Education Can Up Emotional Intelligence in Med Residents

Following an educational intervention, residents from pediatrics and med-ped residency programs have an increase in total emotional intelligence (EI), according to a study published online Sept. 20 in Advances in Medical Education and Practice.

Ramzan Shahid, M.D., from the Loyola University Medical Center in Maywood, Ill., and colleagues examined whether educational intervention increases the overall EI of residents. A total of 21 residents from pediatrics and med-ped residency programs volunteered to complete an online self-report EI survey before and after an educational intervention. The intervention focused on developing four EI skills: self-awareness, self-management, social awareness, and social skills.

The researchers found that, compared with before the intervention, there was a significant increase in total EI median scores after the educational intervention (114 versus 110; P < 0.004). There was also a significant increase in the stress management composite median score (111 versus 105; P < 0.001) and in the resident’s overall wellness score (111 versus 104; P = 0.003).

“Teaching EI skills related to the areas of self-awareness, self-management, social awareness, and social skill may improve stress management skills, promote wellness, and prevent burnout in resident physicians,” the authors write.

Abstract/Full Text (subscription or payment may be required)

http://www.physiciansbriefing.com/Article.asp?AID=738000

Most People Don’t Know if They Have Genetic Risk for Cancer

Most people carrying genes that put them at risk for cancer don’t realize it, new research suggests.

Genetic screenings of more than 50,000 people found that more than 80 percent of those who carry a known gene variant for breast, ovarian, prostate or pancreatic cancer were unaware of their risk.

Researchers noted that most people carrying cancer-associated variants in the BRCA1 or BRCA2 genes only realize they’re at increased risk for cancer when a friend’s or relative’s diagnosis prompts them to undergo screening.

“It usually takes a tragedy for people to get tested,” said study senior author Michael Murray, a professor of genetics at Yale School of Medicine. “Our reliance on a documented personal or family history as a trigger to offer testing is not working. Hopefully, one day we can change that with effective DNA-based screening for everyone.”

Screening found that about 270 of the study participants carried a BRCA gene variant. Only 18 percent knew about it before the study, the researchers found.

About 17 percent of the living BRCA-positive patients had a related cancer. Of the small group of BRCA-positive patients who died before the study ended, about 48 percent had a BRCA-associated cancer, the researchers found.

The findings were published Sept. 21 in the journal JAMA Network Open.

“Once risk is identified, we can apply proven tools for early diagnosis and prevention, and we believe that the 31 percent difference in cancer incidence in these two groups is a window into an opportunity to decrease cancer and cancer deaths through genomic screening approaches,” Murray said.

More information

The American Cancer Society provides more on cancer and genetics.

SOURCE: Yale University, news release, Sept. 21, 2018

https://consumer.healthday.com/cancer-information-5/breast-cancer-news-94/most-people-don-t-know-if-they-have-genetic-risk-for-cancer-737965.html

Euro Meds Agency feeling better about drug supply interruptions from Brexit

The European Medicines Agency says concerns over drug shortages stemming from Brexit have eased, but not all drugmakers feel the same.

The EMA reported this week that it has revised its list of drugs whose supplies might be disrupted by the separation of the U.K. from the European Union next year to 39 from its previous estimate of 108.

Noël Wathion, EMA’s deputy executive director, said in a statement that the agency has been assured by many of the makers of the 108 medicines it was uncertain about that they have taken needed steps to minimize supply risks.

Of the remaining 39 drugs, 25 are for humans and the other 14 are veterinary drugs. The EMA said it is trying to figure out how to reduce the impact if there are difficulties with supplies of those.

Many Big Pharmas have invested to ensure that even if no trade agreements have been hammered out ahead of the March separation, drugs keep flowing across borders seamlessly.

But AstraZeneca CEO Pascal Soriot told the Sunday Times that he is worried about problems getting drugs across borders. The U.K. drugmaker is increasing its medicine stockpiles by 20% in hopes of having plenty of approved drugs ready for patients. Meanwhile, he said the company “wasted” £40 million to duplicate laboratories in Sweden so that it can test and authorize its drugs in Europe to meet EU rules that could result from a so-called hard Brexit.

“I hope more and more people get worried,” he told the newspaper.

Drug and vaccine makers are making logistics plans, assuming long lines at checkpoints if the U.K. and EU negotiators can’t hammer out a deal on trade. Sanofi has committed to stockpiling 14 weeks’ worth of drugs and said it’d consider flying flu vaccines into the U.K. because of tight timelines required to deliver the products. If the parties could agree, Sanofi also said it would consider marking trucks to make a fast pass through customs.

Other top players in the pharma industry have been detailing their Brexit plans, as well. Pfizer and GlaxoSmithKline have both said changes to their supply chains will cost $100 million each to ensure supply. Merck, for its part, plans a 6-month drug supply. Novo Nordisk says it’ll more than double its normal 7-week stockpile to 16 weeks’ worth of insulin. The company supplies more than half of the U.K.’s insulin, according to The Independent.

https://www.fiercepharma.com/manufacturing/ema-feeling-better-about-drug-supply-interruptions-from-brexit

Histogenics to Meet With FDA to Discuss NeoCart Phase 3 Clinical Trial

Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, today announced that the U.S. Food and Drug Administration (the FDA) has granted a Type C meeting on October 30, 2018 to discuss the top-line results from the NeoCart Phase 3 clinical trial and Histogenics’ planned Biologics License Application submission.  Histogenics submitted its briefing materials regarding the top-line data of the NeoCart Phase 3 clinical trial to the FDA in mid-September 2018, and has been working closely with the FDA to schedule the meeting.  Histogenics expects to provide an update following this meeting in early November 2018, with meeting minutes expected by late November 2018 or early December 2018.  During the third quarter of 2018, Histogenics has sold an aggregate of 3,550,416 shares of common stock in at-the-market offerings pursuant to Histogenics’ equity distribution agreement with Canaccord Genuity Inc. for aggregate net proceeds of $2.72 million after deducting sales agent fees and expenses.  Histogenics believes that its existing cash and cash equivalents will be sufficient to fund its projected cash needs late into the fourth quarter of 2018.

https://www.nasdaq.com/press-release/histogenics-to-meet-with-fda-to-discuss-neocart-phase-3-clinical-trial-data-and-potential-20180926-01038

Regulus provides pipeline updates

Regulus provided an update on advancements to its pipeline programs. In Hepatitis B virus programs, the company has identified several microRNA targets that serve as host factors for the virus. The company believes that targeting a host factor in the liver represents a unique mechanism of action for treatment of the virus compared to other programs in development and holds the potential for achieving a functional cure. The company currently expects to file an IND for the HBV program in 2H19, with the potential of achieving human proof-of-concept in a Phase 1 study. In the Glioblastoma multiforme program, its lead anti-miR candidate targeting microRNA-10b demonstrated statistically significant improvements in survival as both a monotherapy as well as in combination with temozolamide in an orthotopic GBM animal model. In combination with TMZ, the addition of a single dose of anti-mir-10b led to a more than two-fold improvement in survival compared to TMZ alone. The company expects to nominate a clinical candidate by year-end and plans to seek a partner to further advance its development. In its Non-Alcoholic Steatohepatitis program, its lead candidate has demonstrated improvement in key endpoints with significant improvement of liver fibrosis and hyperglycemia compared to control-treated animals. The company plans to seek a partner to further advance its development. In its Autosomal Dominant Polycystic Kidney Disease program, and in consultation with the FDA, the company has initiated a new 27-week chronic mouse toxicity study with several changes believed to address the unexpected findings in the earlier terminated chronic mouse toxicity study. Data from the new study are anticipated in 1Q19.
https://thefly.com/landingPageNews.php?id=2796065

LeMaitre Vascular Buys Clot Management Business from Applied Medical

LeMaitre Vascular, Inc. (Nasdaq:LMAT) announced today that it has acquired the vascular clot management business of Applied Medical Resources Corporation for $14.2 million, of which $11.0 million was paid at closing and $3.2 million will be paid in two post-closing installments. As part of the transaction, the parties also signed a transition services agreement under which Applied Medical will continue to manufacture the product line for LeMaitre Vascular for one year.

Applied Medical's clot management product line, including Syntel® embolectomy and thrombectomy catheters, Python® over-the-wire embolectomy catheters, Latis® graft cleaning catheters and irrigation catheters, is now available through LeMaitre Vascular. Sales of the business during the latest 12-month period were $3.4mm.
Dave Roberts, LeMaitre Vascular's President, commented, "We are pleased to expand our clot management product offering through this acquisition, which adds a latex-free over-the-wire embolectomy catheter to our sales bag."
Gary Johnson, Applied Medical's Group President, added, "We are confident that our vascular customers will continue to receive the highest level of service and support from LeMaitre."
Business Outlook
In Q4 2018, LeMaitre Vascular expects the acquired business to add $0.5 million to $0.6 million in sales, and have no impact on operating income due to short-term business transition related costs.
About LeMaitre Vascular
LeMaitre Vascular is a provider of devices, implants and services for the treatment of peripheral vascular disease, a condition that affects more than 200 million people worldwide. The Company develops, manufactures and markets disposable and implantable vascular devices to address the needs of its core customer, the vascular surgeon. The Company's diversified product portfolio consists of brand name devices used in arteries and veins outside of the heart. Additional information can be found at www.lemaitre.com.
About Applied Medical
Applied Medical is dedicated to providing innovative solutions that enhance patient outcomes and enable the advancement of minimally invasive surgery. As a new generation medical device company, Applied is proud to have a significant and sustainable impact on healthcare by delivering breakthrough technologies that enhance clinical care and satisfy the pressing economic needs of its customers.
Headquartered in Southern California, Applied Medical provides its products and unique business model to more than 75 countries. To learn more about Applied Medical, visit appliedmedical.com.
https://www.nasdaq.com/press-release/lemaitre-vascular-acquires-clot-management-business-from-applied-medical-20180926-01074

Hologic to Acquire Focal Therapeutics for $125 Million, Boosting Breast Surgery

Hologic, Inc. (Nasdaq: HOLX), a global leader in women’s health, announced today that it has signed a definitive agreement to acquire Focal Therapeutics, a privately-held company, for $125 million in cash. In conjunction with Hologic’s recent acquisition of Faxitron Bioptics, Focal strengthens the Company’s position in the rapidly growing market for breast conserving surgery.

The transaction adds Focal’s innovative BioZorb marker to the Company’s Breast Health product portfolio. BioZorb is an implantable three-dimensional marker that helps clinicians overcome challenges in breast conserving surgery, or lumpectomy. The marker, placed by the surgeon, is used to mark the tumor excision site for monitoring and future treatments, and its unique open design allows for tissue in-growth during the healing process.

“Focal Therapeutics has commercialized an innovative marker that improves the standard of care for breast cancer patients by creating a permanent, three-dimensional indicator of the surgical site,” said Pete Valenti, Hologic’s Division President, Breast and Skeletal Health Solutions. “Coupled with our recent acquisition of Faxitron, BioZorb further expands our ability to help women diagnosed with breast cancer from screening through surgery.”

“Acquiring Focal Therapeutics strengthens our position in an attractive, adjacent breast health market, and is consistent with our capital deployment goals,” said Steve MacMillan, Hologic’s Chairman, President and Chief Executive Officer. “The transaction is accretive to our revenue growth rate and gross margin, broadens our recurring revenue base, and provides attractive return on invested capital.”

Focal generated approximately $16 million of revenue in the last 12 months. The acquisition, which is expected to close in early October, is estimated to be neutral to Hologic’s non-GAAP earnings per share in fiscal 2019, and accretive thereafter.

“We are very excited to become part of Hologic,” said Dr. Gail Lebovic, Focal’s co-founder and Chief Medical Officer. “Hologic’s long-standing commitment to early cancer detection is key for success in breast conserving surgery. Hologic is the perfect fit for our company.”

https://www.businesswire.com/news/home/20180926005948/en/Hologic-Acquire-Focal-Therapeutics-125-Million-Strengthening