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2015 was a record year for personalized medicine approvals, according to a new analysis from the Personalized Medicine Coalition. This news confirms the growing role of personalized medicine as an approach to treatment that can improve outcomes for patients and also create important efficiencies in the health care system. Personalized medicine is an emerging field of medicine that uses diagnostic tools to identify specific biological markers to help assess which medical treatments and procedures will be best for each patient. Personalized medicine also takes into account patients’ medical history, circumstances and values in developing targeted treatment and prevention plans...45 novel new drugs approved in 2015, the new analysis indicates that 28 percent of novel new drugs approved by the Food and Drug Administration...were personalized, or precision, medicines...Some of the personalized medicine highlights from 2015 include:

• Two new medicines for patients with different forms of non-small cell lung cancer;
• A new combination therapy for patients with cystic fibrosis;
• Two new medicines to help patients with a difficult-to-treat form of high cholesterol; and
• A new targeted therapy for melanoma.

Food and Drug Administration on Friday issued draft guidelines to medical device makers on how to protect patients from cybersecurity vulnerabilities in the devices...Cybersecurity threats to medical devices are a growing concern...The exploitation of cybersecurity vulnerabilities presents a potential risk to the safety and effectiveness of medical devices...The draft guidance, which is not legally binding, recommends companies take a number of actions, including monitoring and assessing risk, adopting a coordinated vulnerability disclosure policy, and taking measures to address cybersecurity risk early.

Patients may be more likely to retain information about their prescribed medications when the pharmacist-patient relationship becomes a 2-way conversation... A recent study published in the Journal of the American Pharmacists Association suggests that more interactive conversations between the pharmacist and patient can more than double the likelihood that the patient will understand how to take their medications properly....“The benefit of the interactive counseling technique is the fact that the patient can let the pharmacist know upfront what they know about their medications. The pharmacist can then fill in the knowledge gaps...The increased health literacy resulting from these more substantive conversations is strongly associated with greater medication adherence, which is widely considered one of the most crucial components of the value-based care model and optimized patient outcomes...This is the first real analysis to prove that [the interactive approach] works, and that the approach could be extremely important for health care in America...

The first issue of Elsevier's new open access journal Contemporary Clinical Trials Communications features a new method to make cancer clinical trials more effective, a better way of determining whether a trial was successful and a dashboard that helps patients enroll in trials... Contemporary Clinical Trials Communications publishes methodology and statistics that answer these questions, helping researchers build on each other's work and design better trials...I trust that the readers will find the journal a valuable source of recent advancements in clinical trials...this knowledge can facilitate the design, conduct and analysis of their trials...The journal also aims to tackle the problem of publication bias towards positive results by making all trial data open access...A major objective of the journal is to reduce publication bias, which is a major issue in the field of clinical trials...provides a platform for trialists around the world to share their knowledge on all aspects of clinical trials. We're making scientifically valid and technically sound original research findings freely accessible regardless of their perceived importance or impact.

The Association of Medical Media plans to hold a meeting to establish an industrywide viewability standard...A group of medical publishers will attempt to develop a new industry standard for digital advertising viewability, a much debated topic that has vexed the broader advertising industry...Viewability—how long is long enough for a user to have viewed a digital ad successfully—has cropped up in recent years as one of the more challenging media issues, and one that needs to be addressed as the business of digital advertising matures. In healthcare, experts say, it's no different..."There's more pressure to account for dollars,"...The group's perspective is that professional medical content differs from other online advertisers..."It is distinguished from general web content in many ways, including in its scarcity and its value to the end reader...industry experts have been saying that drugmakers will likely put more emphasis on digital advertising as brand marketing becomes more targeted to certain patient populations and manufacturers lose direct access to physicians and other prescribers. That could expose more advertisers to the vagueness of viewability and highlight the need to find a solution that makes sense given the nuances of medical advertising, notably content aimed at healthcare providers.

A man left brain dead after a drug trial in northwest France died on Sunday, said the hospital where he was being treated...The Rennes hospital said in a statement that five other volunteers were in stable condition after they were admitted last week...In total, 90 people took part in the trial of the drug made by Portuguese pharmaceutical company Bial, which is intended to treat mood and anxiety issues, as well as movement coordination disorders linked to neurological issues...It was not yet known what caused the tragedy, said Francois Peaucelle, the head of Biotrial, the company that conducted the trials for Bial.

Some execs say easing off of the requirements will allow providers to focus more on innovation...Healthcare chief information officers breathed a sigh of relief on Tuesday when Andy Slavitt said the end of the meaningful use program was near. But many are waiting on the details before celebrating too much...The acting administrator of the Centers for Medicare and Medicaid Services Andy Slavitt said in a speech at the J.P. Morgan Healthcare Conference that meaningful use would be replaced with a more streamlined regulatory approach in line with the merit-based alternative payment models of the Medicare Access and CHIP Reauthorization Act of 2015...“The early stages of meaningful use took the country from ‘zero to 60' in five years, a remarkable achievement that would not have been possible without HITECH,”...“Now, it's time for the new payment model that rewards providers for achieving better health outcomes to be the driver of innovation, using the new electronic infrastructure that is now in place. That was the vision for ‘Phase 3’ from the very beginning.”..."It's truly unfortunate, but I'm not surprised,”...“The lack of alignment in Washington, varied interpretations by our industry and its vendors, and the resulting and inefficient ‘MU clicks,’ as termed and borne by our physicians have led down this path."...“The sad part of it all is that MU was designed with best intentions yet fated by regulation and political interests,”...

Two Indian states have put sales of...Roche's blockbuster drug Avastin on hold, officials said on Tuesday, after it hampered the vision of 15 patients who used it for a condition it is not officially meant to treat...Avastin (bevacizumab) is a cancer drug but is often used by doctors to treat vision loss even though it has not been approved by the U.S. Food and Drug Administration for that purpose. Studies have shown that eye injections of Avastin curb vision loss...Roche's India unit said the company does not promote the use of Avastin for treatments for which it is not approved, but has initiated an internal investigation...H.G. Koshia, the top drug controller in western Gujarat state, said he had directed distributors to recall one batch of the medicine given to the patients last week. Its samples were being tested following the incident at a hospital in Ahmedabad city...The hospital said all standard protocols were followed. Koshia, Gujarat's drug regulator, said they would need to ascertain whether the drug was a fake copy of Avastin.

One person has been left brain dead and five others have been hospitalized after taking part in a clinical trial in France of an experimental drug made by Portuguese drug company Bial, French Health Minister Marisol Touraine said...90 people have taken part in the trial, taking some dosage of the drug aimed at tackling mood and anxiety issues, as well as movement coordination disorders linked to neurological issues...The six men aged 28 to 49 had been in good health until taking the oral medication at the Biotrial private facility that specializes in clinical trials..."This is unprecedented"..."We'll do everything to understand what happened."...The brain-dead volunteer was admitted to hospital on Monday...For three of the five others...there are fears of irreversible handicap...One of the six had no symptoms but was being carefully monitored...The medicine involved is a so-called FAAH inhibitor that works by targeting the body's endocannabinoid system, which is also responsible for the human response to cannabis...Bial said in a statement it was committed to ensuring the wellbeing of test participants and was working with authorities to discover the cause of the injuries, adding that the clinical trial have been approved by French regulators.

Illumina, the world’s largest manufacturer of DNA sequencing machines, announced Sunday the formation of a new company that will develop blood tests that can detect a broad variety of early stage cancers long before symptoms arise. The new company, named Grail, has so far raised $100 million, mostly from Illumina and venture capital firm Arch Venture Partners, but also from Microsoft co-founder Bill Gates, and Amazon founder Jeff Bezos...The holy grail in oncology has been the search for biomarkers that could reliably signal the presence of cancer at an early stage...Illumina’s sequencing technology now allows the detection of circulating nucleic acids originating in the cancer cells themselves, a superior approach that provides a direct rather than surrogate measurement...We hope today is a turning point in the war on cancer...By enabling the early detection of cancer in asymptomatic individuals through a simple blood screen, we aim to massively decrease cancer mortality by detecting the disease at a curable stage...