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Bringing personalized medicine to the market
Personalized medicine has been the holy grail of diagnostics and biomarkers for some time, but at last, it seems like it is becoming a reality. The move toward personalized medicine is driven by a number of factors-insurance companies; desire to select responders as their drug bills increase, and new FDA guidelines supporting the use of biomarkers in new drug development. The biggest area in diagnostics for personalized medicine is going to be oncology, Groen predicts.
The ethics of Alzheimer's risk testing
Knowing the potential risk of Alzheimer's disease can lead to anxiety and depression in people who have not developed symptoms. Increased risk means just that-an increased risk, not a certainty-it will be important to put safeguards in place as the expertise in and access to Alzheimer's disease biomarkers increases. This will include an ethics sub-study, to gauge the emotional impact on patients learning their positive or negative amyloid status.
Medtronic's flunked trial throws its hypertension program into doubt
Medtronic's ($MDT) market-leading renal denervation device failed to meet its primary efficacy endpoint in a pivotal trial, casting doubt over the company's vast and expensive development program and forcing the world's largest devicemaker to rethink its strategy. In a 535-patient trial designed to win FDA approval, Medtronic's Symplicity device proved safe but failed to meet its endpoint of significantly lowering blood pressure in patients with drug-resistant hypertension.
Boston Scientific paying $30M to settle Guidant claims
Boston Scientific's ($BSX) $27.5 billion Guidant buyout didn't just tank its profits; the megadeal saddled the Massachusetts device giant with hundreds of pending product-liability lawsuits. The defibrillators had already been recalled when Boston Scientific acquired Guidant in 2006, but the legal fallout was far from over, and the company agreed to pay the government $296 million back in 2009 to settle charges that Guidant officials misled the FDA.
Crowded market could blunt profits for hypertension techs
The device world's heavy hitters are in a race to get renal denervation devices on the market in the US, but a new report from Millennium Research Group (MRG) says the crowded marketplace could cut into profits. The next generation of renal denervation techs are designed to treat drug-resistant hypertension, a market MRG says will reach $2.9 billion by 2021. If manufacturers think they can demand large price premiums for highly featured devices, they may find themselves disappointed.
Abiomed's Impella devices keep pumping with another 510(k) clearance
Abiomed ($ABMD) gained FDA clearance for another iteration of its Impella heart pump, an important win for a product line that's become vital to Abiomed's bottom line. Abiomed gained a CE mark in April for the device, and it is marketed outside the US as the Impella cVAD. Consider the following: Impella products are driving Abiomed's future in a big way.
Alexion inks genomics pacts to continue R&D reboot
Alexion has teamed up with GNS Healthcare and Sema4 to advance its rare disease R&D agenda. The partnerships give Alexion access to modeling and simulation software used by Celgene and a partner to support its push into genomics. That alliance will see Alexion work on its tool for highlighting suspected rare-disease genes, SmartPanel, with the Mount Sinai Health System spinout. If Alexion can understand these disconnects between genotype and phenotype, it may identify ways to treat patients in whom rare diseases are symptomatic.
In 23andMe's tussle with the FDA, 'diagnostic' is a contentious word
If nothing else, direct-to-consumer DNA testing operation 23andMe has never used the words diagnostic test to describe its Personal Genome Service. Executives take pains, however, to note that the test lacks FDA clearance and is not for diagnostic use. Our relationship with the FDA is important to use, and we are committed to fully engaging with them to address their concerns. At that point, 23andMe's CLIA-certified labs sequence the samples and produce the requested data, covering areas including gene mutations, health risks and drug responses.
Surgeons have implanted a 3-D-printed pelvis into a U.K. cancer patient
A male patient in his 60s suffered from a rare form of bone cancer called chondrosarcoma. The man had to have part of his pelvis removed to stop the cancer's spread. Coated with a mineral onto which new bone can grow, the titanium pelvis was implanted using a standard hip replacement. Much of the patient's bone needed removing that nothing would have been left to which surgeons could attach an implant, Gerrand told The Telegraph.
Navigating the Complexities of Selecting a Vendor in the Crowded e-Clinical Marketplace
It is critical to have a vendor that is easy to contact and responds in a timely manner. If your vendor doesn't respond quickly, your questions will begin piling up and it may cause delays in your study. Similarly, if you have a unique need for your study, make sure you find a vendor that is willing to get creative. At the same time, the rapidly changing development landscape may not favor frequent switching between eClinical vendors.
Six Practices of High Performing Clinical Research Sites
We need research sites to help us develop and test new therapies, and to bring new treatments to patients. Many medical practices and clinicians explore the possibility of participating in clinical research studies. High-performing sites have staff with protected time dedicated to research, which in busier sites means full-time research staff.
Ovarian cancer: Scientists find a way to launch dual attack
Hitting two targets on the cancer cell could greatly increase the power of antibody therapy to kill ovarian cancer. They describe their single-agent dual-specificity targeting method for ovarian cancer in a study paper that features in the journal Cancer Cell. The approach uses a two-pronged antibody that hits two targets on the ovarian cancer cell. One target is a protein called folate receptor alpha-1 (FOLR1), which is highly expressed in ovarian cancer.
Negative memories of gym class may impact adults' lifestyle
Negative childhood experiences in physical education (PE) classes may have long-term effects on adult physical activity, a large study suggests. People's best memories of PE class included receiving positive recognition from peers or teachers regarding their performance. If our instructional practices are causing any of these things not to happen then we need to reconsider our practices. Buenaflor said many of the elimination games children and adolescents used to play in gym class have been replaced with non-elimination games.
One in five human genes are not 'real'
As that project drew to a close in 2003, estimates for that number fell to around 20,000-25,000 protein-encoding genes. Evidence suggested that the majority of these genes were noncoding genes or pseudogenes. The scientists found that an additional 1,470 genes - which were listed as protein-coding in the three collections - did not have the functional characteristics or the typical evolution of protein-encoding genes.
Sanofi wins European approval for rare blood-clotting disorder treatment
French drugmaker Sanofi on Monday said it had secured approval in Europe for a rare blood-clotting disorder treatment using nanobodies. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in June had recommended the approval of caplacizumab, which is to be prescribed to adults suffering acquired thrombotic thrombocytopenic purpura (aTTP). The US Food & Drug Administration (FDA), which has granted the drug a 'Fast Track' designation, is expected to follow suit in early 2019.
China reports second case of African swine fever in Xuancheng city, Anhui province
A new case of African swine fever has been confirmed in eastern China's Anhui province, said the country's agriculture ministry on Monday, a second outbreak of the disease in Xuancheng city. The latest outbreak, the seventh in the country since early August, killed 83 pigs and infected another 152 on a farm with 308 pigs, said the ministry. The new case follows an announcement on Sunday of an earlier case in the same city.
China bans pig shipments from areas hit by African swine fever as disease spreads
The highly contagious disease was also found on another small farm in Xuancheng on Sunday. Until now, authorities had only stopped transportation of pigs and products and shut live markets in and around infected areas. Costs will go up and it will take much longer to get pigs to the consumption areas, said Ni. Xuancheng city is around 70 km southeast of Wuhu city, where another African swine fever case was reported last week.
China has culled 2,310 hogs in Anhui after swine fever outbreak: state media
China had culled 2,310 hogs in east China's Anhui province as of Sept 2 in response to African swine fever, an agricultural ministry official told state radio on Monday. China reported a new case of African swine fever in Xuancheng in Anhui province on Monday, the second in the city in as many days, raising the risk for farmers as the disease spreads rapidly in the world's top pork producer.

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