Almac Group Announces Publication of Prostate Cancer Metastatic Assay Validation

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Almac Group’s Diagnostics business unit has announced the Journal of European Urology has published results relating to its Prostate Cancer Metastatic Assay. The publication demonstrates the assay can be used to analyse primary prostate cancer FFPE samples to identify a molecular subgroup with a high risk of developing distant metastases. The assay therefore has the potential to guide the choice of therapy for patients presenting with primary prostate cancer.

Professor Richard Kennedy, MD, PhD, VP and Medical Director, Almac Diagnostics and McClay Professor in Medical Oncology, Queen’s University Belfast commented “An unbiased discovery approach was used to identify a molecular subtype of primary prostate cancer that demonstrated metastatic biology. This approach has created a very robust assay with excellent performance, independent of clinical factors such as Gleason and CAPRA. We believe it will play a significant role in aiding clinicians to select the most appropriate therapy regimen for their patients.”

The study was conducted in conjunction with The Movember / Prostate Cancer UK funded Prostate Cancer Centre of Excellence at Queen’s University of Belfast and Manchester University along with Cardiff University, University College Dublin, Oslo University and the University of Surrey. Independent assay validation was performed using 322 radical prostatectomy samples with Metastatic Assay positive patients having increased risk of biochemical recurrence (Multivariable HR 1.62; p= 0.0092) and metastatic recurrence (Multivariable HR=3.20; p=0.0001). A combined model with CAPRA-S identified patients at increased risk of biochemical and metastatic recurrence superior to either model alone (HR=2.67; p<0.0001 and HR=7.53; p<0.0001) respectively. “The publication of this manuscript in a journal of this calibre represents a significant milestone in the assay’s development and with two additional manuscripts being prepared for submission, further milestones are expected to be reached later this year. The first is another clinical validation but this time using biopsy FFPE tissue and the second is analytical validation to demonstrate the assay can be transferred to several commercial platforms.” said Professor Paul Harkin, President and Managing Director, Almac Diagnostics. He went on to say “Almac has been at the forefront of RNA based genomic innovation for over 10 years and this assay represents just one of our innovative pipeline of predictive and prognostic tests”.

Metsä Board Launches Its Unified Offering of Products and Services

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The Better with Less initiative highlights the company’s aims to improve consumer experience and make packaging even more sustainable

Metsä Board has launched its clarified product and service portfolio on May 4th at Interpack in Düsseldorf. The company presents its offering of premium paperboards and related services, with focus on contributing to even more sustainable, safe and efficient packaging, now found under one Metsä Board family.

The Better with Less initiative showcases Metsä Board’s aim to create, together with its customers, considered and innovative, renewable contemporary packaging solutions fitting brands and demands of the future world.

“Consumers expect better experiences with less environmental impact. Brand owners are looking at how to optimise packaging to be more sustainable, safer and lighter in weight. We are known for our pioneering expertise in high-quality, lightweight paperboards and are committed to improving further. Now with our unified product portfolio and targeted services we can provide even stronger support to our customers to jointly improve sustainability and efficiency of packaging throughout the value chain,” says Mika Joukio, CEO of Metsä Board.

As part of the launch Metsä Board renews the product names of its premium quality lightweight paperboards to bring the offering to customers in a clearer way that makes product selection even easier. The three service areas – Packaging Analysis & Design, Availability Services and Technical Expertise and R&D – complement the products and provide collaboration initiatives for joint development with customers to develop better and lighter packaging.

While the company’s offering and product names will be harmonised, the products and their specifications will remain unchanged. All Metsä Board mills hold PEFC™ and FSC® Chain-of-Custody certificates, as well as the highest environmental and manufacturing quality standards. Metsä Board’s paperboards use fresh forest fibres from sustainably managed northern European forests.

The “BB Dose”: a Unither innovation that guarantees more safety with the infant

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Unither Pharmaceuticals is the world leader in the production of sterile single-unit dosage forms using the Blow-Fill-Seal (BFS) technology.

Since 1993, Unither Pharmaceuticals has been conducting various studies to better meet laboratories needs and thus facilitate patient medication intake. The new system brought by Unither, called “nose project”, does not damage the baby’s nose.

One of the studies conducted by UC/Consultants focuses on the use of physiological serum on infants. We found that mothers perceive the “physiological serum” as a neutral water, with a neutral pH, which does not necessarily contain antiseptic; Or a liquid such as blood. As for its use, the mothers always operate with a defined ritual, which shows their involvement around the product. Their expectations are very strong: the mothers are paying attention to every detail. The fear of hurting the baby with the (badly cut) tip and the risk of injury inside the nose remain present when using physiological serum.

Recently, Unither Pharmaceuticals partnered with Biolane to developed a single-unit dose featuring a more rounded tip that fits perfectly with babys’ nostrils. The “BB dose” guarantees a greater safety of the gesture of the mother with the infant. And avoids to skin him during the use of the physiological serum.

In addition to that, BFS technology enables the manufacture of preservative-free single-unit doses. Preservatives are recognized as potentially harmful to the sensitive mucosae of the eyes, nose, and lungs, so this is an enormous benefit to sensitive patients such as infants. Another advantage of unit-doses is that they are portable and easy to use individually, excellent properties for today’s active lifestyles.

Catalent Provides Commercial Manufacturing Of Lexicon Pharmaceuticals’ Orphan Drug XERMELO™ Following FDA Approval

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Catalent Pharma Solutions recently welcomed Lexicon Pharmaceuticals, Inc.’s announcement that its pioneering orphan drug, XERMELO™, has been approved by the U.S. Food and Drug Administration (FDA). Catalent has been working in partnership with Lexicon since 2007 to develop the drug formulation, and will be manufacturing XERMELO for commercial supply.

XERMELO (telotristat ethyl) 250 mg is a first-in-class orally administered therapy for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

“We are pleased that the skill and expertise that our scientists have dedicated to this project for ten years has resulted in this pioneering treatment reach the market,” commented Matthew Mollan, Catalent’s General Manager at its Kansas City, Missouri site. “Catalent first partnered with Lexicon when the drug was in Phase I development, and continued to support its manufacture through to supplying launch products.”

“We are proud to have discovered this ground-breaking orphan drug, and our successful collaboration with Catalent means we are now able to make it available for the thousands of patients currently suffering from this condition,” added Lonnel Coats, Lexicon’s president and chief executive officer.

Carcinoid syndrome is a rare condition that occurs in patients living with metastatic neuroendocrine tumors (mNETs) and is characterized by frequent and debilitating diarrhea that often prevents patients from leading active, predictable lives, as well as by facial flushing, abdominal pain, fatigue and, over time, heart valve damage.

Catalent undertook development and manufacture of the drug at its 450,000-square-foot Kansas City facility, where the company provides a range of fully integrated support services, from formulation development and analytical testing, to clinical and commercial scale manufacturing and packaging of various oral dose forms.

Aptar Pharma’s Electronic Lockout Device Approved by EMA

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Aptar Pharma, a world leader in innovative drug delivery systems, is pleased to announce the approval by the European Medicines Agency (EMA) of the first integrated electronic nasal lockout device (e-Lockout) following a multi-year development with Takeda Pharmaceuticals International AG. Aptar Pharma agreed to supply Takeda with its e-Lockout device for a multidose nasal spray version of Instanyl®. The EMA has granted marketing authorization for this multidose nasal spray treatment under the name Instanyl DoseGuardTM.

This represents a major milestone for Aptar Pharma, with the e-Lockout device being the first and only fully integrated electronic nasal drug delivery device to be approved by a U.S. or European regulatory authority.

Already available in unidose and multidose nasal spray versions, Takeda will launch Instanyl® DoseGuard in Europe in several multidose strengths, all using Aptar Pharma’s patented electronic lockout system, which marks another product innovation in the management of breakthrough pain.

Advanced e-Device Technology Ensures Safe Compliance

Instanyl® is a fast-acting nasal opioid approved for relieving breakthrough pain in adult cancer patients already treated with opioids for their usual pain. Breakthrough pain is an additional sudden pain that occurs despite having taken one’s usual pain relieving medicines.
Aptar Phama’s e-Lockout device uses advanced electronic technology to help patient compliance in the treatment of chronic disease. Aptar Pharma’s e-Lockout device is intended to ensure safe patient compliance by limiting the number of doses available during a 24 hour period.

The system’s built-in lock-out mechanism prevents the device from being used for a period of time after a pre-defined number of spray actuations. The electronic display shows the number of priming strokes, the number of doses left in the device and whether the nasal spray is locked or ready for use. The e-Lockout also features a child-resistant cap.

Long-term Strategic Partnership with Takeda

The multi-year supply agreement reinforces a long-standing partnership between Takeda and Aptar Pharma, who currently supplies Takeda with unidose and multidose nasal spray devices for Instanyl® in Europe.

Committed to accompanying pharmaceutical companies throughout their product lifecycle management, Aptar Pharma continues to partner to provide customers with innovative and smart solutions to enable safe, convenient and compliant medication delivery.

“This approval and subsequent product launch underscores Aptar Pharma’s ability to partner with the pharma industry to bring innovative, compliant and safer devices through the regulatory authorization process,” explained Salim Haffar, President, Aptar Pharma. “This is yet another example of Aptar Pharma’s expertise and technology at the heart of a new market launch. This is a significant step in strengthening Aptar Pharma’s credentials in the electronics and connected health markets. We are pleased to be building on our trusted, long-term partnership with Takeda,” he added.

Novartis Access and government of Pakistan sign memorandum of understanding

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Ministry of National Health Services, Regulations and Coordination has signed a Memorandum of Understanding with a multinational healthcare company Novartis to help the poor gain access to treatment of chronic diseases.

Under the MoU, Ministry and Novartis will partner in the delivery of a program called Novartis Access. This program will provide access to a basket of high-quality medicines in the public sector targeting four key non communicable diseases (NCDs)–cardiovascular diseases, diabetes, respiratory illnesses, and breast cancer. These diseases kill one-fifth of Pakistanis between the ages of 30 and 70 years every year.

Products within the Novartis Access portfolio are among the world’s most frequently prescribed medicines for the targeted chronic diseases.

In pilot phase, Novartis Access medicines will be available through selected empanelled hospitals of district Islamabad under the Prime Minister’s National Health Program. The government is committed to making these NOT for SALE drugs available free of charge to patients within the program. The aim is to extend the program to all districts of Prime Minister’s National Health Program over time and work has already started in this regard.

Speaking after witnessing the signing, Saira Afzal Tarar Minister for National Health Services Regulations and Coordination, said: “I am very pleased over the signing of this Memorandum of Understanding with Novartis. Pakistan is grievously affected by the growth of non communicable diseases, and having access to high-quality treatment at low cost is a critical part of our work to lessen the impact of chronic disease in Pakistan. It is part of the Prime Minister’s ambitious plans to make Pakistan a true welfare state.”

The MoU was signed on behalf of Ministry of National Health Services, Regulations and Coordination by Director Prime Minister’s National Health Program Dr. Faisal Rifaq and CEO Novartis Mr. Shahab Rizvi.

This is the beginning of the Novartis Access partnership, and the first treatment against chronic diseases are expected to reach Pakistan soon.

Boehringer Ingelheim Inaugurates World-Class Biopharmaceutical Manufacturing Facility in China

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Boehringer Ingelheim inaugurated its commercial production site for biopharmaceuticals in Zhang Jiang Hi-tech Park of Shanghai (China). The site, with the first-phase investment of more than €70 million, is the first and only biopharmaceutical facility established by a leading multinational active biopharmaceutical manufacturer in China utilizing mammalian cell culture technology. With its global network of biopharmaceutical production sites in Biberach ( Germany), Vienna (Austria), Fremont (USA) and now Shanghai, the contract manufacturing business Boehringer Ingelheim BioXcellence™ is well positioned to fulfil strongly increasing demands of the biopharmaceutical industry for innovative products – both in China and worldwide.

“Our Shanghai facility plays an important role in our globally leading biopharmaceutical contract manufacturing business and embodies our continuous and long-term commitment to China,” said Hubertus von Baumbach, Chairman of the Board of Managing Directors at Boehringer Ingelheim. “With this investment, we expect to have a significant impact on the development of China’s biopharmaceutical industry to ultimately supply innovative medicines to patients following high quality standards.”

Boehringer Ingelheim has made this strategic move with the long-term goal to become a leader for contract development and manufacturing of monoclonal antibodies and recombinant proteins in China. Since 2014, Boehringer Ingelheim China Biopharmaceuticals has been operating its Good Manufacturing Practice (GMP) clinical material supply at 100L and 500L scales. After its inauguration, the facility will operate for clinical and commercial supply on a 2000L single-use bioreactor scale. It is designed to flexibly add additional 2000L single-use bioreactors and fill/finish capabilities to meet increasing market demand.

“As a global leader in biopharmaceutical contract manufacturing, Boehringer Ingelheim has an extraordinarily long history in the field of biotechnology, having been in the industry for over 35 years,” said Dr Luo Jiali, General Manager of Boehringer Ingelheim Biopharmaceuticals (China) Co Ltd. “We offer tailor-made contract development and manufacturing services to the biopharmaceutical industry, providing the entire production technology chain from DNA to the finished product under one roof. With our strong know-how, global network, technology, and international quality standards we can support innovative Chinese and international companies to industrialize their research results.”

Aptar Pharma Partners with Kali Care to Develop Real-Time Medication Management Technology

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Aptar Pharma and Kali Care have announced that they entered into a partnership in order to address the challenge of monitoring adherence in ophthalmic clinical trials. The combination of Aptar Pharma’s ophthalmic device expertise, and Kali Care’s ground-breaking digital monitoring system for ophthalmic medications, is likely to have a significant impact in reducing the costs and complexity of ophthalmic clinical trials.
Kali Care, a Silicon Valley-based technology company, provides a revolutionary sensor technology which allows clinicians to replace adherence assumptions in clinical trials with collected real-time data.
This represents the latest step for Aptar Pharma in the development of drug delivery devices and collaborations in the connected health space.
Combining the Silicon Valley Spirit with Proven Expertise in Drug Delivery Systems
Aptar Pharma has been setting the standard for the drug delivery industry for decades. This strategic collaboration once again underlines the company’s continuous efforts in breaking new ground in innovative healthcare technologies.
Sina Fateh, MD, Founder and CEO of Kali Care, explained that because Aptar Pharma is well-respected for its proven regulatory expertise, this will help his company move forward through approval and compliance processes.
Aptar Pharma’s ability to support complex projects and meet the challenging and changing regulatory requirements was recently demonstrated by their collaboration with Allergan on launching the first FDA-approved prescription preservative-free ophthalmic multidose product (Restasis MultiDose™).

Meeting the Needs of Patients and Clinicians
Using eye drops as a drug delivery system has its own set of challenges which must be recognized and addressed at the clinical level. Clinical trials benefit from more accurate and timely data collection and management.
For ophthalmologists, the ability to see the medication adherence score of patients with glaucoma is a powerful tool in managing treatment plans.
Enhancing Clinical Information
Kali Care has developed the first digital monitoring system for ophthalmic medications. Kali Care’s monitoring technology integrates smart sensors, data analytics and cloud services.
With soaring clinical trial costs and complexity, the biopharmaceutical industry is constantly seeking new approaches to improve efficiency and productivity. In clinical trials, the Kali Care system replaces usage assumptions and self-reporting related to medication adherence. This can result in shorter and more efficient clinical trials. The Kali Care Adherence Score provides critical information for explaining the incongruity between recommended treatment and actual treatment outcomes.
Staying Ahead of the Market
Combined with the recent breakthrough of Aptar Pharma’s ophthalmic drug delivery systems, Kali Care’s revolutionary sensor technology opens new opportunities for the monitoring of patient adherence.
In a joint statement, Salim Haffar, President of Aptar Pharma, and Sina Fateh, MD, highlighted the advantages associated with combining unrivalled microbiological safety and revolutionary sensor technology, “Clinicians are now able to rely on objective and accurate data. Aptar Pharma’s leading dispensing technologies combined with Kali Care’s smart sensors, data analytics and cloud services will help make clinical trials more efficient and effective. This allows ophthalmologists to improve risk strategies to distinguish patients requiring minimal support from those who require closer monitoring.”

THE NCRI PARTNERSHIP LAUNCHES NEW FIVE-YEAR STRATEGY TO ACCELERATE PROGRESS IN CANCER RESEARCH

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The National Cancer Research Institute (NCRI) launches its new five-year strategy today (Tuesday) to accelerate progress in cancer research through collaboration. The strategy will help cancer research funders to maximise opportunities to improve the health and quality of life of people who have had, or may one day develop, cancer. It will also ensure research continues to drive improvements in prevention, treatment, and patient care and support.

Cancer survival rates have doubled in the last 40 years and research has been central to this success. However, many challenges lay ahead that are too vast for one organisation to tackle alone. The NCRI Partnership will work together to achieve four goals: to accelerate the translation of cancer research into clinical practice, to improve the quality and relevance of research related to cancer, to address major opportunities and challenges in cancer research and to ensure a coordinated portfolio of cancer research in the UK.

Around 2.5 million people are living with, or have experienced, cancer across the UK and this number is expected to rise to around 4 million by 2030 as the population ages and research develops better treatments to help more people live longer with and beyond cancer.

Karen Kennedy, Director of the NCRI, said: “There has never been a more urgent need for collaboration to fund research that addresses the complex needs of cancer patients at every stage of their journey through and beyond cancer. Research is making life-changing advances in cancer treatments, but the long-term effects of cancer can have a far-reaching impact, affecting people’s health and quality of life.”

The NCRI Partnership enables collaboration between 19 of the biggest funders of cancer research from the UK’s charity and government sectors. It facilitates more than 250 meetings per year, to bring together the right clinicians, scientists, research nurses, patient experts and other specialists to tackle the big issues facing cancer research.

Its activities include co-ordinating a Clinical Trials Unit Group, where trial specialists collaborate to identify needs common to all cancer clinical trials, and its Clinical Studies Groups – a series of advisory groups spanning all cancer types that bring together UK experts to accelerate research to improve cancer treatments, and help those affected by cancer to live well.

One of the NCRI’s strategic goals is to seize opportunities and address challenges in cancer-related research, and as part of this it will encourage research that meets the needs of people living with and beyond cancer. In partnership with the James Lind Alliance, its new initiative in ‘Living with and Beyond Cancer’ will mean people affected by cancer and clinical health care professionals can pose the questions they feel are unanswered about living with or beyond cancer, so they can be addressed through research. People affected by cancer and health care professionals will work together to prioritise the questions in to a top-ten. The NCRI will also be working with researchers to help ensure research proposals to address the top-ten questions are successfully funded.

It’s through this kind of collaboration that NCRI will help improve the health and quality of life of cancer patients and the wider public.

Baroness Delyth Morgan, chair of the NCRI, said: “Collaboration is at the centre of the NCRI’s new strategy, ensuring patients, health care professionals and researchers all have a voice. Working together will ensure the cancer research community overcomes the enormous challenges facing them in this uncertain political and economic environment.”

The NCRI partnership was set up to facilitate collaboration between cancer research funders and to address gaps and challenges in research that wouldn’t be possible for one organisation to tackle alone. It comprises 19 key funders in cancer research across the four UK nations which, collectively, have spent more than £6 billion pounds on cancer research since the partnership was established in 2001.