Georgia State Partners With American Cancer Society To Support National Tobacco-Free Campus Initiati
Monday, September 25, 2017 12:00 AM

ATLANTA—Researchers at Georgia State University’s School of Public Health are partnering with the American Cancer Society (ACS) on a project to help colleges and universities across the United States develop and implement tobacco-free policies.

ACS started the Tobacco-free Generation Campus Initiative (TFGCI) in 2016 with funds from the CVS Health Foundation to help 120 colleges and universities advocate for, adopt and implement 100 percent smoke- and tobacco-free campus policies. ACS estimates that of the 20 million college and university students in the country, 1 million will die prematurely due to smoking. Cigarette smoking remains responsible for nearly a third of all cancer deaths in the nation, and 99 percent of smokers take up the habit by the age of 26, making college campuses an ideal target for efforts to curb tobacco use, according to the ACS website for the initiative.

“We look forward to helping the American Cancer Society and participating universities in creating a tobacco-free generation of young people,” said Dr. Michael Eriksen, dean of the School of Public Health and an internationally recognized expert in tobacco control.

“Tobacco use still cuts too many lives short and causes serious health problems that burden individuals and society as a whole,” Eriksen said. “We want to do everything we can to support efforts to keep young people from getting addicted, and to help those who have started smoking or using tobacco in other forms to quit before they develop a deeply entrenched habit that is hard to break.”

Researchers Pamela Redmon and Amelia Jazwa will evaluate the effectiveness of the Tobacco-free Generation Campus Initiative by assessing tobacco use on participating campuses, the intentions to quit among students who use tobacco products, perceptions of anti-tobacco policies and their enforcement, among other issues.

The work is designed to help ACS gauge progress on participating campuses. For the first two cohorts of the program, ACS selected 64 campuses ranging from community colleges to major research universities such as the University of Michigan and Penn State University. The campuses serve more than 950,000 students across 27 states.

“College is a time when young people are susceptible to starting or developing a tobacco addiction,” said Richard C. Wender, M.D., chief cancer control officer of the American Cancer Society. “With the expert support from Georgia State University, we can ensure we are effectively reducing tobacco use among college students, and in turn, reducing the number of people who get sick and die from tobacco-related diseases.”

 
New Infographic: A Response to “A Better Deal” on Drug Pricing
Thursday, September 21, 2017 12:00 AM

The United States is the global leader in biomedical innovation, discovering more new cures than the rest of the world combined. We have brilliant scientists, world-class research institutions, and dedicated investors. But what sets us apart is a commitment to free-market policies that reward innovation and recognize the inherent costs and risks of discovering new treatments.

As BIO President and CEO Jim Greenwood says, “The only thing that can stop the next wave of new cures is bad policy.” That’s why BIO created a video to “follow the pill” and launched DrugCostFacts.org to explain how drug prices are setwho determines what patients pay out of pocket for prescription drugs, and what are the real drivers behind health care spending. Our goal is to ensure the right policies are in place to protect patients and the future of biomedical innovation.

That effort continues with the release of a new infographic. Recently, Democratic leaders released an economic agenda called “A Better Deal.” This agenda includes numerous claims on prescription drug costs and outlines policy proposals that would harm biomedical innovation and patients. It’s important for policymakers and the public to have all the facts, and that is precisely what this new infographic is intended to do.

 
Immune Cells Produce Wound Healing Factor, May Lead To New IBD Treatment Immune Cells Produce Wound
Wednesday, September 20, 2017 12:00 AM

ATLANTA—Specific immune cells have the ability to produce a healing factor that can promote wound repair in the intestine, a finding that could lead to new, potential therapeutic treatments for inflammatory bowel disease (IBD), according to a new research study.

The research team, led by Georgia State University and the University of Michigan, wanted to understand how a wound heals in the intestine because in IBD, which includes Crohn’s disease and ulcerative colitis, damage to the intestinal epithelial barrier allows bacteria in the intestine to go across the barrier and stimulate the body’s immune system. This can lead to excessive inflammation and IBD. Efficient repair of the epithelial barrier is critical for suppressing inflammation and reestablishing intestinal homeostasis.

In this study, the researchers found that a specific population of immune cells called macrophages have the ability to secrete or produce a protective or healing factor known as Interleukin-10 (IL-10), which can interact with receptors on intestinal epithelial cells to promote wound healing. The findings are published in The Journal of Clinical Investigation.

“Understanding how wounds can be healed is believed to be very important and a potential therapeutic avenue for the treatment of inflammatory bowel disease,” said Dr. Tim Denning, associate professor in the Institute for Biomedical Sciences at Georgia State. “In this study, we tried to understand some of the cellular mechanisms that are required for optimal wound healing in the intestine. To do this, we used a cutting-edge system, a colonoscope with biopsy forceps, to create a wound in mice. This is analogous to colonoscopies in humans. This cutting-edge system allowed us to begin to define what cells and factors contribute to wound healing in the mouse model.”

The researchers used a small, fiber optic camera and forceps to pinch the mouse’s intestine and take a small biopsy, just as how colonoscopies are done in humans. This small pinch created a wound, which the researchers observed as it healed. The study compared intestinal wound healing in two groups of mice: 1) typical mice (wild type) found in nature and 2) mice genetically deficient in the healing factor IL-10, specifically in macrophages, which impairs their ability to have normal wound repair.

The team also analyzed the effects of IL-10 on epithelial wound closure in vitro using an intestinal epithelial cell line.

They concluded that macrophages are a main source of IL-10 in the wound bed, and IL-10 stimulates in vitro intestinal epithelial wound healing and increases in expression during in vivo intestinal epithelial wound repair. In vitro, exposure to IL-10 increased wound repair within 12 hours and the response was further enhanced after 24 hours.

“Basically, you have a wound, and you have an immune cell that comes in,” Denning said. “That’s the macrophage. The macrophage can produce a factor (IL-10), and that factor can then cause the cells that are around the wound to start closing the wound.”

In addition, the researchers defined some of the signaling pathways that IL-10 uses to orchestrate wound repair. They found IL-10 promotes intestinal epithelial wound repair through the activation of cAMP response element-binding protein (CREB) signaling at the sites of injury, followed by synthesis and secretion of the WNT1-inducible signaling protein 1 (WISP-1).

“The implications are that understanding these cells, the factors and the pathways may offer us the ability to modulate this pathway during inflammatory bowel disease, which could lead to treatment and promote healing and recovery from inflammatory bowel disease,” Denning said. “There are different ways we think about it, but perhaps we could deliver the beneficial compounds (IL-10 and the downstream signaling pathways) to those patients, orally or even intravenously, or somehow drive the natural production of those compounds.”

Co-authors of the study include Dr. Asma Nusrat and Dr. Charles A. Parkos of the Department of Pathology at the University of Michigan, as well as researchers from Emory University, Technische Universität München and Ludwig-Maximilian University.

The study was funded by the National Institutes of Health, the Crohn’s and Colitis Foundation and the German Research Foundation.

To read the study, visit https://www.jci.org/articles/view/90229.

 
Neuroscience Professor Chassaing Receives $100,000 Innovator Award
Wednesday, September 20, 2017 12:00 AM

ATLANTA—Dr. Benoit Chassaing of Georgia State University’s College of Arts and Sciences has received a $100,000 Innovator Award from the Kenneth Rainin Foundation, part of $3 million awarded for Inflammatory Bowel Disease (IBD) research.

The grants will support researchers across the world as they study new ideas that could lead to breakthrough discoveries about IBD. Those who demonstrate significant progress are eligible for additional years of support.

Chassaing’s research involves the role of gut microbiota—which are known to be involved in a number of chronic inflammatory diseases—in intestinal inflammation. Chassaing and Dr. Andrew Gewirtz in the Institute for Biomedical Sciences have previously demonstrated in animal studies that food additives known as dietary emulsifiers, commonly found in processed foods to improve texture and extend shelf life, alter the composition of bacteria residing in the gut. They found such changes allowed bacteria to penetrate the mucus layer that lines and protects the intestine, which is normally sterile.

Chassaing will use the grant to study the impact of dietary emulsifiers on human microbiotas taken from IBD patients. The study will help advance scientific understanding of the non-genetic factors that contribute to IBD, and may result in new dietary advice for IBD patients.

“This year’s grantees are pursuing research that has the potential to yield important insights into this chronic disease.” said Dr. Laura Wilson, director of health strategy and ventures at the Kenneth Rainin Foundation. “Our Innovator Awards provide critical initial support to high-risk research that will help us improve the prevention and prediction, as well as better management, of the disease by doctors and patients.”

 
New indication for BRIVIACT® (brivaracetam): UCB’s newest antiepileptic drug approved by FDA as monotherapy treatment of partial-onset seizures in adults
Friday, September 15, 2017 12:00 AM
  • RIVIACT® CV provides a new monotherapy treatment option for epilepsy patients 16 years of age and older with partial-onset (focal) seizures, which can be initiated at a therapeutic dose at day one.
  • Approval applies a newly established regulatory pathway which allows monotherapy treatment options to reach epilepsy patients sooner.
  • New indication comes just 18 months after launch of BRIVIACT® in the U.S.

Atlanta, Georgia (U.S.) & Brussels (Belgium), 15 September, 2017 – 0700 (CEST): UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for BRIVIACT® (brivaracetam) CV as monotherapy for partial-onset (focal) seizures (POS) in patients 16 years and older with epilepsy.1

This is a new indication for BRIVIACT, which is already approved in the U.S. as adjunctive treatment for POS in patients in this age group. As a result, adults and adolescents aged 16 years and older with POS in the U.S. can now be initiated on BRIVIACT as monotherapy or adjunctive therapy.

BRIVIACT is the newest antiepileptic drug (AED) in the ‘racetam’ class of medicines and demonstrates a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to its anticonvulsant effects. Gradual dose escalation is not required when initiating treatment with BRIVIACT for monotherapy or adjunctive therapy, allowing clinicians to initiate treatment at a therapeutic dose from day one.1

The most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms1.

Please see additional BRIVIACT Important Safety Information below. 

“This new monotherapy indication builds on an already strong and compelling clinical profile for BRIVIACT, providing doctors the flexibility to tailor their choice of AED to match individual patient needs and circumstances,” explained Dr. Pavel Klein, director of the Mid-Atlantic Epilepsy and Sleep Center. “In helping to progress their journey towards seizure freedom by providing a choice of treatment which can be initiated as monotherapy, at a therapeutic dose, from day one, BRIVIACT provides an additional treatment choice for neurologists and their patients.”

UCB submitted a supplemental application for a BRIVIACT monotherapy indication taking into account a recent General Advice Letter, issued by the FDA,2 which stated it is acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of POS to their use as monotherapy for the treatment of POS. As a result of the FDA’s approach to assessing extrapolated data, UCB was able to support its BRIVIACT monotherapy submission with a wealth of brivaracetam clinical trials data, which involved more than 2,400 adult patients with POS.1

“We are delighted that, with this new monotherapy indication for BRIVIACT, we can support people with epilepsy to reach their treatment goals. Coming just 18 months after our launch in the U.S., this is evidence of our commitment to increasing the speed at which our therapies are approved and made available to as many patients as possible,” explained Jeff Wren, Executive Vice-President, Head of UCB’s Neurology Patient Value Unit. “Discovering, validating and improving access to new and innovative solutions to support people living with epilepsy has been, and will continue to be, a core UCB mission. With this BRIVIACT monotherapy indication, we build on our longstanding commitment to help people with seizure disorders at every point of their journey.”

About Epilepsy3,4,5,6

Epilepsy is a chronic neurological disorder of the brain. It is the fourth most common neurological condition worldwide and affects approximately 65 million people. In the U.S., more than 3 million people have epilepsy. Anyone can develop epilepsy; it occurs across all ages, races and genders, and is defined as one or more unprovoked seizures with a risk of further seizures. Around one third of patients with epilepsy currently live with uncontrolled seizures.

About UCB in Epilepsy

UCB has a rich heritage in epilepsy with over 20 years of experience in the research and development of antiepileptic drugs. As a company with a long-term commitment to epilepsy research, our goal is to address unmet medical needs. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies and other organizations who share our goals. At UCB, we are inspired by patients, and driven by science in our commitment to support patients with epilepsy.

About BRIVIACT 1,7

BRIVIACT (brivaracetam) is a new molecular entity that was rationally designed and developed by UCB.

Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect. However, the precise mechanism of action by which BRIVIACT exerts its anticonvulsant activity is not known.

In the U.S., BRIVIACT is approved as monotherapy and adjunctive therapy (a therapy used together with primary treatment) for the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. BRIVIACT is available in three formulations (film-coated tablets, oral solution, and injection).

In the European Union, BRIVIACT is approved as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. The European Medicines Agency has different regulatory requirements from FDA for approval of monotherapy indications.

Important Safety Information about BRIVIACT® in the U.S.1

Warnings and Precautions

  • Suicidal Behavior and Ideation: Antiepileptic drugs, including BRIVIACT, increase the risk of suicidal behavior and ideation. Monitor patients taking BRIVIACT for the emergence or worsening of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or self-harm. Advise patients, their caregivers, and/or families to be alert for these behavioral changes and report them immediately to a healthcare provider.
  • Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue, dizziness, and disturbance in coordination. Somnolence and fatigue-related adverse reactions were reported in 25% of patients taking at least 50 mg per day of BRIVIACT compared to 14% of patients taking placebo. Dizziness and disturbance in gait and coordination were reported in 16% of patients taking at least 50 mg per day of BRIVIACT compared to 10% of patients taking placebo. The risk is greatest early in treatment but can occur at any time. Monitor patients for these signs and symptoms and advise them not to drive or operate machinery until they have gained sufficient experience on BRIVIACT.
  • Psychiatric Adverse Reactions: BRIVIACT causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms. These events were reported in approximately 13% of patients taking at least 50 mg per day of BRIVIACT compared to 8% of patients taking placebo. A total of 1.7% of adult patients taking BRIVIACT discontinued treatment due to psychiatric reactions compared to 1.3% of patients taking placebo. Advise patients to report these symptoms immediately to a healthcare provider.
  • Hypersensitivity: BRIVIACT can cause hypersensitivity reactions. Bronchospasm and angioedema have been reported. Discontinue BRIVIACT if a patient develops a hypersensitivity reaction after treatment. BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients.
  • Withdrawal of Antiepileptic Drugs: As with all antiepileptic drugs, BRIVIACT should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.

Dosing Considerations

  • Dose adjustments are recommended for patients with all stages of hepatic impairment.
  • When BRIVIACT is co-administered with rifampin, an increase in the BRIVIACT dose is recommended.

Adverse Reactions

The most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.

BRIVIACT is a Schedule V controlled substance.

Please refer to full Prescribing Information at http://www.briviact.com/briviact-PI.pdf. 

For more information on BRIVIACT®, contact 844-599-CARE (2273).

BRIVIACT® is a registered trademark of the UCB Group of Companies.


For further information:

Corporate Communications

France Nivelle, Global Communications, UCB

T+32.2.559.9178, [email protected]

Jim Baxter, Neurology Communications, UCB

T+32.2.473.78.85.01, [email protected]

Investor Relations

Antje Witte, Investor Relations, UCB

T+32.2.559.94.14, [email protected]

Isabelle Ghellynck, Investor Relations, UCB

T +32.2.559.9588, [email protected]

About UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7 500 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

Forward looking statements - UCB

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations,  changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.

There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.

References:

  1. Briviact® U.S. Prescribing Information. Brussels, Belgium: UCB, 2017. https://www.briviact.com/briviact-PI.pdf  accessed 15th September 2017. 
  2. Data on File (FDA General Advice Letter, dated 09/13/2016)
  3. The Epilepsy Foundation of America. About epilepsy basics http://www.epilepsy.com/learn/about-epilepsy-basics  accessed 15th September 2017.
  4. The Epilepsy Foundation of America. What is epilepsy? http://www.epilepsy.com/learn/epilepsy-101/what-epilepsy  accessed 15th September 2017. 
  5. The Epilepsy Foundation of America. Who gets epilepsy? http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy accessed 15th September 2017. The Epilepsy Foundation of America. Who gets epilepsy ?http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy accessed August 30, 2017
  6. Centers for Disease Control and Prevention, Epilepsy Fast Facts https://www.cdc.gov/epilepsy/basics/fast-facts.htm  accessed 15th September 2017.
  7. Briviact® EU Prescribing Information. Brussels, Belgium: UCB, 2016. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003898/WC500200206.pdf    accessed 15th September 2017.
 
<< first < Prev 31 32 33 34 35 36 37 38 39 40 Next > last >>

Page 33 of 47