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Immunoglobulin A (IgA) antibodies protect against this disease. And preterm infants get IgA from their mother's breast milk during the first weeks of life, researchers from the University of Pittsburgh and UPMC Children's Hospital of Pittsburgh explained.

IgA antibodies bind to bacteria in the gut. The more bacteria that's bound with IgA, the less likely babies are to develop NEC, this study found.
"It's been well-known for a decade that babies who get NEC have particular bacteria -- Enterobacteriaceae -- in their guts, but what we found is that it's not how much Enterobacteriaceae there is, but whether it's bound to IgA that matters. And that's potentially actionable," said study senior author Timothy Hand. He's an assistant professor of pediatric infectious diseases at Pitt's School of Medicine.
The researchers analyzed fecal samples from 30 preterm infants with NEC and 39 without NEC. Breast-fed babies had more IgA-bound gut bacteria -- a good thing -- than formula-fed babies. Infants who developed NEC were more likely to have been formula-fed.
Among babies without NEC, Enterobacteriaceae was largely tied up by IgA, allowing diverse types of bacteria to flourish. But among infants with NEC, IgA-unbound Enterobacteriaceae dominated in the days before the disease was diagnosed, according to the researchers.
The study was published June 17 in the journal Nature Medicine.
As part of their research, the team bred mice that couldn't produce IgA in their breast milk. Pups that received IgA-free milk from their mothers were just as susceptible to NEC as those that were fed formula.
However, preventing NEC may not be as simple as adding IgA to infant formula, Hand said.
He noted that breast milk provides other benefits beyond IgA, so donor milk is the best choice if breastfeeding or pumped breast milk isn't an option.
"What we showed is that IgA is necessary but may not be sufficient to prevent NEC," Hand said in a university news release. "What we're arguing is that you might want to test the antibody content of donor milk and then target the most protective milk to the most at-risk infants."

Ailing Heart Can Speed the Brain's Decline, Study Finds

 The strong link between brain health and heart health is reinforced in a new study. The research showed that as cardiovascular health falters, so too does thinking and memory.
In one of the largest and longest studies of its kind to date, researchers studied a group of nearly 8,000 people in the United Kingdom. The participants were over 49 years of age and their health was tracked from 2002 to 2017.
Everyone in the study had relatively healthy hearts and brains at the beginning of the research. People with a history of stroke, heart attack, angina, dementia or Alzheimer's disease were excluded.
But over 15 years of follow-up, nearly 6% of the participants did go on to suffer a heart attack or angina (chest pain), according to a team led by Wuxiang Xie, a research fellow at the Imperial College School of Public Health in London.
The researchers found that all of these participants also displayed a faster decline in their mental function, concurrent with the heart trouble.
Patients who suffered from angina had a significant decline in tests of "temporal orientation" -- being able to accurately state the current date, day of week and time. Patients who had a heart attack showed a substantial decline in tests of verbal memory (assessed by a word-memory test) and language fluency. They also had the worse cognitive decline overall, the researchers found.
All of that is important, because "even small differences in cognitive function can result in an increased risk of dementia in the long-term," Xie said in a news release from the American College of Cardiology.
"Because there is no current cure for dementia, early detection and intervention are essential to delay the progression to dementia," Xie said. "Heart attack and angina patients need careful monitoring in the years following a diagnosis."
The connection between declines in memory and thinking and heart disease may be as simple as the brain not getting the amount of oxygen that it used to, the researchers theorized. Tiny "microinfarcts" -- heart-linked damage to small vessels in the brain -- might hamper blood flow and oxygen supply.
Two U.S. experts who reviewed the findings agreed that the heart-brain connection is crucial to health.
"This study further emphasizes that approaching the body holistically is crucial for brain health and to prevent dementia," said Dr. Gayatri Devi. She is a neurologist specializing in memory disorders at Lenox Hill Hospital in New York City.
"Brain health is dependent on heart health and health of the entire individual," Devi added.
Dr. Guy Mintz directs cardiovascular health at North Shore University Hospital in Manhasset, N.Y. He called the new study "a wake-up call for physicians to improve the risk factors associated with atherosclerosis [hardening of the arteries] early in life."
Mintz pointed out that "patients can live with heart disease, but patients and their families suffer from decline in brain function. Watching someone become mentally lost in life is tragic and, in some cases associated with atherosclerosis, may be preventable."
Devi stressed that keeping the brain sharp involves fitness of both mind and body.
"It is not enough to do Sudoku or crossword puzzles. It is just as important to take care of the body," she said. "Proven ways to prevent brain disease, including Alzheimer's dementia and stroke, are to take better care of one's heart and body, by exercising, eating and sleeping well, and refraining from smoking."
The new report was published June 17 in the Journal of the American College of Cardiology.

Ozanimod

 Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug

Administration (FDA) has accepted for review the New Drug Application for ozanimod for the treatment of people with relapsing forms of multiple sclerosis (RMS) in the United States. The European Medicines Agency (EMA) also accepted for review the Marketing Authorization Application for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) in the European Union. Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). Under the Prescription Drug User Fee Act, the FDA has set its action date as March 25, 2020. A regulatory decision from the EMA is expected in the first half of 2020.
Both applications are based primarily on ozanimod data from the SUNBEAM™ and RADIANCE™ Part B phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trials.
“The U.S. Food and Drug Administration and European Medicines Agency acceptances of our applications represent a crucial step forward in our efforts to bring ozanimod to people with multiple sclerosis,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “We believe that ozanimod has the potential to be an important option early in the treatment of relapsing forms of MS and a best-in-class S1P receptor modulator.”
Ozanimod is an investigational compound that is not approved for any use in any country.
About SUNBEAM™

SUNBEAM is a pivotal, phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of two doses of oral ozanimod (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI respectively) against weekly intramuscular interferon beta-1a (Avonex®) for at least a 12-month treatment period. The study included 1,346 people living with RMS across 152 sites in 20 countries.
The primary endpoint of the trial was annualized relapse rates (ARR) during the treatment period. The secondary MRI endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 12 months, number of gadolinium-enhanced brain MRI lesions at month 12 and percent change from baseline in whole brain volume at month 12. Cortical grey and thalamic volume changes were also prospectively assessed versus active comparator.
An analysis of the time to onset of 3-month confirmed disability progression was pre-specified using pooled data from both the SUNBEAM and RADIANCE Part B phase 3 trials.
About RADIANCE™

RADIANCE Part B is a pivotal, phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of two doses of oral ozanimod (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI respectively) against weekly intramuscular interferon beta-1a (Avonex®) over a 24-month treatment period. The study included 1,320 people living with RMS across 150 sites in 21 countries.
The primary endpoint of the trial was ARR over 24 months. The secondary MRI endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 24 months, number of gadolinium-enhanced brain MRI lesions at month 24 and percent change from baseline in whole brain volume at month 24. Cortical grey and thalamic volume changes were also prospectively assessed versus active comparator.
An analysis of the time to onset of 3-month confirmed disability progression was pre-specified using pooled data from both the SUNBEAM and RADIANCE Part B phase 3 trials.
About Ozanimod

Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). Ozanimod causes lymphocyte retention in lymphoid tissues. The mechanism by which ozanimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve the reduction of lymphocyte migration into the central nervous system.
Ozanimod is in development for immune-inflammatory indications including RMS, ulcerative colitis and Crohn's disease.
About Multiple Sclerosis

Multiple sclerosis (MS) is a disease in which the immune system attacks the protective myelin sheath that covers the nerves. The myelin damage disrupts communication between the brain and the rest of the body. Ultimately, the nerves themselves may deteriorate — a process that's currently irreversible. Signs and symptoms vary widely, depending on the amount of damage and the nerves affected. Some people living with MS may lose the ability to walk independently, while others experience long periods of remission during which they develop no new symptoms. MS affects approximately 400,000 people in the U.S. and approximately 2.5 million people worldwide.
RMS is characterized by clearly defined attacks of worsening neurologic function. These attacks — often called relapses, flare-ups or exacerbations — are followed by partial or complete recovery periods (remissions), during which symptoms improve partially or completely with no apparent progression of disease. RMS is the most common disease course at the time of diagnosis. Approximately 85 percent of patients are initially diagnosed with RMS, compared with 10-15 percent with progressive forms of the disease.
About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next‐generation solutions in protein homeostasis, immuno‐oncology, epigenetics, immunology and neuro‐inflammation. For  

HTX-011

Heron Therapeutics Receives Complete Response Letter For HTX-011 For The Management Of Postoperative Pain

SAN DIEGO, May 1, 2019 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a
commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on April 30, 2019 regarding its New Drug Application (NDA) for HTX-011 for the management of postoperative pain.
The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional CMC and non-clinical information. Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues, and there is no requirement for further clinical studies or data analyses.
"We plan to request a meeting with the FDA to obtain its agreement on our approach to resolve the issues outlined in the CRL and resubmit the NDA as soon as possible," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics.
About HTX-011 for Postoperative Pain

HTX-011, which utilizes Heron's proprietary Biochronomer® drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine solution in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from the FDA in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted an NDA to the FDA for HTX-011 in October of 2018 and received Priority Review designation in December of 2018. A CRL was received from the FDA regarding the NDA for HTX-011 on April 30, 2019. An MAA for HTX-011 was validated by the EMA in March 2019 for review under the Centralised Procedure.
About Heron Therapeutics, Inc.

Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer. For  

Avapritinib

Blueprint Medicines Submits New Drug Application to U.S. Food and Drug Administration for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST

CAMBRIDGE, Mass., June 14, 2019 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avapritinib for the treatment of adult patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST), regardless of prior therapy, and fourth-line GIST. Currently, no effective therapy exists for either population. Avapritinib is an investigational, potent and highly selective KIT and PDGFRA inhibitor for patients with advanced GIST.
Avapritinib has received Breakthrough Therapy Designation from the FDA for the treatment of patients with unresectable or metastatic GIST harboring the PDGFRα D842V mutation, as well as Fast Track Designations for the treatment of patients with GIST harboring a PDGFRα D842V mutation regardless of prior therapy, and patients with GIST who have progressed following treatment with imatinib and a second tyrosine kinase inhibitor.
Blueprint Medicines has requested priority review for the application, which, if granted, could result in a six-month review process. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.
"There is an important need for new treatment options that offer durable responses for PDGFRA Exon 18 mutant and fourth-line GIST patients," said Andy Boral, M.D., Ph.D., Chief Medical Officer at Blueprint Medicines. "By targeting the underlying molecular drivers of GIST, avapritinib has the potential to help these patients realize the benefits of precision therapy. We plan to work closely with the FDA to bring avapritinib to appropriate GIST patients as quickly as possible."
About GIST

GIST is a sarcoma, or tumor of bone or connective tissue, of the gastrointestinal (GI) tract. Tumors arise from cells in the wall of the GI tract and occur most often in the stomach or small intestine. Most patients are diagnosed between the ages of 50 to 80, and diagnosis is typically triggered by GI bleeding, incidental findings during surgery or imaging and, in rare cases, tumor rupture or GI obstruction.
Most GIST cases are caused by a spectrum of clinically relevant mutations that force the KIT or PDGFRA protein kinases into an increasingly active state. Because currently available therapies primarily bind to the inactive protein conformations, certain primary and secondary mutations typically lead to treatment resistance and disease progression.
In unresectable or metastatic GIST, clinical benefits from existing treatments can vary by mutation type. Mutational testing is critical to tailor therapy to the underlying disease driver and is recommended in expert guidelines. Currently, there are no approved therapies for patients with KIT-driven GIST whose disease progresses beyond imatinib, sunitinib and regorafenib. In patients with metastatic PDGFRα D842V-driven GIST, progression occurs in a median of approximately three to four months with available therapy.
About Avapritinib

Avapritinib is an investigational, oral precision therapy that selectively and potently inhibits KIT and PDGFRA mutant kinases. It is a type 1 inhibitor designed to target the active kinase conformation; all oncogenic kinases signal via this conformation. Avapritinib has demonstrated broad inhibition of KIT and PDGFRA mutations associated with GIST, including potent activity against activation loop mutations that are associated with resistance to currently approved therapies.
Blueprint Medicines is initially developing avapritinib for the treatment of advanced GIST, advanced systemic mastocytosis (SM), and indolent and smoldering SM. The FDA has granted Breakthrough Therapy Designation to avapritinib for two indications: one for the treatment of unresectable or metastatic GIST harboring the PDGFRα D842V mutation and one for the treatment of advanced SM, including the subtypes of aggressive SM, SM with an associated hematologic neoplasm and mast cell leukemia.
Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of avapritinib and certain other drug candidates in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for avapritinib in the rest of the world.
About Blueprint Medicines

Blueprint Medicines is a precision therapy company striving to improve human health. With a focus on genomically defined cancers, rare diseases and cancer immunotherapy, we are developing transformational medicines rooted in our leading expertise in protein kinases, which are proven drivers of disease. Our uniquely targeted, scalable approach empowers the rapid design and development of new treatments and increases the likelihood of clinical success. We are currently advancing four investigational medicines in clinical development, along with multiple research programs. For  

Meds for Blood Pressure, Cholesterol Help the Heart -- But Maybe Not the Mind

 While effective at cutting heart risks, blood pressure and cholesterol drugs may not help preserve seniors' brain health, new research finds.
That conclusion came from the tracking of more than 1,600 men and women in 21 countries.
Over an average span of nearly six years, all of the seniors took different combinations of drugs to lower blood pressure and/or statins to control high cholesterol. All took memory and thinking tests at the start and end of the study, the Canadian researchers said.
The result: None of the drugs appeared to have any impact on long-term mental declines.
Study author Jackie Bosch said her team was not really surprised by the findings. She is an investigator at the Population Health Research Institute and an associate professor in the School of Rehabilitation Science at McMaster University in Hamilton, Ontario.
Why no surprise? On the one hand, Bosch noted that "there have been few studies to demonstrate an effect of blood pressure-lowering on cognitive decline."
At the same time, "there have not been [any] studies to show a protective effect" linked to statins, with some prior research having raised "concerns, based on observational data, that statins [may even] cause memory loss," she added.
On the bright side, "results actually confirm that there is no greater cognitive decline in those taking statin compared to placebo," Bosch said. "So, no effect is actually reassuring in this case."
Worldwide, roughly 1 in 10 individuals over the age of 60 suffer from some degree of thinking impairment, the investigators noted.
Prior research has suggested that living with uncontrolled high blood pressure and/or high cholesterol during middle age may raise the long-term risk for developing thinking declines.
Still, research has been mixed as to whether that risk can be limited by taking drugs to control heart disease risk factors.
In the latest study, published online Feb. 27 in the journal Neurology, the participants were an average age of 74, while 6 in 10 were women. Just under half (45 percent) had high blood pressure, and all were believed to face a moderate risk for developing heart disease.
Over the course of the study, all participants took one of four daily regimens: a high blood pressure drug combination including 16 milligrams (mg) of the ARB (angiotensin II receptor blocker) medication candesartan (Atacand) along with 12.5 mg of the diuretic hydrochlorothiazide (Microzide); or a daily 10 mg pill of the cholesterol-lowering drug rosuvastatin (Crestor); a combination of the two; or a placebo pill.
All participants underwent a battery of thinking and memory tests, both when the study began and ended, along with biannual physical checkups.
In the end, the drugs were found to have no effect on mental health outcomes.
Still, Bosch acknowledged that more research would be needed to explore the possibility that such drugs might prove protective if started earlier in life and taken over a longer period of time.
That point was seconded by Keith Fargo, director of scientific programs and outreach with the Alzheimer's Association in Chicago. He agreed that "certainly, more research is needed in this area."
For one, Fargo underscored the fact that other investigations had come to different conclusions. In particular, he highlighted the findings of the recent SPRINT MIND study, which weighed similar questions among a larger pool of patients.
The SPRINT study, said Fargo, permitted doctors to prescribe any blood pressure control med they wanted, in contrast to the Bosch effort, which only explored the potential impact of a few specific medications.
And the SPRINT investigation did find that "lowering blood pressure in people with existing hypertension significantly decreases risk for developing mild cognitive impairment [MCI]," Fargo said.
So the latest investigation, suggested Fargo, is not the final word, and "should not be interpreted to mean that controlling heart health risk factors is ineffective in decreasing risk for cognitive impairment or dementia."