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Adaptimmune’s GSK-partnered T cells trigger responses in solid tumor patients

Adaptimmune has seen partial responses in three of the first four myxoid/round cell liposarcoma (MRCLS) patients treated with its T cells. The early data raised hopes the GlaxoSmithKline-partnered drug will be effective in multiple types of solid tumor, sending Adaptimmune shares up nearly 20%.

Abingdon, U.K.-based Adaptimmune first posted clinical data linking NY-ESO SPEAR T cells to responses in synovial sarcoma patients in 2015. Those results gave Adaptimmune preliminary validation that it can engineer T cells to take out solid tumors but left the biotech needing more evidence to show its platform is effective against a range of cancers.

The MRCLS data mark a small step toward that goal. MRCLS, like synovial sarcoma, is a soft-tissue sarcoma but the underlying genetics and clinical manifestations of the two diseases are different.

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Acacia Pharma’s Baremis® Prevents Post-Operative Nausea And Vomiting In High-Risk Patients

Cambridge, UK and Indianapolis: Acacia Pharma Group plc (“Acacia Pharma”, the “Company” or the “Group”), (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialisation of new nausea & vomiting treatments for surgical and cancer patients, announces that data and analysis from its Phase 3 prophylaxis trial with intravenous amisulpride (BAREMSIS®) in combination with standard antiemetics have been published in the Online First edition of Anesthesiology, the peer-reviewed medical journal of the American Society of Anesthesiologists (ASA) (Kranke et al.). Positive headline results were first announced by the Company in January 2016.

The Phase 3 trial demonstrated that BAREMSIS is safe and resulted in a statistically significant reduction in the emergence of post-operative nausea & vomiting (PONV) when given in combination with an antiemetic drug from another class to adult patients undergoing elective procedures who are at high risk of PONV.

“Tens of millions of Americans undergo surgery each year and many suffer with nausea and vomiting after their operation,” said Peter Kranke, M.D., Professor of Anaesthesiology at the University of Würzburg in Germany and the trial’s lead investigator. “PONV contributes to patient distress, can delay recovery after surgery and increases hospital costs. Patients with multiple risk factors for PONV require a multimodal approach for its prevention, including using a combination of anti-nausea drugs with different mechanisms of action, since it cannot be predicted which pathway(s) will be active in a patient.”

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TraceLink Grows Market Position in DACH Region by 215% in 2017

NORTH READING — TraceLink Inc., the World’s Largest Track and Trace Network for connecting the life sciences supply chain and providing real-time information sharing for better patient outcomes, today announced 215 percent customer growth in the DACH region (Germany, Austria and Switzerland) for 2017.
Now serving over 40 customers in the region, TraceLink experienced a 138 percent growth in revenues from its German, Austrian and Swiss customers in 2017. To meet demand for its expanding DACH customer base, TraceLink has grown its European team by 169 percent, currently employing 22 native German-speaking team members.

In order to counter the threat of falsified medicines entering the legal supply chain, companies who manufacture, sell or dispense medications in the European Union must comply with track and trace regulations outlined in the Falsified Medicines Directive (FMD), including serialization, compliance reporting and verification requirements, by February 2019. Characterized by a strong community of small and mid-sized life sciences organizations, in addition to several domestic large pharmaceutical companies, the DACH region represents a core area in the European market with a significant need for serialization and compliance with the EU FMD.

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Orchard Therapeutics Scientific Founder Prof Donald Kohn Recognized with Pediatric Blood and Marrow Transplant Consortium Lifetime Achievement Award

London, UK  — Orchard Therapeutics, a clinical-stage biotechnology company dedicated to transforming the lives of patients with rare disorders through innovative gene therapies, today announced that one of its scientific founders and scientific advisory board member, professor Donald Kohn, has been recognized with the Pediatric Blood and Marrow Transplant Consortium (PBMTC) Lifetime Achievement Award on Feb. 22, 2018 in Salt Lake City.

The PBMTC Lifetime Achievement Award recognizes outstanding individuals who have made major contributions to the field of pediatric hematopoietic stem cell transplantation. The award highlights and honors the contributions and careers of individuals whose work exemplifies the PBMTC mission statement: “To support research and education to improve the availability, safety, and efficacy of hematopoietic cell transplantation and other cellular therapeutics for children and adolescents.”

Professor Kohn has focused his career on the development of hematopoietic stem cell gene therapy for immunodeficiencies, hemoglobinopathies and inborn errors of metabolism. His work includes the development of tools for efficient gene addition or correction, and persistent transgene expression, for the amelioration of genetic disease.

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Froedtert Provides Patients with Symptom Checker from Boston Startup Buoy Health

Froedtert & the Medical College of Wisconsin says it’s made an online symptom checker developed by a Massachusetts startup available to patients who receive care at the Milwaukee-based hospital and clinic network.

The new tool for Froedtert patients is from Buoy Health. The Boston-based company has developed an online chatbot that searches through thousands of clinical papers in order to suggest diagnoses based on information users enter about themselves and their symptoms.

Mike Anderes, Froedtert’s chief innovation and digital officer, says the purpose of Buoy Health’s symptom checker is to educate patients about their health, and is “not meant as a substitute for professional medical advice.”

Buoy Health co-founder and CEO Andrew Le says his company’s software uses machine learning techniques and is aimed at connecting symptom information shared by patients with contextual information, such as where they live and work, and what medications they take regularly.

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China’s Hua Medicine plans $400 million Hong Kong IPO, led by Goldman: Sources

HONG KONG (Reuters) – Chinese drug developer Hua Medicine is planning to raise at least $400 million in an initial public offering in Hong Kong in the latest in a series of biotech floats in the city, said people with knowledge of the matter.

Hong Kong is formulating new rules for early-stage drug developers in an effort to woo companies in the fast-growing sector – notably those in China – into choosing the city over New York, the traditional hub for initial public offerings from the industry.

 Shanghai-based Hua, a diabetes-focused drug developer, had considered both locations but selected Hong Kong because of the city’s proposed new listings regime, which Hong Kong Exchanges and Clearing (0388.HK) expects to have in place within a couple of months, said a source with direct knowledge of the deliberations.

Goldman Sachs (GS.N) is leading the transaction while CLSA, the offshore platform of China’s Citic Securities(600030.SS), is also working on the deal, the sources added. The company plans to go public in the second half of the year, said one of them.

Surface Oncology and ProBioGen Sign Second Antibody Manufacturing Program

Berlin, Germany — ProBioGen AG, a premier German service & technology provider for complex therapeutic glycoproteins announced signing the second antibody development project with Cambridge, MA-based Surface Oncology Inc., an immuno-oncology company developing next-generation antibody therapies that target the tumor microenvironment.

Under the terms of the agreement Surface Oncology will contract with ProBioGen to develop and manufacture another antibody for potential use in clinical trials. ProBioGen will develop several stable cell lines in parallel, gradually reduce the candidate number and conclude with process development and GMP manufacturing for a single antibody product candidate. The advantage of this approach is the meticulous analysis of several candidates at the same time while strongly reducing time lines.

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WuXi Biologics and Adagene Announce Strategic Development and Manufacturing Partnership of New Antibody Therapeutics

SHANGHAI  — WuXi Biologics (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, and Adagene Inc., an emerging biotech company discovering and developing innovative antibody therapeutics for the global market, today announced a strategic collaboration agreement.

Adagene is building a global biotech company with an internal pipeline of antibody therapeutics focused on difficult antigens, and therapeutic candidates with enhanced biophysical properties. The collaboration with WuXi Biologics will support supply of Adagene’s products for clinical trials under Investigational New Drug (IND) applications in both China and United States.

“The strategic collaboration with WuXi Biologics will enable Adagene to focus on our core competency in the discovery of novel antibody therapeutics and by leveraging the process development and manufacturing capabilities of WuXi Biologics will accelerate Adagene’s next wave of innovative products into the clinic,” said Dr. Peter Luo, Co-Founder and CEO of Adagene.

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VitalWare’s™ Medical Necessity Edits Now Used Nationwide with New Partnership

VitalWare™, the leading provider of healthcare mid-revenue cycle SaaS solutions, confirmed another major partnership with a nationally known large healthcare IT company serving providers, payers and consumers. These partnerships center on utilizing VitalIntelligence™, VitalWare’s comprehensive Medical Necessity data files to power multiple applications.

VitalIntelligence is VitalWare’s B2B solution, giving partners on demand access to over 175 proprietary and public regulatory coding, compliance and reimbursement data sets through integration tools and web services. Partners often site VitalIntelligence’s ability to quickly deliver data in many formats (to meet needs) as a core reason for choosing VitalWare. Whether it’s through web services, raw data feeds, or private-labeled web components, VitalIntelligence is chosen consistently by partners for its amazing flexibility, and comprehensive content delivery system via VitalWare’s private cloud.

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Tiny biotech takes on Glaxo’s $730,000 gene therapy

GlaxoSmithKline has seen precious few takers for its $730,000 gene therapy for a rare and life-threatening immune illness known as “bubble-boy disease.” Now a tiny startup thinks it can succeed where the British giant is struggling.

In almost two years since Glaxo’s Strimvelis came to the market, just five patients have received the treatment, offered only through a single center in Milan. Orchard Therapeutics, a closely held company in London with about 80 employees and no products on the market, is preparing to sell a competing version that may reach more sick children.

Orchard, whose team includes three former Glaxo executives, wants to one-up the larger company by taking aim at a Strimvelis shortcoming. While Glaxo’s therapy can’t be transported, Orchard is planning to use frozen cells that can travel to markets all over the world.

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