Strayer Education announced that Capella University received notice that its regional accreditor, the Higher Learning Commission, has approved the change of ownership of Capella University in connection with the merger between Capella University’s parent company, Capella Education Company, and Strayer Education, Inc., the parent company of Strayer University, which will change its name to Strategic Education, Inc. The merger is expected to close on or before August 1.
Monday, July 9, 2018
Celgene, Acceleron hit endpoints in Phase 3 blood disorder study
Celgene Corporation (CELG) and Acceleron Pharma (XLRN) announced results from a phase III, randomized, double-blind, multi-center clinical study. Luspatercept achieved a highly statistically significant improvement in the primary endpoint of erythroid response, which was defined as at least a 33 percent reduction from baseline in red blood cell transfusion burden with a reduction of at least 2 units during the protocol-defined period of 12 consecutive weeks, from week 13 to week 24, compared to placebo. BELIEVE evaluated the efficacy and safety of luspatercept plus best supportive care versus placebo plus best supportive care in adults with transfusion-dependent beta-thalassemia. In addition to achieving the primary endpoint of the study, luspatercept also met all key secondary endpoints of demonstrating statistically significant improvements in RBC transfusion burden from baseline of at least a 33 percent reduction during the period from week 37 to week 48, at least a 50 percent reduction during the period from week 13 to week 24, at least a 50 percent reduction during the period from week 37 to week 48, and a mean change in transfusion burden from week 13 to week 24. Adverse events observed in the study were generally consistent with previously reported data. The companies also recently announced that luspatercept met the primary and key secondary endpoints in the MEDALIST study, a phase III, randomized, double-blind, multi-center clinical trial evaluating the efficacy and safety of luspatercept versus placebo in patients with IPSS-R very low, low or intermediate risk myelodysplastic syndromes with chronic anemia and refractory to, intolerant of, or ineligible for treatment with an erythropoietin-stimulating agent, ring sideroblast-positive and require frequent RBC transfusions. Data from BELIEVE and MEDALIST will be submitted to a future medical meeting in 2018. The companies plan to submit regulatory applications for luspatercept in the United States and Europe in the first half of 2019. Luspatercept is not approved for any indication in any geography.
Pfizer responds to Trump, says list price ‘unchanged’ for majority of medicines
CNBC’s Meg Tirrell tweeted a statement from Pfizer in response to an earlier tweet sent from U.S. President Donald Trump about drug prices. “The list price remains unchanged for the majority of our medicines,” Pfizer said. “Our portfolio includes more than 400 medicines and vaccines; we are modifying prices for approximately 10% of these, including some instances where we’re decreasing the price. Importantly, list prices do not reflect what most patients or insurance companies pay. In the first quarter of 2018 the net selling price increase was 0% due to the growing amount of rebates paid back to stakeholders in the biopharmaceutical supply chain.”
American Renal Associates, UnitedHealth execute binding settlement term sheet
American Renal Associates Holdings (ARA) and UnitedHealthcare, a UnitedHealth Group company (UNH) announced that they have executed a binding Settlement Term Sheet and will be negotiating terms of a definitive settlement by August 1, 2018. Under the terms of the Agreement, ARA will pay $32M and will follow certain procedures and share information with UnitedHealthcare. In conjunction with the Agreement, ARA and UnitedHealthcare will enter into a three-year network agreement, effective August 1, 2018, that will provide UnitedHealthcare plan participants with more cost effective, in-network access to all of ARA’s dialysis clinics in 26 states and the District of Columbia. The network agreement will include UnitedHealthcare’s health benefit products across the commercial, Medicare Advantage and Medicaid managed care markets, and will allow chronically-ill end-stage renal disease patients to better coordinate their access to care with ARA’s clinics and ARA-affiliated nephrologist partners who are part of the UnitedHealthcare network. The network agreement will also include certain value-based contracting features designed to improve quality and lower hospitalization costs for UnitedHealthcare plan participants who receive kidney care at ARA clinics. In a joint statement, the companies said, “We are pleased to have reached a resolution on this matter and we look forward to building a more cooperative relationship that enables us to collaborate on high quality care for dialysis patients.”
Weight Watchers started at buy by KeyBanc
Weight Watchers initiated with an Overweight at KeyBanc. KeyBanc started Weight Watchers with an Overweight rating and $115 price target.
HTG Molecular started at buy by Leerink
Leerink today initiated coverage of HTG Molecular with an Outperform rating for its stock and a target price of $6 per share.
In a note to investors, analyst Puneet Souda said that HTG has a growing funnel of biopharma partnerships and projects that have the potential to convert to US Food and Drug Administration-approved companion diagnostics and drive “significant revenue upside.”
He noted that the firm has about “40 early-stage projects in the mix from biopharma with hopes of increasing that number to 60 as the project funnel continues to grow.” Though timing remains unclear, he said, 10 percent of those should become “full-blown CDx projects” in the long term.
“We believe [HTG] will continue to differentiate itself from rest of the tumor-tissue diagnostics offerings on the market, given its unique chemistry and workflow that delivers higher sensitivity at low sample requirements,” Souda added. He further noted that despite the recent failure of a biopharma partner project trial in May, HTG’s upcoming project pipeline looks solid, given a backdrop of more than 3,000 oncology trials in the market.
Souda specifically pointed to a partnership agreement HTG inked with Qiagen in November 2016, noting that support from the partnership means HTG can deliver on the need of biopharma companies conducting oncology trials who are seeking partners that can deliver on companion diagnostics from assay development to regulatory approval. As part of the exclusive agreement, the companies are combining their technological and commercial strengths to offer pharma companies a next-generation sequencing solution for the development and commercialization of companion diagnostic tests with a focus on oncology.
HTG’s full-year revenue is likely to wind up at the lower end of its guidance of $21 million to $25 million for 2018, Souda said. However, he added, the firm’s research-use-only business — about 46 percent of its total sales — “should continue to deliver” with a long-term compound annual growth rate of 28 percent.
For good sleep for baby, food may be key
If there’s one thing frazzled new parents crave, it’s that their baby sleeps well.
Now, research suggests that the odds for good infant slumber rise when solid foods are introduced relatively early.
The British findings contradict some long-held guidelines on infant feeding, however, and were met with mixed reviews by experts in the United States.
Dr. Michael Grosso directs pediatrics at Northwell Health’s Huntington Hospital in Huntington, N.Y. He agreed with the findings, which he said are “debunking the widely held belief that infants woke up at night — or didn’t — for reasons that have nothing to do with food.”
But neonatal dietitian Meghan Reed, of Lenox Hill Hospital in New York City, disagreed. She said that “while there was a short period of time in which the infants [in the study] seemed to sleep better, it can be argued that the benefits [of early solid foods] do not outweigh the risks and possible future negative effects.”
Currently, the American Academy of Pediatrics recommends exclusive breast-feeding for new babies for the first six months of life. The AAP also notes that introducing solid foods to baby before 4 months of age has been linked to excess weight gain and body fat as children grow.
In short, conventional wisdom by experts has been that infant sleep is not influenced by how babies are fed.
Many parents have long disagreed, however. To help sort the issue out, researchers at King’s College London tracked the sleep and nutrition of more than 1,200 infants in the United Kingdom who were breast-fed only for their first three months.
The babies were then divided into two groups, with one group continuing to breast-feed exclusively for another three months, while the other group started solid foods while still being breast-fed.
Infants in the group that began solid foods at 3 months slept longer, woke less frequently at night and had fewer serious sleep problems than those who were breast-fed exclusively until 6 months of age, the researchers reported July 9 in JAMA Pediatrics.
Those differences peaked at 6 months, with the group introduced to solid foods earlier sleeping for nearly 17 minutes longer per night and nearly two hours longer per week, and the night waking decreasing from just over two times per night to 1.74 times per night.
“The results of this research support the widely held parental view that early introduction of solids improves sleep,” said study co-lead author Gideon Lack, professor of pediatric allergy at King’s College London.
“While the official guidance is that starting solid foods won’t make babies more likely to sleep through the night, this study suggests that this advice needs to be re-examined in light of the evidence we have gathered,” Lack said in a school news release.
U.S. pediatrician Grosso agreed, saying the study could prompt a new look at guidelines.
“This whole area seems to have been controversial for decades,” he noted. “Generations of pediatricians on both sides of the Atlantic have encouraged parents to delay the introduction of solid foods, [in part] based on expert opinion which said that this would limit food allergy.”
But Grosso noted that recent studies have suggested that the early and controlled introduction of certain allergens — peanut, most notably — can actually help prevent food allergies.
Likewise, with infant sleep, the new study may support early solid foods as a helpful measure, he said.
“A full tummy may turn out to be as good for making infants sleepy as it is for us big folk,” Grosso.
But Reed remained cautious. She still backs the directive that “if an infant seems hungry before 6 months of age, it is recommended to increase the volume of breast milk provided rather than introducing solid foods early.”
Reed said the study also left out one important group: babies who, for whatever reason, are formula-fed. She stressed that while breast milk is strongly preferred, it’s not clear what the study might mean for the millions of U.S. babies who gain their nutrition via bottle-feeding.
And Reed suggested that “this study could also be identified as subjective. One parent’s perception of a ‘very serious sleep problem’ might be ‘not a problem at all’ to another.”
More information
The American Academy of Pediatrics has more on babies and feeding.
SOURCES: Michael Grosso, M.D., chair, pediatrics, Northwell Health’s Huntington Hospital, Huntington, N.Y.; Meghan Reed, R.D., C.S.P., C.D.N., neonatal dietitian, Lenox Hill Hospital, New York City; King’s College London, news release, July 9, 2018
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