September 1, 2015

CeQur announces financing to scale up T2D wearable three-day insulin-delivery device.

CeQur Type 2 Insulin Patch

PR Newswire, LUCERNE, Switzerland and MARLBOROUGH, Mass., 1 September, 2015  
CeQur SA (“CeQur” or the “Company”), a leader in simple insulin infusion for people with diabetes, today announced a Series C financing of $100 million. The financing will support further clinical and regulatory activities, manufacturing scale-up and commercial operations for the 2016 first commercial launch of PaQ®, the Company’s fully optimized second-generation three-day insulin infusion device.
“We are very excited to work with such experienced investors who share our views about the significant opportunity PaQ brings to transform the lives of millions of people with type 2 diabetes,” said Doug Lawrence, CEO of CeQur. “Today when people with type 2 diabetes progress to insulin they need to inject, and current alternatives have cost and complexity limitations. CeQur’s second-generation PaQ will provide a superior alternative to injection therapy and allow us to build a high-growth business in the emerging category of simple and cost-effective insulin infusion to benefit patients, physicians and payors.” 

We Take Hits. - Thanks Emily Coles - #DOCBurnout2015

 If life with diabetes is comparable to battle then maybe the DOC is sitting around the bar swapping war stories. Ok, that is a bit of a stretch but it lets me bring in this picture

The picture Emily Coles from Master Lab. You can see her presentation on YouTube here. She talked about the planes that came back with hits.

The places where there were not red dots is where the holes brought down the plane. No stories at the bar.

Speaking up means taking hits. In the DOC what is really sad is some of these may have been friendly fire. Christel writes about that here.

My contribution to DOC burnout day is this: know you are going to take hits if you speak up. That is part of the process. Reinforces the places where the hits may keep you from succeeding in your mission.

There was a reason missions flew in formation back in the day. Strength in numbers.

The DOC is not combat. We can take a day off. It is OK to not trade stories at the bar. My 2¢ for the day is simply; we are stronger together.


August 31, 2015

Sanofi and Google Life Science Team Up

Sanofi and Google announced and agreement to work jointly on diabetes projects report Boolmberg and Wall Street Journal report and a press release. 

Sanofi's press release states the two companies will:

- Will work together on new digital technology and tools for diabetes -

- Aim to use data and miniaturized technology to provide patients with more tools to self-manage their disease, healthcare professionals with the ability to better support and treat patients -

- Strive to shift from episodic, event-driven diabetes care to continuous, value-based care

Bloomberg quote Google saying:
“Diabetes is the first disease we’re focusing on as we become an independent company,” Google said in the statement. “We’re announcing a new partnership with Sanofi to move technology out of the lab more quickly and work on better ways for patients and physicians to collect, analyze, and understand all the multiple sources of information that impact diabetes management.”

August 25, 2015

FDA Approves Dexcom G5®

FDA Approves Dexcom G5® Mobile Continuous Glucose Monitoring System


First and Only Fully Mobile CGM System Allows Adults and Children as young as 2 years old to Conveniently and Discreetly Monitor and Share Glucose Levels
SAN DIEGO--(BUSINESS WIRE)-- Dexcom, Inc., (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that the U.S. Food and Drug Administration (FDA) has approved the Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) System. With wireless Bluetooth® technology built into the device transmitter, the G5 Mobile CGM System is the first and only fully mobile CGM system approved by the FDA for both adults and children as young as 2 years of age that sends glucose data directly to a smartphone, freeing users from the need to carry a separate receiver. The new transmitter securely sends vital glucose information directly to an app on iOS-enabled devices for real-time diabetes management. Android applications will follow early next year. Like its predecessor, the G4 PLATINUM CGM with Share, users can also select up to five designated recipients, or "followers." These followers can remotely monitor a patient's glucose information and receive alert notifications from almost anywhere.
"Dexcom is rapidly advancing technology for continuous glucose monitoring devices to improve diabetes management. Since January, the company has introduced the G4 PLATINUM CGM with Share, apps to enable the first CGM on the Apple WatchTM and now the Dexcom G5® Mobile CGM. These advances are making diabetes management more convenient and flexible than ever before," stated Kevin Sayer, President and Chief Executive Officer of Dexcom. "We are excited for the promise this new technology holds for patients and caregivers."
About the Dexcom U.S. G5 Mobile Launch
  • The G5 Mobile system is anticipated to begin shipping in late September 2015.
  • All purchasers of a G4 Platinum with Share system from August 1, 2015, until the G5 Mobile system is shipped, will be eligible to receive a no-cost upgrade to the G5 Mobile system.
  • There will be a low cost cash upgrade to the G5 Mobile system for those patients who are still under warranty with their existing system.

August 21, 2015

Three Quick Things

... before I check out for the weekend.

All are about pregnancy and diabetes. So they don't apply to me but they are wonderful efforts, doing good things and they should get shout outs.

The Plaid Journal:

PLAID is cool. PLAID is an open access, peer-reviewed, research journal that aims to encourage dialogue among people living with and inspired by diabetes.

They're doing an issue on "Pregnancy & Diabetes." The deadline for submissions is September 15, 2015.

JDRF has a lovely toolkit for pregnancy and Type 1 diabetes. 

"This guide provides information for parents-to-be or future parents-to-be with T1D—explaining the disease management goals for pregnancy and reviewing how to obtain the best possible support from healthcare providers at every stage."

MyGlu has a survey about preconception, pregnancy, and childbearing at  Help them out, take the survey. 

July 16, 2015

FDA Report on Targeted Drug Development: The Diabetes Section

Are you a policy geek? FDA has a white paper out on drug development and it has some background on diabetes (T1 and T2) and how they go about drug approval.

It isn't page turner like Game of Thrones (GoT) but hey let be honest GoT books 4 and 5 dragged on.  

Here is the preface of what they say about diabetes and a link to the section of the white paper on diabetes:
..our understanding of disease causation and progression is sufficient to permit our use of certain tools such as surrogate endpoints. But it is insufficient to develop others such as biomarkers to help target specific subset of patients who are less likely to suffer side effects from specific drugs. Even where scientific research has not yet identified the molecular and genetic bases for a disease and its treatment, FDA is using tools other than targeting and biomarkers to reduce the length and cost of clinical trials, including flexible trial designs, expedited development pathways, public-private research collaborations, and intensive engagement with drug sponsors. In addition, these tools can support the development of one of the most promising avenues for accelerating drug development: targeted, or precision, medicine—the ability to target the right drug to the right patient based on understanding of the genetic and biochemical basis of a disease in patient subgroups.
Diabetes :

Have fun reading geeks.

The reader digest version is summed up in these quotes:
  • FDA has long allowed manufacturers to show that a diabetes drug works by using a simple surrogate endpoint—lowering blood sugar. 
  • There have been longstanding concerns that some drugs for type 2 diabetes that successfully lower blood sugar may nevertheless increase rather than decrease the risk of heart attack.
  • To minimize the impact on innovation while ensuring acceptable cardiovascular safety, FDA asks for preliminary CV safety data before approval and for detailed additional data to characterize CV effects after the product is on the market.
  • FDA has approved seven new diabetes drugs in the last two years. This includes three drugs that represent entirely new drug classes—a measure of how innovative these drugs are. In June 2014, FDA approved the only inhaled insulin product. The diabetes drug pipeline is among the strongest for any disease category and includes potentially transformative advances for type 1 diabetes.
 Yeah there is more in there. If you like wanting around in Westeros, enjoy the read.

June 2, 2015

Of Spinal Tap, One Louder and Advocacy

Diabetes advocacy can learn from the great philosopher, Nigel Tufnel, who offered this sage observation, “Well, it's one louder, isn't it?

We need to turn up the volume and to keep it up. Why? The diabetes caucus is the largest in the US Congress, yet many pieces of diabetes legislation lack the support of those very caucus members.
Worse, in the current policy environment the squeaky wheel is going to get cut less, the other are going to get slaughtered. Diabetes needs to turn it up. We can't let them just move on after checking the diabetes box. So we to turn up the advocacy volume to help keep attention and accountability on diabetes.

But, I hear you say, “Just taking care of diabetes is a time major attention already, advocacy is just more.” 

No kidding. So advocacy needs to be easy. Click simple. OK, it will be. I am proud to partner with Christel in creating the Diabetes Patient Advocacy Coalition (DPAC.) Join us.

DPAC is a non-profit and non-partisan organization founded to provide united, simple, and effective advocacy opportunities for people impacted by diabetes for safety, quality and accessibility of care.
DPAC will keep track of issues, opportunities, and how to contact officials and make it easy to advocate.

Be one louder.