Go Neighborhood-Hopping in Baltimore
The city’s once-grungy northern districts have transformed into a thriving area with hip boutiques, destination restaurants, and a homegrown art and nightlife scene.
When WellDoc was founded in 2005, it was one of the first companies that sought 510(k) clearance for its patient and physician facing mobile health DiabetesManager platform. By putting its flagship apps through the discipline of clinical trials that generated positive results, it has helped earn confidence from physicians to prescribe it to their patients. Insurance companies are providing reimbursement for physicians and that has been critical for the company’s growth.
The Baltimore, Maryland-based company’s fundraise last year of about $8.4 million, in an amended Form D filing today, shows that confidence in the company is building. In a phone interview with WellDoc Chief Strategy and Commercial Officer Chris Bergstrom, he said the company continues to be entirely funded by angel investors who are flexing more power as Super Angels. “Each year we have brought on a higher caliber of angel investors. We’re really raising angel money at an institutional investor level.” He added: “It’s a great time and place for institutional investors, but angel investors can provide as much strategic value as institutional investors.”
QIAGEN N.V. today announced a partnership with Clovis Oncology CLVS +1.11% to co-develop and co-commercialize a companion diagnostic test to guide the use of CO-1686, a novel Clovis Oncology product candidate currently in clinical development. The Clovis drug candidate will initially target an unmet clinical need in patients with epidermal growth factor receptor (EGFR) driven non-small cell lung cancer (NSCLC) for whom current EGFR-inhibiting drugs no longer control disease.
The diagnostic will build on QIAGEN’s therascreen® EGFR RGQ PCR Kit, which was approved by the U.S. Food and Drug Administration (FDA) in July 2013 as a companion diagnostic for use in the treatment of metastatic NSCLC in patients whose tumors have certain EGFR mutations. Analytical performance of the therascreen EGFR test has been established for 21 EGFR mutations, including the most prevalent resistance mutation, T790M. The test supports efficient laboratory workflow with real-time PCR technology on the FDA approved Rotor-Gene Q MDx, which is part of the QIAsymphony family of laboratory solutions.
Governor Martin O’Malley today joined with Montgomery County Executive Isiah Leggett and City of Gaithersburg Mayor Sidney Katz to announce that Emergent BioSolutions is expanding into a new headquarters building in Gaithersburg, and also plans to make improvements to its existing Research and Development site. As part of the expansion, the global pharmaceutical company will retain its existing 235 employees, and hire an additional 133 employees over the next five years.
“Emergent BioSolutions’ continued investment in Maryland helps solidify our position as a life sciences powerhouse,” said Governor O’Malley. “I am proud that Emergent BioSolutions is growing in Maryland, continuing to create jobs and working to develop life-saving vaccines that will give hope to millions of people around the world.”
This Notice is to provide NIH’s extramural community with information on how NIH is resuming operations after the government shutdown.
eRA Systems Availability
eRA systems will be available for use by the applicant/grantee/reviewer community on Monday, October 21.
Rescheduling October Application Due Dates
All October grant application due dates have been rescheduled as follows: Standard Due Dates:
Cleveland Clinic is in the midst of its annual Cleveland Clinic Medical Innovation Summit today at the new Global Center for Health Innovation. More than 1,100 entrepreneurs, investors, executives and clinicians have gathered for a show and tell of new ideas in the medical world. Cleveland Clinic Chief Information Officer C. Martin Harris talks about how the health system stays nimble on the innovation front.
Cleveland Clinic Innovations, the corporate venturing arm of Cleveland Clinic, was founded in 2000, and it has been hosting the Medical Innovation Summit since 2003. Since Cleveland Clinic Innovations was founded, it has:
When Pascal Soriot took the reins of AstraZeneca last fall, he said he planned to corral firms with promising innovations in their pipeline to reinvigorate the Anglo-Swedish pharma’s offerings.
And so he has – to the tune of more than $1 billion.
Since the former chief operating officer of Roche AG was named CEO on Oct. 1, 2012, the firm has made five acquisitions, five collaborations with other pharmas to develop drugs, and entered two licensing deals. Six of the 12 moves are tied to cancer treatment developments, a core focus for the firm, while the remaining are in diabetes and renal, kidney, cardiovascular and respiratory diseases.
The research, by Gary Dushnitsky, Associate Professor of Strategy and Entrepreneurship, London Business School and his co-author Dr Alvarez-Garrido, is featured in the British Venture Capital Association’s report ‘The Missing Piece’ and finds that corporate venture capital is now the driving force behind cutting edge medical innovation.
Dr Dushnitsky, also Academic Director, Deloitte Institute for Innovation and Entrepreneurship, said, “Biotech start-ups are increasingly turning to corporate venture capital arms, which are steadily on the rise, while traditional venture capital funds are partially drying out. In a recent Nature Biotechnology study, my co-author and I find that the shift in funding patterns is resulting in an increase in scientific publications as well as patenting output.
There is one certainty about the current regulatory process for drug approval in the United States and Europe: No one likes it.
Manufacturers are frustrated by the need for large, complex, and lengthy clinical-development programs that often hinge on meeting a single endpoint in one pivotal clinical trial. As a result, the cost to bring a drug to market has been estimated to be well over $1 billion — and it may be much higher. Patients and providers are disturbed by lack of timely access to medicines that show early promise in addressing significant unmet needs. Even regulators, who are responsible for enforcing the current structure, chafe at what manufacturers typically present to them: successful trial results in patients who are carefully selected to show the drug offers benefits but who are not very representative of the broader population likely to receive it. Payers then have a mess on their hands: pressure to pay for premium-priced medications that, when broadly employed, don’t offer much therapeutic benefit over existing alternatives.
Nutty things are happening in biotech. Irrational exuberance has returned. Generalist investors with lots of money are suddenly buying these stocks first and asking questions later. Companies can fire off meaningless press releases, and be rewarded. I heard a big-time money manager talk the other day about a recent biotech IPO being one of the “best performers” in the market. It had a two-week track record, and had done nothing fundamental to earn its tag as a “best performer.”
If markets are driven by cycles of fear and greed, and I believe they are, we are in the greed cycle.