Category Archives: Collaborations

Launch of first breast cancer biosimilar in the UK

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MSD has announced the launch of Ontruzant®, (trastuzumab), a biosimilar referencing Herceptin® (trastuzumab/TRZ), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

This was the first trastuzumab biosimilar to receive regulatory approval in Europe and is the first to launch in the UK.

Biosimilar trastuzumab represents the first product approved in the UK under a global biosimilars development and commercialisation agreement between MSD and Samsung Bioepis Co Ltd.

The European Medicines Agency (EMA) requires biosimilars to show they are highly similar to the reference medicine in terms of structure, biological activity and efficacy, safety and immunogenicity profile. Ontruzant (trastuzumab biosimilar (SB3)) is a monoclonal antibody and has been shown to have similar safety and efficacy as its reference product Herceptin (TRZ) in early breast cancer, with breast pathologic complete response rates (bpCR) being 51.7% and 42.0% with SB3 and TRZ respectively. The adjusted ratio of bpCR was 1.259 (95%CI, 1.085 to 1.460), which was within the predefined equivalence margins. The adjusted difference was 10.70% (95% CI, 4.13% to 17.26%), with the lower limit contained within and the upper limit outside the equivalence margin. The overall response rates were 96.3% and 91.2% with SB3 and TRZ.

Dr Mark Verrill, Head of the Department of Medical Oncology at the Newcastle upon Tyne Hospitals NHS Foundation Trust, and the deputy lead clinician for breast cancer in the North of England Cancer Network said, “This is good news for so many cancer patients and the NHS. The launch of biosimilar trastuzumab provides a high-quality treatment alternative for patients, while offering significant potential savings for the NHS. The biggest category of medicines in oncology is monoclonal antibodies and the introduction of biosimilars such as trastuzumab could provide a substantial cost saving.”

Denise Blake, Senior Lead Clinical Pharmacist at Newcastle Hospitals, explains, “The introduction of biosimilar trastuzumab provides an opportunity for the NHS to realise substantial financial savings without compromising patient care. Close collaboration between oncologists, pharmacists and nursing staff is required to ensure a seamless introduction into routine clinical practice.”

“As a company committed to inventing new treatment options for both common and neglected types of cancer, MSD is also pleased to be offering the NHS a biosimilar medicine in an established area of care. Biosimilar trastuzumab marks a significant milestone for both MSD and the oncology community, providing the UK’s first biosimilar trastuzumab, based on our collaboration with Samsung Bioepis,”explains Louise Houson, UK Managing Director, MSD.

Regulatory approval was based on a Phase III study that compared SB3 with reference TRZ in patients with human epidermal growth factor receptor HER-2 positive early breast cancer in the neoadjuvant setting.

The study showed the total pathologic complete response rates were 45.8% and 35.8% and the overall response rates were 96.3% and 91.2% with SB3 and TRZ, respectively. Eight hundred patients were included in the per-protocol set (SB3, n = 402; TRZ, n = 398). The bpCR rates were 51.7% and 42.0% with SB3 and TRZ, respectively. The adjusted ratio of bpCR was 1.259 (95%CI, 1.085 to 1.460), which was within the predefined equivalence margins. The adjusted difference was 10.70% (95% CI, 4.13% to 17.26%), with the lower limit contained within pre-specified equivalence margins and the upper limit of the confidence interval slightly exceeding the pre-specified equivalence margins (-13%, 13%).

Overall, 96.6% and 95.2% of patients experienced one or more adverse event, 10.5% and 10.7% had a serious adverse event, and 0.7% and 0.0% had antidrug antibodies (up to cycle 9) with SB3 and TRZ, respectively.


Merck, Eisai sign deal to further develop, sell Eisai cancer drug

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Merck & Co and Japan’s Eisai Co Ltd on Wednesday announced a potential multibillion-dollar collaboration to develop and sell Eisai’s cancer drug Lenvima, which is already approved in many countries for two uses.

The deal, under which Lenvima will be developed for several types of cancer alone and in combination with Merck’s immunotherapy Keytruda, could be worth up to $5.76 billion to Eisai, but most of that would be contingent on eventual sales.

Meanwhile, Merck will be entitled to half of all global Lenvima sales, even for its already-approved uses for thyroid cancer and in combination with another drug for kidney cancer.

The deal is similar to a multibillion-dollar oncology collaboration Merck struck with AstraZeneca Plc last July.


Blood test could predict response to breast cancer drug early

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A new study has found that a blood test for cancer DNA could predict if a woman is responding to the new breast cancer drug palbociclib, months earlier than current tests.

Scientists from The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, say the test could detect in two to three weeks whether the drug is working, although they caution that the results need replicating before they are used clinically.

The research, published today in the journal Nature Communications, was largely funded by the Medical Research Council (MRC). The researchers tested women with oestrogen receptor positive breast cancer – the most common kind – who were taking part in a clinical trial of palbociclib for advanced breast cancer.

In November 2017, palbociclib was approved for use on the NHS by NICE for women with previously untreated advanced breast cancer.

Currently, women must wait two to three months to find out if palbociclib is working, via a scan.

The new blood test instead looks for circulating tumour DNA – fragments of DNA shed by the cancer that have entered the bloodstream. The DNA mutations associated with the cancer can be detected in these samples.

The researchers found that they could predict if the palbociclib treatment would work by comparing the amount of a gene PIK3CA detected in a blood test before treatment and 15 days after starting treatment. In the study, 73 women had the PIK3CA mutation and were given blood tests before and after starting palbociclib treatment.

In these women, the researchers found that those who had a small decrease in PIK3CA circulating DNA at 15 days had a median progression-free survival (the length of time the patient survived and the cancer did not get worse) of only 4.1 months, compared to women with a large decrease in PIK3CA, who had a median progression-free survival of 11.2 months.

The test could allow the women in the first group for whom the treatment is not as effective to be identified early, so that they could consider altering their treatment.

Professor Nicholas Turner, senior author and Professor of Molecular Oncology at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, said: “Palbociclib is one of a new class of drugs that delays cancer progression for patients with advanced breast cancer, but it’s not effective for everybody. The problem is we have to wait for two to three months before doing a scan to see if the therapy is working.

“Our new study found that a blood test for cancer DNA in the first two weeks of treatment indicated whether the drug was likely to be effective. Having an early indication of how likely a treatment is to work might allow us to adapt treatment – switching some patients to an alternative drug that is more likely to benefit them.”

Dr Nathan Richardson, Head of Molecular and Cellular Medicine at the MRC, said: “This study provides early evidence that might help us understand sooner when a drug is successfully treating breast cancer, and if not, it can be discontinued and better approaches pursued.”

The research also received funding from the charity Breast Cancer Now and the pharmaceutical company Pfizer.


Autoimmune disease research community gets boost from AMP RA/SLE study results

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Data from the Phase I study of collaborative industry partnership AMP are now available, meaning scientists can benefit from access to important research about Rheumatoid Arthritis and Systemic Lupus Erythematosus.

Datasets characterising individual cells in rheumatoid arthritis and systemic lupus erythematosus disease tissue from the Accelerating Medicines Partnership for Rheumatoid Arthritis and Systemic Lupus Erythematosus (AMP RA/SLE) Phase I study are now available to the research community. Scientists from across the biomedical research community can access the AMP RA/SLE datasets to explore important research questions about these autoimmune conditions.

Commenting on what they hope to achieve from the research programme, National Institutes of Health Director Francis S. Collins, M.D, Ph.D said:

“This pioneering programme seeks to speed the development of new ways to combat a range of devastating diseases that affect millions of people.”

“AMP RA/SLE is entering an exciting phase as experts around the world will begin to mine this invaluable biomedical resource in search of tomorrow’s cures.”

This study used state-of-the-art technologies to analyse individual cells from the lining of the joints in people with rheumatoid arthritis (RA) and the kidneys from people with lupus from research cohorts whose clinical characteristics were well-studied. Other research tools tend to examine signals from across populations of cells, and as such may miss important factors coming from only a few individual cells. By focusing on single cells, researchers can tease out the contributions of specific pathways inside these cells that may play a role in disease, providing a new approach to understanding autoimmunity.

Autoimmune diseases with similar characteristics

RA and lupus are autoimmune diseases that can last a lifetime, cause significant disability, greatly reduce quality of life and are associated with increased risk of early death. These disorders share similar flaws in immune function and regulation, leading to inflammation that damages tissues. People with these conditions need more and better treatments, as some fail to respond to existing therapies.

The newly released information holds clues for potential research targets that may lead to future treatment options. Availability of the data expands the search for genes, proteins, biological pathways and other factors that influence these conditions. Researchers mining the data can seek to identify treatment targets to develop medicines for diseases of interest. The data also has potential implications for precision medicine, as AMP RA/SLE researchers identify differences in the pathways active in the tissue of different patients.

Power of collaboration

The AMP RA/SLE programme is one of three AMP projects launched in 2014 as part of an unprecedented public-private partnership to identify promising biological targets for potential therapeutics and reduce the time and cost of developing them. The NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases, alongside the National Institute of Allergy and Infectious Diseases (NIAID), manages the AMP RA/SLE programme. The Foundation for the National Institutes of Health (FNIH) manages the partnership between the NIH and the external partners, which include participating members from industry (AbbVie, Bristol-Myers Squibb, Merck & Co. Inc., Pfizer Inc., Sanofi, and Takeda Pharmaceuticals International Inc.) and non-profit partners (Arthritis Foundation, Lupus Foundation of America, Lupus Research Alliance, and Rheumatology Research Foundation). Within the context of the partnership, industry and non-profit partners are also actively involved in sharing resources and expertise.

“No single organisation has the resources to take on the challenges facing the rheumatoid arthritis and lupus communities,” said Maria C. Freire, Ph.D., president and executive director of the FNIH. “AMP brings together government, pharmaceutical and not-for-profit expertise to collaboratively move therapies forward for these autoimmune diseases.”

The AMP RA/SLE investigators are currently conducting Phase II studies that include a larger cohort of patients with RA and lupus.

The Phase I data are freely available through the NIAID-sponsored Immunology Database and Analysis Portal Genomic data are also being submitted to be made available through the NIH’s database of Genotypes and Phenotypes


AI predicts heart attack risk factors from retinal scans

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Artificial Intelligence can be used to predict heart attack risk using retinal images, according to new research backed by Google.

The researchers trained deep learning algorithms on data from thousands of patients recorded in a massive UK study, which was used with retinal scans to produce a program that can identify risk factors from the scan information alone.

This predicted cardiovascular risk factors not previously thought to be quantifiable using retinal images: these included age, gender, smoking status, gender, systolic blood pressure and major adverse cardiac events.

Reporting results in the journal Nature Biomedical Engineering, the team used a dataset from the UK’s Biobank, a study where 500,000 were recruited between 2006 and 2010, and agreed to have certain health measurements recorded.

Health outcomes such as hospitalisation, mortality and cause of death were also logged. Smoking status was obtained via survey using a touchscreen interface in the research backed by Google and Verily, Alphabet’s healthcare subsidiary.

Participants were also asked to identify whether they are a current smoker, former smoker, or had never smoked, and blood pressure readings were also taken.

A further 67,725 had paired images of their retina fundus taken, along with a second group that was used to create a training dataset with known risk factors.

The researchers asked a neural network to make an output prediction based on the fundus image.

It was able to analyse images from the group with unknown risk factors, compare it with the training data set and after the process was repeated, was eventually able to predict cardiovascular risk factors from new images.

This is just the latest in a series of studies showing the potential of AI to predict healthcare outcomes, saving lives and reducing costs by ensuring patients receive timely and sometimes life-saving treatments.

Early last month, the government’s life sciences tsar, Sir John Bell, said that similar techniques could save the NHS billions.

A team at Oxford’s John Radcliffe Hospital is using AI to identify abnormalities in ECG read-outs that could be missed by the human eye, for instance.

The hope is that this system could be used in hospitals across the country to prevent unnecessary hospitalisations caused by false positives, and prevent heart attacks where at-risk patients are sent home because doctors have failed to spot problems.

Another AI system outperformed a panel of experts when asked to diagnose breast cancer based on stained tissue samples, in a separate study published in the Journal of the American Medical Association last month.


Gilead signs $3bn-plus gene-editing deal with Sangamo

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Gilead Sciences has claimed another stake in the emerging cell therapy sector with a $3bn agreement to use Sangamo Biosciences gene-editing platform for new cell-based cancer therapies.

The company seems determined to stay in the forefront of the pharma industry’s push into cell therapies, with the latest deal coming shortly after it acquired CAR-T specialist Kite Pharma for $12bn and almost immediately bolted on another CAR-T tech through the takeover of Cell Design a few weeks later.

Sangamo is getting $150m upfront from Gilead in the deal, which will see Kite claim an exclusive license to use the biotech’s zinc finger nuclease (ZFN) technology to develop up to ten off-the-shelf (allogeneic) as well as autologous CAR-T therapies. It also stands to receive up to $3bn in milestones – $300m per product – as well as tiered royalties on sales.

Kite will be responsible for all development, manufacturing and commercialisation of products under the collaboration, and will be responsible for agreed upon expenses incurred by Sangamo.

Gene-editing techniques are used to modify the cells – either harvested from patients or taken from donor stocks – that are infused into cancer patients in order to mount an immunotherapeutic assault on cancers. The deal with Sangamo means rivals in the CAR-T category such as Novartis, Celgene/Juno and off-the-shelf specialist Cellectis won’t be able to use the ZFN technology in their own gene-editing toolboxes.

ZFN is a gene-editing approach that uses a DNA-cutting nuclease enzyme attached to zinc finger -binding proteins to recognize and edit specific sequences of DNA. Other techniques include CRISPR/Cas9 – used by Novartis and Juno – and Cellectis’ favoured TALENS.

However, according to CEO Sandy Macrae, Sangamo has made significant strides in improving the precision, efficiency and specificity of ZFN, which means the technique now “sets the standard on what therapeutic genome editing should be”.

He said that Kite’s “financial strength and clear determination” to bring new cellular therapies products forward makes it an ideal partner for ZFN in this setting.

Kite highlighted the potential of the technology for developing allogeneic CAR-Ts, which have been put forward as potentially a major advance over autologous therapies, as they should be much quicker and cheaper to deliver – an important consideration given the current debate over the escalating costs of cancer treatment.

“The emergence of gene editing as a tool to edit immune cells holds promise in the development of therapies with potentially improved safety, efficacy and efficiency,” commented Gilead’s CEO John Milligan.


Largest clinical trial ever conducted in postpartum haemorrhage completed

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Ferring Pharmaceuticals and MSD, through its MSD for Mothersinitiative, has announced the completion of CHAMPION (Carbetocin Haemorrhage Prevention), a global clinical trial conducted by the Human Reproduction Program (HRP) at the World Health Organization (WHO).

CHAMPION is investigating whether Ferring’s proprietary and heat-stable carbetocin could offer a new solution to prevent excessive bleeding after childbirth (postpartum haemorrhage or PPH).2,3Involving nearly 30,000 women in 10 countries, it is the largest clinical trial ever conducted in PPH.2,3

Each year, 14 million mothers are affected by PPH.1 As the leading direct cause of maternal mortality, 480,000 mothers died from PPH between 2003-09.1 Even when women survive, PPH can result in the need for serious medical interventions, including surgical removal of the uterus (hysterectomy) as well as blood transfusions to address severe anaemia.2 By preventing PPH from ever occurring, heat-stable carbetocin has the potential to both save lives and avoid severe, dangerous and costly long-term side effects.

Despite progress towards the UN Sustainable Development Goal of reducing maternal mortality, every single day women across the world are dying unnecessarily from childbirth complications such as PPH. Timely administration of effective medicines can avoid the maternal deaths that occur due to excessive bleeding after childbirth,”3 said Mariana Widmer, Technical Officer, Maternal and Perinatal Health, WHO. “If the results of the trial for heat-stable carbetocin are favourable, this collaboration between private life sciences and the global public health community could help save women’s lives worldwide.”

The CHAMPION trial compares the effectiveness and safety of Ferring’s heat-stable carbetocin versus the current standard of care, oxytocin, for preventing PPH after vaginal birth.2,3 Heat-stable carbetocin could  address a significant limitation associated with oxytocin – the need for refrigeration during shipping and storage to prevent degradation in temperatures above 8°C.3,4 Heat-stable carbetocin may remain active long-term in hot and humid climates,3and could potentially reduce the incidence of PPH in areas where cold storage is difficult to achieve and maintain,3,4 and where 99% of maternal deaths due to PPH currently occur.4

Using our established expertise in Reproductive Medicine and Women’s Health, we strive to find innovative treatments that will help to dramatically reduce the number of mothers dying as a result of childbirth,” said Professor Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals. “Our heat-stable carbetocin is just one example of this research effort and forms part of our ongoing commitment to safeguarding the health of families worldwide. We are looking forward to seeing the results from the CHAMPION trial and hope that the learnings will usher in a new era in the prevention of PPH.”

If the results of the CHAMPION trial are favourable, Ferring will seek registration of heat-stable carbetocin on a broad basis around the world. If approved, Ferring would manufacture the product and it would be provided to the public sector of low- and lower-middle-income countries at an affordable and sustainable access price. Results from the trial are expected to be presented and published during the second half of 2018.

The CHAMPION trial has the potential to change the paradigm in how we save more mothers from dying during childbirth,” said Julie L Gerberding, MD, MPH, Executive Vice President & Chief Patient Officer, Strategic Communications, Global Public Policy and Population Health at MSD. “Along with our partners, we recognized that heat-stable carbetocin could be a transformative solution to preventing PPH, which is the number one cause of maternal mortality.  Through MSD for Mothers, we provided our company’s scientific expertise and financial resources to prove the concept and ultimately make a sustainable impact on the health of mothers, families and communities.”


  1. Say L. et al. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33.
  2. Australian New Zealand Clinical Trial Registry. Available at: Last accessed: January 2018.
  3. Widmer M. et al. Room temperature stable carbetocin for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally: study protocol for a randomized controlled trial. Trials. 2016;17(1):143. doi: 10.1186/s13063-016-1271-y.
  4. World Health Organization. Priority diseases and reasons for inclusion. Postpartum haemorrhage. Available at: accessed: January 2018.


Type 1 diabetes trial reaches full enrollment

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A clinical trial studying type 1 diabetes has reached full enrollment.

Interim data analysis from T-Rex study expected in the first quarter.

The Sanford Project: T-Rex Study, a Phase 2 clinical trial conducted collaboratively by Sanford Health and Caladrius Biosciences, Inc., (Caladrius)(Nasdaq: CLBS), has completed enrollment of 110 children with type 1 diabetes. The study started with two sites at Sanford Health in Sioux Falls, South Dakota, and Fargo, North Dakota, and expanded to 13 additional sites across the United States.

The project is studying the potential of CLBS03, Caladrius’ cell therapy consisting of each patient’s own regulatory T cells, or Tregs, to help the body fight type 1 diabetes.

Subjects will be followed for two years, with the primary endpoint of persistence of insulin production at one year after treatment. A planned, interim analysis of the first half of the participants at six months after treatment is expected by the end of the first quarter.

“I am thrilled to have reached this important milestone,” said Kurt Griffin, M.D., Ph.D., director of clinical trials for The Sanford Project. “It has taken a tremendous amount of work from a large team to get this far. We still have another year of follow-up before we can really see how this treatment may be working.”

Griffin and Fargo-based pediatric endocrinologist Luis Casas, M.D., are the study’s principal investigators at Sanford Health.

Individuals with type 1 diabetes experience a loss of insulin-producing beta cells as their immune system targets these cells inappropriately. Treg cells usually keep the immune system under control, but they are lacking in number and activity in people with type 1 diabetes. The Sanford Project: T-Rex Study is exploring whether expanding the body’s supply of Treg cells can rebalance the immune system, stop destruction of beta cells and preserve insulin production. Participants were randomized to either of two doses in the treatment arms or to placebo. For those in the treatment groups, the participant’s own Treg cells were extracted from the body, purified, expanded in culture, and returned to blood circulation. The cell identification and expansion process is patented technology licensed by Caladrius, a cell-therapy development company.

The therapy being used in this trial, CLBS03, has received fast track designation from the U.S. Food and Drug Administration (FDA), a first for any type 1 diabetes intervention. That designation is reserved for drugs or biologics that address a serious health condition, like type 1 diabetes, where there is an unmet medical need. This status allows for more frequent communication with the FDA and faster feedback about the therapy during the approval process. It also allows researchers to submit data and reports on a rolling basis. CLBS03 also has been granted European Medicines Agency’s Advanced Therapeutic Medicinal Product classification and FDA Orphan Drug designation as a potential new treatment for recent-onset T1D.

The Sanford Project is a cornerstone initiative at Sanford Health focusing on finding a cure for type 1 diabetes. The initiative was launched as part of a $400 million gift from philanthropist Denny Sanford in 2007.

About Caladrius Biosciences

Caladrius Biosciences, Inc. is a clinical stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications. The Company is investigating its lead product candidate, CLBS03, an ex vivo expanded polyclonal T regulatory cell therapy for the treatment of recent-onset type 1 diabetes, in an ongoing Phase 2 trial. CLBS14, CD34+ cell therapy intended as a treatment for coronary microvascular dysfunction, is Caladrius’ proprietary and patent protected formulation of CD34 cells designed specifically to enhance the potency of the CD34 cells for repair and regeneration of cardiovascular tissue. Its companion product, CLBS12, is specifically formulated for intramuscular administration for the treatment of lower extremity ischemia. A phase 2 study of CLBS12 as a treatment for critical limb ischemia has initiated in Japan, a successful outcome of which will qualify the program for consideration of early conditional approval based on discussions with the Japanese regulatory authorities as provided for under Japan’s progressive regenerative medicine regulations. For more information about Caladrius please visit

About Sanford Health

Sanford Health is one of the largest health care systems in the nation, with 44 hospitals and nearly 300 clinics in nine states and four countries. Headquartered in Sioux Falls, South Dakota, and serving the Upper Midwest, with nearly 1,400 physicians, Sanford Health is dedicated to several initiatives, including global clinics, genomic medicine and specialized centers researching cures for type 1 diabetes, breast cancer and other diseases. Sanford Health has 28,000 employees, making it the largest employer in the Dakotas. Nearly $1 billion in gifts from philanthropist Denny Sanford over the past decade have transformed how Sanford Health can improve the human condition. For information, visit


Merck Foundation and Uganada Ministry continue support Heroines of ‘Merck More Than A Mother’

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Merck Foundation, a non-profit organization and a subsidiary of Merck KGaA Germany, and Uganda Ministry of Health continue their commitment towards childless women Through ‘Merck More Than a Mother’ campaign in the heart of Africa.

Merck Foundation evaluated the social and economic impact of ‘Merck More Than a Mother’ on childless women in Uganda and encouraged them to continue leading an independent and happier life.

In 2016, Merck Foundation in partnership with Uganda Ministry of Health had started ‘Merck More Than a Mother’ Campaign In the country with the aim to raise awareness about infertility prevention and management, build fertility care capacity and break the stigma around infertile women. They established various income generating projects to support infertile women across the country with the aim of empowering them socially and economically. The business set by Merck Foundation has benefitted over 800 women across Uganda.

“The childless women groups we created in each village are doing a great job. I remember last year they had no purpose in life, no respect from their community and no source of income. Today they have a bank account and a steady monthly income; now they are much happier and stronger,” said Rasha Kelej, CEO Merck Foundation.

“For me, it’s essential to frequently visit ‘Merck More Than a Mother’ heroines across Africa to influence their transformation. The base of change in these villages is remarkable, and with our efforts and passion this change will be sustainable,” she added.

“The journey that Merck Foundation has started is a very special journey that has touched the lives of women who have been forgotten in the communities. It has touched not only women but also the lives of men who have been mistreating their women thinking that infertility is an issue of women, not know that 50% infertility is due to the malefactor. I want to thank Merck Foundation for thinking about these women,” said Sarah Opendi, Minister of State of Health, Uganda.

“I feel grateful and honored to be a part of the joy and happiness of these amazing women, who suffered the infertility stigma all their lives. I am glad that the efforts of ‘Merck More Than a Mother’ paid off. Now, these women are independent and getting the respect and support they deserved from the community,” said Kelej.

About ‘Merck More Than a Mother’ campaign; in many cultures, childless women suffer discrimination, stigma, and ostracism. Their inability to have children results in great isolation, disinheritance, and assaults. ‘Merck More Than a Mother’ empowers such women through the access to information, health, change of mindsets and economic empowerment.

Merck Foundation provided for more than 40 candidates, three months to six months clinical and practical training for fertility Specialists and embryologists in more than 15 countries across Africa and Asia.

Merck Foundation is making history in many African countries where they never had fertility specialists or training facilities before ‘Merck More Than a Mother’ intervention to train the first Fertility specialists such as; in Sierra Leone, Liberia, The Gambia, Niger, Chad, and Guinea.

Merck Foundation plan supported the establishment of the first public IVF in Ethiopia through providing the clinical and practical training necessary for their staff. Merck Foundation also plans to support the establishment of the first public IVF in Tanzania soon.

Over 1,200 infertile women in Kenya, Uganda, Nigeria, Ghana, Tanzania, CAR, Ethiopia, Liberia, Tanzania, Niger, The Gambia and Cote D’Ivoire who can no longer be treated have been empowered socially and economically to lead independent and happier lives through “Empowering Berna”.(ANI)


Psoriasis drug found to reduce aortic vascular inflammation

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An antibody used to treat the skin disease psoriasis is also effective at reducing aortic inflammation, a key marker of future risk of major cardiovascular events.

An antibody used to treat the skin disease psoriasis is also effective at reducing aortic inflammation, a key marker of future risk of major cardiovascular events.

Researchers from the Perelman School of Medicine at the University of Pennsylvania, in collaboration with the National Heart, Lung, and Blood Institute, led a randomised, double-blind, placebo-controlled study and found patients who took the drug ustekinumab had a 19 percent improvement in aortic inflammation, as measured and confirmed by imaging, when compared to the placebo group. Dr Joel M. Gelfand, a Professor of Dermatology and Epidemiology at Penn and the study’s first author.

Ustekinumab, sold under the name Stelara, is approved by the US Food and Drug Administration to treat psoriasis, psoriatic arthritis, and Crohn’s Disease. Researchers wanted to know if the benefits of the drug go beyond clearing the skin.

“The type of inflammation we see in psoriasis is similar to what we see in atherosclerosis – a type of heart disease that involves the build-up of fats, cholesterol, and inflammatory cells in the artery walls,” Dr Gelfand said. “Since ustekinumab blocks the specific pathways involved in both skin and cardiovascular inflammation, we wanted to test whether it can improve aortic vascular inflammation.”

Psoriasis patients were randomly divided into two groups, with 21 patients in the placebo group and 22 patients receiving the treatment. The primary outcome was aortic inflammation, as measured by 18-FDG-PET/CT scans – an imaging technique that reveals inflammation in the aorta. The imaging was performed before treatment and at 12 weeks. The treatment group saw a 6.6 percent decrease in aortic inflammation, while the placebo group saw a 12 percent increase, meaning the drug is responsible for a 19 percent improvement relative to untreated patients. As expected, ustekinumab also resulted in a dramatic improvement in skin inflammation as well, with 77 percent of treated patients achieving a 75 percent or better improvement in psoriasis activity, compared to just 10.5 percent in the placebo group. Both findings were highly statistically significant (p?0.001).

The results are consistent with a previous, smaller uncontrolled trial of ustekinumab, but they are in direct contrast to two large trials using a different drug called adalimumab, which is sold as Humira.

“This is the first placebo-controlled trial of a biologic drug to show a benefit in aortic inflammation, a key marker of cardiovascular disease,” Dr Gelfand said. “The effect is similar to what we would expect if we put the patient on a statin.”

Dr Gelfand, who conducted the study in collaboration with Dr Nehal N. Mehta, Chief of the Section of Inflammation and Cardiometabolic Diseases at the National Heart, Lung, and Blood Institute, confirmed their results by having a second, separate lab independently evaluate imaging data.

“This study represents a promise that this treatment may reduce the risk of heart attack and stroke in the future. It’s an encouraging finding,” Dr Gelfand said.

The trial is ongoing, and Dr Gelfand says his team will evaluate these patients at a longer follow up to see if the effects are sustainable and if patients continue to improve.