Category Archives: Healthcare Services

Origami and citoQualis will work together to help Medical Device startups get products to global markets faster

KFAR SABA, Israel, 9-Nov-2021 — /EPR HEALTHCARE NEWS/ — Origami, a leading provider of no-code business process automation software for Medical Device and other industries, and citoQualis, a regulatory and business advisory leader for EU Medical Device companies, are announcing a partnership to help Medical Device startups get products to global markets faster.

Medical Device startups face unique pressures due to numerous country-specific regulations. This new partnership will help companies efficiently manage their regulatory approval processes, and enable rapid business growth.

Origami’s medical device customers operate around the world. With recent EU regulatory updates, companies are seeking strategic regulatory and business guidance to help them get and maintain product approval in that geography. The new partnership will provide Origami customers with access to citoQualis expertise in business and complex regulatory landscapes.

The citoQualis team points out that Medical Device startups have global workforces that “expect to access their systems from wherever they’re located, and to use those systems to collaborate internally and with citoQualis” says Mr. Wolfgang Werner, CEO of citoQualis.

According to Mr. Werner, “As advisors, it’s our job to identify opportunities and share our insights. For startups, the faster a product moves from idea to production, the better. With Origami’s flexibility, we are able to give our clients a software option that works for them now and as they scale.”

Germany and other EU countries have strong medical device startup ecosystems, which citoQualis is well connected to. Origami is excited to work with citoQualis and the startups they advise, noting how both companies focus their solutions and teams on helping customers succeed in complex environments.

Yaniv Shimony, CEO of Origami says “startup CEOs recognize Origami’s business value, in that they always have the solution their company needs. When you create a new and innovative medical device, using inflexible software point solutions slows your business down. With Origami, information is instantly available about any part of your business such as sales, quality, design, product approvals, manufacturing, equipment maintenance, purchasing, supplier compliance, invoicing, complaints and more.”

Existing customers will be able to maintain and expand EU market access by working with local regulatory experts, facilitating hundreds of millions of Euros of revenue.

SOURCE: EuropaWire

Black-Owned FitTech Start-Up Aims to Fix Healthcare for African Americans

LOS ANGELES, CA, 2021-Sep-21 — /EPR HEALTHCARE NEWS/ — JunBugg Fitness Social Network, Wall Street’s “first and only luxury social media brand,” created by African American founder Louis Green, today announced the launch of its NextGen fitness website. Using computer algorithms, JunBugg integrate entertainment into health by sharing unique fitness solutions related to one’s body-type, that leads to better fitness results in least time — influencing success for a higher quality of life.

The start-up website boasts a sleek interface, vibrant logo, sophisticated font-type, and beautiful images, built on sophisticated software engineering. Through social engagement, members of similar health conditions and body-types share fitness strategies and medical solutions to get fit. JunBugg use algorithms that recommend relevant solutions to newsfeeds, the same technology that has allowed — TikTok, Netflix, and Amazon to be successful. The NextGen Search Database deliver relevant fitness matches for personalized training.

A personalized fitness solution, members engage, collaborate, and work as a team. Teamwork allows members to foster camaraderie, innovate, and better problem solve fitness and health obstacles. The bigger the network grows, the more cures that are created. Algorithms see patterns of successful fitness solutions, learns the most effective ones, and recommend them to newsfeeds. As solutions evolve and improve, the algorithm learns and thus recommend those.

The African American community was hit hard by COVID19, who stand to gain the most from JunBugg, for a higher quality of life. The platform is easily accessible and allows equal quality of health care while being affordable. The management of health conditions is the biggest benefit, and prevention of disease as opposed to disease treatment, by being fit through exercise and eating healthy. See boutique fitness solutions — https://www.junbugg.net

Unlike traditional social media services — TikTok, Facebook, Instagram, Snapchat, and Twitter, whose services are free, JunBugg’s boutique membership offerings range between $30 and $500 a month. Fees are comparable to other boutique studios and fitness services, such as — Equinox, SoulCycle, Peloton, and YogaWorks.

It’s all about fitness wealth and a higher quality of life. The first of its kind, JunBugg will forever change fitness and healthcare,” said Louis. “People are an amazing resource that’s never been used in this way — through the power of social media technology, to solve problems through entertainment.”

 

Via EPR Network
More Healthcare press releases

University of Freiburg spin-off with strong preclinical evidence for significant breakthrough in curing prostate cancer

FREIBURG, Germany, 1-Jul-2021 — /EPR HEALTHCARE NEWS/ — Prostate cancer is the second most common cancer. According to the American Cancer Association, 1 in every 8 men will be diagnosed with it in their lifetime. In 2018 around 1.2 million men were diagnosed and there were 360,000 deaths. In Europe alone, 450,000 men are diagnosed with prostate cancer every year. But there could be a cure on the horizon.

B66, a new company in Germany and a spin-off from the University of Freiburg, Germany, has strong preclinical evidence that its research has made a significant breakthrough after 6 years of dedicated work. Professors Roland Schule, Manfred Jung and Dr Eric Metzger have pioneered research into inhibitors of the histone methyltransferase KMT9 that controls the growth of castration and enzalutamide resistant prostate tumours. These small molecular inhibitors are superior to current state-of-the-art Gold Standard drugs in preclinical models. This new treatment has the prospect of increasing survival in the normally fatal outcome of castration-resistant prostate cancer and becoming the universal therapeutic agent. In addition, the research team’s work shows that their new therapeutic agent has potentials in other cancers including colorectal, breast, bladder and the biggest of all killers, lung cancer.

Professor Roland Schule, one of the B66 founders, and a professor of Biochemistry in the University Medical Centre of Freiburg said “Our findings and approach to treatment is far in advance of anything that is going on in the world at the moment.”

Fellow founder, Professor Manfred Jung, added “many cancer treatments cause damage to the patient’s normal cells but the B66 inhibitor does not target normal cells indicating that our treatment will have minimum side effects”.

Although focused on prostate cancer right now, the B66 team’s long-term objective is to create a world-class development platform that will work on the defeat of many other types of cancer. The Freiburg region, thanks to the University, is a unique centre of leading medical knowledge. B66 will expand their work and draw in some of the skilled scientists from the area to help them work towards building a leading medical development hub.

The B66 team is already seeking commercial partners in order to forward their breakthrough work and advance as quickly as possible to defeat this major cancer.

SOURCE: EuropaWire

Palette Life Sciences unveils 4 international sites for its Deflux online presence

SANTA BARBARA, CALIF. / STOCKHOLM, 27-Oct-2020 — /EPR HEALTHCARE NEWS/ — Palette Life Sciences, a fully integrated global life sciences company dedicated to improving patient outcomes, today introduced valuable new online resources for healthcare providers in France, Germany, Italy and Spain. By expanding its Deflux online presence to international audiences, Palette Life Sciences demonstrates its commitment to supporting the global paediatric community.

Deflux.fr is a French-language resource for healthcare providers in France. Deflux.com/de is a German-language site serving practitioners in Germany. Deflux.com/es and Deflux.it are English-language sites serving physicians in Spain and Italy respectively. These new sites offer best-in-class online resources, important information and education about VUR, including symptoms, causes, risk factors and treatment options, such as Deflux®. All of the European sites provide physicians with access to the global Deflux Learning Center, a leading education platform that features information and training for paediatric urologists and their peers who treat VUR. The Deflux Learning Center includes clinical articles, educational videos, webinars, brochures, downloadable tools and The PedSpace podcast series, created for and presented by paediatric urology healthcare professionals.

The Deflux Learning Center for each respective country also provides downloadable educational materials for parents and caregivers managing children with vesicoureteral reflux (VUR).

“My personal long-term experience with Deflux has proven its effectiveness and safety in reducing VUR and preventing UTI recurrence in patients who fail medical management, thus avoiding use of long-term antibiotics. It is my hope that the new website initiative, which includes helpful resources for physicians, will help raise awareness of this treatment option in patients with primary VUR, troubled by recurrent febrile UTIs,” said Dr. Marie-Klaire Farrugia, Consultant Paediatric Urologist and Service Lead for Paediatric Surgery at Chelsea & Westminster and Imperial College Hospitals.

“We are excited to offer these new online resources to the healthcare community in France, Germany, Italy and Spain,” said Rich Low, Head of Marketing at Palette Life Sciences. “We are confident they will benefit the global paediatric urology ecosystem and serve as valuable resources by providing critical information and access to educational resources through the Deflux Learning Center.”

SOURCE: EuropaWire

CoapTech Raises $7 Million in Series B Funding Led by Hunniwell Lake Ventures

Baltimore, MD, 2020-Aug-28 — /EPR HEALTHCARE NEWS/ — CoapTech LLC (Baltimore, MD), a leading medical device start-up pioneering the world’s first and only ultrasound-based feeding tube placement system, announced today the closing of a Series B investment of $7 million led by Palo Alto-based medical device venture capital firm Hunniwell Lake Ventures. The financing will be used to fund CoapTech’s commercialization of its FDA-cleared PUMA-G System.

By simplifying gastrostomy procedures to the point where they can be conducted at the patient’s bedside with ultrasound, hospitals using PUMA-G benefit by freeing up surgical suites and personnel resources for COVID and other clinical priorities, minimizing cross-contamination, and improving efficiencies in care.

CoapTech was founded by critical care physician Dr. Steven Tropello and clinical innovation researcher Howard Carolan, to reduce unnecessary delays, harm, and costs for feeding tube placement, a vital therapy for millions of patients each year around the world.

Howard Carolan, CEO and Co-Founder, states: “We have been receiving fantastic feedback from hospitals in our initial launch program, which are using the PUMA-G System to revolutionize feeding tube placement. By using ultrasound at the patient bedside, rather than the conventional approach of orchestrating expensive and inefficient consults, critical care physicians are completing these procedures in minutes, on the same shift a feeding tube is first indicated. We’re seeing early indications those efficiencies result in patients leaving the ICU sooner, which saves hospitals many thousands of dollars per admission. A substantial portion of this new funding is from physicians who have seen the device and believe it can become the new default method for feeding tube placement.”

Dr. Steven Tropello elaborates, “the PUMA-G System is proving itself ready for standard-of-care adoption for safe and timely gastrostomy tube placement. It is also proving a powerful approach in the fight against COVID, by completely eliminating transport of patients, team members, and reprocessed tools throughout the hospital in favor of a sterile, disposable, bedside solution. I am also very excited about other clinical applications of the PUMA platform we are developing and aim to have for patients in the near future.”

This Series B investment was led by Hunniwell Lake Ventures, a Palo Alto-based medical device venture capital firm.

Daniel Teo, Managing Partner at Hunniwell Lake Ventures, further states “Coaptech’s PUMA System has the potential to transform gastrostomy and many other surgical procedures by allowing them to be performed using ultrasound at the bedside, in hospitals, ambulatory centers, skilled nursing facilities, and LTACHs (Long-term Acute Care Hospitals). This also benefits patients by bringing the procedure closer to the Point-of-Demand (PoD) and giving them more options with a larger community of medical providers capable of performing the procedure.

Via EPR Network
More Healthcare press releases

Exclusive Interview on Addictiveness During the Coronavirus Pandemic with Dr. Henry Balzani, the “Addictiveness Doctor”

Fort Lee, NJ, USA, 2020-May-15 — /EPR HEALTHCARE NEWS/ — In an exclusive interview with Practicomm, nationally recognized addictiveness expert provides valuable update on controversial addiction issues.

Q1. In light of the Coronavirus pandemic, it appears that people who were not addicts could become addictive just from being quarantined? Do you think that would be a large number of new addicts?

Our “Basic Survival Thinking” is mostly negative and being quarantined produces increased life stresses such as, unemployment, financial loss, fear of death, forced isolation and mental illnesses. During the pandemic, there has been an increase in alcohol consumption (as well as other substances) to blunt the negative thoughts. Also, there was an increase in sugary-high carb “comfort foods” used to stimulate positive feelings through the increased production of neurotransmitters like dopamine and serotonin.

But in fact, almost all the Covid-19 deaths are directly related to our addictiveness to high carb, processed food and the abuse of drugs, alcohol, tobacco, especially high blood sugar, diabetes and high blood pressure, which compromise the immune system. In brief, “Yes”, there will be an increase in addictiveness to try to relieve the pressure and mental stress from this pandemic

Q2. Some people say that smoking is a worse addiction than alcohol and drugs. Is that true? If so, why?

Smoking leads to strong persistent cravings for more nicotine within minutes to hours of the last puff. Vaping allows nicotine to almost always “be in hand’ day and night, inside or out. Addiction to different substances varies with the substance and the individual, and is tempered by availability, legality, cost, social acceptance, the onset of health issues, age of user, and more. Smoking health issues usually develop later in life; products are readily available, and vaping is now cool and socially acceptable. Fortunately, tobacco products are banned in buildings and outside in parks, thus making it harder to use freely.

Q3. It seems that most addiction treatment centers have a high percentage of patients who are “cured” for only a small period of time before going back to the addiction. Is that a correct statement?

The LIFETIME tendency to relapse (recidivism) after treatment is still high. The “Post Treatment Cure” is, for most, a physiologic removal of the substance from the body; and, for a time, a psychologic re-education and respite for the client before entering the real world. The “Roots of Addiction” can start early in life and become deeply and unconsciously embedded over years, and can always be reactivated under stress. To achieve a lifetime cure, addicts must always be actively involved in their recovery, because life just doesn’t get easier. I have seen my clients relapse a number of times before being able to maintain sobriety; and, some who have relapsed after many years of sobriety.

Q4. Can addicts actually change the way they think? How would they do that if they could? Does this vary by the type of addiction?

Adult addicts can change the way they think if they have a strong Desire, Interest and Commitment to recover. But, being pushed into recovery usually doesn’t last long.

They must deal with the root causes of their addiction, as they can be reactivated during times of stress. For any addiction, they must fully commit and actively participate in their process of Detox, Treatment, Counseling, and follow up, remove people places and things, and have (or seek out) a strong support system which can help in stressful situations. The stresses of life will always be there and it’s the psychological aspect of addiction that can be persistent!

For more information on the root causes of addiction, visit  addictivenessdoctor.com and/or go to Dr.Balzani on Facebook.

Via EPR Network
More Healthcare press releases

MEDIS expands into new areas of cardiovascular disease with the acquisition of Italian medtech company AMID

LEIDEN, Netherlands, 11-May-2020 — /EPR HEALTHCARE NEWS/ — MEDIS, a leading developer and supplier of software applications for image-based diagnosis and quantitative assessment of cardiovascular disease, today announced that it acquired Advanced Medical Imaging Development S.r.l. (AMID), a developer and supplier specialized in cardiovascular mechanics and innovative image processing in ultrasound and other modalities. The strategic acquisition will expedite MEDIS’ expansion in new areas of cardiovascular disease, and secure MEDIS’ access to key technologies to further enhance its innovative portfolio of post-processing solutions for X-ray, MR, CT, IVUS, OCT and US devices.

The acquisition of AMID, based in Sulmona (Italy), will further increase MEDIS’ share in the cardiovascular market. “This acquisition expands our product portfolio and brings in new sales channels. The combination of AMID’s products with our product and services portfolio will enable us to provide our customers a unique and more complete multi-modal offering for cardiovascular imaging analysis”, said Hans Brons, CEO of MEDIS.

“As part of MEDIS we will have significantly more leverage to position our portfolio of innovative technologies in the global market for cardiovascular imaging software,” commented Giovanni Tonti, CEO of AMID. “Our technology offerings will allow MEDIS to complement and further enhance its already impressive suite of clinical offerings and spur innovation.”

“MEDIS and AMID have already had an excellent cooperation for over five years, both commercially and in product development. I am very excited about our access to the unique know-how and innovative power of AMID’s founders and their technology, and to intensify the cooperation leading to new solutions that ultimately will benefit the patients“ says Hans Reiber, founder and CSO of MEDIS.

MEDIS will leverage AMID’s proprietary state-of-the-art software and know-how to provide even more sophisticated cardiac and cardiovascular imaging software solutions to its customers. “The integration of both companies will take place over the next months. We expect to significantly strengthen our power to innovate and are very excited about our new relationships with AMID’s existing OEMs and sales channels” added Hans Brons. “Our new customers will continue to receive the same high quality of service which they have come to expect.”

AMID, which will continue to operate under that name is now a wholly owned subsidiary of MEDIS.

Over the last 6 months Van Herk Ventures has made significant further equity investments in MEDIS with the aim to help accelerate the growth of the company and to enable the acquisition of AMID.

“With this investment, Van Herk Ventures enables us to further expand on our position as an independent vendor of high specialty software and a leader in this industry,” stated Hans Brons, CEO of MEDIS.

“We have been intrigued by the broad spectrum of innovations in the cardiovascular imaging domain that MEDIS has created and commercialized over the years, and in particular the more recent exciting and disruptive opportunities in the field of interventional cardiology.

MEDIS has been recognized worldwide as a company that develops high quality software, listening to the needs of the clinicians and researchers and supporting them with new and expanded applications. We believe that there is a great upwards potential in MEDIS and we like to stimulate these developments and see the company grow to the next level. We are therefore very excited about the MEDIS acquisition of AMID,” said Dharminder Chahal, managing director of Van Herk Ventures.

SOURCE: EuropaWire

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

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

###

Wilson Dental of McLean, a Veteran-owned Business Teams Up With Soldiers’ Angels to Collect Halloween Candy for Troops and Veterans

 

McLean, Virginia, 2019-Oct-30 — /EPR HEALTHCARE NEWS/ — Every year, millions of pounds of candy end up in the trash after Halloween. From over-buying, to kids collecting more than they can eat while Trick-or-Treating, candy is wasted across the country. This year, Wilson Dental of McLean is participating in a program that will help our community produce less waste after Halloween while also showing our support for our service members and veterans! Owner, Dr. Lois Wilson, is herself a Veteran who proudly served as an Army Dentist both here and overseas.

Soldiers’ Angels, a national 501(c)3 nonprofit, hosts an annual collection drive for excess Halloween candy. The organization ships the candy to deployed service members around the world for a sweet treat from home! They also utilize their “Angel” volunteers to distribute candy to veterans of all eras in VA Hospitals across the country.

Wilson Dental of McLean is proud to team up with the national organization to get our local community involved with giving back to the brave men and women who have sacrificed so much for our country. Our business has registered with Soldiers’ Angels to be an official drop-off site for Halloween candy. Once our collection drive is over, Wilson Dental of McLean will donate all collected candy to Soldiers’ Angels where it will be packaged and shipped to deployed or distributed in VA Hospitals.

“As a veteran of the US Army, I am excited to facilitate a donation for our service men and women who are deployed or currently in the hospital. I know first hand that being away from your family during joyful holidays is extremely difficult and I hope that this small token can help bring joy to those who sacrifice so much for our country.” – Dr. Wilson

The vision of Soldiers’ Angels is: May No Soldier Go Unloved. Although the gesture of handing out miniature candy bars may seem small, the impact that small gesture can have on troops and veterans is huge.

“When you are deployed to a combat zone, there are many comfort items you may go without for an extended period of time,” says Amy Palmer, President and CEO of Soldiers’ Angels. “Receiving care packages from home is a wonderful and unexpected surprise. The joy these service members get from opening a package of treats from home is immense and has a profound impact on their morale. The same can be said for veteran patients in VA Hospitals. Some patients have no family or regular visitors. When our Angel volunteers come in with treats like candy, the spirits of these patients are immediately lifted!”

Our collection drive will run from October 25th 2019 to November 18th 2019. Please call ahead before stopping by our location to drop off your candy:

Wilson Dental of McLean
1447-C Dolley Madison Blvd
McLean Virginia 22101

For more information on the program, or if you are interested in registering your business as a drop-off site, visit: www.SoldiersAngels.org/TreatsForTroops

Via EPR Network
More Healthcare press releases

First Rhenium-SCT® (Skin Cancer Therapy) treatment in Germany done by Dr. Lutz-Hendrik Holle

HANAU, Germany, 4-Oct-2019 — /EPR HEALTHCARE NEWS/ — OncoBeta®, a Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), announced today, that Dr. Lutz-Hendrik Holle, Medical Director of the interregional professional association for nuclear medicine in Hanau, has accomplished the first Rhenium-SCT® (Skin Cancer Therapy) treatment in Germany. This state-of-the-art technology of local radionuclide therapy offers a painless and non-invasive treatment option for patients with basal cell carcinoma and squamous cell carcinoma (BCC and SCC) and the interregional professional association for nuclear medicine Hanau is the first center in Germany that offers the Rhenium-SCT®.

With approximately 50.000 outpatient examinations annually, the interregional professional association for nuclear medicine Hanau is one of the biggest nuclear medicine service providers in Hesse. The offered services include a variety of different modern treatment and diagnostic methods. The key argument for the expansion of the spectrum was that the Rhenium-SCT® is a new, painless and highly efficient treatment option that also delivers excellent cosmetic results. Besides being a painless alternative to other procedures, the Rhenium-SCT® also allows the treatment of numerous NMSC lesions consecutively in a single session, which was already realized during the first treatment in Hanau. This has also attracted international attention so that an American patient travelled to Hanau for the treatment.

“This therapy is particularly suitable for tumor localizations where good cosmetic results are to be achieved. The fact that the treatment is completely painless and can be performed in just one session is a great advantage”, says Dr. Lutz-Hendrik Holle, Medical Director of Nuclear Medicine in Hanau.

“We are very happy and proud to be able to offer our revolutionary treatment to patients in Germany now. The interregional professional association of nuclear medicine in Hanau is an excellent partner for NMSC patients in the fight against NMSC”, said Shannon D. Brown III, CEO and Managing Director of OncoBeta® GmbH. “Unfortunately, Germany is one of the countries that has experienced a drastic increase in newly diagnosed NMSC cases in recent years. Our highly qualified team strives to provide physicians and patients with a non-invasive and affordable solution to treat NMSC, while focusing on the needs of the patient.”

The global incidence of non-melanoma skin cancers has been drastically increasing over the past decades. Depending on the source, it is estimated that there are over 5 million non-melanoma skin cancer cases reported globally each year. In certain analyzed areas of Germany there was an increase in the incidence between the year 2005 and the year 2014 by about 30%1. To serve the increasing medical need for innovative therapies in this field and to improve the quality of patients’ lives, OncoBeta® GmbH has developed its innovative Rhenium-SCT® which only require a single application in most of the cases, applied in one single session with excellent aesthetic outcomes.

Via EPR Network
More Healthcare press releases

2019 PDA Europe Biomanufacturing Conference in Munich: new speakers announced

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

2019 Red Herring North America Top 100 Winner: New recognition of OncoBeta’s success in developing and providing an innovative therapy for non-melanoma skin cancer patients

Pasadena, CA, U.S.A., 6-Jul-2019 — /EPR HEALTHCARE NEWS/ — OncoBeta®, a Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), announced today, that it was honored as a Red Herring Top 100 North America Award winner recognizing the continent’s most exciting and innovative private technology companies. After being recognized with the Red Herring Top 100 Europe Award earlier this year, this is now the second recognition obtained by Red Herring.

The winners, celebrated at a special awards ceremony at the Westin Pasadena hotel, have been chosen from thousands of entrants, whittled down to hundreds making the trip to California. The ceremony, led by Red Herring chairman Alex Vieux, was preceded by two days of keynote speeches, discussions and finalist presentations.

Companies were judged by industry experts, insiders and journalists on a wide variety of criteria including financial performance, innovation, business strategy, and market penetration. Winners ran the gamut of verticals, from FinTech and Marketing to Security, IoT, and many more industries.

Red Herring’s editors have been evaluating the world’s startups and tech companies for over two decades. It gives them the ability to see through the industry’s hype to pick firms that will continue on a trajectory to success. Brands such as Alibaba, Google, Kakao, Skype, Spotify, Twitter and YouTube have all been singled out in Red Herring’s storied history.

“2019’s crop of Top 100 winners has been among our most intriguing yet,” said Vieux. “North America has led the way in tech for so many years, and to see such unique, pioneering entrepreneurs and companies here in California, which is in many ways the heartland of the industry, has been a thrilling experience.”

“What has excited me most is to see so many people forging niches in high-tech and cutting edge sectors,” added Vieux. “Some of the technical wizardry and first-rate business models showcased here at the conference has been fantastic to learn about. We believe OncoBeta® embodies the drive, skill and passion on which tech thrives. OncoBeta® should be proud of its achievement – the competition was incredibly strong.”

“Being named as one of the Red Herring’s Top 100 North America award winner in addition to the Top 100 Europe is a great honor for us.” states Shannon D. Brown III, CEO of OncoBeta®. “The spirit of the award aligns perfectly with our team’s mission in the fight against non-melanocytic skin cancer (NMSC) with the Rhenium-SCT®.”

The complete list of the 2019 Red Herring North America Top 100 Winners can be found here in alphabetical order: https://www.redherring.com/2019-rhna-top100-winners/

Red Herring’s press release is available online at https://www.redherring.com/red-herring-2019-top-100-north-america-winners-press-release/

SOURCE: EuropaWire

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

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

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

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

The interregional professional association for nuclear medicine in Hanau has become the first treatment center in Germany to offer the Rhenium-SCT® (SCT= Skin Cancer Therapy)

GARCHING N. MUNICH, Germany, 13-May-2019 — /EPR HEALTHCARE NEWS/ — OncoBeta® GmbH, a commercial stage Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), is pleased to announce that the interregional professional association for nuclear medicine in Hanau now offers the Rhenium-SCT ® (SCT= Skin Cancer Therapy) as the first treatment center in Germany.

With approximately 50.000 outpatient examinations annually, the interregional professional association for nuclear medicine Hanau is one of the biggest nuclear medicine service providers in Hesse. The offered services include a variety of different modern treatment and diagnostic methods which are state-of the art in science and technology.

“Offering NMSC skin cancer patients a highly efficient, painless, innovative therapy with excellent aesthetic results was the driving reason to establish this treatment method in our clinic,” says Dr. med. Lutz-Hendrik Holle, Medical Director of Nuclear Medicine in Hanau.

“We are delighted that our innovative skin cancer therapy Rhenium-SCT® is now being offered by the Nuclear Medicine in Hanau and we are looking forward to this collaboration”, states Shannon D. Brown III, CEO and Managing Director of OncoBeta® GmbH. “For us, this is an important step to offer the treatment method in addition to Italy, South Africa and Australia now also in Germany. In order to provide our treatment to as many skin cancer patients as possible, it is of course our goal to offer the availability of the therapy nationwide in Germany in the future.”

The global incidence of non-melanoma skin cancers has been drastically increasing over the past decades. Depending on the source, it is estimated that there are over 5 million non-melanoma skin cancer cases reported globally each year. In Germany the number of newly diagnosed patients is about 200,000 annually and it is assumed that this number increases within the next years. To serve the increasing medical need for innovative therapies in this field and to improve the quality of patients’ lives, OncoBeta® GmbH has developed its innovative Rhenium-SCT® which only require a single application, applied in one single session with excellent aesthetic outcomes.

If interested, patients and doctors can either contact the interregional professional association for nuclear medicine in Hanau directly or OncoBeta® GmbH.

SOURCE: EuropaWire

GD E-BRIDGE™ EARNS FIRSTNET LISTED DESIGNATION

Ridgefield, New Jersey, 2019-May-02 — /EPR Network/ — General Devices (GD) has announced that, after following a rigorous review process, GD e-Bridge™ is now FirstNet Listed and available via the FirstNet App Catalog.

FirstNet – America’s public safety communications platform – features the first-ever App Catalog geared to first responders. This gives FirstNet subscribers a dedicated location to find meaningful new solutions that have been specifically reviewed for use with FirstNet services. Before any mobile solution can be added to the FirstNet App Catalog, it must pass stringent tests for security, relevancy, data privacy and more.

Achieving a FirstNet Listed designation means GD e-Bridge is a vetted and trusted solution for public safety, meeting FirstNet app requirements. Additionally, FirstNet subscribers will be able to experience the benefits of key FirstNet capabilities – like First Priority®, which enables priority and, for first responders, preemption – while using GD e-Bridge. FirstNet subscribers will also be able to take advantage of the GD e-Bridge solution while benefitting from the enhanced security provided by the FirstNet network core, which is the only physically separate network core dedicated entirely to public safety in America.

Out-of-hospital healthcare is changing, and mobile telemedicine is making a real positive difference. The emphasis now is providing the right care, at the right place and right time. This is especially true in rural regions, but also in the case of time sensitive, acute care issues everywhere like heart attack, stroke and sepsis.

“From the first medical contact by EMS in the field, the GD e-Bridge mobile telemedicine and workflow app provides data and team communications that shave precious minutes off lifesaving treatment,” said Curt Bashford, GD’s CEO.

The hospital ED is not always the appropriate destination for non-acute emergencies. The role of Mobile Integrated Healthcare and Community Paramedicine is growing. Plus, the newly announced HHS ‘Emergency Triage, Treat and Transport’ (ET3) program better aligns reimbursement incentives and enables appropriate on-site treatment and transport to alternate destinations, such as urgent care centers – provided they are managed with mobile telemedicine and telehealth support. That’s where GD e-Bridge also comes in and enables simply better, more cost-effective care.

Built with AT&T in a public-private partnership with the First Responder Network Authority, FirstNet is bringing public safety a much-needed technology upgrade to help them connect to the critical information they need – every day and in every emergency.

“Only highly secure, high quality, public safety relevant applications are added to the FirstNet App Catalog. And we’re pleased that GD e-Bridge is now Listed and available to FirstNet subscribers,” said Bob Sloan, chief operating officer, FirstNet Program at AT&T. “GD e-Bridge will bring public safety additional capabilities to improve decision-making, enhance situational awareness, help save lives and improve outcomes.”

“Through our work with first responders, we heard their need for innovative applications to assist with their lifesaving mission. FirstNet is helping to address these needs, and we are pleased to welcome GD e-Bridge to the FirstNet App Catalog,” said Mark Golaszewski, executive director of Technology and Innovation, First Responder Network Authority.

To learn more about GD e-Bridge, go to General-Devices.com. For more on FirstNet, check out FirstNet.com.

FirstNet and the FirstNet logo are registered trademarks of the First Responder Network Authority. All other marks are the property of their respective owners.

Via EPR Network
More Healthcare press releases

Mr RICHARD GUILLAUME IS APPOINTED TO THE DIAFIR BOARD OF DIRECTORS

RENNES, FRANCE, 2019-Apr-08 — /EPR HEALTHCARE NEWS/ — DIAFIR, a medical technology company focused on the development, manufacture and sale of innovative diagnostic solutions in nonalcoholic steatohepatitis (NASH) and septic arthritis announces today the appointment of Mr Richard Guillaume to its Board of Directors.

Mr Guillaume has a wide experience of over 30 years in international management and operations in the pharmaceutical industry as well as in the medtech. Drawing on his experience and knowledge in the field of medical devices and diagnosis, Mr Guillaume will advise and help the Company in its development.

Alongside his role at Diafir, Richard Guillaume has been the General Manager of Echosens from 2008 until 2013. He was previously Executive Vice President Global Sales and Marketing at Blatchford, a UK medical device company. He was also member of the board. Prior, he held various positions such as Director Global Marketing of Abbott International in Chicago and Director Category Development Europe of Mead Johnson. Richard holds a Master in Business Administration from Poitiers University and a DESS in Marketing from Paris Dauphine completed by a general management program at INSEAD.

 

Via EPR Network
More Healthcare press releases

GenieMD to Feature Award Winning AI-based Telemedicine Platform at HIMSS19

San Francisco, CA, 2019-Jan-24 — /EPR Network/ — GenieMD will be exhibiting at HIMSS19 in Orlando, Florida February 11-15, 2019. The GenieMD team will be showcasing their iVisit Telemedicine platform. GenieMD’s award-winning Telemedicine platform, driven by an AI engine, assists in the patient’s triage allowing for a streamlined consult with their physician through its HIPAA compliant text messaging, video visits and question-based asynchronous visits.

Patients are demanding convenience, expanded access and lower cost of health care. Doctors are overwhelmed with simple cases which take up most of their consult time. Clinics are struggling to manage costs in light of their patients increasingly use of alternative channels to seek treatment. To address these challenges, technology companies are innovating new ways for patients to gain access to providers. Government regulators are responding more favorably to the use of these methods including Telemedicine. Therefore, Telemedicine adoption is growing at a rapid pace.

“At GenieMD, our mission is to help improve the quality of human life by providing solutions that enable people to live healthier and longer.” – Dr. Soheil Saadat, CEO

The company offers a wide range of products and services designed to democratize healthcare globally.

Via EPR Network
More Healthcare press releases

University of Pretoria Prof. Mike Sathekge is First in South Africa to Treat Non-Melanocytic Skin #Cancer Patients with Rhenium-SCT®

Garching n. Munich, Germany, 26-Nov-2018 — /EPR HEALTHCARE NEWS/ — OncoBeta® GmbH, a commercial stage Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), announced today that Prof. Mike Sathekge from the University of Pretoria, Steve Biko Academic Hospital Nuclear Medical department and his clinical team has treated the first non-melanocytic skin cancer patients in South Africa with the innovative Rhenium-SCT® skin cancer treatment System. This next-generation radionuclide therapy technology applied by the nuclear medicine physician offers a new singles session, painless treatment for patients suffering from Basal Cell – and Squamous Cell Carcinomas (BCCs and SCCs).

The global incidence of non-melanoma skin cancers has drastically increased over the few past decades. Depending on the source, it is estimated that there are over 5 million non-melanoma skin cancer cases reported globally each year. Approximately 80% of non-melanoma skin cancers are basal cell carcinomas or squamous cell carcinomas with South Africa having one of the highest incidence rates in the world.

Prof. Mike Sathekge and his team at the University of Pretoria, Steve Biko Academic Hospital are focused on providing patients with personalized care using state-of-the-art technology that can deliver high-precision therapy and diagnostics with minimal side effects. The specialized team of experts in the nuclear medicine and medical physics, work closely with other disciplines within the university hospital, referring physicians, and other institutions, to ensure patients receive the best possible treatment for their specific type of cancer.

Martin Magwaza, CEO of Tautomer (PTY) LTD Oncobeta®’s distribution partner for the Rhenium-SCT® in Africa, is dedicated to providing South Africans with new innovative and effective therapies across the continent, coordinating with representatives from all levels of government and state for the health care landscape.

“The start of the Rhenium-SCT® in South Africa is a significant milestone in the international expansion of our ground-breaking treatment for BCCs and SCCs.,” said Shannon D. Brown III, CEO and Managing Director of OncoBeta® GmbH. “Our vision of bringing a revolutionary affordable skin cancer therapy to physicians and patients all over the world has come one step closer today”.

SOURCE: EuropaWire

Just For Diabetics Website Offers Hope for Pre-diabetics, Type 2 diabetics, and the Overweight

Research shows that the best time to take action to reverse pre-diabetes and type 2 diabetes is when you are at the stage of managing these conditions.

Vancouver, BC, Canada, 2018-Nov-06 — /EPR HEALTHCARE NEWS/ — November is world diabetes month. When people are diagnosed type 2 diabetic, the first line of defense is the use of prescription drugs in order to manage the diabetes. But what victims of pre-diabetes and type 2 diabetes are not aware of is that research performed by Just For Diabetics website founder, Ernest Quansah, shows that when patients are managing their pre-diabetes or type 2 diabetes, it is the best opportunity for them to reverse it and be weaned off the prescription drugs. The research results are evidence based. Many doctors and institutions now agree that this is the case. Recently, the University of British Columbia, in conjunction with Pharmasave, a drugstore chain, began offering obese people and type 2 diabetics a diet plan aimed at reversal of pre-diabetes and type 2 diabetes. The cost of their plan is $500 a month. The diet plan calls for no consumption of refined sugar, potatoes, fruit, fruit juices, sweet drinks of any kind, rice, bread, and consumption of cooked vegetables for lunch, cooked chicken breast for dinner and so on. Many of the participants are seniors, the overweight, or obese. After several thousand of dollars spent, many participants lose weight and their doctors take them off their diabetes drugs.

Quansah’s program includes a specialized diabetes exercise regime along with vitamin therapy and a carefully designed tasty menu cycle. He himself completely reversed his severe case of type 2 diabetes after compiling this program, which was the culmination of thorough research. This research included the advice of several physicians. Quansah, founder of Just For Diabetics and the author of Diabetics Journey says: “For several years, I have been educating people about how type 2 diabetes and pre-diabetes can be reversed through the program offered on my website. Now we see that one of Canada’s finest Universities and a drug store chain are doing the same.”

The website, justfordiabetics.com offers a free weight-loss program, a free diabetes reversal program, as well as an inexpensive paid program. The extensive program includes a full menu regime, exercise videos, tutorials, in addition to a cooking video demonstration, all for less than $180. Quansah wisely suggests that those on the program be monitored by their doctors.

Quansah’s research and findings have been published in the WebMD Diabetes magazine in the article “Secret recipe: How a Chef Cured His Type 2 Diabetes”, as well as on the WebMD website. There is hope for reversing pre-diabetes, type 2 diabetes (the type that does not require insulin injections,) and for overcoming being overweight.

“Misinformation about type 2 diabetes is rampant. For diabetics to heal, they need a complete change of attitude and way of thinking. This means, they should not just accept managing their condition, but rather, understand that they can be healed. Further, complacency about pre-diabetes leads to full-blown diabetes, which can lead to heart disease, blindness, liver failure, impotence, limb amputations and early death,” cautions Quansah.

Quansah has been asked to be guest speaker at the Diabetes and Healthcare Conference being held in Helsinki, Norway, in November 2018 and to be keynote speaker at the Diabetes Care Conference being held in Malaysia in May of 2019. His speech topic will include how to help diabetics heal and resultantly reduce healthcare costs.

Via EPR Network
More Healthcare press releases