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Medtech Insight
By Catherine Longworth 21 Jun 2018
In a move to accelerate adoption of its AI-driven genomics platform, SOPHiA Genetics has acquired Interactive Biosoftware, the French developer of Alamut, a clinical decision support software used in genomic data interpretation.
Pink Sheet
By Derrick Gingery 21 Jun 2018
Sarepta will face a US FDA staff with which it does not have a controversial history, the Center for Biologics Evaluation and Research, likely avoiding the reviewers that evaluated its Duchenne muscular dystrophy treatment Exondys 51.
Topic Diseases
Pink Sheet
By Francesca Bruce 21 Jun 2018
PRIMA, the new service the National Institute for Health and Care Excellence offers to review economic models, must not be affected by confidentiality and conflict of interest issues, warns UK the pharmaceutical industry group, ABPI.
Topic Business strategies
Medtech Insight
By Amanda Maxwell 21 Jun 2018
There's been confusion and conflicting opinions about notified bodies conducting mock audits on companies' documentation to prove conformity with the impending EU Medical Device and IVD Regulations. Has the lack of clarity led to different and unfair practices? Does it matter?
Topic Medtech
Scrip
By Emily Hayes 21 Jun 2018
Among other debates at the American Diabetes Association annual meeting, clinicians will discuss the future of cardiovascular outcomes studies for diabetes drugs – whether they should maintain course or are due for an overhaul.
Topic Diabetes
Scrip
By Eleanor Malone 21 Jun 2018
Emerging Company Profile: ENYO Pharma has been around for barely four years, but it is already advancing its lead programs into Phase II trials in hepatitis B and NASH, and anticipates many more uses for its virology-based platform that will go way beyond treating virus infections.
Topic Company analysis Hepatitis B
Awareness
20 Jun 2018
Listen to this podcast with Generics bulletin editor Aidan Fry and deputy editor David Wallace. The Global Generics & Biosimilars Awards reward ‘best practice’ in the two industries, while at the same time encouraging improvements in every aspect of the way business is conducted.
Biomedtracker
By Amanda Micklus 19 Jun 2018
Gain a deeper understanding of the implications of the Regenerative Medicine Advanced Therapies (RMAT) designation and the significance of its support and advancement by the FDA in this webinar recording, "RMAT Designation – Impact on Regenerative Medicine Sector".
Awareness
By Dominique Fontanilla 19 Jun 2018
There has been little change to standard treatment for AML in recent years; however, 2017 saw a flurry of new targeted drug approvals, sparking significant market growth. Patient age remains the biggest factor in driving treatment decisions for AML. Cases of AML are expected to increase, and prognosis remains poor – especially among older adults. Drug developers are targeting patient segments with high unmet clinical need to gain access to the AML market and the budget impact of AML is expected to grow considerably.
Topic Cancer
Awareness
By Patricia Reilly 19 Jun 2018
The promises of gene therapy are taking a long time to be fulfilled, in part due to challenges in developing gene vectors capable of safe and efficient delivery of therapeutic genes (transgenes) into patients’ cells. Nonetheless, these challenges are being addressed in innovative ways. A variety of first-generation vectors, both viral and non-viral, have been employed in clinical trials with varying degrees of success, and the experience gained is guiding the design of next-generation vectors.
Meddevicetracker
By Tina Tan 15 Jun 2018
The webinar will provide a thought leadership perspective on the key challenges and trends in the emerging Robotic Surgery market.
Topic Digital Health Research
Medtech Insight
By Reed Miller 14 Jun 2018
Results of the WATER II trial confirm that Aquablation is a safe and effective treatment of benign prostate hyperplasia for large prostates, and manufacturer Procept BioRobotics is confident the procedure will eventually displace all other prostate resection techniques because it is easy for surgeons to learn.
In Vivo
By Ashley Yeo 14 Jun 2018
The health products industry, methods of care delivery and even the public's expectations for improved tools to prevent, monitor and treat disease have transformed dramatically in the past five years. The changes anticipated over a similar period ahead are potentially even more marked, with business continuity impacts for medtech and pharma concerns, according to Deloitte LLP experts who were on the circuit at health care industry events in Germany and the UK this spring.
In Vivo
By Mark Ratner 14 Jun 2018
A plethora of clinical studies are showing that new types of data, often captured in the EHR, can help improve the correlation between treatments and outcomes and favorably affect patient care as well as enhance drug development.
Pink Sheet
By Sue Sutter 14 Jun 2018
Internal group headed by Principal Deputy Commissioner Rachel Sherman will develop implementation recommendations, which could include new guidance, regulations, a Q&A document or ‘nothing at all,’ Commissioner Gottlieb tells BIO annual meeting; he promises consultation with the law’s supporters and critics on Capitol Hill ‘to fully understand what the intent was with different provisions.’
Topic FDA
Medtech Insight
20 Jun 2018
Scrip
20 Jun 2018
In Vivo
20 Jun 2018
Medtech Insight
20 Jun 2018
Pink Sheet
20 Jun 2018
Medtech Insight
20 Jun 2018
Scrip
20 Jun 2018
Pink Sheet
20 Jun 2018
Scrip
20 Jun 2018
In Vivo
20 Jun 2018
Medtech Insight
20 Jun 2018
Pink Sheet
20 Jun 2018
Pink Sheet
20 Jun 2018
Scrip
20 Jun 2018
Medtech Insight
20 Jun 2018
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23 Sep 2018
USA
Awards
09 Oct 2018
Spain
Awards
28 Nov 2018
Awards
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