of spending, Johns Hopkins University has maintained the top spot in a ranking of all institutions receiving federal money for the 36th consecutive year.

In a statement Wednesday, the university said the National Science Foundation, National Institutes of Health, NASA and other agencies spent $1.95 billion on research at Hopkins, including at the Johns Hopkins Applied Physics Laboratory in Laurel.

In a tiny office in a high-rise building in the Rockville Towncenter that houses the Innovation Center, two Montgomery County men toil to unlock what they believe will be the future of the way all of us will consume entertainment.

"This is the next revolution, absolutely," says Sergio Reyes.

Springboard’s Health Innovation Hub is a year-long program for women-led healthcare and life science companies seeking seed and growth funding to fuel expansion and product development. Companies selected for one of the program’s two tracks – Pharma and Health IT/Devices – will be matched with a team of relevant, targeted advisors and participate in several in-person and virtual workshops and presentation sessions throughout the year that provide exposure to influencers, active investors, and potential strategic partners.

Roche will join Pieris Pharmaceuticals in an up-to-CHF 415 million ($409 million) cancer immunotherapy collaboration designed to develop new drug candidates based on Pieris’ Anticalin® technology platform against an undisclosed target.

Under its first partnered immune-oncology program, Pieris will discover, characterize and optimize Anticalin-based drug candidates. Pieris will then work with Roche to assess various drug formats against the target, and advance them through preclinical development.

The University of Maryland, Baltimore has given a Baltimore-based biotech company worldwide, exclusive licensing rights to the university's patents and technology to develop a faster, cheaper way to identify dangerous pathogens, University of Maryland Ventures said Wednesday.

Biotech firm Pataigin LLC, founded by university researchers, has created a library of pathogens with chemical barcodes that can be used to identify types of infection. Infectious diseases are responsible for more than 18 million deaths a year, but the technology to detect potential infectious agents is slow, expensive and labor intensive.

Johns Hopkins University spent more on research and development than any other high education institution for the 36th year in a row.

The Baltimore institution spent a total of $2.2 billion in fiscal 2014 on research and development — nearly twice the amount as the second highest spender, University of Michigan, which spent $1.3 billion, according to an annual report by the National Science Foundation.

Roche, a leader in research-focused healthcare, announced regulatory clearance to finalise acquisition of Kapa Biosystems, Inc. (Kapa), a privately-held company headquartered in Wilmington, Massachusetts. Kapa Biosystems is a provider of genomic tools in the life sciences sector that employs proprietary technologies to optimize enzymes for next-generation sequencing (NGS), as well as polymerase chain reaction (PCR) and real-time PCR applications.

Illumina, Inc. (NASDAQ:ILMN) announced today that Illumina Accelerator—the world’s first business accelerator focused solely on creating an innovation ecosystem for the genomics industry—has selected four new investments from a competitive pool of highly qualified applicants to be a part of its third funding cycle.

“Illumina Accelerator is pleased to have such a promising group of startups join our growing genomics community,” said Mostafa Ronaghi, Ph.D., Illumina’s Senior Vice President and Chief Technology Officer and co-founder of Illumina Accelerator. “We’re here to provide access to our best-in-class sequencers, a support team of genomics professionals and entrepreneurial coaches, and the tools each of these startups need to advance breakthrough applications in genomics.”

The selected startups for the third funding cycle are:

If you are interested in submitting a NSF Innovation Corps Sites Program (I-Corps Sites) proposal, send an abstract no more than three pages in length to This email address is being protected from spambots. You need JavaScript enabled to view it. by the internal deadline of Tuesday, May 10, 2016 at noon. Follow Illinois Tech’s guidelines for internal competitions available here.

Institutional Limit: One Internal Deadline: Tuesday, May 10, 2016 at noon Full Proposal Deadline Date: Tuesday, June 14, 2016

The digital revolution continues to transform healthcare fundamentally, and many people believe that a tipping point is finally within reach. In 2014, digital health investments topped $6.5 billion, compared with $2.9 billion a year earlier.

The critical question now for pharmaceutical companies is how to stay ahead of these changes. To answer it, we sought to learn the trends and implications of digital health by interviewing 20 thought leaders across a variety of segments, including analytics, biotech, data, pharma, providers, technology, and venture capital. 

Baltimore will be well-represented at a “Shark Tank”-inspired event focusing on teacher professional development this week.

The virtual competition, organized by Edsurge and the Gates Foundation, is set for 8 p.m. on Tuesday, Dec. 8. Three companies will pitch four educators. But it’s the audience who decides the winner.

Virginia’s Mach37 cybersecurity accelerator gained an important endorsement this week with a four-year platinum sponsorship from General Dynamics Mission Systems.

The agreement will help further Mach37’s public-private partnerships that leverage Virginia’s university, industry and government cybersecurity assets to produce new innovative products and companies.

University of Maryland (UM) Ventures and Pataigin, LLC, announced today that the University of Maryland, Baltimore (UMB) has granted Pataigin worldwide, exclusive licensing rights to UMB patents and technology to develop a method to quickly and accurately identify dangerous pathogens. Robert Ernst, Ph.D., professor of microbial pathogenesis at University of Maryland School of Dentistry, and David Goodlett, Ph.D., professor of pharmaceutical sciences at University of Maryland School of Pharmacy, are patent inventors. The University of Washington is also a co-owner on one of the patents Pataigin (the Irish word for pathogen) is licensing. Erik Nilsson, who has headed software and mass spectrometry companies for nearly 20 years, will serve as Pataigin’s CEO and President.

Infectious diseases remain a major global killer, responsible for 18 million deaths worldwide every year. And yet, detecting potential infectious agents remains hampered by current technological methods that are slow, require cell culture and are expensive and labor-intensive. The licensed technology exploits the presence of lipids in the outer membranes of pathogens that are unique to each pathogen strain. A “barcode” for each lipid coating is created that allows laboratory staff to quickly use available mass spectrometry methods to identify specific strains of bacteria, fungi and yeast that cause disease. The technology will allow pathogen identification directly from tissues like blood, urine, and wounds, without the need for cell culture. And importantly, the technology can differentiate between drug-susceptible and drug-resistant variants; thereby allowing for quicker medical treatment decisions as well as containment of dangerous pathogens.

Biopharmas come and go, but the places to find jobs remain largely the same 10 regions highlighted by GEN last year and in 2013. The cornerstones of their success are hardly secrets: they include strong research universities, anchor biopharmas, younger startups, and networks that connect those budding businesses to expertise and, especially, capital.

Physician entrepreneurs come in several basic flavors and medicine needs to change to make room for them.

The young and the restless  These are the millenials and others who are medical students, residents, fellows and those who have been in practice less than 5 years. While I think stereotyping generations is stupid , work-life balance, debt repayment and lack of loyalty to an employer or career seems to figure into the psychographic calculus

GlycoMimetics, Inc. (NASDAQ: GLYC) announced that preclinical data on its novel E-selectin antagonist drug candidate GMI-1271, shared via an oral presentation at the 57th American Society of Hematology (ASH) annual meeting, showed the compound could be used in combination with G-CSF (filgrastim) to mobilize and enrich progenitor T cells known as T memory stem (Tscm) and T central memory (Tcm) cells, which provide improved reconstitution and persistence. The company also announced that the first healthy participant has been treated with an intravenous (IV) formulation of GMI-1271 in a Phase 1, multiple-dose clinical study to evaluate the investigational drug’s ability to mobilize and enrich Tscm or Tcm cells. In addition, the trial will evaluate safety and tolerability of the drug, alone and in combination with filgrastim, a treatment for neutropenia that is approved by the U.S. Food and Drug Administration (FDA).

Google Life Sciences got a rebrand today: It’s now called Verily. A new site is up as well to illustrate the company’s emphasis on wielding technology “to create a true picture of human health” – and “effecting prevention.”

Just as Google formed parent company “Alphabet” earlier this year, it’s clearly sticking to a literary theme with “verily,” which is a florid, Shakespearean way to say “truth, truly, confidently.”

Paris-based venture capital firm, Sofinnova Partners, has closed its Sofinnova Capital VIII fund with €300 million ($324 million) that will be dedicated toward adding 15 to 20 more biotech companies to its portfolio, two thirds of which will reportedly be in Europe, the rest in North America.

Back in 2012, the firm raised €240m, and with this new fund it brings the current amount under management at Sofinnova Partners to €1.5 billion ($1.6 billion).  The company’s focus will remain in the biopharmaceutical and medical device sectors.

Holiday Celebration Time is Coming! Join us as we remember this amazing year of WIB-DC/Baltimore on December 15, 2015, from 6:00 p.m. to 8:30 p.m., at Paladar Latin Kitchen & Rum Bar in Rockville. Food, drinks, and music will be provided - and of course networking opportunities with all our members and guests. Also the WIB scholarship award winner sponsored from our chapter will be announced!

Not only are we thankful for all you members’ support and engagement, we are also looking forward to hearing your feedback for what we can do better in 2016!

Standing in a virtual-reality lab at the University of Maryland here, Ramani Duraiswami passed around a standard pair of headphones.

Music played over them — but to the wearer, the source of the sound seemed to move around the room. As the music quieted down, it sounded as if it came from farther away. As it got louder on one side of the headset, it sounded as if it came from that side. “We’re able to perceive the world in all dimensions using our ears,” said Mr. Duraiswami, a computer-science professor and co-founder of the start-up company VisiSonics.

Rockville-based Sucampo Pharmaceuticals Inc. finalized its acquisition of the Japanese biotech R-Tech Ueno for $275 million, officials said Monday.

In August, Sucampo (NASDAQ: SCMP) made a $278 million all-cash offer to acquire R-Tech Ueno, a Japanese pharmaceutical company that manufactures Amitiza, Sucampo's flagship drug that eases drug-related constipation using fatty acid-derived compounds known as prostones.

Care Progress, LLC announced today that it was awarded a Phase II Small Business Innovation Research (“SBIR”) grant from the National Science Foundation (“NSF”). The Phase II award will fund the further development of the company’s CarePrompter© software platform, which improves outcomes for cancer patients as well as workflow and profitability for oncology departments and practices.

“It provides support for further development of our critical technology. With this award, we will accelerate our plans to develop additional functionality for cancer providers and patients within a large and growing market.” Tweet this "This Phase II SBIR award is a significant milestone for us," said Howard Isenstein, Founder of Care Progress. "It provides support for further development of our critical technology. With this award, we will accelerate our plans to develop additional functionality for cancer providers and patients within a large and growing market."

PharmaCyte Biotech, Inc. (PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that, upon the recommendation of the European Medicines Agency (EMA), the European Commission has granted the Orphan Drug designation to PharmaCyte’s subsidiary, PharmaCyte Biotech Europe Limited, for PharmaCyte’s pancreatic cancer treatment. Receiving Orphan Drug designation for PharmaCyte’s pancreatic cancer treatment carries with it 10 years of marketing exclusivity in countries in the European Union. In addition, the EMA provides special assistance in the development of PharmaCyte’s treatment for pancreatic cancer.

The Orphan Drug designation in the European Union is given to drugs for life-threatening diseases with low prevalence, or that make it unlikely an investment in a drug to treat a life-threatening disease would be cost justified, and that demonstrate there is a significant benefit to patients being treated with the drug.

With payers increasingly rewarding value and expectations of the customer experience on the rise among all stakeholders, one of the key ways pharmas will differentiate their products is through understanding their customers’ pain points and providing tools and services that address them. For today’s physician, EHRs are a real pain, and prior authorizations are another. So we were interested to learn of a Avhana Health, a startup that is currently piloting a cloud-based clinical decision support system that sits on top of four of the big EHR systems – Epic, Allscripts, AthenaHealth and Greenway.

Is Google about to take a huge dive into the health industry?

The search engine giant has just filed a patent for a “needle-free blood draw” system that could be worn on your wrist and help people who need regular draws to get blood quickly and painlessly, according to a The Verge report.

In the past couple of years there has been a rise in sovereign wealth funds’ investments in healthcare. These cover a wide range of areas from hospital chains to pharmaceutical companies, but it also includes direct investments in digital health startups. China Broadband Capital invested in smartphone diagnostic developer Scanadu and French Groupe Arnault includes Clue, a maker of female health apps, among its investments. Alaska Permanent Fund is one of the founding investors in Denali Therapeutics, a biotech business targeting neurodegenerative disorders.

Two years ago, life science startups were only six percent of the Google Ventures portfolio. 



As 2015 draws to a close, that industry now is nearly one third of Google Ventures investments and is only going to grow larger, says the president and CEO of Google's venture arm, Bill Maris.

Rockville-based Supernus Pharmaceuticals, Inc. was recently recognized as the #1 fastest growing Biotechnology/Pharmaceutical company in North America and the #4 overall fastest growing technology company in the latest Technology Fast 500 put out annually by Deloitte.

On November 13, 2015, Deloitte released the 2015 Technology Fast 500, an annual ranking of the fastest growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors.  Supernus claimed the top spot in the Biotechnology/Pharmaceutical industry with a growth rate of over 15,000 percent from 2011 to 2014.  Headquartered in Montgomery County, Maryland, Supernus is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) disorders.

We're another step closer to extending the life span of human beings.

Researchers in Switzerland have been studying the effect of genes on the aging process and have published their results in the journal Nature Communications. Of the 40,000 genes they studied, they found 30 that allow a variety of animals, including roundworms, zebrafish, and mice, to stay healthier and live longer. But these scientists focused specifically on genes that are also found in human beings, so the next step in their project is to see if these genes also have an impact on us as well.

Arlington cybersecurity start-up ThreatConnect said Tuesday that it has raised $16 million from investors, led by the corporate venture capital arm of SAP’s North American subsidiary in Rockville. The next morning just down the road in Sterling, Va., a similarly-named start-up called ThreatQuotient said it raised $10.2 million, led by prolific technology investor New Enterprise Associates. A few weeks ago Arlington-based Trustar announced a $2 million in seed funding.

Jeff Carroll inherited the DNA mutation that causes Huntington’s disease. It means that in a decade or two, he’ll lose control over his body and slowly go mad, just like his mother.

That’s the reason Carroll, 38, says he’d be in favor of gene editing embryos. He says the idea of correcting DNA errors in the next generation has no “ick factor” for him at all. “I have no compunctions about it,” says Carroll, who is a neuroscientist at Western Washington University, in Bellingham. “I am saying, please, please do mess with our DNA.”

Supports K@W's Innovation Content Pfizer Inc. raked in more than $12.4 billion in revenue in both 2007 and 2008 from just one drug, Lipitor. The cholesterol-lowering mega-blockbuster accounted for more than a quarter of the pharmaceutical giant’s total revenue in those years.

But those golden days couldn’t last.