The pill will identify cancers and other diseases before they become a problem. The pill contains magnetized nanoparticles attached with antibodies or other proteins are specific for the disease biomarker such as cancer or other diseases. These magnetized particles can be called back to a particular site to deliver their results. The data would then be collected by a wrist-worn smart device. This could lead to fast, painless diagnosis. Detail can be found in link below:
Google’s research division unveiled a new sensor-packed wristband, a medical device, to monitor the vital signs (pulse measuring, heart rhythm and skin temperature). It can also quantify environmental factors such as light exposure and noise levels. Google X can be used in clinical trials or as a doctor-to-patient communication tracking tool. Device could help doctors to get a complete picture of patients’ health related activity, when they are not coming for an examination. It is currently up for test its accuracy in trials. Google will be seeking regulatory approval on both sides of the Atlantic. Detail can be found in Bloomberg:
FDA News: Weekly Review… June 28th
APPROVED! KENGREAL (cangrelor) an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. (The Medicines Company, Parsipanny, NJ, Approved 6/22/15)
Indication : Adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor
- CHAMPION PHOENIX Trial – Primary outcome measure of first occurrence of any one of the composite endpoint of all-cause mortality, myocardial infarction, ischemia-driven revascularization, and stent thrombosis within 48 hours after randomization. Kangreal vs Clopidogrel (p<0.005)
- Two additional trials, CHAMPION PCI and CHAMPION PLATFORM were terminated early for futility
- Higher Bleeding – all categories – with Kangreal vs clopidogrel.
- Higher rate of discontinuation for bleeding higher with Kangreal.
Positioning: While Kengreal provides another treatment option for patients – it requires intravenous administration and causes increased bleeding vs clopidogrel, an orally administered antiplatelet that is generic. Innovative Payor strategy will be important to effectively differentiate the drug.
Post-Marketing Safety Assessments and Label Updates:
- POTIGA (ezogabine, GlaxoSmithKline): Risks of vision loss adequately managed by approved labeling. No updates to Labeling (Boxed Warning) and approved REMS. Long-term observational study required. Skin discoloration is a cosmetic effect. http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm452049.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
- DAYTRANA PATCH (methylphenidate transdermal system, Noven Pharmaceuticals, Inc.,): Permanent loss of skin color may occur – chemical leukoderma. Labeling updated to include Warning. http://www.fda.gov/Drugs/DrugSafety/ucm452244.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
- XELIJANZ (tofacitinib, Pfizer): Increased risk of herpes zoster in Japanese patients. Updates to labeling and REMS.http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=69
Analysis : Effective Pharmacovigilance and Signal Detection (FDA and Sponsor initiated) critical for benefit/risk assessment and appropriate labeling for marketed products. Highlights the importance of use of the MedWatch program by patients and health care professionals.
APPROVED! BrainPortV100 to help the blind process visual signals via their tongues (Wicab, Inc., Middleton, WI, Approved 6/18/15)
Non-surgical assistive device for blind with no useful vision. Translates digital information from a video camera into gentle electrical stimulation patterns on the surface of the tongue. Users feel moving bubble-like patterns on their tongue which they learn to interpret as the shape, size, location and motion of objects in their environment.
- CDRH De novo premarket review pathway : Low- to moderate-risk medical devices, not substantially equivalent to an already legally-marketed device
- Effectiveness Assessment : Object recognition and word identification, oral health exams to. Studies showed that 69 percent of the 74 subjects who completed one year of training with the device were successful at the object recognition test.
- Safety Assessment: Risks associated with holding the intra-oral device in the mouth. Reports of burning, stinging or metallic taste, no serious device-related adverse events.
FDA Summary of Safety and Effectiveness Data and Labeling POSTED!
Misago Peripheral Stent System – P140002 (Terumo Medical Corporation, Elkton, MD, Tokyo, Japan, Approved 5/22/15)
The Misago Peripheral Stent System is used to re-open narrowed regions of an artery that supplies blood to the leg. Consists of : Stent and Delivery System. Stent is a small nickel and titanium alloy tube, mounted within the long, thin, tube delivery catheter to deliver the stent into the artery.
- CDRH Premarket Approval Appliction (PMA) : US and ex-US clinical studies to establish reasonable assurance of safety and effectiveness of stenting
- Effectiveness Assessment : Primary Effectiveness endpoint (stent patency of 66% at 12 months – NOT met). FDA considered Sponsor’s analysis ‘overly conservative’! Analysis conforming to FDA guidance using Kaplan-Meier method (time-to-event format with appropriate censoring); freedom from loss of patency at 12 months was 78.9%
- Safety Assessment: Freedom from major adverse events (MAE) at 30 days post-procedure >99%
- Benefit/Risk Assessment : Approved even though Sponsor -Defined Endpoint not met. Approval based on FDA analysis for precedents and differentiation from other approved devices (high unmet need, Quality of Life improvement, risk minimization by safe and effective device use, Commitment for Extended Follow-Up Study:
Editorial: When Drugs Don’t make it to market. We need to know why and regulators should tell us.
Mintzes B., British Medical Journal.
2015; 350 doi: http://dx.doi.org/10.1136/bmj.h2852 (Published 09 June 2015)
Analysis: FDA does not post rejections (Complete Response Letters are confidential). Brief External communication only if company is publicly traded in the US. No public knowledge of the totality of evidence and FDA analysis of Risks to outweigh Benefits. Sharing of learnings, while protecting competitive/confidential information, is absent. FDA should take a cue from EMA who posts non-approval assessments.
- 6/16/15: Naming of Drug Products Containing Salt Drug Substances
- 6/17/15: Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices – Guidance for Industry and Food and Drug Administration Staff
- 6/18/15: CVM GFI #187 Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs
- 6/18/15: Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions – Draft Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff
- 6/18/15: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
Framework and structured approach to facilitate new device clinical investigation by expediting IDE decision making – CONTEXT, RISK ASSESSMENT, BENEFIT ASSESSMENT, PATIENT PREFERENCE, UNCERTAINTY
Cipla Limited (Mumbai, India) announced that Co. received US FDA approval for an innovative formulation – Lopinavir/ritonavir for pediatric specific treatment for infants. According to the article, globally 3,200,000 children were living with HIV in 2013 and 240,000 children were newly infected with HIV. Although antiretroviral therapy can be life saving for these children, only 24% are currently on treatment. One third of the children born with HIV without treatment die before their first birthday and 50% die before they turn two. Detail can be found in the link:
Three natural herbs in the A2X compound work together to aid body’s natural defense against anxiety. Ashwagandha, L-Theanine, and Passion Flower have been clinically proven to boost gamma-aminobutyric acid (GABA) and serotonin levels in the human body. GABA is a biologically active substance found in some plants. It is a neurotransmitter that inhibits activation of neurones. Studies have shown that these natural ingredients can stimulate the production of GABA. A2X treatment, over time, helps to calm body’s natural response to anxiety. Side effects from prescription medication are worse than the anxiety problem itself. A2X effectiveness reported to be safe for long-term use with no side effects. Detail can be found in the link:
Authors in a study examined the association between chocolate intake and the risk of future cardiovascular events in total of 20951 men and women. Authors evaluated chocolate consumption and cardiovascular outcomes. Results suggested that higher chocolate intake is associated with a lower risk of future cardiovascular events. There does not appear to be any evidence to say that chocolate should be avoided in terms of cardiovascular risk. Detail is in attached link from Heart Journal (an official journal of the British Cardiovascular Society):
Mars Inc., maker of M&M’s, Snickers and other candies, discussing with large pharmaceutical companies about developing a line of prescription medicines to treat a variety of illnesses including age-related memory loss, according to an article in the Washington Post. This could be due to cocoa-flavanol consumption. Researchers from Harvard, the UC-Davis and European universities presented papers on the relationship between cocoa-flavanol consumption and increased cerebral blood-flow. Mars opinion is that cocoa flavanols could increase blood flow and help fight diseases such as age-related memory loss. According to Mars, several drug companies showed interest in developing drugs that use the medicinal properties of cocoa.