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MedNess: bite-size biopharma and medtech news

28th January, 2020
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Drug Approvals
FDA grants accelerated approval of TAZVERIK™ (tazemetostat) in Epithelioid Sarcoma
“Despite industry advancements, there are limited therapeutic options for treating patients with epithelioid sarcoma who struggle with high rates of recurrence and toxicities associated with currently used therapies,” said Gary K. Schwartz, M.D., chief of hematology and oncology at Columbia University and NewYork-Presbyterian Hospital, deputy director of the Herbert Irving Comprehensive Cancer Center, professor of oncology at Columbia University Vagelos College of Physicians and Surgeons and an investigator in Epizyme’s Phase 2 trial. “The TAZVERIK data from the ES cohort in Epizyme’s Phase 2 trial support its potential to provide clinically meaningful and durable responses, and tolerability for ES patients. This approval of TAZVERIK represents an important advancement in the treatment of patients with ES.”
European Commission approves Polivy for R/R DLBCL patients based on Ph 1/2b trial results
“With this approval, people in the EU with relapsed or refractory diffuse large B-cell lymphoma will have the opportunity to benefit from this new Polivy combination,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “For patients battling this aggressive disease, the prognosis is poor and few treatments are available. We are proud to bring this first-in-class treatment option to those who need it most.”
Regulatory News
sBLA submitted to the FDA for Tecentriq + Avastin combination for 1L unresectable HCC patients based on the results of the Phase III IMbrave150 trial
“Liver cancer is the most rapidly increasing cause of cancer-related death in the United States. In the IMbrave150 study, Tecentriq in combination with Avastin became the first treatment in more than a decade to improve overall survival compared with the current standard of care,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are pleased that these results are being reviewed under the FDA Real-Time Oncology Review pilot programme, and we are working closely with the agency to bring this potential new treatment option to people with unresectable hepatocellular carcinoma as quickly as possible.”
BLA filed for belantamab mafodotin in RRMM patients; granted Priority Review based on results from Ph 2 DREAMM-2 trial
  • Priority review for BL) seeking approval of belantamab mafodotin (GSK2857916) for relapsed or refractory multiple myeloma patients whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
  • BLA based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study
  • DREAMM-2 results recently published in The Lancet Oncology, which enrolled heavily pre-treated patients who had actively progressing multiple myeloma that had worsened despite current standard of care.
  • In 2017, belantamab mafodotin was granted Breakthrough Therapy designation by the FDA
Click Here for more Regulatory News
Trial Results
Ph 2 DESTINY-Gastric01 trial of Enhertu versus chemotherapy met primary endpoint of ORR and key secondary endpoint of OS in patients with previously treated HER2-positive metastatic gastric cancer
José Baselga, Executive Vice President, Oncology R&D, said: “Gastric cancer is usually diagnosed in the advanced stage and patients face markedly high mortality rates, making the need for new therapies especially urgent. Given the previous results seen in our HER2-positive development programme and now in HER2-positive metastatic gastric cancer, we believe this antibody drug conjugate has the potential to redefine the treatment of patients with HER2-expressing cancers.”
Ph 3 Trial of Tislelizumab in 1L squamous NSCLC patients met primary endpoint of PFS improvement at interim analysis
“Tislelizumab was recently approved in China for patients with relapsed or refractory classical Hodgkin’s lymphoma, and we have a broad development program with more than 5,000 patients enrolled in over 25 tislelizumab studies, including 15 potentially registration-enabling trials,” commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. “We are extremely excited about the compelling results that tislelizumab demonstrated in this Phase 3 trial and for its potential use as a first-line treatment for patients in China with advanced squamous NSCLC. We look forward to continuing the development program for tislelizumab in lung cancer, which includes three other Phase 3 trials, and reporting additional data.”
FAILED TRIAL: Ph 3 IMvigor010 trial of adjuvant Tecentriq® (atezolizumab) did not meet primary endpoint of DFS improvement in MIUC patients
“Reducing the risk that muscle-invasive urothelial cancer will recur after surgery is very difficult, and we are disappointed that we were not able to significantly prolong disease-free survival,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “We remain committed to exploring the potential benefits of immunotherapy for more people with early cancers.”
Surufatinib Ph 3 SANET-p trial met primary endpoint in advanced pNET tumors in China; to stop early
Christian Hogg, Chief Executive Officer of Chi-Med, said, “This positive data is a further important milestone for Chi-Med.  Following surufatinib’s NDA submission for the treatment of non-pancreatic neuroendocrine tumors, these positive results for pancreatic neuroendocrine tumors reinforce that surufatinib has the unique opportunity to address all advanced neuroendocrine tumors.  We believe that no targeted therapies are approved in China or globally for such a broad spectrum of neuroendocrine tumor disease.”
Read on for more Results and Status/Progress of trials
Collated by : Richa Tewari, PhD
Medness @ Health-IT
Mental well-being: It is all about building connections
The concept of interoperability in clinical care, that is receiving copious amount of attention (read more on it here), means the connections between organizations across the care continuum, from primary care and specialty services to inpatient admissions and long-term care. Behavioral healthcare, unfortunately, has received the short end of it primarily due to lack of specialists, means of communication and right insurance coverage. However, with growing body of evidence linking behavioral health to physical health, the landscape is changing. While the reimbursement system in healthcare moves toward rewarding the continuity in care, interoperability is finally catching up with the mental health. In New York City, the nation’s largest public health information exchange (HIE) has taken the needful step to transform this new perspective into action while focusing on the first step: bringing clinical and behavioral health data together into the same patient record.
Healthix, one of New York State’s eight health information exchange organizations, covers 16 million patients across 61 hospitals among the 1300 facilities served by its services. By utilizing a combination of predictive analytics, standardized alerts, risk stratification, and other important population health management techniques, Healthix is connecting primary care providers, hospitals, and other clinical organizations with behavioral health providers such as ICL, a non-profit network of clinics, shelters, and residential care facilities that serve a uniquely urban population. Read more about it here.
SMS text messaging just got medically smart
The partnership of Globaltel Media and Scribe-Well recently announced the Scribe-Well Medical Transcription Solution, a first of its kind innovation enabling medical transcriptionists to share digitized patient records and clinical notes along with embedded images such as X-rays, MRIs and CT scans: all via SMS text messaging. The Scribe-Well Medical Transcription Solution aims to reduce the time from dictation to delivery by enabling the secure exchange of physician-dictated notes with rich media from any PC to any mobile phone and vice versa, regardless of mobile carrier: accelerating communications between patient care, treatment, coding, compensation and billing. It also complies with the guidelines and recommendations of the Association for Healthcare Documentation Integrity (AHDI) and the Medical Transcription Industry Association (MTIA) regarding the secure capture and transmission of patient healthcare records.
Globaltel Media addresses the needs of customers across a range of vertical markets including healthcare, entertainment, education, government, law enforcement and emergency communications. It was the first company to provide true two-way text dialog with rich media from any PC to any mobile phone and back regardless of the wireless technology, wireless operator or wireless device. On the other hand, Scribe-Well is one of the fastest-growing medical transcription companies in the US, while enjoying the highest customer retention rate in the industry.  Scribe-Well is the first and only company to offer the unique combination of medical transcription with optional imbedded imagery. Read more on this news here.
Collated by : Debarati Banik
Medness Business
Onco-News
Basilea announces clinical supply agreement for its planned study FIDES-03 with derazantinib in gastric cancer
Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “The unique kinase inhibition profile of derazantinib and convincing pre-clinical in vivo data in gastric cancer models support this phase 1/2 study with derazantinib alone and as a combination therapy in biomarker-defined groups of patients with advanced gastric cancer. Advanced gastric cancer is associated with a very poor prognosis and is an area of high unmet medical need.”
Collated by : Richa Tewari, PhD
Bio-Pharma and MedTech
MedNess Reviews

2019 Coronavirus outbreak

China sees another outbreak caused by Coronavirus, now known as Wuhan coronavirus (2019-nCoV), that has gripped the world. China's handling of the situation has been lauded. The effort of the scientific community in understanding the disease is also unprecedented. Scientists in China and Australia reported the viral sequence within 10 days of the first report of the outbreak. With the new age of social media, the scientific community is also able to share the data almost in real-time. As of now, the number of people who have been infected by the virus is 3000, with nearly 100 confirmed deaths. 

The virus has nearly 80% similarity with the SARS virus and uses angiotensin-converting enzyme-2 as its receptor to enter intrapulmonary epithelial cells, and so the transmission of the virus is possible only after the lower respiratory tract is infected. However, there are many uncertainties about the virus. How many strains are there, what is the mutation rate of the virus, at what rate the virus is transmitting from human to human, and so on.
Zhu et al., have reported the genome of the coronavirus that will at least help now in rapid diagnosis as well as help develop an antiviral strategy.
Click here for an excellent review by Derek Lowe and more
Drug Approvals to look forward to in 2020!!
 With 53 drug approvals in 2019 out of which 48 were new molecular entities (NME) FDA remains as bullish as it was in 2018. The question is, with the new commissioner Stephen Hahn, will we see similar aggression that is commendable of FDA but, at the same time, alarming. 
 Last year Biogen and Eisai's Aducanumab got a mixed response from wall street and others when they told that they would move ahead with filing for BLA in 2020. Many analysts predict that the FDA will approve the drug, but time will only tell how this chapter unfolds. 
 Other drugs in the pipeline are, recently acquired The Medicine's company drug that targets PCSK9 (an RNAi therapy named Inclisiran), to help lower low-density lipoprotein cholesterol. Last year they presented a strong result followed by the acquisition news by Novartis. 
Alnylam will also look forward to its drug lumasiran, an N-acetylgalactosamine-conjugated siRNA targeting glycolate oxidase, in the rare kidney disease primary hyperoxaluria, The conjugated sugar helps target the drug to the liver. They announced a positive phase 3 data in December last year. 
Bluebird Bio's Zynteglo (autologous CD34+ cells encoding the βA-T87Q-globin gene) was approved by EMA in 2019, is also in the FDA approval pipeline. Similarly, Biomarine's Valoctogene, an AAV based gene therapy for hemophilia A. 
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
I-cube
Debarati Banik
HealthIT
Mayur Vadhvani, PhD
Consulting Editor
Abhi Dey
Consulting Editor
Nisha Peter, PhD
Managing Editor
Ananda Ghosh, PhD
Founder
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The editors take care to share authentic information.  In case of any discrepancies please write to medness.newsletter@gmail.com
The sponsors do not have any influence on the nature or kind of the news/analysis reported in MedNess. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Medness. Examples of analysis performed within this article are only examples. They should not be utilized in real-world analytic products as they are based only on very limited and dated open source information. Assumptions made within the analysis are not reflective of the position of anyone volunteering or working for Medness. This blog is strictly for news and information. It does not provide medical advice, diagnosis or treatment nor investment suggestions. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
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Content Editors: Richa Tewari , Esha Sehanobish , Mayur Vadhvani and Abhinav Dey 
Concept and Design: Ananda Ghosh and Nisha Peter
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