The subcutaneous ICD

The concept of applying high voltage to shock a heart out of Read more »

The Weekly Summary

Body in fieldJuly 14th – July 20th

In the general news, Russia escalated the Ukraine invasion to a new level when Russian-backed terrorists downed a civilian airliner with a surface-to-air missile, killing 283 Europeans and Asians. Elsewhere, Israel invaded Gaza with tanks. In the U.S., Fed Chair Yellen said that biotech and social media stocks were a bubble. In sports, Rory McElroy won the British Open.

In healthcare business news, Read more »

45 years ago, a humble man from Ohio landed on the moon

Neil ArmstrongJuly 19, 2014- By Steven E. Greer, MD

Forty-five-years ago tomorrow (July 20th, 1969), Neil Armstrong became the first human to step onto the moon, with his poignant and profound proclamation, “That’s one small step for a man, one giant leap for mankind”. Who was Neil Armstrong and why was he chosen to be the first? Read more »

100 HIV researchers killed as Russian missile takes down jetliner MH17

19jet4-superJumboJuly 19, 2014- By Steven E. Greer, MD

I emailed earlier today a leading HIV researcher, Monica Gandhi MD, MPH from Read more »

Senator Angus King discusses the slowdown in healthcare costs

July 9, 2014- Interviewed by Steven E. Greer, MD

Senator Angus King from Maine discusses the various forces that are working to keep healthcare cost growth the slowest in decades.

The Weekly Summary

lebron-cleveland-home-nba-social-media-July 7th – July 13th

In the general news, Israel’s battle with Hamas in Gaza escalated. In the U.S., the Republican House plans to sue President Obama over the ACA law, and LeBron James switched teams to Cleveland.

In healthcare business news, Abbott (ABT) plans to sell its generics business the Mylan (MYL). Abbvie (ABBV) and Shire are still talking about the inversion move merger. Also, some small M&A’s were announced. Thoratec (THOR) acquired Apica, mostly for the IP, and Salix (SLXP) plans to merge with Irish Cosmo Technologies in another inversion deal.

On the data front, Regeneron (REGN) met endpoints with dupilumumab (IL-4R antibody) to treat atopic dermatitis. Also, Sarepta (SRPT) shares fell 30% after eteplirsen failed again in Duchenne muscular dystrophy.

From the FDA, Anacor’s (ANAC) Kerydin was approved to treat onychomychosis. In other regulatory matters, the Senate has joined the House in grilling Gilead (GILD) about the price for Sovaldi.

Senator Angus King discusses his bill to make medical device pricing transparent to the public

July 9, 2014- Interviewed by Steven E. Greer, MD

Senator Angus King from Maine has proposed a a bill that would make the pricing of medical devices more transparent. Currently, hospitals are required to sign confidentiality agreements, and the market is entirely in the dark. If such a law were passed, it would turn the medical device industry on its head.

How did a small academic lab succeed where big medical device companies failed?

July 5, 2014- Interviewed by Steven E. Greer, MD

The New England Journal of Medicine recently published the early clinical data on the “bionic pancreas” being developed by engineers at Boston University and medical doctors at Massachusetts General hospital. We interviewed Ed Damiano, PhD, the lead biomedical engineer, and Steven Russell, MD PhD, the lead endocrinologist.

In Part 3, we asked them how their small lab funded only by the NIH succeeded at developing the bionic pancreas when large companies, such as Roche, Medtronic, Abbott, and JNJ all failed.

 

The Weekly Summary

Tropical Storm Arthur Threatens North Carolina's Outer BanksJune 30th – July 6th

In the general news, World Cup soccer mesmerized the world, even Americans. In the U.S., the Supreme Court struck down a provision of the ACA law mandating employers provide birth control to employees. A new head of the VA medical system was chosen. Hurricane Arthur hit the East Coast washing out July 4th for many. The stock markets broke all-time records, once again, as the Fed maintains the zero-interest-rate climate. In the economy, June added 288,000 jobs and unemployment dipped to 6.1%.

In healthcare business news, Roche acquired private Seragon for $725 Million to obtain breast cancer drugs in the estrogen receptor degrader class. In M&A, small deals included another Stryker (SYK) acquisition, Small Bone Innovations. Abiomed (ABMD) acquired ECP, and Bluebird Bio (BLUE) bought private Pregenen. Lastly, Bind (BIND) ended its partnership with Amgen.

On the data front, the Agenus (AGEN) vaccine doubled survival in glioblastoma multiforme. Salix (SLXP) announced that Xifaxan met endpoints in the irritable bowel study. Synageva’s (GEVA) sebelipase alfa for LAL deficiency met its primary endpoint. Lastly, the American College of Physicians now recommends against routine pelvic exams for healthy women.

From the FDA, Spectrum (SPPI) received approval for Beleodaq to treat lymphoma. Allergan (AGN) was rejected for the migraine aerosol treatment drug Levadex. AGN acquired it from MAP Pharma for $1 Billion earlier this year. However, AGN also received approval for Ozurdex to treat diabetic macular edema. In other regulatory news, French agencies will support off-label use of cheaper Avastin to treat AMD rather than costlier Lucentis.

The bionic pancreas data

July 2, 2014- Interviewed by Steven E. Greer, MD

The New England Journal of Medicine recently published the early clinical data on the “bionic pancreas” being developed by engineers at Boston University and medical doctors at Massachusetts General hospital. We interviewed Ed Damiano, PhD, the lead biomedical engineer, and Steven Russell, MD PhD, the lead endocrinologist. In Part 1, they review the clinical data.

The research was funded by the NIH and not a medical device or drug company. The researchers selected the components based on merit. They chose the Dexcom G4 Platinum continuous glucose sensor and a Tandem Diabetes t:slim pump, and used software that ran on a standard Apple iPhone 4S.

In Part 2, the team discusses the details of the pivotal study, that could be concluded by 2016, allowing for an FDA approval by 2017. Industry partners yet to be determined would be involved. However, the final marketed product will not require any particular smartphone to be used by the patient.

 

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