Category Archives: Drugs

Biotech, Business of Medicine, Diseases, Disorders, Drugs, Health Products, Healthcare Information, Healthcare Products, Healthcare Professionals, Healthcare Services, Healthcare Solutions, Medicine, Public Health, Society

Novartis, Lundbeck, and GSK Among Pharmaceutical Companies to Present at Patients as Partners Europe 2023

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NEW YORK, NY, United States, 13-Apr-2023 — /EPR HEALTHCARE NEWS/ — The Conference Forum announced that the 7th annual European Patients as Partners® in Clinical Research conference will return to London at the Thistle Hotel Marble Arch on June 12-13, 2023. The event will showcase the progress made by pharma R&D executives with input from patients on achieving greater representation in clinical research, building trust and engagement in communities, and building truly patient-centric R&D organizations.

“We are delighted to be back in person to offer an unparalleled opportunity to hear from pharma R&D and patient advocacy together on how patient involvement gets done to drive greater efficiencies in clinical research with better outcomes,” said Valerie Bowling, Executive Director, Patients as Partners in Clinical Research Europe.

A variety of pharmaceutical companies will report on the progress they’ve made engaging communities and partnering with patients. Sanofi will open with the evolution of patient-informed research and its impact on medicine development. Novartis will be speaking on the organization’s global approach to implementing systematic and consistent patient engagement across the medicine lifecycle with a focus on measurement.

Lundbeck will share how they are generating insights through engagement with patient communities and making patient input actionable for medicines development. CSL Behring will discuss how they are evaluating clinical research sites based on patient-focused principles.

Several companies, including Regeneron, the Center for BME Health and Sanofi, will discuss their progress in increasing diversity amongst underrepresented communities in clinical research. GSK will lead a session on understanding barriers to community engagement in clinical research.

Boehringer Ingelheim will discuss the company’s approach to engaging patients throughout the clinical trial and how to leverage those patient insights to improve the process. Alnylam Pharmaceuticals will share how the organization has developed a top-down approach to integrating the patient perspective.

The conference features incredible patient advocate representation, addressing the realities of underrepresented communities to better serve them. For the first time, Patients as Partners Europe will have a patient-led session on supporting mental health for patients in clinical research.

“I look forward to hearing from patients and industry colleagues about what matters most and what has the greatest impact when partnering with patients and their communities on our efforts to new therapeutic options available,” said Deirdre BeVard, SVP, R&D Strategic Operations, CSL Behring and Patients as Partners Europe co-chair.

Key topics for 2023 include:

  • The evolution of patient informed research
  • Increasing diversity in clinical research
  • Patient access to research through digital innovation
  • Understanding barriers to community engagement in clinical research
  • Turning patient insights into action
  • Navigating patient engagement and compliance
  • Mapping and how to measure patient engagement
  • Regulatory requirements and patient engagement in drug development

To learn more about the event, and a full overview of speakers, please click here (https://theconferenceforum.org/conferences/patients-as-partners-europe/overview/)

About Patients as Partners EU
Patients as Partners is co-produced with patients, industry, academia, government and nonprofit organizations to establish a well-rounded program that addresses the needs of all stakeholders seeking to implement and advance patient involvement across the entire clinical development continuum.

About the Conference Forum
The Conference Forum is a life science industry research firm that develops conferences primarily around how to get therapeutics to patients faster. They examine and challenge the complex ecosystem of drug development and delivery, bringing ideas together from a variety of sources to help advance clinical research with common goals that are patient-focused.

They currently offer conferences for pharma/biotech professionals including R&D leaders, CEOs, business development/licensing, medical affairs/safety, chief patient officers/advocates, clinical innovation champions, investors and drug delivery specialists. The company also publishes six newsletters and produces PharmaTalkRadio and virtual events.

SOURCE: EuropaWire

Biotech, Business of Medicine, Diseases, Doctors, Drugs, Healthcare, Healthcare Information, Healthcare Products, Healthcare Professionals, Healthcare Services, Online, Pharmaceuticals, Physicians, Public Health, Society

EU Patients as Partners in Medicines Development conference to be held virtually on Jan 24-25, 2022

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(PRESS RELEASE) New York, NY, United States, 5-Jan-2021 — /EPR HEALTHCARE NEWS/ — The Conference Forum announced the launch of the 6th annual EU Patients as Partners in Medicines Development conference to take place virtually on January 24-25th, 2022 GMT time.

​​This annual event, the first of its kind in Europe, will feature successful collaborations between patients and pharma where patient input directly impacted aspects of how a pharmaceutical company either designed or conducted a clinical trial.

Of the 20 sessions, half include a patient or patient advocate. This two-day program will demonstrate how patient-led research can improve the way pharma conducts clinical trials.

Examples include UCB developing new assessment tools to measure the effectiveness of novel treatments for Parkinson’s disease, changes in the design and implementation of an MS trial for greater patient engagement, and the development of a new toolkit to change the way patients are compensated for their contributions in clinical research.

“Patients have become more empowered,” says co-chair Michaela Dinboeck, Head, Center of Excellence for Patient Engagement at Novartis. “So patient engagement must be integrated into the DNA of how medicines are developed, approved, and used. Patients as Partners Europe will provide Pharma with valuable insights on how to achieve this.”

Participating pharma companies include Novartis, Pfizer, Merck KGaA, EMD Serono, Janssen, Johnson & Johnson, GSK, Ipsen, UCB, Takeda, AbbVie, Noema Pharma, Gilead Sciences, Regeneron, and Pierre Fabre.

Other topics to be addressed include: Scaling patient engagement activities company-wide, engaging patients in early clinical development, leveraging social media to gain patient insights, diversity and inclusion in research and updates on patient engagement activities in Eastern Europe.

To learn more, please visit Patients as Partners Europe.

SOURCE: EuropaWire

Allergies, Biotech, Diseases, Drugs, Healthcare Products, Healthcare Solutions, Pharmaceuticals, Public Health, Society, Therapies

URSAPHARM and CEBINA collaborating to repurpose the antihistamine drug azelastine hydrochloride as a potential anti-SARS-CoV-2 therapeutic

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SAARBRÜCKEN / VIENNA, 17-Feb-2021 — /EPR HEALTHCARE NEWS/ — In the fight against the SARS-CoV-2 virus, a large number of pharmaceutical companies are looking for new approaches to combat the pandemic. In addition to vaccines, intensive research and development efforts around the world are focusing on identifying new anti-COVID therapeutics that includes re-evaluation of existing product portfolios with a view to re-purpose drugs that have antiviral properties.

With this goal in mind, URSAPHARM Arzneimittel GmbH, based in Saarbrücken, and the Vienna-based biotech company CEBINA GmbH (Central European Biotech Incubator and Accelerator) are collaborating to repurpose the antihistamine drug azelastine hydrochloride as a potential anti-SARS-CoV-2 therapeutic. Azelastine has been successfully used for many years in anti-allergic therapy.

Starting with a novel computational drug repurposing prediction method, developed and performed by Prof Dr Robert Konrat (University of Vienna), CEBINA selected already approved active substances for experimental testing in collaboration with Prof Dr. Ferenc Jakab (Virology National Laboratory, Szentágothai-Research-Center, University of Pécs, Hungary). This collaborative effort led to the identification of azelastine as a potent antiviral compound effective against SARS-CoV-2, a finding confirmed by now by several independent research groups. The potent anti-SARS-CoV-2 activity of azelastine was demonstrated in a reconstituted human nasal tissue model and was evident at a lower dose than present in commercially available nasal sprays [1].

A clinical trial has started on February 16th 2021 to verify whether the use of a nasal spray preparation containing azelastine can achieve a reduction in viral load in the the nasal cavity. The aim of the study is to show whether the anti-allergic medication Pollival® Nasal Spray, or a diluted version, can achieve a reduction in the viral load, therefore reducing transmission and positively influencing the course of the disease.

If positive results of the running clinical studies are demonstrated, URSAPHARM Arzneimittel GmbH and CEBINA GmbH believe this will be an important new approach to control viral spread and contain the current pandemic.

SOURCE: EuropaWire

Diseases, Drugs, Gynecology, Health Products, Healthcare, Healthcare Products, Healthcare Solutions, Medicine, Neurology, Non-Surgical Procedure, Oncology, Pharmaceuticals

LIDBREE™ receives marketing authorization in the United Kingdom

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SANTA BARBARA, CALIF., U.S.A. / BUDAPEST / STOCKHOLM, 5-Aug-2020 — /EPR HEALTHCARE NEWS/ — Palette Life Sciences AB (‘Palette’) with Gedeon Richter Plc. (‘Richter’), today announced that as a part of a decentralised regulatory procedure including thirty European Union Economic Area member states, Palette and Richter received national marketing authorization for LIDBREE™ in the United Kingdom (UK). The product is a novel, proprietary thermo gelling intrauterine formulation that can provide significant pain relief during common gynecological procedures.

LIDBREE’s marketing authorization is based on compelling data from clinical trials and investigations of sensory innervation in the reproductive area. In a pivotal clinical trial, LIDBREE treatment was associated with a significant reduction of pain and discomfort in women undergoing gynecological interventions.¹

“Our research group has detected pain nerves superficially throughout the uterus, which enable the use of local pain relief in many gynecological procedures such as insertion of an intrauterine device and sampling biopsies from the cervix and/or from the uterus – procedures that are currently routinely performed today without pain relief. LIDBREE is a novel gel containing the local anesthetic lidocaine which adheres to the mucosal tissue upon application to provide excellent analgesic effect”, says Gunvor Ekman-Ordeberg, MD PhD Professor at Karolinska Institute and founder of the LIDBREE program. “The gratification of observing the culmination of over 40 years of research into clinical practice via a new, simple, and effective treatment is a great privilege to share with all of my colleagues.”

In October 2017, Richter and Palette signed an agreement to commercialise LIDBREE, a novel innovative proprietary pain relief pharmaceutical formulation, in Europe and in certain other markets.

“We are very pleased with the approval of LIDBREE in the UK, it is a great accomplishment from everyone involved.  This is an important milestone and allows us to address a significant unmet medical need in women’s health. We look forward to supporting LIDBREE’s product launch through our partner Gedeon Richter and pursuing additional markets, such as the U.S., in collaboration with future regional partners.” says Helena Jansson, Managing Director at Palette Life Sciences AB.

“We’ve been expecting this regulatory development and we are looking forward to successfully introduce LIDBREE to all of the territories covered by our agreement in order to further improve the quality of life of women experiencing pain during their gynaecological interventions,” stated Tibor Horváth, Commercial Director of Gedeon Richter Plc.

SOURCE: EuropaWire

Biotech, Child health, Diseases, Drugs, Healthcare, Healthcare Products, Medicine, Oncology, Pediatrics, Pharmaceuticals, Radiology, Urology

Palette Life Sciences unveils an online resource aimed at paediatric urologists, parents and caregivers in the UK dealing with vesicoureteral reflux (VUR)

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SANTA BARBARA, CALIF., U.S.A. / STOCKHOLM SWEDEN, 4-Aug-2020 — /EPR HEALTHCARE NEWS/ — Palette Life Sciences, a fully integrated global life sciences company dedicated to improving patient outcomes, today announced the launch of Deflux.com/UK as part of its global expansion. Deflux.com/UK is a best-in-class online resource developed specifically for healthcare practitioners in the United Kingdom, as well as parents and caregivers managing children with vesicoureteral reflux (VUR). VUR, sometimes referred to as urinary or bladder reflux, is a serious paediatric urinary condition in which urine flows from the bladder through one or both ureters toward the kidneys.

Deflux.com/UK features important information about VUR, including symptoms, causes, risk factors and treatment options, such as Deflux®. Comprised of hyaluronic acid (HA) and dextranomer polysaccharides to form a gel, Deflux is a minimally invasive biocomopatible treatment for VUR. Endoscopic treatment with Deflux takes about 15 minutes in a day procedure setting, and generally allows the child to go back to normal activities the next day.

Deflux.com/UK also provides physicians with access to the Deflux Learning Center, a leading global education platform that features information and training for paediatric urologists and their peers who treat VUR as well as other paediatric urology conditions. The Deflux Learning Center includes clinical articles, educational videos and webinars, brochures, downloadable tools and The PedSpace podcast series, created for and presented by paediatric urology healthcare professionals.

“Deflux is an effective, minimally-invasive treatment option that many caregivers simply aren’t aware of,” said Dr. Marie-Klaire Farrugia, Consultant Paediatric Urologist and Clinical Director for Paediatric Surgery at Chelsea and Westminster Hospital. “My personal long-term experience with Deflux has proven its effectiveness and safety in reducing VUR and preventing UTI recurrence, thus avoiding use of long-term antibiotics. It is my hope that the new website initiative, which includes helpful resources for both physicians and caregivers, will help raise awareness and utilisation of this treatment option.”

“The entire Palette commercial team is excited to launch Deflux.com/UK, which we believe will help elevate the standard of care for VUR patients in the UK,” said Rich Low, Head of Marketing, Palette Life Sciences. “Deflux.com/UK will serve as a truly valuable resource for caregivers, providing critical information to paediatric urology healthcare professionals through the Deflux Learning Center, and to caregivers, connecting them to highly-trained specialists who provide high quality care.”

SOURCE: EuropaWire

Biotech, Child health, Diseases, Drugs, Healthcare, Healthcare Products, Medicine, Oncology, Pediatrics, Pharmaceuticals, Radiology, Urology

Palette Life Sciences expands distribution network across Europe

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STOCKHOLM, SWEDEN / SANTA BARBARA, CALIF., USA, 15-Jun-2020 — /EPR HEALTHCARE NEWS/ — Palette Life Sciences, a fully integrated global life sciences company dedicated to improving patient outcomes, today announced global distribution expansion for two of Palette’s products, Deflux and Solesta. The expansion provides commercial access to more than 20 countries through five distributors around the globe, while adding direct sales in four additional countries: Cyprus, Greece, Hungary and Portugal.

KEBOMED, a leading European distributor of medical devices and equipment, will distribute the products in France, Sweden, Norway, Finland, Denmark and Iceland. Stratarium Sarl, will commercialize the products in Germany, Austria, Belgium, Luxembourg, Netherlands and Switzerland leveraging their urology focused subsidiary, RA Distribution. CJ Medical, a UK-based distributor of innovative technologies specializing in surgical and medical devices, will distribute the products in Ireland and the United Kingdom. Grifols, one of the leading companies in the production and sale of plasma-derived medicines and a top distributor of a broad range of products within their country will cover Spain, and GP Dermal, a specialist with deep ties across urology and pediatric call points will serve as the distributor in Italy and Malta.

“This enhanced distribution network allows Palette to ensure our customer and patient needs are adequately met across Europe,” said James Leech, Head of Corporate Development at Palette Life Sciences. “We have selected strong partners with deep experience and relationships in the urology and pediatric setting who will help us serve the product and education needs of physicians and hospitals. Palette and its network of partners are making significant investments within local markets to improve physician access to Palette resources, best management and treatment practices, and renewed product training.”

For more information or to place an order, please contact a Palette Life Sciences representative at eusales@palettelifesciences.com. Contact information for product orders or inquires by distributor are as follows:

KEBOMED: ordre@kebomed.dk
Stratarium Sarl: deflux-solesta@stratarium.com
CJ Medical: office@cjmedical.com
Grifols: jose.sagales@grifols.com
GP Dermal: luigi.galandini@gpdermal.com

SOURCE: EuropaWire

Biotech, Drugs, Healthcare, Healthcare Information, Healthcare Products, Healthcare Services, Healthcare Solutions, Medicine, Pharmaceuticals

Parenteral Drug Association’s “ICH Q7 GMP for APIs” online training module is now endorsed by ICH

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BERLIN, 22-Nov-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) is proud to announce that its “ICH Q7 GMP for APIs” online training module is now endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use as an “ICH Recognised Training Programme.”

The training module received the distinction after PDA demonstrated to ICH that it meets the twelve eligibility criteria for the program. Among these are its mission to serve as a neutral convening platform to engage expert stakeholders from industry, academia, advocacy groups, non-profits, and/or regulatory agencies on critical regulatory topics, and its promotion of regulatory convergence to accelerate innovation and improve healthcare globally.

The free “ICH Q7 GMP for APIs” training module introduces and improves understanding of the ICH quality guideline, Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. The webinar is intended for pharmaceutical professionals working with APIs. More information on the webinar is available here: https://www.pda.org/global-event-calendar/ich-q7-gmp-for-apis.

SOURCE: EuropaWire

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Biotech, Drugs, Healthcare, Healthcare Information, Healthcare Products, Healthcare Services, Healthcare Solutions, Pharmaceuticals

2019 PDA Europe Biomanufacturing Conference in Munich: new speakers announced

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2019 PDA Europe Biomanufacturing Conference in Munich: new speakers announced

BERLIN, 14-Aug-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) today announced representatives of seven health authorities have been invited to speak at the 2019 PDA Europe Biomanufacturing Conference, 3-4 September 2019 in Munich, Germany. The following health authorities have confirmed speakers:

  • Danish Medicines Agency
  • Dutch Medicines Evaluation Board
  • European Medicines Agency
  • European Directorate for the Quality of Medicines & Healthcare (EDQM)
  • Swedish Medicines Agency

Mats Welin, Medical Products Agency, Sweden, and Dolores Hernan, European Medicines Agency, will provide an opening plenary talk on Accelerated Access and discuss the results of a 2018 EMA/FDA workshop on quality considerations for early access approaches. Those intrigued by Accelerated Access can learn more in the follow-up session, moderated by Martjin van der Plas, Dutch Medicine Evaluation Board. Welin and Hernan will participate in a panel discussion ending that session.

After a the first-day luncheon, Nanna Kruse, Danish Medicines Agency, will peel away some of the mystery surrounding the forthcoming International Conference on Harmonization (ICH) Guideline Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. In a parallel track, the Austrian Agency for Health and Food Safety (speaker TBD) will intrigue the audience with a review of challenges regulators routinely face with the advent of new vaccines and innovative biologics.

Bright and early on 4 September, the EDQM’s Gwenael Cirefice and the Dutch Medicines Evaluation Board (speaker TBD) turn the attention to ICH and advances in test methodologies. In a parallel track, Martjin van de Plas returns to the podium to review regulatory ideas regarding quality by design and control strategies. Hernan takes the mic as the conference’s last speaker to discuss EMA’s 2025 regulatory science strategy.

The meeting will close with a panel discussion including all the regulatory representatives participating.

Learn more about the topics that will be examined in-depth and/or to register. https://www.pda.org/global-event-calendar/event-detail/biomanufacturing-conference

Members of the press are welcome to apply for a press pass. https://www.pda.org/about-pda/press-pass-request-form

SOURCE: EuropaWire

Biotech, Drugs, Healthcare, Healthcare Information, Healthcare Products, Healthcare Services, Healthcare Solutions, Pharmaceuticals

EMA, MHRA and U.S. FDA among regulatory agencies participating at PDA’s 4th Annual European Meeting in Amsterdam

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BERLIN, 10-Jun-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) is excited to host its 4th Annual European Meeting: Global Healthcare of the Present and the Future, June 25-26 in Amsterdam, The Netherlands, the new location of the European Medicines Agency, where industry and regulatory agencies will present their perspectives on the transformation unfolding in the pharmaceutical sector regarding the digitalization and automation of manufacturing processes.

From the Max Planck Institute for Human Development, Felix G. Rebitschek will deliver the keynote speech, “Decision-Making Under Uncertainty.” Following him, the opening plenary “Regulatory Updates – Current Situation” will discuss understanding regulatory frameworks in an atmosphere of rapid change and provide the opportunity to participate in conversation with regulators and industry representatives.

Regulatory agencies sharing industry updates include the European Medicines Agency, U.S. FDA, WHO, MHRA and HPRA, PIC/S.

A series of parallel tracks will offer the chance to learn about topics ranging from virtual reality, data quality management, manufacturing technologies and much more.

Learn more about the topics that will be examined in-depth.

Registration (https://store.pda.org/Meetings/Login.aspx?ID=4520) can be completed until June 24.

Bona fide members of the press are welcome to apply for a press pass.

SOURCE: EuropaWire

Biotech, Drugs, Healthcare, Healthcare Information, Healthcare Products, Healthcare Services, Healthcare Solutions, Pharmaceuticals

2019 PDA EU Advanced Therapy Medicinal Products: Cell and Gene Therapy – From Promise to Cure Conference

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BERLIN, 28-May-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) is pleased to announce the speaker lineup for the 2019 PDA EU Advanced Therapy Medicinal Products: Cell and Gene Therapy – From Promise to Cure Conference, in Vilnius, Lithuania, June 4-5. Expert speakers representing industry, government and academia will cover the full breadth of scientific and regulatory considerations for successfully launching and manufacturing cell and gene therapies.

Lithuanian University of Health Science professor Romaldas Maciulaitis will get the meeting off to a quick start with his presentation, “Development and the Use of ATMPs in EU/Lithuania.”

Following him in the opening plenary session is Alistair Gibb from the UK Medicines and Healthcare Products Regulatory Agency, presenting “ATMPs System-wide Challenges from Innovation to Uptake – Pragmatic Supportive Regulation and Standards.”

The Paul-Ehrlich Institute’s Isabelle Bekeredjian-Ding takes the podium after her British counterpart with, “From Individualized to Standardized Microbiological Quality Control in ATMP Manufacturing.”

The PDA EU ATMP Conference comes just a month after PDA’s successful Cell and Gene Therapy Conference in Long Beach, Calif., May 6 – 7. That conference drew 200 participants. Earlier this year, PDA published Technical Report No. 81: Cell-Based Therapy Control Strategy.

Go here to see the full speaker lineup.

Press passes are available here to bona fide members of the press.

SOURCE: EuropaWire

Biotech, Drugs, Genetics, Healthcare, Medicine, Public Health

The LentiGlobin application for cMAA at the EMA from bluebird bio still in review process by CHMP

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LONDON, 27-Mar-2019 — /EPR HEALTHCARE NEWS/ — The LentiGlobin application for Conditional Marketing Authorization (cMAA) at the EMA from bluebird bio is still in the process of being reviewed by CHMP during their 25-28 March 2019 meeting. An opinion for the cMAA is expected to be released soon.

SOURCE: EuropaWire

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Alternative medicine, Biotech, Drugs, Healthcare, Healthcare Products, Healthcare Professionals, Healthcare Services, Healthcare Solutions, Homeopathic Treatment, Medicine, Pharmaceuticals, Public Health, Therapies

Dr. Christina Marrongelli chosen by the World Congress on Pharmacology & Chemistry of Natural Compounds to moderate their 2018 conference in Paris

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Dr. Christina Marrongelli chosen by the World Congress on Pharmacology & Chemistry of Natural Compounds to moderate their 2018 conference in Paris

Marrongelli selected for her expertise in Botanical Drug Development

LONDON, Jun-16-2018 — /EPR Healthcare News/ — As a leading expert in her field, Dr. Christina Marrongelli, PharmD has been chosen by the World Congress on Pharmacology & Chemistry of Natural Compounds to moderate their 2018 conference: Exploring New Trends & Innovations in Pharmacology and Natural Compounds. The conference is being held in Paris, France on June 18, 2018.

Dr. Marrongelli, who is an adjunct professor at the Medical University of South Carolina in the department of drug discovery and biomedical sciences will also present “Developing and Marketing Botanical Drugs in the United States”.

The United States, which has the largest pharmaceutical market in the world, demonstrates a strong demand for the use of botanicals as medicine. However, to date only two prescription botanical drugs are currently approved for use in the USA: Veregen® (sinecatechins) and Mytesi™Â (crofelemer).

Marrongelli attributes this disconnect between supply and demand to hidden barriers. She notes that with the worldwide herbal drug market is expected to reach nearly $86.74 billion by 2022, businesses must identify and address these barriers so that heterogeneous botanical drug products can obtain the approvals necessary to meet the consumers growing expectations and demands for botanical medicines.

To further explain the barriers to regulation of botanicals, Marrongelli points to the Botanical Drug Development Guidance for Industry from the U.S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER) that was last updated in 2016. According to publication, regulation of botanicals in the U.S. is different from regulation in the rest of world. The U.S. does not have a separate regulatory category for traditional or herbal medicines: A botanical product may be classified as a food (including a dietary supplement), drug (including a biological drug), medical device, or cosmetic under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Whether an article is a food, drug, medical device, or cosmetic depends in large part on its intended use.

To learn more about the issues and barriers to the development of botanical drugs, please contact Dr. Marrongelli at Marronge@musc.edu or DrM@pharmD.expert.

SOURCE: EuropaWire

Biotech, Business of Medicine, Diseases, Drugs, Health 2.0, Healthcare, Healthcare Professionals, Healthcare Services, Healthcare Software, Healthcare Solutions, Medicine

Alliance Life Sciences to present expanded portfolio of pricing & market access services at the World Pharma Pricing and Market Access Congress 2018

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SOMERSET, N.J. / LONDON, UK, 19-Mar-2018 — /EuropaWire/ — Alliance Life Sciences, a leading global life sciences consulting, pricing data and technology provider, announced that it is a sponsor at the World Pharma Pricing and Market Access Congress 2018 taking place March 20-21 in London, United Kingdom. As part of the largest pharmaceutical commercialization organization that services more than 300 of the industry’s top pharmaceutical, biotech and medical device companies, Alliance will present its expanded portfolio of pricing and market access services. The focus will be on pricing and reimbursement data managed by PricentricOne and pricing governance, reference and tender pricing software manage by PriceRight.

Now in its 12th year the World Pharma Pricing and Market Access Congress brings together the most innovative leaders and organizations to discuss all aspects of evidence, access and pricing. This year’s event will feature over 150 speakers and a greater range of topics being covered including Big Data & AI, rare diseases, advanced therapies and other emerging, innovative areas.

Alan Crowther, President of Global Markets noted “Alliance Life Sciences is pleased to be a sponsor of the World Pharma Pricing & Market Access congress, particularly this year. We have made a number of investments in our people and infrastructure in Europe. Our acquisition by Water Street partners in 2017 allowed us to offer enhancements in our Market Access offerings too. Europe continues to be our focus market and World Pharma Pricing & Market Access congress is a great venue to showcase our expended capabilities”.

SOURCE: EuropaWire

Biotech, Business of Medicine, Cancer, Critical Care, Diseases, Doctors, Drugs, Emergency Medicine, Health Plans, Health Reform, Healthcare, Healthcare Professionals, Medicine, Oncology, Pharmaceuticals, Public Health, Regulation, Society, Therapies

Prof. Lucien Abenhaim: There is an incredible challenge for the sustainability of health systems across the world

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Prof. Lucien Abenhaim

LONDON, Dec-3-2017 — /EuropaWire/ — On December 5-6, 2017, 200 high-level experts from government, academia, biopharmaceutical developers and patient organisations convene in London (UK) to address the mounting challenge of accessibility and patient access to high-value, high-cost medical therapies.

The not-for-profit executive forum is organised by the London School of Hygiene and Tropical Medicine and analytica|LASER, a global research consultancy, to investigate topical questions around drug policy, global health systems sustainability and innovation funding through a combination of case studies, panel sessions, and roundtables. Delegations are registered from over 70 public and private organisations, including the World Health Organization, as well as health systems representatives from Belgium, England, Estonia, Croatia, France, Germany, Italy, Norway, Sweden, the United States and Wales. Multiple patient organisations support the meeting to ensure that the patient voice is reflected in all deliberations.

“Access to life-saving drugs is not a new challenge. The paradigm of accessibility was changed completely in the face of the deadly HIV epidemic. This time, however, accessibility concerns almost every domain of medicine such as cancer, auto-immune diseases and rare diseases. We must act now,” says Prof Peter Piot, Director of the London School of Hygiene & Tropical Medicine and former head of UNAIDS.

“There is an incredible challenge for the sustainability of health systems across the world”, says Prof. Lucien Abenhaim, London School of Hygiene & Tropical Medicine and Chairman of Analytica Laser. “It is critical that drug developers and health system engage on actionable proposals that address concerns around value, cost and overall access to innovation for the patients who need it. We are at an inflection point – the paradigms of the 1990’s can no longer guide us,” he adds.

The main plenary on December 6th features scheduled remarks by over a dozen authorities in the field, including Professor Baron Peter Piot (Director, London School of Hygiene & Tropical Medicine and former Head, UNAIDS), Dr. Olivier Brandicourt (Chief Executive Officer, Sanofi), Dr. Sarah Garner (World Health Organization), Prof. Dominique Le Guludec (President, French HAS), Sir Andrew Dillon (Chief Executive, National Institute for Health and Care Excellence UK) and Dr. Harold Paz (Chief Medical Officer, Aetna). The plenary is preceded by a scientific seminar on December 5th which gathers globally renowned academics to explore new frontiers on the methodology for the appraisal and valuation of high-value medicines.

Please contact the organisers for more information on the programming and media access, or refer to www.accessibility-symposium.org

SOURCE: EuropaWire

Biotech, Business of Medicine, Drugs, Health 2.0, Healthcare Products, Healthcare Professionals, Healthcare Services, Healthcare Software, Healthcare Solutions, Pharmaceuticals

Global leader in serialization solutions Systech to attend the annual pharmaceutical congress CPhI Worldwide in Barcelona, 4 – 6 Oct 2016

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systech_international_slogo_europawireBRUSSELS, 28-Sep-2016 — /EuropaWire/ — Systech International, a global leader in brand protection technologies, will partner with Sharp Packaging and SINEL SYSTEMS, part of the Autajon Group, at CPhI Worldwide, the annual pharmaceutical congress held in Barcelona from 4 – 6 October 2016.

Systech will be part of Sharp’s panel discussion addressing delegates on the theme of “Serialization: Optimizing Your Supply Chain Means Optimizing Your Partners.” The presentation will explore the critical path to supply chain readiness, risk assessment, benchmarking and serialization risk mitigation options. The briefing will take place in the Pharma Insight Briefing room on Tuesday, 4 October 2016 at 11:30am CEST.

Systech will also showcase its UniSeries™ serialization software offered as an integrated solution within Autajon’s exhibit booth #2P16 (Hall 2).

CPhI Worldwide, together with co-located events ICSE, InnoPack, P-MEC and FDF, will host more than 36,000 visiting pharma professionals from 4-6 October at the Fira Gran Via, Barcelona, Spain. More than 2,500 exhibitors from 150+ countries gather at the event to network and take advantage of more than 100 free industry seminars. Every sector of the pharmaceutical market is represented under one roof, this year in a new location in Barcelona.

With thousands of implementations across the globe, Systech is the world’s most trusted brand protection expert, and its UniSeries offering is the industry standard for serializing products. UniSeries is offered as an integrated solution with both Sharp Packaging and Autajon Group’s hardware. Systech’s patented, configurable software offers manufacturers the flexibility to adapt to new regulations without extensive reworking or revalidation, thereby reducing implementation, training and support costs.

“We are recognized as the world leader in serialization and brand protection,” states Manfred Voglmaier, Senior Director Sales Europe, Systech International. “With more than 30 years of experience in providing highly configurable solutions for serialization across a variety of industries ― along with our partners Sharp Packaging and Sinel ― gives us a unique insight for this panel.”

Systech’s products are in greater demand than ever before since it is estimated that over 15,000 production lines for prescription medication in Europe must be fitted with a serialization system over the next three years. The European Commission adopted a regulation on October 2, 2015, under which the serialization of prescription medicine packages will become mandatory in all EU countries by 2019.

Show exhibit hours are on Tuesday, 4 October – Thursday, 6 October. Systech representatives will be available in the Sharp Packaging booth #3L56 (Hall 3) during the event, as well as in the Autajon booth #2P16 (Hall 2). They will showcase Systech’s software solutions on sample packaging lines and via live demos throughout the event.

SOURCE: EuropaWire

Business of Medicine, Consultations, Drugs, Healthcare Software, Healthcare Solutions

Finnish Servicepoint to resell, install and support Systech’s serialization solutions in Scandinavia, the Baltic States, and Russia

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servicepoint-fi__logo_europawireFinland, 23-Sep-2016 — /EPR HEALTHCARE NEWS/ — Systech International, a global leader in brand protection technologies, today announces the extension of its strategic partnership with Servicepoint, a leading serialization automation supplier.

Systech has signed a global agreement with Servicepoint, allowing the company to act as a single point of contact for customers across Europe. Through this agreement, Servicepoint will now resell, install and support Systech’s serialization solutions to customers of any size across Europe, especially in Scandinavia, the Baltic States, and Russia.

This agreement comes at a critical time within the pharmaceutical industry, as the European market is growing exponentially. It is estimated that over the next three years, 15,000 production lines for prescription medication in Europe must be fitted with a serialization system. The European Commission adopted a regulation on October 2, 2015, under which the serialization of prescription medicine packages will become mandatory in all EU countries by 2019.

Systech and Servicepoint first engaged two years ago when jointly delivering serialization and automation/integration solutions to a pharmaceutical manufacturing client. As a result, both companies were able to offer enhanced solutions and increase their speed of delivery.

Servicepoint maintains and offers professional services, automation services, retrofit/upgrade services to Systech customers and provides Level 1 and 2 support, while Systech provides Level 3 support for the software.

“Servicepoint has a solid network of over 50 professionals in Europe, which, when combined with Systech’s growing regional support, creates a large and experienced talent pool for the delivery of serialization initiatives,” states Harry Saint-Preux, Director, Global Alliances & Channels, Systech International.

“Servicepoint has extensive expertise and a long history automating hundreds of production lines for different fields of industry and European pharmaceutical manufacturers, as well as experience with track-and-trace initiatives. Systech and Servicepoint’s combined approach provides manufacturers with the solutions, services and support required to address Europe’s challenging serialization requirements,” notes Saint-Preux.

Risto Finne, chairman of the board, Servicepoint, comments, “Servicepoint is honored to enter into this partner agreement with Systech, who we consider to be the global market leader in serialization. This cooperative paves the way for numerous new business opportunities, particularly with Russian companies that need to rapidly employ serialization. Our experience in integrating modifications and upgrades of existing production lines, in addition to new, turnkey, fully-automated solutions for the serialization and packing of medical, food and other sensitive products puts us in an enviable market position.”

Servicepoint is one of only a handful of suppliers in the European market that provides an all-inclusive production automation solution including planning, installation, testing, and maintenance.

SOURCE: EuropaWire

Biotech, Drugs, Healthcare Products, Healthcare Services, Healthcare Solutions, Medicine, Society

ViroCarb’s anti HIV Crowd Funding Campaign

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Toronto, Canada, December 01, 2014 — /EPR HEALTHCARE NEWS/ — ViroCarb Inc. has launched a worldwide crowd funding campaign to promote the development of its new HIV infection inhibitor.

WORLD AIDS DAY – Make a donation to save lives from AIDS! Support new treatment development at: https://www.indiegogo.com/projects/funding-a-new-therapy-against-drug-resistant-hiv/x/9240077

Despite the great progress made in HIV/AIDS treatment, there is still an urgent need for new drugs, particularly for people who have had to abandon existing treatments due to HIV drug resistance and side effects.

The current treatment of HIV/AIDS involves the use of three or more drugs from five main general classes, used in combination. While this antiretroviral therapy (ART) has helped to reduced morbidity and mortality from AIDS, long term toxicity and the emergence and transmission of drug resistant HIV strains limit the effectiveness. Thus, despite therapy which can render this a chronic, rather than acute fatal infection, development of new drugs to prevent infection and overcome drug resistant strains, is increasingly urgent.

ViroCarb Inc. is developing a novel technology that addresses infections by drug resistant HIV strains. Developed from the identification of a new, natural resistance factor against HIV infection by scientists at SickKids and Canadian Blood Services, ViroCarb’s inhibitor works against a previously overlooked target on the virus to block HIV from entering human cells, the very first step in the infection. It works against all HIV strains.

Funds are needed to aid in moving forward to support preclinical studies; therefore ViroCarb Inc. has started an international crown funding campaign to carry out these HIV model studies needed before conducting clinical trials.
Please support this new way to block HIV.

Contact-Details: Dr. Mario Huesca
479 Simonston Boulevard.
Thornhill ON.
L3T 4M4 Canada

Facebook: https://www.facebook.com/ViroCarb;
Website: http://www.virocarb.com

 

Via EPR Network
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Biotech, Cancer, Drugs, Health Products, Healthcare, Healthcare Products, Pharmaceuticals

Sprint Bioscience Strengthens Its Cancer Metabolism Portfolio

Sprint Bioscience, a Swedish company developing oncology therapeutics targeting cancer metabolism, announced today that it has raised money to strengthen its drug discovery portfolio.

The investment by Första Entreprenörsfonden and Almi Invest will enable the company to continue to build a pipeline of drug discovery projects within cancer metabolism.

“We are investing in Sprint Bioscience because we consider their entrepreneurial drive and their particular skills in drug development to be key success factors for the changing environment of the future pharmaceutical industry. Sprint Bioscience’s business strategy involves out-licensing or collaborating at an early stage of drug discovery to ensure that projects are developed with a focus on current and relevant market needs,” says Rune Nordlander, partner at Första Entreprenörsfonden.

Sprint Bioscience is a company founded by experienced drug hunters with an ambition to improve the drug discovery process. “We believe in small organisations with effective working procedures and collaborations throughout the sector,” says the company’s CEO and co-founder, Dr. Anders Ã…berg.

“Sprint Bioscience has developed an efficient, fragment-based drug discovery (FBDD) platform that can take parallel projects from initial idea to active molecules tested in cell-based systems in a very short time” Anders Ã…berg continues. Our goal is to align the early phase in the laboratory with pharmaceutical companies’ needs.

Targeting the metabolism in tumours provides exciting opportunities to develop drug therapies with novel mechanisms of action. This could be used to overcome the resistance that many cancer cells develop to current treatments.

Via EPR Network
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Addictions, Clinics, Diagnostics, Drugs, Healthcare, Healthcare Information, Healthcare Services, Medicine, Rehab, Society, Therapies

New Study Suggests Alcohol Abuse Rewires Brain, Impedes Trauma Recovery

A recently published study suggests that heavy alcohol use may interfere with recovery from traumatic situations.

The study was published in the journal Nature Neuroscience and focused on mice that were chronically exposed to alcohol in doses twice the legal driving limit imposed on humans. Conversely, the control group of mice wasn’t exposed to any alcohol. After administering, and then ceasing, tiny electrical shocks mimicking trauma within humans, the mice chronically exposed to excessive alcohol had a more difficult time recovering from the trauma. In addition, a key receptor within the brains of the alcohol-exposed mice was suppressed and nerve cells within the brain were found to have taken on a different shape.

“This study offers valuable insight into how chronic alcohol abuse may disrupt recovery pathways in human brains,” begins a spokesperson for Mountainside Drug Rehab andAlcohol Treatment Center. “By understanding the correlation between chronic alcohol abuse and anxiety associated with traumatic events, researchers could eventually develop drugs that could assist in recovery for chronic alcohol abusers.”

The Centers for Disease Control and Prevention states that excessive alcohol use is the third leading lifestyle-related cause of death within the United States, estimating nearly 80,000 deaths annually. If you fear that a loved one may be excessively consuming alcohol, Mountainside Drug Rehab and Alcohol Treatment Center can assist them in getting their life back on track. Mountainside’s comprehensive alcohol rehab program has been recognized as a standout program among their peers.

Mountainside Drug Rehab and Alcohol Treatment Center is a modern drug rehab and alcoholism treatment facility that is skilled in serving a variety of clients with various addictions and in varying stages of addiction. The caring, compassionate team is made up of licensed and certified social workers and counselors who have extensive experience and specialty in the addiction treatment field. In addition, the staff includes a Nurse Practitioner, as well as a Registered Nurse, both of whom also have specializations and experience within the field of addiction treatment and alcohol rehab.

Mountainside also has available services for those individuals who come to them with dual diagnoses and require the services of a Psychiatrist to help conquer the unique challenges that dual diagnosis brings.

For the past 13 years, Mountainside has established itself as an innovator within the addiction treatment field, and the treatment modalities Mountainside utilizes are regarded as among the most cutting-edge approaches in helping individuals to get, and to remain, sober. As a result of their unique, innovative approaches to addiction treatment, Mountainside has become the model for the addiction treatment field.

The program and its professional addiction treatment team have earned national recognition and resulted in Mountainside being invited to Washington by the White House to meet with the White House Drug Czar, John P. Walters, for an in-depth meeting on what makes its program so successful. These accolades did not go unnoticed within the addiction treatment field and resulted in the adoption by many throughout the country of a more holistic approach to drug addiction treatment.

If you or someone you love is addicted to drugs or alcohol, or if you have any questions, please contact Mountainside Drug Rehab and Alcohol Treatment Center for a confidential discussion at 800-762-5433.

Via EPR Network
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Addictions, Clinics, Diagnostics, Drugs, Healthcare, Healthcare Information, Healthcare Services, Medicine, Rehab, Society, Therapies

Drug-Related Deaths Outnumber Deaths By Automobile Accident

The Centers For Disease Control (CDC) has declared prescription drug overdoses as an epidemic in the United States.

The CDC estimates that one death from abuse of prescription drugs happens every 19 minutes- a greater number than those killed in automobile accidents. The National Institute of Health estimates that nearly ten percent of Americans abuse narcotics over their lifetime; 20% of teens are estimated to be experimenting with opioids.

“The number of individuals who experiment with narcotics is alarming,” begins a spokesperson for Mountainside Drug Rehab and Alcohol Treatment Center. “It seems as if many individuals believe that experimenting with narcotics is safe simply because they are prescribed by a physician and filled at a pharmacy. These statistics show that these beliefs couldn’t be further from the truth. Prescription drugs are prescribed by a physician, or other qualified medical professional, for a specific individual – others abusing them are endangering their lives. We need to make certain that we are sending the right message, all of the time, to Americans. We must be vigilant as we declare war on this epidemic.”

While opioid abuse is growing at a staggering rate, there is hope. If you believe that your child or other loved one is among those who are experimenting with opioids or any other substance, Mountainside Drug Rehab and Alcohol Treatment Center can help provide professional intervention services that will help you to approach them in a non-confrontational manner.

Through their unique drug addiction treatment program, Mountainside’s team of professionals will customize a program that is unique to the specific treatment needs of the individual. In addition, their comprehensive family care program will educate the entire family as well and give them the tools to support the family member’s recovery process leading to the journey of life-long sobriety.

Mountainside Drug Rehab and Alcohol Treatment Center is a modern drug rehab facility that is skilled in serving a variety of clients with various addictions and in varying stages of addiction. The caring, compassionate team is made up of licensed and certified social workers and counselors who have extensive experience and specialty in the addiction treatment field. In addition, the staff includes a Nurse Practitioner, as well as a Registered Nurse, both of whom also have specializations and experience within the field of addiction treatment and alcohol rehab.

Mountainside also has available services for those individuals who come to them with dual diagnoses and require the services of a Psychiatrist to help conquer the unique challenges that dual diagnosis brings.

For the past 13 years, Mountainside has established itself as an innovator within the addiction treatment field, and the treatment modalities Mountainside utilizes are regarded as among the most cutting-edge approaches in helping individuals to get, and to remain, sober. As a result of their unique, innovative approaches to addiction treatment, Mountainside has become the model for the addiction treatment field.

The program, along with its professional addiction treatment team, have earned national recognition and resulted in Mountainside being invited to Washington by the White House to meet with the White House Drug Czar, John P. Walters, for an in-depth meeting on what makes its program so successful. These accolades did not go unnoticed within the addiction treatment field and resulted in the adoption by many throughout the country of a more holistic approach to drug addiction treatment.

Via EPR Network
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