Mouth May Tell The Tale Of Lung Damage Caused By Smoking
Posted on April 21, 2008
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Mouth May Tell The Tale Of Lung Damage Caused By Smoking
Main Category: Smoking / Quit Smoking
Also Included In: Respiratory / Asthma; Genetics; Clinical Trials / Drug Trials
Article Date: 14 Apr 2008 - 0:00 PDT
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Cells lining the mouth reflect the molecular damage that smoking does to the lining of the lungs, researchers at The University of Texas M. D. Anderson Cancer Center report today at the annual meeting of the American Association for Cancer Research.
Examining oral tissue lining the mouth to gauge cancer-inducing molecular alterations in the lungs could spare patients and those at risk of lung cancer from more invasive, uncomfortable procedures used now, said senior researcher Li Mao, M.D., professor in M. D. Anderson’s Department of Thoracic/Head and Neck Medical Oncology.
“We are talking about just a brushing inside of the cheek to get the same information we would from lung brushings obtained through bronchoscopy,” said study presenter and first author Manisha Bhutani, M.D., a post-doctoral fellow in Thoracic/Head and Neck Medical Oncology.
The team examined the oral and lung lining tissue called the epithelium - in 125 chronic smokers enrolled in a large, prospective lung cancer chemoprevention study.
The status of two crucial tumor-suppressing genes was analyzed. The genes, p16 and FHIT, are known to be damaged or silenced very early in the process of cancer development. “There is substantial damage long before there is cancer,” Mao said.
Study participants gave both an oral and lung sample initially and then another at three months. The researchers tracked whether either p16, FHIT or both had been silenced by methylation - the attachment of a chemical methyl group to crucial spots in a gene that shut down its function. Patterns of methylation were compared between the tissues.
The baseline tissue comparison showed methylation of p16 in the lungs of 23 percent of study participants, of FHIT in 17 percent and of either of the two genes in 35 percent. The percentages were similar in oral tissue, with p16 methylated in 19 percent, FHIT in 15 percent and one of the two in 31 percent.
Strong correlations were observed between methylation patterns in both tissues. When methylation of either gene was considered positive, 37 of the 39 individuals (95 percent) with p16 and/or FHIT promoter methylation in the oral samples had promoter methylation in at least one matched bronchial sample. This compared with only 59 of the 86 (69 percent) individuals without the promoter methylation in the oral samples. Similar correlations were seen at the three-month analysis.
“Our study provides the first systematic evidence that accessible tissue, the oral epithelium, can be used to monitor molecular events in less accessible tissue,” Bhutani said. “This provides a convenient biomonitoring method to provide insight into the molecular events that take place in the lungs of chronic smokers.”
One follow-up area of study is to find additional biomarkers in oral tissue. “We hope that our findings encourage researchers to test an increasing compendium of biomarkers to confirm the reliability of oral epithelium not only in lung cancer chemoprevention but also in therapeutic settings” said Ashutosh Kumar Pathak, M.D., another key study author and a post-doctoral fellow in Surgical Oncology.
“Our study opens the door to enhancing our ability to predict who has higher probability of getting tobacco-related cancers,” Mao said. “Not only lung cancer, but pancreatic, bladder and head-and-neck cancers, which also are associated with tobacco use.”
The study was funded as part of a grant National Cancer Institute to evaluate celecoxib, known commercially as Celebrex, as a preventive agent against lung cancer.
Co-authors with Bhutani, Mao and Pathak, are You Hong Fan, Jonathan Kurie, Edward Kim, and M. D. Anderson Chair of the Division of Cancer Medicine Waun Ki Hong, all of the Department of Thoracic/Head and Neck Medical Oncology; Diane Liu, of M. D. Anderson’s Division of Quantitative Sciences; J. Jack Lee, of the Department of Biostatistics; Hongli Tang, of the Department of Molecular Genetics; and Rodolfo Morice of the Department of Pulmonary Medicine.
University of Texas M. D. Anderson Cancer Center
1515 Holcombe Blvd., Box 229
Houston, TX 77030
United States
http://www.mdanderson.org
Arena Pharmaceuticals Initiates Phase 2b Clinical Trial Of APD125 For The Treatment Of Insomnia
Posted on April 21, 2008
Filed Under Sleep Disorders | Leave a Comment
Arena Pharmaceuticals Initiates Phase 2b Clinical Trial Of APD125 For The Treatment Of Insomnia
Main Category: Sleep / Sleep Disorders / Insomnia
Also Included In: Clinical Trials / Drug Trials; Pharma Industry / Biotech Industry
Article Date: 09 Apr 2008 - 0:00 PDT
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Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) announced that it initiated
screening in a Phase 2b clinical trial of APD125 in patients with primary
insomnia. APD125 is an oral drug candidate discovered by Arena with the
potential to reduce insomnia symptoms and improve sleep maintenance and
quality.
The Phase 2b trial of APD125 is a double-blind, randomized, placebo-
controlled subjective study evaluating the efficacy and tolerability of
APD125 in patients with primary insomnia characterized by difficulty
maintaining sleep. The trial, which is expected to enroll a total of
approximately 675 male and female patients in about 70 clinical sites in
the United States, will evaluate two doses (20 mg and 40 mg) and placebo
over 14 nights of treatment. The trial will evaluate standard subjective
measurements of sleep, including change from baseline in subjective number
of awakenings after sleep onset (sNAASO), which is the primary endpoint.
“We are very encouraged by the emerging profile of APD125. We believe
APD125 has the potential to significantly improve sleep maintenance and
quality for patients with insomnia without the potential for dependence or
impairing psychomotor function,” said Jack Lief, Arena’s President and
Chief Executive Officer. “Results from this trial are expected around year
end, and we believe they will increase our understanding of APD125 while
supporting ongoing partnership efforts.”
In a Phase 2a trial, when compared to placebo, patients treated with
APD125 achieved statistically significant improvements in objective
measurements of sleep maintenance, or the ability to maintain sleep during
the night after falling asleep, and sleep architecture. The improvements
were achieved without any limiting next day cognitive effects. In both the
Phase 1 program and the Phase 2a trial, APD125 was well tolerated at all
doses investigated.
About APD125
Discovered by Arena, APD125 is a novel and oral selective inverse
agonist of the 5-HT2A serotonin receptor. The vast majority of approved
drugs for insomnia activate the GABA-A receptor complex in the brain,
causing a general suppressive effect on the central nervous system, or CNS.
These GABAergic drugs are generally associated with CNS side effects,
including a sensation of dullness and lethargy upon awakening, often
referred to as the “hangover effect.” Other potential problems associated
with the GABAergic drugs include the risk of developing tolerance and drug
dependency in at-risk populations. In addition, GABAergic drugs are
scheduled controlled substances by the Drug Enforcement Administration due
to their potential for abuse.
By selectively targeting the 5-HT2A receptor, APD125 acts through a
different mechanism than currently marketed insomnia drugs and blocks one
of several CNS activating pathways. Because of the different mechanism of
action, APD125 may not have the side effects or abuse potential generally
associated with currently approved GABAergic drugs. Through its novel
mechanism, APD125 has the potential to reduce insomnia symptoms by
improving sleep maintenance.
About Insomnia
Insomnia is characterized by inadequate or poor sleep due to
nonrefreshing sleep, frequent wakening with difficulty falling back to
sleep, difficulty falling asleep or waking too early. Most insomnia
complaints relate to sleep maintenance issues, such as waking frequently or
awakening too early, as opposed to problems with sleep latency (i.e.
falling asleep). About 30% of US adults report some level of insomnia in
the course of a year, and about 10% of US adults indicate that their
condition is chronic. In these cases, the lack of restful sleep impairs the
person’s ability to carry out their daily responsibilities because they are
too tired or have trouble concentrating.
Insomnia has a variety of causes. It is often a symptom of some other
disease or condition (e.g. life stress, psychiatric and medical disorders,
or use of certain medications), but it can also be a distinct disorder. The
prevalence of insomnia increases with age and is more common in women.
Common symptoms of acute insomnia are sleepiness, negative mood and
impairment of performance. Chronic insomnia is often associated with
fatigue, mood changes, difficulty concentrating and impaired daytime
functioning.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on
discovering, developing and commercializing oral drugs in four major
therapeutic areas: cardiovascular, central nervous system, inflammatory and
metabolic diseases. Arena’s most advanced drug candidate, lorcaserin, is
being investigated in a Phase 3 clinical trial program for the treatment of
obesity. Arena’s broad pipeline of novel compounds targeting G
protein-coupled receptors, an important class of validated drug targets,
includes compounds being evaluated independently and with its partners,
Merck & Co., Inc. and Ortho-McNeil Pharmaceutical, Inc.
Arena Pharmaceuticals(R) and Arena(R) are registered service marks of
the company. “APD” is an abbreviation for Arena Pharmaceuticals
Development.
Forward Looking Statements
Certain statements in this press release are forward-looking statements
that involve a number of risks and uncertainties. Such forward-looking
statements include statements about the continued development of APD125;
the protocol, design, scope, enrollment, number, timing and other aspects
of clinical trials of APD125; the timing of the results from the Phase 2b
clinical trial of APD125 and expectations related to such results; the
tolerability, side effects, safety profile, efficacy and the commercial and
other potential of APD125 and other of Arena’s drug candidates; the
possibility of APD125 to be a non-scheduled treatment; the relevance of
indicators of sleep maintenance; the advancement and content of Arena’s
pipeline; and other statements about Arena’s vision, outlook, strategy,
preclinical and internal and partnered clinical programs, and ability to
develop compounds and commercialize drugs. For such statements, Arena
claims the protection of the Private Securities Litigation Reform Act of
1995. Actual events or results may differ materially from Arena’s
expectations. Factors that could cause actual results to differ materially
from the forward-looking statements include, but are not limited to,
clinical trials and studies may not proceed at the time or in the manner
Arena expects or at all, the results of clinical trials or preclinical
studies may not be predictive of future results, Arena’s ability to partner
lorcaserin, APD125, APD791 or other of its compounds or programs, the
timing, success and cost of Arena’s research, out- licensing endeavors and
clinical trials, Arena’s ability to obtain additional financing, Arena’s
ability to obtain and defend its patents, the timing and receipt of
payments and fees, if any, from Arena’s collaborators, and Arena’s ability
to redeem with common stock any outstanding shares of its series B
convertible preferred stock. Additional factors that could cause actual
results to differ materially from those stated or implied by Arena’s
forward- looking statements are disclosed in Arena’s filings with the
Securities and Exchange Commission. These forward-looking statements
represent Arena’s judgment as of the time of this release. Arena disclaims
any intent or obligation to update these forward-looking statements, other
than as may be required under applicable law.
Arena Pharmaceuticals, Inc.
http://www.arenapharm.com
New Data Confirm Pramipexole (Mirapexin®/Sifrol®) Can Significantly Reduce Sleep Disturbance For People With Restless Legs Syndrome (RLS)
Posted on April 21, 2008
Filed Under Sleep Disorders | Leave a Comment
New Data Confirm Pramipexole (Mirapexin®/Sifrol®) Can Significantly Reduce Sleep Disturbance For People With Restless Legs Syndrome (RLS)
Main Category: Neurology / Neuroscience
Also Included In: Sleep / Sleep Disorders / Insomnia; Clinical Trials / Drug Trials; Pharma Industry / Biotech Industry
Article Date: 21 Apr 2008 - 0:00 PDT
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A new study has shown that pramipexole (Mirapexin®/Sifrol®) can significantly reduce sleep disturbance, often the most troublesome symptom experienced by people with Restless Legs Syndrome (RLS).1 The important finding, presented at the 60th Annual Meeting of the American Academy of Neurology (AAN) in Chicago, U.S.A., highlights the benefit of an RLS treatment which effectively targets the core symptoms of the condition, such as an uncontrollable urge to move the legs as well as secondary symptoms including sleep disturbance. For the many people affected by Restless Legs Syndrome, this means that overall sleep patterns and quality of life can be greatly improved with pramipexole, - a fast-acting treatment which has been shown to bring relief already after one night.2
According to Professor Luigi Ferini-Strambi from the Sleep Disorders Center, Università Vita-Salute, San Raffaele, Milan (Italy) and lead author of the study: “Most people with RLS who seek medical advice have often suffered for a long time from sleep deprivation due to the debilitating impact of RLS. To feel the benefit of a simple, effective treatment right from the start, is a huge step forward for these patients. Beyond enabling them to sit comfortably through an evening, they can look forward to a night of sleep without being disturbed by the uncontrollable urge to move their legs. For many people with RLS, this means that they can finally start regaining their quality of life.”
In the study, a randomised, double blind and placebo controlled trial in adults with scores >15 on the International RLS Study Group Rating Scale (IRLS) and symptoms at least 2-3 times per week, improvements were assessed based on the MOS* sleep scale. The study was the first-ever evaluating the effect of pramipexole on sleep, using a multi-dimensional patient-reported instrument. Sleep disturbance scores for the patient group treated with pramipexole were reduced from 52.5 to 27.8 after 12 weeks from baseline compared to 55.6 to 38.5 in the placebo group (p=0.0001), i.e. the pramipexole treated patient group reaching a near to normal level, and in some instances already after the first night of treatment2 (a score of 24.5 is considered normal).1
Although worsening of symptoms at night is a hallmark of RLS, many people with RLS also experience bothersome symptoms during the day. Furthermore, daytime function is also disrupted by somnolence due to sleep disturbance, further heightening the need for fast acting treatment options that effectively treat both the night and daytime symptoms of the condition.
In a study assessing the rapid onset and sustained efficacy of pramipexole, rapid symptom improvements were shown after the first intake, reached their peak after four weeks and were maintained throughout the 12 week trial. Adjusted mean changes from baseline on IRLS were greater for pramipexole at all item points: day 9, day 14, week 4 and week 12 (p<0.0001 for all versus placebo). Patient Global Impression (PGI) responder rates were improved over placebo at day 1 (16.4% vs 8%), day 5 (36.2% vs 15.2%), day 9 (44.1% vs 19.6%), day 14 (53.1% vs 34.1%), week 4 (65.7% vs 39.7%) and week 12 (62.9% vs 38%).2
The effect of pramipexole on daytime symptoms of RLS was shown in another study. This study showed a median baseline of 4.0 in both severity of daytime symptoms at rest and daytime sleepiness, as measured with the RLS-6 scale (0 = none/not at all, 10 = very severe). At week 12, the median reduction was 2.0 (pramipexole) versus -1.0 (placebo) for daytime RLS severity (p = 0.0017) and -2.0 versus -1.0 (p = 0.0024) for daytime sleepiness.3
Overall the data presented at AAN reaffirm pramipexole as a highly effective and fast-acting treatment for Restless Legs Syndrome, in many cases even at the lowest dose and already after one night. Pramipexole not only alleviates the very unpleasant and sometimes painful feelings in the legs experienced by patients with RLS during periods of rest, but can also improve daytime RLS symptoms.
Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.
Medical Outcomes Study (MOS) sleep scale
The MOS Sleep Scale is a self-administered scale measuring specific aspects of sleep (problems with sleep disturbance [initiation and maintenance], adequacy, somnolence, quantity, respiratory impairments and snoring). It was designed for use in patients who may have varying co-morbidities. The frequency with which each problem has been experienced during the previous 4 weeks is rated on a 6-point scale ranging from `none of the time` to `all of the time`, except sleep quantity, which is reported in hours. All scores are transformed linearly to range from 0 to 100 with the exception of the sleep quantity subscale, which is scored in hours. Higher scores indicate more of the attribute implied by the scale name (e.g. more sleep disturbance, more adequate sleep, greater sleep quantity).
About Restless Legs Syndrome (RLS)
Restless Legs Syndrome is a neurological disorder characterised by an uncontrollable urge to move the legs, usually accompanied by unpleasant and sometimes painful sensations in the legs. Restless Legs Syndrome affects up to ten percent of the population worldwide aged between 30 and 79 years4 and around one-third of sufferers experience symptoms more than twice weekly causing moderate to severe distress.5 The motor-restlessness worsens during the evening and night causing difficulty initiating and maintaining sleep. The sleep disruption can lead to excessive daytime sleepiness and compromise work performance. Restless Legs Syndrome also has considerable impact on social activities that require immobility.
About pramipexole
Pramipexole (known in Europe under the trade names Mirapexin® and Sifrol® and in the U.S.A. as Mirapex®) is a compound from Boehringer Ingelheim research first approved in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson`s disease, as monotherapy or in combination with levodopa. Pramipexole was approved in 2006 for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS). Pramipexole is currently registered in over 80 countries across the globe.
The most commonly reported adverse reactions in clinical trials for Restless Legs Syndrome were nausea, headache, dizziness and fatigue.The most commonly reported adverse reactions in early and late Parkinson’s disease in clinical trials were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Pramipexole may cause patients to fall asleep without any warning, even while doing normal daily activities such as driving. When taking pramipexole hallucinations may occur and sometimes patients may feel dizzy, sweaty or nauseated upon standing up. It should be noted that impulse control disorders/compulsive behaviours may occur while taking medicines to treat Parkinson`s disease, including pramipexole.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
References:
1. Ferini-Strambi L et al. Pramipexole for Restless Legs Syndrome and associated sleep disturbance. Presented 16 April 2008, 60th Annual Meeting of the American Academy of Neurology (AAN), Chicago (IL), U.S.A.; Poster # P05.172.
2. Ferini-Strambi L et al. Rapid onset and sustained efficacy of pramipexole in Restless Legs Syndrome. Presented 16 April 2008, 60th Annual Meeting of the American Academy of Neurology (AAN), Chicago (IL), U.S.A.; Poster # P05.164.
3. Partinen M et al. Effects of pramipexole on daytime symptoms of Restless Legs Syndrome. Presented 16 April 2008, 60th Annual Meeting of the American Academy of Neurology (AAN), Chicago (IL), U.S.A.; Poster # P05.165.
4. Phillips B et al. Epidemiology of Restless Legs symptoms in adults. Arch Intern Med 2000; 160(14): 2137-2141.
5. Allen RP et al. Restless Legs Syndrome prevalence and impact: REST general population study. Arch Intern Med 2005; 165(11): 1286-1292.
Boehringer Ingelheim
http://www.boehringer-ingelheim.com
View drug information on pramipexole
Critical Health Care Does Not Reach Most Women And Children In High Mortality Countries, Despite Gains In Fighting Child Killer Diseases
Posted on April 21, 2008
Filed Under Women's Health | Leave a Comment
Critical Health Care Does Not Reach Most Women And Children In High Mortality Countries, Despite Gains In Fighting Child Killer Diseases
Main Category: Pregnancy / Obstetrics
Also Included In: Women’s Health / Gynecology; Pediatrics / Children’s Health
Article Date: 17 Apr 2008 - 5:00 PDT
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Leading global health experts, policy-makers and parliamentarians are convening in Cape Town to address the urgent need for accelerated progress to reduce maternal, newborn and child deaths, if internationally-agreed targets are to be met.
According to the 2008 report Tracking Progress in Maternal, Newborn & Child Survival released, few of the 68 developing countries that account for 97% of maternal and child deaths worldwide are making adequate progress to provide critical health care needed to save the lives of women, infants and children. Parliamentarians attending the 118th Assembly of the Inter-Parliamentary Union in Cape Town will join global health experts and policy makers to discuss the role they can play in accelerating action to achieve Millennium Development Goals 4 and 5 on reducing child and maternal mortality.
Over 10 million women and children still die each year from causes which are largely preventable and treatable. The majority of maternal and child deaths occur in Africa and South Asia, with sub-Saharan Africa increasingly bearing the global burden of mortality. One in five children are born in sub-Saharan Africa, yet some 50% of all child deaths globally occur in the region, as do half of maternal deaths worldwide. In Niger, for example, women face a lifetime risk of dying in pregnancy or childbirth which is as high as one in seven.
Tracking Progress in Maternal, Newborn & Child Survival uses existing data to measure coverage of key interventions and approaches proven to reduce maternal and child mortality. The 2008 report highlights the rapid progress that many of the 68 countries are making in providing vaccinations, vitamin A supplementation coverage and insecticide-treated mosquito nets to prevent major killers such as measles and malaria.
Nonetheless, treatment for potentially fatal illnesses and other vital health services still fail to reach the majority of women and children according to the findings. These services are dependent on strong health systems that can provide 24-hour care within the community, at health clinics, and through a functioning referral system when more serious intervention is necessary. Access to these services is most critical at the time of birth and during the first two weeks of life which are riskiest for mother and infant.
Tracking Progress in Maternal, Newborn & Child Survival identifies a series of missed opportunities to save lives:
- Family planning: The unmet need for contraceptives is high. Only one-third of women in the 68 priority countries are using a modern contraceptive method - a proven means of boosting maternal and infant survival;
- Skilled care at birth: Only around half of women and newborns benefit from a skilled birth attendant at the time of birth, and even fewer receive care in the critical days and weeks after childbirth;
- Clinical care for sick children: Only about one-third of children with pneumonia - the biggest single killer of children - receive treatment;
- Nutrition: Undernutrition is the underlying cause of 3.5 million child deaths annually, and as many as 20 per cent of maternal deaths.
Despite these missed opportunities, the report also notes that a number of countries, including China, Haiti, Turkmenistan and several countries in sub-Saharan Africa, have made demonstrable progress in reducing deaths of children under-five in the past three years. Sixteen of the 68 Countdown priority countries are now ‘on track’ to achieve Millennium Development Goal 4.
To pave the way for a well-functioning ‘continuum of care’, governments and their partners must address obstacles such as weak health systems, funding shortages, and inequalities in access to care. The report findings show poor families missing out twice, on skilled care at birth and on care for newborns and children when they are ill. Other barriers include armed conflict and a high HIV prevalence, which together have erased any gains in child survival in at least 12 African countries.
Overall funding from donor governments for maternal, newborn and child health has increased in recent years, with Official Development Assistance (ODA) rising from US$2.1 billion to almost US$3.5 billion between 2003-2006, a 64 percent increase. This investment has resulted in significant health gains, notably to boost immunization levels and prevent malaria, Nonetheless, health systems for maternal, newborn and child health remain grossly under-funded in relation to the needs of priority countries. Total donor funding for maternal, newborn and child health still represents just 3% of total donor aid disbursements. Most donor assistance is delivered through specific projects and only 5% has been dedicated to general budget support in recipient countries.
The Countdown findings will be discussed during a three day conference in South Africa, from
17-19 April. The Countdown findings are also the subject of a special issue of the medical journal The Lancet.
Countdown to 2015: Maternal, Newborn and Child Survival is a collaborative effort of United Nations agencies, non-governmental organizations, universities, and other institutions and individuals established to track progress towards Millennium Development Goals 4 and 5, to reduce child and maternal mortality respectively. For more information, visit http://www.countdown2015mnch.org.
Countdown to 2015 partners: Aga Khan University, Australian Agency for International Development (AusAID), The Basic Support for Institutionalizing Child Survival (BASICS) Project, USAID, Bellagio Child Survival Group, Department for International Development, UK (DfID), Family Care International, International Paediatric Association, Johns Hopkins University, London School of Hygiene and Tropical Medicine, The Norwegian Agency for Development Cooperation (Norad), Save the Children, The Bill & Melinda Gates Foundation, The Lancet, The Partnership for Maternal, Newborn & Child Health, The World Bank, University College London Centre for International Health and Development, United Nations Population Fund (UNFPA, United Nations Children’s Fund (UNICEF), Universidade Federal de Pelotas, University of Aberdeen, USAID and the World Health Organization.
For video b-roll : Visit http://www.thenewsmarket.com/unicef to access broadcast quality footage from Nepal (”Applying Life-Saving Interventions to Save Nepalese Newborns”) and Senegal (”A Rural Healthcare Center Plays Key Role in Reducing Infant and Child Mortality”).