Author: Peter

From Pepper, the emotional interactive robot, to the new da Vinci Xi Integrated Table Motion to pipeline vaccines, ECRI Institute highlights 10 healthcare technologies C-suiters (Chief-level executives) should keep an eye on in 2017...The organization's annual watch list outlines technologies that hospital leaders should bring into their hospitals—and which ones to keep out. But separating the facts from the hype isn't easy, they note...Here's the list of 10 technologies and research areas that ECRI says are poised to affect care delivery over the next 12 to 18 months:

1. Liquid biopsies: ...these genetic tests that use blood or urine, rather than biopsied tissue, to identify genetic variants and mutations.
2. Opioid addiction or relapse prediction: A couple of lab tests have emerged to find genetic variants believed to be associated with addiction, but critics are skeptical.
3. Abdominal surgery improvements: Some major research universities are working on initiatives that add a web-based risk-assessment algorithm and interactive patient coaching in order to improve outcomes and cut costs of abdominal surgery.
4. Long-term planning: Healthcare leaders should scan the horizon for important and disruptive new technology developments and care processes to revisit and refresh long-term planning efforts.
5. LED infection control: New and highly effective technologies emit light in the “deep UV” range and can be used as a disinfectant on myriad surfaces.
6. Robotic artificial intelligence: Two Belgian hospitals use the Pepper robot to support reception staff, but its programming comes at a hefty price.
7. Robotic surgery tables: This table communicates with the da Vinci system’s robotic arms to reduce time required for re-positioning.
8. New endoscopy technique: Using a near-infrared imaging technique, indocyanine green imaging enables physicians to visualize malignant tissue that is undetectable under conventional white light.
9. Crohn’s disease treatments: Immunotherapy and stem cell treatments look promising, though approval is likely one or two years away.
10. Vaccines for Type 1 diabetes: Keep an eye out for both preventative and therapeutic versions.

In a sign of improving cooperation between the U.S. and China to fight the global drug trade, the Drug Enforcement Administration will open a new office there...acting administrator Chuck Rosenberg will visit Beijing, Guangzhou and Hong Kong...at the invitation of China's Ministry of Public Security...DEA maintains that China is the top source country for synthetic opioids like fentanyl and its precursors, which have been fueling the deadliest drug abuse epidemic in U.S. history. China is also emerging as a laundering destination for drug money... Beijing has taken significant steps to crack down on the production and export of synthetic drugs, even though these substances are not widely abused within China...

Greek officials announced Tuesday that they are investigating Novartis for bribery in the wake of local media reports raising questions about the company. It is the fourth set of bribery allegations…to go public in the past year…Greek authorities have interviewed scores of sources and raided Novartis offices in Greece, according to multiple local news outlets. Justice Minister Stavros Kontonis ordered the inquiry after "denunciations concerning bribes paid to functionaries by Novartis" appeared in the press… Greece’s investigation follows a similar probe launched in South Korea last February and corruption allegations leveled by a Turkish whistleblower…South Korean prosecutors indicted a half-dozen Novartis executives for issuing improper rebates to local doctors…last year, Novartis agreed to pay $25 million to settle an SEC investigation into bribery allegations in China…Novartis offered Chinese doctors lavish entertainment…and other inducements to boost prescriptions of its drugs in the country.

...Indian drug manufacturer Wockhardt is in trouble again with the US Food and Drug Administration, this time for destroying current good manufacturing practice documents, among a list of other major violations...FDA sent a warning letter to the company following an eight-day inspection...of its Ankleshwar...manufacturing site that uncovered “torn and shredded equipment maintenance documents, raw material labels, and change control work orders” in the site’s scrap yard awaiting incineration...The site was banned from shipping products to the US in August...This is the latest in a series of failures by Wockhardt to meet the standards of not just FDA but other regulators...

Citing burdens on clinicians that could lead to treatment delays, the Joint Commission said its ban on doctors using text messages to order treatments will stay in place for the time being...The Joint Commission...with the Centers for Medicare & Medicaid Services...are working out guidelines for how doctors can use messaging apps and texting to make orders...a number of concerns that led to the decision:

• Using texts or other messaging apps to order treatments could increase the burden on nurses or other clinical staff who would be responsible for inputting such data into electronic health records
• Talking in-person allows for easier clarifications if there are questions about an order, and allows for better confirmation of directives
• ...any clinical decision support alerts triggered during the EHR process, the clinician inputting the information into the system will have to take time to contact the ordering physician to resolve the issue, potentially causing treatment delays

Kelly Walsh, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

The Food and Drug Administration is ironing out new rules for how drug companies can electronically submit medications for approval, and on Dec. 28 unveiled a draft of what they have planned so far…The draft largely focused on manufacturing establishment information (MEI) — things like a production facility's address, what it's manufacturing, how to reach the person in charge of scheduling inspections, as well as a unique facility identifier, which the agency uses to keep track manufacturing plants…The FDA is requiring companies to electronically submit MEI for each facility, but all in a single list. Companies must provide those lists for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and any other supplemental materials… Once the final version of the guidance gains approval, drugmakers will have 24 months before the new rules become mandatory…The agency noted several reasons for the push toward electronic MEI submissions. The primary one was the convenience of having all the information on a single file versus non-electronic applications, where it can be scattered.

The top two Democrats in the Nevada Legislature are calling on U.S. Sen. Dean Heller to explain how Republicans in Congress will replace key provisions of the Affordable Care Act if they repeal it...Aaron Ford and Jason Frierson...sent a letter...posing...questions to Nevada’s senior senator in Congress...the state leaders asked what steps will be taken to ensure people who purchased coverage through the state exchange and those who receive federal tax credits will still be able to buy affordable insurance...what will be done to ensure more than 217,000 Nevadans receiving coverage under expanded Medicaid eligibility will remain covered; guarantees for women’s health care; and continued mandates to cover people with pre-existing conditions and allow parents to keep children on their policies until age 26...“I would anticipate nobody’s going to lose their health care for the next two or three years until the replacement is put in place,” Heller said...

Laura Joszt, with The American Journal of Managed Care. Welcome to This Week in Managed Care, from the Managed Markets News Network.

A promising drug candidate, an innovative technology, a great business model or just a bunch of venture funding. Any one of those factors can prime a biopharma for success, yet is also likely to attract attention from industry peers and competitors...While 2016 wasn't a groundbreaking year for M&A, industry followers believe next year might see an uptick amid a new tax plan under president-elect Trump, continued loss of patent protections for top-tier branded drugs and strong growth projections for promising fields such as gene editing and immuno-oncology...With that in mind, here's a crop of takeover targets likely to make their way into the spotlight in 2017…

1. Spark
2. Tesaro
3. Axovant
4. Biogen
5. BioMarin
6. Vanda
7. ​Actelion