Pacific Bio and Illumina down on merger concerns from UK competition watchdog

Illumina (ILMN -2.1%) and acquisition target Pacific Biosciences of California (PACB -13.4%) are both under pressure, the latter on more than double normal volume, in response to a final report from the UK Competition & Markets Authority (CMA) that concluded that their planned tie-up will lessen competition and has referred the matter for phase 2 assessment (more in-depth investigation).

The CMA signaled its concerns in late June that would recommend a higher level of scrutiny regarding the transaction.

ILMN announced its $1.2B bid for PACB in November 2018.

https://seekingalpha.com/news/3479354-pacific-bio-illumina-merger-concerns-uk-competition-watchdog

Canada warns U.S. against drug import plans, citing shortage concerns

Canada opposes any U.S. plans to buy Canadian prescription drugs that might threaten the country’s drug supply or raise costs for its own citizens, officials have told U.S. authorities, in a new setback to the Trump administration’s efforts to tackle high drug prices, according to documents obtained by Reuters.

Canadian opposition is a problem for U.S. lawmakers, who have argued they can lower sky-high prescription drug prices by approving imports from Canada, where prices are lower.

At least ten U.S. states, including Florida, have passed or proposed laws to allow such imports, but actual shipments would not be legal without federal approval. The U.S. Health and Human Services secretary said last week the government was looking into ways to import cheaper prescription drugs from overseas.

“Canada does not support actions that could adversely affect the supply of prescription drugs in Canada and potentially raise costs of prescription drugs for Canadians,” reads an April briefing for Canadian officials obtained under freedom of information laws.

The talking points, prepared by Canada’s foreign ministry for use by Canadian officials who speak with U.S. officials, cite research suggesting shipments to the United States could cause shortages in Canada.

Health Canada confirmed the government’s position has not changed since the talking points were prepared. The ministry said officials have “made Canada’s position clear” to both federal and state officials in the United States and it stood ready to “take action to ensure Canadians have uninterrupted access to the prescription drugs they need.”

U.S. drugmakers, keen to protect profits in the United States, their most important market where prices are generally much higher, have also argued against imports, saying they would put the safety of the U.S. drug supply at risk. Health Canada says the Canadian drug supply is safe.

The documents instruct Canadian officials to say that “importing drugs from Canada is probably not your silver bullet.” It suggests noting that “there are other solutions” and offering to share the ways Canada keeps healthcare costs low.

The issue may pose a fresh challenge to Canada’s relationship with U.S. President Donald Trump, while disruptions in the drug market would be an unwelcome headache for Prime Minister Justin Trudeau’s government, especially ahead of Canada’s October election.

In 2005, an earlier Canadian government promised a bill that would restrict drug exports in response to similar U.S. proposals, but never followed through.

The Trump administration has promised to lower drug prices, but it has failed to push through several initiatives, including forcing drugmakers to disclose prices in TV ads and overhauling the system of drug discounts.

U.S. Democrats see Trump as increasingly vulnerable to criticism on healthcare costs. U.S. presidential contender Bernie Sanders has offered several bills and amendments that would allow drug imports, while Minnesota Senator Amy Klobuchar recently announced a drug price plan that would include letting patients order drugs from countries like Canada.

Sanders is set to join a group of U.S. patients traveling to Windsor, Ontario, to buy cheap insulin later this month.

The documents say the U.S. proposals have not been detailed enough to properly assess impact, but cite a study from 2010 which estimated that if 10% of U.S. prescriptions were filled from Canada, the drug supply would run out in 224 days.

They also note there are already barriers to shipping drugs from Canada to the United States. For example, many purchase agreements forbid the re-export of drugs.

Most of the entities that regulate Canadian pharmacists forbid filling prescriptions written by foreign doctors, but some Canadian pharmacies do ship across the border. The U.S. Food and Drug Administration does not generally block small-scale imports for personal use.

Innovative Medicines Canada, which represents drugmakers including the major U.S. manufacturers, said it is concerned about the import proposals, and raised the issue with Health Canada.

“Canada cannot supply medicines and vaccines to a market ten times larger than its own population without jeopardizing Canadian supplies and causing shortages,” the organization said in a statement.

https://www.reuters.com/article/us-canada-pharmaceuticals-exports-exclus/exclusive-canada-warns-u-s-against-drug-import-plans-citing-shortage-concerns-idUSKCN1UD2LN

Turning Back the Learning Clock for Seniors

Older adults who learned multiple new skills at the same time improved their cognitive function to the level of people 30 years younger, two small prospective studies showed.

After 3 months of learning in an “encouraging” classroom environment, the composite score on a battery of cognitive function tests improved significantly from baseline (P=0.003). Individual components of the assessment also improved significantly, particularly during the first 6 weeks.

The findings may have implications for long-term functional independence, which requires learning new skills to adapt to a changing environment, Rachel Wu, PhD, of the University of California Riverside, and coauthors reported online in the Journals of Gerontology: Series B, Psychological Sciences.

“Learning is totally necessary, no matter how old you are,” Wu told MedPage Today. “As the world changes — with technological advances and things like that — if you’re not learning to keep up, you’re going to be dependent on someone else.”

The findings are complementary to those of other studies that focused on cognitive reserve and strategies to preserve or slow the decline of cognitive functioning with aging. However, the real payoff of “mental exercise” activities is maintenance of functional independence, said Wu. Previous research provided evidence of improved cognitive functioning in older adults who learned a new skill or who learned several skills in sequence. In general, the studies showed improvement only in abilities required for the skill.

In contrast, the natural learning experience of infancy to adulthood “mandates learning multiple real-world skills simultaneously,” Wu and coauthors wrote. They hypothesized that the same approach would be feasible for older adults and would improve cognitive abilities and functional independence, even if the skills were not directly related to the cognitive and functional independence assessments.

“We wanted to put older adults back into the same learning environment as kids, which included having very good teachers, a very supportive environment, and learning a bunch of new things,” said Wu. “How much is that environment actually driving development? We know that it drives development and growth early in the lifespan, because kids who don’t go to school, who aren’t in that kind of environment, also decline. I can see a lot of parallels between older adults who aren’t learning as much and kids who aren’t learning as much.”

Participants and Methods

Investigators recruited healthy, community-dwelling older adults for two studies. The first included 15 participants, who were assigned to intervention and control groups. The second study included 27 individuals, all of whom participated in the intervention. Women accounted for two-thirds of participants in both studies, and the 42 total participants ranged in age from 58 to 86.

In the first study, participants in the intervention group learned Spanish, painting, and how to use an iPad. For the second study, investigators added music composition and drawing to the classes and randomly assigned participants to three of the five skills.

Study 1 lasted 15 weeks, and the second study was shortened to 12 weeks after consultation with the participants.

The intervention included three 2-hour classes weekly, consisting of lectures, class assignments, and group exercises. Additionally, Wu led an informal discussion session after the third class. People assigned to the control group in the first study did not attend classes or the discussions.

The class instructors were age 55 or older, degreed, and had teaching experience. Two of the three led classes in skills they had learned after retirement, reinforcing the idea that new skills can be learned later in life. They also had the option to sit in on classes they were not leading.

Participants in the first study completed a battery of tests at baseline, 8 weeks, and 15 weeks. The tests included assessments of working memory, cognitive control (how goals or plans influence behavior), and episodic memory (recalling a word list).

For the 27-person intervention study, the first assessment occurred 4 to 6 weeks prior to the intervention (baseline), then at the start of the intervention (pretest), and at 6 and 12 weeks. Investigators added two more measures of working memory, including a digit-sequence recall activity.

Participants in both studies completed a measure of functional independence (including questions about daily tasks).

Key Findings

In the first study, the intervention group showed significant improvement at the 6-week mark in composite cognitive scores, cognitive control, working memory, and episodic memory. At 3 months, cognitive control and episodic memory remained significantly improved versus baseline, whereas the composite score and working memory did not. The control group showed no significant improvement in any of the measures.

Results of the second intervention study showed significant improvement at 6 weeks in the composite score, cognitive control, and working memory but not digit recall . At the 3-month assessment, the composite and working memory scores remained significantly improved but not the other two.

Scores on the functional assessment improved in both studies. The intervention group in the first study improved from a mean of 74.23% at baseline to 86.19% at the end of the intervention, whereas the mean for the control group declined from 81.11% to 78.62%. The mean score in the second study improved from 82.46% to 88.27%.

Wu said the magnitude of improvement observed 6 weeks into the intervention put the older adults’ cognitive abilities on par with those of people 30 years younger.

Principal support for the study came from the American Psychological Foundation Visionary Grant.

The authors reported having no relevant disclosures.

• Primary Source

  Journals of Gerontology: Series B, Psychological Sciences

  Source Reference: Leanos S, et al “The impact of learning multiple real-world skills on cognitive abilities and functional independence in healthy older adults” J Gerontol B Psychol Sci Soc Sci 2019; DOI: 10.1093/geronb/gbz084.

https://www.medpagetoday.com/geriatrics/generalgeriatrics/81100

Marker hit on MultiTAA data

Marker Therapeutics (MRKR -17.6%) slumps on 12% higher volume in early trade in response to preliminary data from a Phase 1/2 clinical trial evaluating its MultiTAA T cell therapy in patients with pancreatic adenocarcinoma, the most common type of pancreatic cancer. Investors appear to have been expecting a more significant treatment effect. The results were published this morning on the American Association for Cancer Research website.

18 patients have been treated to date, each receiving up to six monthly infusions. In the nine patients who received MultiTAA T cells in conjunction with first-line chemo, the radiographic disease control rate (DCR) (responders + stable cancer) was 56% (n=5/9), two progressed and two were not yet evaluable. In six treated patients with progressive cancer, three continued to progress and three had stable disease. Three patients with potentially resectable cancer who received one MultiTAA infusion are still receiving postoperative infusions and adjuvant therapy.

The company will host a conference call on Monday, July 22, at 8:30 am ET to discuss the data.

https://seekingalpha.com/news/3479339-marker-18-percent-multitaa-data

Why Is Midatech Pharma Trading Higher?

Why is MTP moving?

Shares of Midatech Pharma MTP 66.15% moved about 80% higher Friday morning.

Midatech Pharma shares are trading higher after the company announced positive results from a first in human study of its MTX102 immuno-tolerising vaccine product candidate in diabetes.

https://www.benzinga.com/news/19/07/14102827/why-is-midatech-pharma-trading-higher

Most U.S. hospitals do not meet minimum volume standard for high-risk surgeries

The majority of U.S. hospitals are not meeting minimum hospital or surgeon volume standards when it comes to performing high-risk surgical procedures, according to a new report from The Leapfrog Group.

With guidance from scientific advisers at the Armstrong Institute for Patient Safety and Quality at Johns Hopkins Medicine, Leapfrog experts examined data from about 1,300 hospitals that voluntarily submitted their data to Leapfrog and had performed at least one high-risk procedure in 2018. They looked at eight high-risk procedures including bariatric surgery, three heart surgery procedures and four cancer procedures.

Of the eight high-risk procedures, the report found fewer than 3% of hospitals met a minimum volume standard when it came to the number of open abdominal aortic aneurysm repairs or esophageal resections for cancer they performed. For five of the eight procedures, no rural hospitals are fully meeting Leapfrog’s volume standard.

The report found most of those hospitals also did not have criteria for gauging the appropriateness of those high-risk procedures for patients to prevent the overuse of such procedures, the report found. They found about 75% of those hospitals did not have appropriateness criteria for procedures they performed.

“This is deeply concerning and its enough of a problem that we believe hospitals should put in place at least a minimum policy to try and assure patients undergoing these serious surgeries are in fact needing them,” said Leah Binder, president and CEO of Leapfrog.

Binder said it has been well-established in research that volume of procedures performed is associated with better outcomes, saying no surgeon or hospital should only perform one or two of these procedures a year.

“We are not saying that a surgeon or a hospital that does a higher volume is, therefore, higher quality,” Binder said. “What we are saying, however, that if a surgeon or a hospital does a lower volume of these surgeries than our standard, that is not adequate for safety. These procedures require practice and ongoing practice by the surgeons and by the OR teams in a hospital.”

There was one standout of the group: bariatric surgery. Of the eight procedures, hospitals were most likely to meet the safety standard for bariatric surgery for weight loss (38%). Of those hospitals that performed the procedure, 44% said they had an appropriateness standard. That may be because payers are more likely to require certain standards linked to the weight loss surgery, officials said.

https://www.fiercehealthcare.com/hospitals-health-systems/majority-u-s-hospitals-do-not-meet-minimum-volume-standard-for-high-risk

Healthy.io, Walgreens Boots Alliance roll out smartphone-based UTI test in the U.K.

Healthy.io’s smartphone-based UTI testing kit enables patients to do at-home testing and skip a visit to the doctor. (Healthy.io)

Urinary tract infections are a common health issue and account for nearly 10 million doctor visits a year in the U.K.

Through a new agreement with Walgreens Boots Alliance, a smartphone-based UTI testing kit from Tel Aviv-based Healthy.io is being rolled out in hundreds of pharmacies in the U.K. with the aim to reduce physician visits.

UTIs are the most common bacterial infections in humans. Research suggests that at least 40 to 60% of women develop a UTI during their lifetime, according to the National Institutes of Health. The infections account for millions of physician visits and ER visits in the U.S. each year.

“By partnering with Boots pharmacies, we’re giving women across the U.K. a new option to quickly and easily test and receive treatment for UTIs, without the need to visit a clinic,” Yonatan Adiri, founder and CEO of Healthy.io, said in a statement. “This partnership, and others like it in the future, will turn community pharmacies into a point of care and, by doing so, expand access to clinical-grade tests while improving health outcomes and lowering costs.”

Healthy.io officials say they have the only smartphone-based urinalysis cleared by the U.S. Food and Drug Administration (FDA) and European regulators as equivalent to lab-based testing. The U.K. rollout could lay the groundwork for the launch of the technology in the U.S. market. Healthy.io has done studies with Geisinger and Johns Hopkins University and plans to expand its pilot studies in the U.S.

Healthy.io said it built the product around the established urinalysis dipstick and uses the smartphone camera as a clinical-grade medical device.

Healthy.io also is launching a pilot with the NHS England and East Midlands Academic Health Science Network to examine how a home-based UTI testing kit can reduce the need for clinician visits. evaluate how the smartphone-based test can help provide women with quicker relief from symptoms, reduce complications due to delayed treatment, and prevent the overprescription of antibiotics. In addition, it will examine to what extent the Dip UTI test reduces the workload for local primary care practices.

“Our aim as an organization is to identify, test, and spread innovations in health which improve outcomes and experiences for patients and save the NHS money,” Tim Robinson, commercial director at East Midlands Academic Health Science Network said in a statement. “By supporting this technology-enabled pathway, we hope to provide patients with quicker and easier access to UTI treatment and reduce general practitioner appointments.”

In a study published in the American Journal of Obstetrics and Gynecology, researchers at Johns Hopkins University found that Healthy.io’s prenatal testing was effective and largely preferred by pregnant women. Two-thirds of the women in the study said they preferred at-home self-testing as compared to just 10% who preferred conventional testing at a medical clinic.

Healthy.io’s smartphone-based tests measure 10 parameters, indicating a range of infections, chronic illnesses like chronic kidney disease and pregnancy-related complications.

A study by Geisinger Health and the National Kidney Foundation found a 71% test completion rate among a population of previously non-compliant patients with hypertension being tested for chronic kidney disease.

Modality Partnership, a large primary care practice in York, England, also used the tests with patients with diabetes who had previously not completed a chronic kidney disease screening. Of those patients who completed the screening, 10% had previously undiagnosed chronic kidney disease.

https://www.fiercehealthcare.com/tech/healthy-io-walgreens-boots-alliance-roll-out-smartphone-based-uti-test-u-k