Tags: FDA, fetal heart monitor, fetal monitor, fetal monitoring system, medical device, medical devices, medical technology, MERIDIAN M110, mindchild, U.S. Food and Drug Administration
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MindChild Medical, Inc., a client of MBBP, has received FDA clearance for its Pre-Marketing Notification (510(k)) for its MERIDIAN™ M110 non-invasive fetal heart monitor. The FDA clearance will enable MindChild to enter the U.S. market with MERIDIAN™.
MindChild’s MERIDIAN™ M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate, maternal heart rate, and uterine contractions.
Congratulations to MindChild on this achievement!
Tags: Abpro, antibodies, antibody, AstraZeneca, biochemistry, collaboration, DiversImmune, Ian Chan, industrial, Life Sciences, MedImmune, technology
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MBBP’s client Abpro, a pioneer in the field of industrial biochemistry, has recently entered into a Collaboration Agreement with MedImmune, the global biologics research and development arm of AstraZeneca. The collaboration will advance the development of a preclinical, novel bispecific antibody targeting angiopoietin-2 and vascular endothelial growth factor (Ang2-VEGF). Abpro will contribute its strong scientific, technical and clinical expertise to this partnership, along with its core technology platform, DiversImmuneTM, which will be utilized to further develop the bispecific antibody. Ian Chan, CEO and co-founder of Abpro, has expressed the Company’s enthusiasm towards collaborating with MedImmune, as the two businesses work together to advance these innovative therapeutics into the clinic.
For more information, read the full article.
Tags: boston children's hospital, david scadden, Harvard, harvard university, magenta therapeutics, massachusetts general hospital, medical field, medical technology, medicine, mgh, regenerative biology, stem cell, stem cell research, technology
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Harvard University has recently completed a license agreement with Magenta Therapeutics, a newly launched start-up in Cambridge, Massachusetts, in order to continue research and development related to new approaches to blood stem cell transplantation. The deal will help transform this science from that of a “last resort” into safer, more effective therapy for patients who suffer from blood diseases, cancers, and immune disorders. The license agreement has given Magenta the opportunity to utilize a platform of technologies developed at Harvard, Massachusetts General Hospital (MGH), and Boston Children’s Hospital.
This revolutionary technology has been most recently advanced in the laboratory of David Scadden, the Gerald and Darlene Jordan Professor of Medicine and professor of stem cell and regenerative biology at Harvard, and director of the Center for Regenerative Medicine at MGH. Scadden’s lab has made advances in how donor cells are selected, harvested, and prepared for transplant, improving projected outcomes for patients. For more information, read the Harvard Gazette and Boston Business Journal articles.
Client Paragonix Technologies Enters Into Distribution Agreement with Pacific West Medical Sales for Paragonix SherpaPak™ Transport Systems 11/17/2016Posted by Morse, Barnes-Brown Pendleton in Client News, Deal News, Licensing & Strategic Alliances, Life Sciences, Medical Devices.
Tags: agreement, distribution, distribution agreement, pacific west medical sales, paragonix technologies
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MBBP client, Paragonix Technologies Inc. recently entered into an exclusive distribution agreement with Pacific West Medical Sales to market Paragonix Technologies’ SherpaPakTM Cardiac and Kidney Transport Systems. The SherpaPakTM Cardiac and Kidney Transport Systems are innovative medical devices that are indicated for the static hypothermic preservation of donor hearts and kidneys during transportation and eventual transplantation into a recipient.
Pacific West Medical Sales is a medical equipment sales company that provides services for hospitals, doctors’ offices, and long-term care facilities, and provides supplies for emergency medical services and home medical needs. Paragonix Technologies, is a privately held medical device company founded in 2010 and is headquartered in Braintree, Massachusetts. For more information, read the full press release.
Tags: biomedical, biotech, biotechnology, Diabetes, diabetes cure, disease, Harvard, insulin, Semma Therapeutics, stem cells, technology
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A group of Boston-area health institutions, known as the Boston Autologous Islet Replacement Program, are teaming up to develop, test and deploy stem cells to cure diabetes. The group includes the Harvard Stem Cell Institute, Brigham and Women’s Hospital, the Joslin Diabetes Center, Dana-Farber Cancer Institute and Semma Therapeutics.
The innovation began when Doug Melton, Co-Director of Harvard Stem Cell Institute and Co-Founder of Semma Therapeutics, developed a way to turn embryonic stem cells into insulin-producing beta cells without needing to put the cells into mice to mature. After this discovery, he knew he had to get these beta cells into humans but that it was going to take a group with the proper qualifications.
Melton explains, “No one institution anywhere has the expertise and technical abilities to make this kind of clinical trial possible, but in the unique Harvard biomedical ecosystem, we are able to bring all the necessary expertise and infrastructure to bear.” This new organization has the goal of testing the created beta cells in human patients within three years.
Congratulations to our client Harvard on these exciting new developments! For more information, read the full article.
Interview with MBBP Client Valeritas Included in Wall Street Transcript Medical Devices Report 08/09/2016Posted by Morse, Barnes-Brown Pendleton in Client News, Intellectual Property, Life Sciences, Medical Devices.
Tags: Diabetes, insulin delivery, Intellectual Property, ip, John Timberlake, medical device, medical devices, medical technology, patent, type II diabetes, V-Go, Valeritas, wall street transcript
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The most recent Wall Street Transcript Medical Devices Report includes an interview with Valeritas, Inc.’s CEO, John Timberlake. Timberlake discusses in detail Valeritas’s V-Go Disposable Insulin Delivery Device. The V-Go is a wearable basal-bolus insulin delivery device that allows patients to deliver insulin at a continuous preset basal rate, with bolus delivery as needed. The V-Go has been cleared for use in the United States and in Europe. The fact that V-Go is a wearable product with scheduled insulin delivery enables patients to more easily go about their daily routines without having to stop to deliver insulin, and also allows them to discreetly deliver insulin during mealtimes without drawing attention to the act.
Valeritas is a commercial-stage medical technology company that develops new Type II diabetes technology products aimed at improving the lives of patients with Type II diabetes. For more information about Valeritas and its V-Go product, read the full interview with The Wall Street Transcript.
Tags: Corista, Corista DP3, Digital pathology, medical device
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Exciting news for MBBP client Corista as Johns Hopkins Medicine, one of the leading health care systems in the United States, has successfully installed Corista’s DP3 system. The DP3 is a digital pathology network platform that removes the physical boundaries from pathology and enables real-time remote expert diagnoses. It is a workflow solution integrating multiple facilities, scanners, physicians, patients and Laboratory Information Systems.
Johns Hopkins is standardizing this DP3 system as its centralized digital pathology platform in order to streamline workflows among its five hospital centers. The overall objective is to provide more efficient and accurate flow of information across core systems that manage diverse functions in the hospital system. Specifically, the system will help improve each hospital’s Tumor Board process, integration of existing systems including LIS, and global remote access.
Congratulations, Corista! MBBP serves as general counsel to Corista and assisted in negotiating its contract with Johns Hopkins. For more information, visit Corista News & Events.
Tags: app, apptomics, bbk worldwide, clinical trial, entrepreneur, neurologists, parkinson's disease, patient recruitment, patients, startup
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Firm client BBK Worldwide is partnering with Wellesley-based digital health app maker, Apptomics, as it prepares to launch a one-year clinical trial in September. Using a combination of apps (iMotor and MyPD), for monitoring patients with Parkinson’s disease, the trial will test the effectiveness of these tools in impacting the management of Parkinson’s disease and health outcomes. iMotor measures objectively patients’ motor function by combining several variables and MyPD focuses on collecting data related to symptoms, medications, side effects sleep quality, and emotional status. Data collected are transmitted in reports to patients’ neurologists.
BBK Worldwide is the foremost patient recruitment and engagement technology firm, providing a range of award-winning creative services and technology solutions to the world’s most innovative pharmaceutical and biopharmaceutical companies and their outsourced suppliers, such as CROs and eClinical providers. Apptomics works to achieve optimal management of chronic neurological conditions, including Parkinson’s, through scientifically validated mobile applications that allow collection of objective and patient reported data on disease progression. BBK Worldwide is now a minority investor in Apptomics, with BBK Principal Matthew Stumm serving on the Apptomics Board of Directors.
The two companies will work to develop a collection of apps aimed at monitoring patients with chronic neurological diseases and relaying the information to their doctors. Apptomics has already had success with the iMotor app through two studies that clearly demonstrated the scientific effectiveness of its data collection. The app also proved able to distinguish Parkinson’s patients from healthy individuals, and distinguished with high sensitivity the effects of treatment plans.
Congratulations to both companies on their new venture!
Tags: client, clinical study, ConforMIS, employment law, joint replacement implants, knee replacement, medical technology
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ConforMIS, Inc., a medical technology company that manufactures and sells joint replacement implants, received positive results from its iTotal CR study. The iTotal CR is a fully customized implant for use in total knee replacement, and the study found that 92% of patients were satisfied with the product in the year after receiving a knee replacement.
In developing, manufacturing, and selling joint replacement implants, ConforMIS uses its iFit Image-to-Implant technology, which allows for a customized implant specifically designed to fit an individual’s anatomy. The iTotal CR study included 300 patients in the United States, and is still ongoing. The interim study results were presented at the 2016 SICOT International Orthopaedic “Specialized Knee Surgery” Conference in Germany, which ran from June 30th to July 2nd.
The positive feedback is consistent with a previous study that showed that patients noted significantly higher satisfaction with the ConforMIS iTotal CR in their knee replacements, than with off-the-shelf implants. The positive results speak to the benefits of anatomically customized implants, and illustrate how ConforMIS’s products are making a positive and lasting impact in the joint replacement implant market.
To read more about the study and ConforMIS’s technology, read the full article.
PULSE@Mass Challenge Now Open in Boston! 06/10/2016Posted by Morse, Barnes-Brown Pendleton in Client News, Life Sciences, Medical Devices.
Tags: biotechnology, digital health, entrepreneur, entrepreneurs, innovation, Life Sciences, MassChallenge, research
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PULSE@MassChallenge officially opened in Boston last week, adding to the already increasing number of digital health companies in the area. MBBP’s Peter Barnes-Brown attended the ribbon cutting ceremony.
Read more about Peter’s thoughts on the growing digital health industry and about the company on our VCs & Startups Blog.
Tags: entrepreneaurship, entrepreneurs, Germany, healthcare, investors, Life Sciences, science, Summit
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John Hession, Co-Chair of both the Corporate Department and the Life Science Task Force at Morse Barnes-Brown & Pendleton, PC, will be the Moderator of the prestigious Charité Entrepreneurship Summit 2016-Rethink & Transform Healthcare being held in Berlin, Germany May 26th & 27th. This is the 4th time John finds himself in this role, and he proclaims it as being one of his favorite and most rewarding “extra- curricular” activities.
Among the largest life sciences and health care industry conferences held in Western Europe each year, the Charité Summit brings together over 400 international entrepreneurs, scientists, investors and healthcare industry professionals. This year’s agenda features such diverse and relevant topics as the digitalization of health care, the prospects of genome editing, and the growing understanding of the compelling impact of gender differences on research and in the practice of medicine.
John says the role of Summit moderator is one he relishes with particular enthusiasm because it affords him the opportunity to interact with both the learned speakers and the diverse audience of life sciences and healthcare professionals. As he remarked, “The insights are scintillating and informative, the speakers animated and trenchant, and the networking before, during and after the program – in the Berlin beer halls- robust and gregarious.” Hession is the only American to repeat as Moderator in its 9 year history.
Tags: decision, mayo, patent, petition, Prometheus Lab, scope, Sequenom, supreme court
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Late last month, Sequenom, Inc. filed a Petition for Writ of Certiorari requesting the United States Supreme Court to clarify the scope of its Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) decision, as applied to Sequenom’s claimed inventions. The Mayo decision, which held that a method correlating a drug dosage regimen and levels of the drug in the blood was an unpatentable law of nature, has had the profound effect of narrowing the scope of patent-eligible subject matter in the United States and has cast doubt on the validity and enforceability of previously-issued United States patents.
Sequenom’s discovery related to the discovery of cell-free fetal DNA circulating in maternal plasma, which was used to invent a test for detecting fetal genetic conditions in early pregnancy, and thereby avoid subjecting the mother to dangerous, invasive techniques such as amniocentesis. The Federal Circuit agreed that Sequenom’s invention combined and utilized man-made tools of biotechnology in a new way that revolutionized prenatal care; however, in view of Mayo, such inventions were deemed patent-ineligible as a matter of law, since their new combination involved only a “natural phenomenon” and techniques that were “routine” or “conventional” on their own.
Despite the Federal Circuit’s reluctant holding that Sequenom’s claimed inventions were not patent-ineligible, multiple judges wrote separately to explain that while this result was probably not intended by Mayo, that decision controlled and only the Supreme Court could clarify Mayo’s reach to prevent a “crisis of patent law and medical innovation.” Sequenom’s petition now asks the Supreme Court to clarify the scope of its Mayo decision in view of Sequenom’s claimed inventions, and to determine whether a novel method is patent-eligible where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery.
If the Supreme Court grants certiorari it will have a compelling set of facts before it to clarify the scope of Mayo, and we patiently await its decision, which will have high stakes for the life sciences community.
For more information, contact Patent Attorney Stan Chalvire.
Tags: boston scientific challenge, caregiver, device, elderly care, health, medical device, technology, watchrx, wearables
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MBBP client WatchRx, is an early stage startup founded while trying to help aging parents manage their medications and health conditions remotely. Current solutions available in the market, like mobile apps and pill caps/bottles, didn’t fit the need and only added to the confusion. WatchRx provides a a simple dedicated reminder solution. From voice reminders to GPS tracking this device addresses so many needs. The watch can even send alerts to family and caregivers.
The Boston Scientific Connected Patient Challenge is an open competition focused on ideas and early-stage companies that improve patient care and/or drive down the cost of health care through the use of Remote Patient Monitoring using wearable, implantable or ubiquitous sensors. The top five ideas based on the online crowd voting and online judge scores were honored at a live event on February 25, 2016, where they presented their ideas to the Challenge Sponsors and fellow participants. Arun Buduri, Founder and Chief Product Officer, presented for WatchRx and walked away the winner! Watch the pitch (skip to 56:45) and award (skip to 1:53:00) here.
This isn’t the only thing the Greater Boston-based company is celebrating. Just yesterday WatchRx Founder and CEO Jayanthi Narasimhan was awarded 2016 Women to Watch in Science & Technology by the Boston Business Journal.
Congrats to WatchRx. If you aren’t a client to “watch” we don’t know who is!
Tags: Amgen, biosimilars, FDA, Sandoz
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By: David Fazzolare
On January 5, 2015, the US Food and Drug Administration’s (“FDA’s”) Oncologic Drugs Advisory Committee (the “Committee”) announced its recommendation that the FDA approve Sandoz Inc.’s application to market Zarxio® (EP2006), a biosimilar version of Amgen, Inc.’s Neupogen® drug. The Committee explained its recommendation in a 62-page, publicly-issued briefing document. Zarxio® is the first drug reviewed by the Committee under new biosimilars provisions enacted as part of the Patient Protection and Affordable Care Act. The Committee’s recommendation is therefore a key step forward not only for Zarxio®, but also for implementation of the new biosimilars provisions (known as the Biologics Price Competition and Innovation Act of 2009, or “BPCIA”).
Sandoz is not yet seeking interchangeability status for Zarxio®, a designation which allows pharmacists to substitute biosimilars in place of prescribed reference biologics—i.e., Zarxio® in place of Neupogen®. Sandoz told the Committee it plans to file for interchangeability only after Zarxio® is fully approved as a biosimilar.
The Committee’s recommendation, while a milestone for the drug and the FDA, does not automatically clear the way for approval of Zarxio®. The Committee noted that the lack of comparative data available left some “residual uncertainty about whether ADA [anti-drug antibodies] incidence is similar in subjects administered [Zarxio®] and … Neupogen®.” On January 7, 2015, the FDA will take testimony from experts, who may weigh in on this issue, and provide their own recommendations as to whether the FDA should approve Zarxio® as a Neupogen® biosimilar. The FDA will then undertake a full review of Zarxio®. In the background is Amgen’s pending federal lawsuit against Sandoz, brought on October 24, 2014, which alleges Sandoz’s conduct violated the procedures required by the BPCIA. Amgen also submitted a citizen’s petition to the FDA on October 29, 2014, asking that the FDA require biosimilar applicants to fully comply with all BPCIA procedures. How the Committee’s recommendation will affect these filings remains unclear.
For more information, please contact David Fazzolare.
Federal Circuit in Sandoz v. Amgen Upholds District Court Ruling on Standing Requirements in Biosimilars Cases 12/19/2014Posted by Morse, Barnes-Brown Pendleton in Legal Developments, Life Sciences, Medical Devices, New Resources.
Tags: Amgen, biosimilars, clinical trials, Enbrel, FDA, Sandoz
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The recent back and forth between Amgen and Sandoz took another dramatic turn on December 5, 2014, when the Federal Circuit affirmed the district court’s dismissal of Sandoz’s declaratory judgment lawsuit against Amgen because Sandoz’s alleged injury did “not meet the requirements of immediacy and reality” necessary for standing. Regarding immediacy, Judge Taranto noted that Sandoz had brought the suit at a time when it was years away from completing its Phase III clinical trials for its Enbrel® biosimilar. Obtaining FDA approval would further push back the earliest possible date on which Sandoz could hope to market its drug. Regarding reality, Judge Taranto further opined that it was possible that Sandoz’s biosimilar would never infringe the patents licensed to Amgen. For example, Sandoz’s drug could fail completely in Phase III trials and never be approved by the FDA; the drug might also require modifications making it dissimilar enough from Enbrel® as to prevent infringement, even while remaining biosimilar. For those reasons, Judge Taranto concluded Sandoz could not demonstrate that either of these possibilities was “so unlikely to arise” that Sandoz could show it had a concrete injury in the pipeline.
While seemingly fact-specific, the Federal Circuit’s decision may have larger ramifications for future cases involving the BPCIA. Judge Taranto noted in his opinion: “The biosimilarity approval standard is new; indeed, the FDA has not yet applied the new standard to complete its review of and approve any product under the BPCIA.” Yet elsewhere in the opinion, Judge Taranto suggested that the Federal Circuit, at least, had an idea of how courts should evaluate BPCIA cases. He wrote: “Our conclusion is consistent with our cases under the Hatch–Waxman Act. As noted above, we have found no justiciability where a declaratory-judgment plaintiff had not filed an application for the FDA approval required to engage in the arguably infringing activity. On the other hand, where we have found a case or controversy in the Hatch–Waxman setting, we have focused on the presence of an application for the required FDA approval.” Thus Sandoz’s failure to submit a biosimilar application to the FDA before filing seeking its declaratory judgment seems to have played a role in the outcome of the case.
The Federal Circuit’s decision to consider this BPCIA ruling’s conformity with Hatch–Waxman may be due to the fact that the BPCIA provision under which Sandoz’s brought suit was directly “borrow[ed] from” Hatch–Waxman. Whether other courts hearing BPCIA cases will look to Hatch–Waxman or view this part of the Federal Circuit opinion as dicta remains to be seen.
The Federal Circuit ultimately declined to review the district court’s alternative grounds for dismissal involving Sandoz’s failure to comply with BPCIA procedures, limiting the extent of its holding. While Sandoz may appeal this decision to the Supreme Court, it is clear for now that parties must continue to carefully evaluate standing prior to bringing a patent infringement suit under the BPCIA.
For more information on this topic, please contact David A. Fazzolare.
BBK Worldwide raises $3M, eyes acquisitions 09/18/2014Posted by Morse, Barnes-Brown Pendleton in Client News, Medical Devices.
Tags: bbk worldwide, patient recruitment
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MBBP client BBK Worldwide has raised $3 million from a private, undisclosed investor and its two founders. The consultancy specializes in patient recruitment for the clinical R&D segments of the pharmaceutical, biotechnology, and medical device industries.
BBK moved from Newton to a new 15,000-square foot space in Needham earlier this year and has plans to grow its headcount by 10 percent before the end of the year. BBK’s patient recruitment software is called TrialCentralNet, and its mobile app is My Clinical Study Buddy. The women-owned business says it has helped 23 of the world’s top 25 pharmaceutical companies to find patients for studied in the past year.
Read more in the Boston Business Journal.
Way to grow, BBK!
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Medical Development Group (MDG), an organization for professionals in the medical device industry, is hosting an upcoming forum event entitled “Intellectual Property Approaches to Safeguard Value”. MBBP IP and Licensing Attorney Stanley F. Chalvire will serve as one of the speakers of this forum event, which will generally be directed to intellectual property strategies for creating and preserving value of medical devices.
During the forum, some topics that Stan will address include:
- Trade Secrets and the protections they can provide
- Distinguish Trade Secrets and Patents
- Discuss Strategic Considerations to Maintain Trade Secrets
The event takes place at Constant Contact headquarters in Waltham, MA on Wednesday October 1st.
To register, please visit MDG Boston
Tags: Best Lawyers, biotech, Boston's Rising Stars, health technologies, Intellectual Property, medical devices, National Law Journal
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MBBP’s Joanna Brougher was selected for the 2014 National Law Journal’s list of Boston’s Rising Stars. The National Law Journal Rising Stars program recognizes the region’s 40 most promising lawyers age 40 and under. Joanna graduated from the University of Rochester with a B.S. in Microbiology, a B.A. in German, and a masters in public health. Joanna received her J.D. from Boston College Law School in 2008. She is a biotech, pharma, medical device and intellectual property consultant, and is also a adjunct lecturer at Harvard School of Public Health where she teaches a course on intellectual property and health technologies.
More info on Boston’s Rising Stars