Immutep initiated with a Buy at B. Riley FBR. B. Riley FBR analyst Dylan Dupuis started Immutep with a Buy rating and $7.75 price target. The analyst views the company as a leader in LAG-3 immunotheraphy.
Friday, September 28, 2018
Teladoc target raised to $88 after analyst day at Piper Jaffray
Piper Jaffray analyst Sean Wieland raised his price target for Teladoc to $88 from $84 following the company’s analyst day. Management committed to 20%-30% organic revenue growth, positive free cash flow in 2019, and inched up 2018 guidance on greater revenue per client, Wieland tells investors in a research note. He believes the Advance Medical acquisition should drive international share gains and reiterates an Overweight rating on Teladoc shares.
Qiagen receives FDA approval to expand use of EGFR test in lung cancer
Qiagen (QGEN) announced that the FDA has approved a PMA Supplement expanding the labelling claim of the therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer’s VIZIMPRO for first-line treatment of patients with non-small cell lung cancer with epidermal growth factor receptor, or EGFR, exon 19 deletions or an exon 21 L858R mutation. The therascreen EGFR RGQ PCR kit is now approved as a companion diagnostic to guide the use of three FDA-approved therapies It is registered in more than 40 countries globally. This was a project governed under an agreement between QIAGEN and Pfizer (PFE).
PTC Therapeutics price target raised to $51 from $15 at JPMorgan
JPMorgan analyst Eric Joseph raised his price target for PTC Therapeutics to $51 heading into risdiplam clinical updates for both Type 1 and Type 2/3 spinal muscular atrophy at World Muscle next week. The analyst sees 15% share swings on definitively positive and negative data. Joseph believes the World Muscle conference creates incremental upside potential but that longer term appreciation is based on execution. He keeps a Neutral rating on PTC Therapeutics.
https://thefly.com/landingPageNews.php?id=2796905
Novo Nordisk: Growth hormone med phase 2 data demonstrates potential
Novo Nordisk announced that somapacitan, a novel growth hormone derivative in development for once-weekly administration of growth hormone, matched the therapeutic benefits of once-daily Norditropin in a phase 2 trial in children with growth hormone deficiency. The REAL 3 trial data were presented today at the 57th Annual Meeting of the European Society for Paediatric Endocrinology. The trial compared three somapacitan doses to Norditropin 0.034 mg/kg/day. Annualized height velocity did not differ significantly for the 0.08 and 0.16 mg/kg/wk doses compared to Norditropin. The mean annualized height velocity for the three dose levels of somapacitan was 8.0 cm, 10.9 cm and 12.9 cm, respectively, as compared to 11.4 cm for daily Norditropin. Somapacitan was well tolerated at all doses investigated, with no clinically relevant safety or local tolerability issues identified.
https://thefly.com/landingPageNews.php?id=2796921
Thursday, September 27, 2018
Many Drivers Rely Too Much on New Car Safety Features
New cars are now coming out with high-tech safety features designed to prevent crashes. But if you don’t know how they work you could be inviting an accident, new research suggests.
These advanced driver assistance systems (ADAS) — including blind-spot monitoring, forward-collision warning and lane-keeping assist — can, when used properly, make your driving safer. But many drivers are unaware of the limitations of these advances, the authors of the report said.
“When properly utilized, advanced driver assistance system technologies have the potential to prevent 40 percent of all vehicle crashes and nearly 30 percent of traffic deaths,” said Dr. David Yang, executive director of the AAA Foundation for Traffic Safety.
But the new findings, published Sept. 26 by the foundation, show that a lot of work needs to be done in educating drivers about the limitations of these devices and their proper use, he added.
For example, nearly eight out of 10 drivers with blind-spot monitoring systems didn’t know the limitations of this feature. These systems only work when a car is traveling in a driver’s blind spot, and many systems do not detect vehicles traveling at high speeds.
Not understanding driver assistance systems may lead to misuse or over-reliance and could result in a deadly crash, the researchers said.
In the United States in 2016, more than 37,400 people were killed in traffic crashes — a 5 percent increase from 2015, according to a AAA news release.
For the new study, researchers from the University of Iowa surveyed drivers who purchased a 2016 or 2017 car with ADAS technologies.
The investigators evaluated drivers’ opinions, awareness and understanding of these safety features, and found that most did not know or understand the limitations of these systems.
Most drivers (80 percent) did not know the limitations of blind-spot detectors. Many incorrectly believed that the systems could monitor the road behind the car or reliably detect bicycles, pedestrians and vehicles passing at high speed.
As for forward-collision warning and automatic emergency braking systems, nearly 40 percent did not know the systems’ limits or confused the two technologies.
Drivers incorrectly assumed that forward-collision warning would apply the brakes in the case of an emergency, but the technology is only designed to deliver a warning signal, the researchers said.
In addition, one in six drivers didn’t know if their vehicle had automatic emergency braking.
About 25 percent of drivers felt comfortable that blind-spot systems would pick up pedestrians and traffic, so they didn’t do visual checks or look over their shoulder for oncoming traffic or pedestrians.
Moreover, about 25 percent of drivers with forward-collision warning or lane-departure warning systems felt comfortable doing other tasks while driving.
“New vehicle safety technology is designed to make driving safer, but it does not replace the important role each of us plays behind the wheel,” Yang said in the news release.
These findings should motivate more focus on the importance of educating new and used car buyers about how safety technologies work, the study authors said.
Only about half of the drivers who purchased a new car from a dealership recalled being offered training on the new technology. Among those who were, nearly 90 percent completed the training.
AAA advises all new car owners to read up on the car’s safety devices and actually see how they work. Drivers should also ask the dealer questions to be sure they understand what these safety features will and will not do.
More information
Visit the AAA Exchange for more on driving safety.
SOURCE: AAA Foundation for Traffic Safety, news release, Sept. 26, 2018
Supreme Court takes up multibillion DSH payment dispute
The justices agreed to review a Circuit Court ruling that HHS had violated the Medicare Act in its reimbursement calculation for disproportionate share hospitals.
KEY TAKEAWAYS
The Supreme Court agreed to review the appellate ruling written by Judge Brett Kavanaugh.
At issue in this case is whether HHS has the discretion to engage in “interpretive rulemaking” without public notice-and-comment steps.
The dispute implicates up to $4 billion in reimbursements.
The U.S. Supreme Court agreed Thursday to review a case with major consequences for hospitals that serve high numbers of low-income patients.
The justices granted a request from Health and Human Services to revisit a lower court’s decision that had invalidated a piece of the government’s Medicare reimbursement calculations for disproportionate share hospital (DSH) payments.
Only nine hospitals, led by Allina Health Services, are party to the case. But their claims total $48.5 million in additional reimbursement for a single year. Since hundreds of similarly situated hospitals have filed dozens of follow-on lawsuits making similar claims, the total amount implicated in this dispute is $3-4 billion for fiscal years 2005 through 2013, HHS said in court filings.
By taking up the case, the Supreme Court agreed to review a ruling issued last year by the D.C. Circuit Court, which declared HHS in violation of the Medicare Act for changing the reimbursement formula without going through a public notice-and-comment rulemaking process for fiscal year 2012.
That decision, which overruled a District Court judgment in favor of HHS, was written by Judge Brett Kavanaugh, who is now President Donald Trump’s nominee to replace recently retired Justice Anthony Kennedy on the Supreme Court.
“Unlike the [Administrative Procedure Act], the text of the Medicare Act does not exempt interpretive rules from notice-and-comment rulemaking. On the contrary, the text expressly requires notice-and-comment rulemaking,” Kavanaugh wrote, knocking down a series of arguments HHS had raised.
This position is not universally agreed upon, however, as even Kavanaugh acknowledged.
“We recognize that we are breaking with several other courts of appeals by holding the Medicare Act does not incorporate all of the APA’s exceptions to the notice-and-comment requirement. … But we respectfully disagree with those opinions,” he wrote.
This disagreement among the circuit courts was one reason HHS cited in its request for the Supreme Court to review the case. But there were also suggestions that the eight sitting justices could shy away from reviewing this case at this time if they would expect a 4–4 tie.
“If the justices saw themselves as likely to be evenly divided on the merits in Allina, they could well decide to leave the issue for another day,” A.E. Dick Howard, a professor at the University of Virginia School of Law, told Bloomberg Law in August.
There were concerns, also, that Kavanaugh’s pending nomination could factor into the justices’ decision, since he is likely to recuse himself from the case, if confirmed.
The court’s order states that the justices will review one very specific question: “Whether 42 U. S. C. §1395hh(a)(2) or §1395hh(a)(4) required the Department of Health and Human Services to conduct notice-and-comment rulemaking before providing the challenged instructions to a Medicare Administrator Contractor making initial determinations of payments due under Medicare.”
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