Scientists Simplifying Science
Donate
Facebook Twitter Instagram Linkedin
Club SciWri header

Medness Plus

SHARE THIS

 

FDA approves a new generic version of an angiotensin II receptor blocker (ARB), Valsartan.


FDA recently announces the approval of a new generic version of Diovan (valsartan). These are ARB molecules or angiotensin II receptor blockers that usually treat heart failure and high blood pressure [1]. The multiple recalls of the generic valsartan products due to contamination of certain lots with nitrosamine impurities led to a recent shortage of medicine. It is due to this reason that FDA prioritized the review of this drug application. The approval of the new generic Diovan was granted to Alkem Laboratories Ltd.

High blood pressure is a widespread disease that causes blood to flow through the arteries and blood vessels at a pressure higher than the normal. Heart failure occurs when the organ is unable to pump enough blood as per the requirement of the body. Both these conditions are critical and if left untreated, can cause major episodes in patients. Valsartan is a drug used to treat high blood pressure and heart failure. The most common side effects associated with the drug include hypotension, increased level of blood creatinine and potassium, and dizziness. The expedited review process was initiated to relieve the shortage caused by the recalls of valsartan due to contamination caused by the presence of nitrosamine in certain generic ARB products. In collaboration with the companies, the FDA has been pro-active in removing all of such products from the market. FDA has taken steps to understand how such impurities get incorporated into the products. Based on extensive analysis they are also working on new and improved testing systems to help manufacturers produce impurity-free ARBs especially detectable levels of nitrosamines. FDA scientists are also using the information obtained from this investigation to evaluate all the currently available ARBs and intend to use this information to assess future applications to prevent such contaminations. For this approval, the FDA did take a couple of precautionary measures. They evaluated the company’s manufacturing processes and made sure that appropriate testing methods were used to identify any potential NDMA or NDEA contamination. From the various tests conducted, they concluded that there was no known risk for the formation of other nitrosamine impurities. This is a part of an on-going process by which FDA continues to investigate other ARB medicines for nitrosamine impurities and those that do not meet the agency’s quality standards. They will continue to update the list for recalled medicines and have advised patients and healthcare providers to check the list periodically as information on these ARB medicines might change.

The Importance of Healthy Blood Pressure

From Visually.

 

“We know that the ongoing recalls to prevent certain lots of valsartan that contain unacceptable limits of impurities from reaching patients has resulted in a shortage of these important medicines,” said FDA Commissioner Scott Gottlieb, M.D. “So, to address the public health consequences of these shortages, we’ve prioritized the review of generic applications for these valsartan products. When faced with a drug shortage situation, the FDA employs a number of strategies to help mitigate the effects of the shortage on patients. As part of that work, we look at where we may be able to prioritize review of pending generic applications of the medicine in shortage, or similar products. We hope that today’s approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products. We’ll continue to work with manufacturers so that more medicines like valsartan, that belong to a class of drugs called angiotensin II receptor blockers, can be approved that are free of nitrosamine impurities to continue to address this ongoing shortage.”

 

FDA approves a new indication for a heart valve repair device to treat patients with mitral regurgitation.


FDA recently announced the approval of a new indication for a heart valve repair device that is supposed to reduce moderate-to-severe mitral regurgitation in patients [2]. Mitral regurgitation is a leakage that causes the backward movement of blood through the mitral valves into the left atrium of the heart. This leads to observation of various symptoms such as fatigue, shortness of breath and swelling in legs, all corresponding to heart failure. The version of MitaClip Clip delivery system (MitraClip) that was approved back in 2013, was indicated to treat patients with significant mitral regurgitation and heart failure symptoms. These abnormalities were caused by problems with the mitral valve also known as degenerative or primary mitral regurgitation. The new one that just got approved is supposed to treat patients with normal mitral valves who develop heart failure symptoms and severe or moderate-to-severe mitral regurgitation due to reduced activity of the left heart function. It is called secondary mitral regurgitation. The patients who are indicated to undergo this treatment are those that have already been treated with optimal medical therapy. This includes heart failure medications along with, in case of certain patients, cardiac resynchronization therapy and implantation of cardioverter defibrillators. The approval of the MitraClip Clip Delivery System was for Abbott Vascular Inc. It is not intended for use in patients who are incapable of tolerating blood thinners during or after procedures. This treatment should also be avoided for patients who have evidence of blood clots in the hearts or veins leading to the heart, have endocarditis (active inflammation) of the mitral valve and rheumatic mitral valve disease.


Approximately 6.5 million Americans have heart failure. Heart failure can be defined as a chronic and progressive condition in which the heart is unable to pump and deliver enough blood to satisfy the body’s need of oxygen and blood. Among these patients there are some who develop moderate-to-severe or severe mitral regurgitation thus complicating the treatment for heart failure. With the approval of the MitraClip, patients will now be able to get treatment in combination with optimal medical therapy. It is a minimally invasive procedure and occurs through the femoral vein in the leg guided into the heart’s left ventricle where it holds on to the two leaflets of the mitral valve, adjusting them to be together and to reduce the blood backflow. The approval was based on data from the study of 614 patients with heart failure who had moderate-to-severe or severe secondary mitral regurgitation. They were randomly assigned to either continuation with their optimized medication treatment or to carry on their optimized medication treatment in combination with MitraClip. The latter group saw a decrease of approximately 47 percent in terms of re-hospitalization due to heart failure. The risk of death within two years was also reduced by approximately 37 percent in the MitraClip group when compared to the control group. The potential adverse effects include stroke, major bleeding, erratic heart beat (atrial fibrillation) and in some cases, even death.

Mitral Regurgitation

From Visually.

 

“Expanding the approval of this device to heart failure patients with significant secondary mitral regurgitation, who have failed to get symptom relief from other therapies, provides an important new treatment option,” said Bram D. Zuckerman, M.D, director of the Division of Cardiovascular Devices in the Center for Devices and Radiological Health. “Careful evaluation by a team of specialists is essential to determining whether a particular patient is an appropriate candidate for this procedure.”

 

FDA approves Optimizer Smart system for the treatment of patients with moderate-to-severe chronic heart failure.


FDA recently announced the approval of Optimizer Smart system, a new device, for the treatment of patients with chronic, moderate-to-severe heart failure [3]. It is expected to be beneficial for patients who do not respond well or are not suited to be treated with other heart failure devices such as cardiac resynchronization therapy to restore the normal pattern of the heartbeat. Since the device treats a life-threatening disease and addresses an unmet medical need in patients, the FDA gave this device a Breakthrough Device designation. It is indicated to be useful for patients who do not benefit from the standard treatments and have no alternative treatment options. The approval was given to Impulse Dynamics, USA. To qualify for the Breakthrough Device designation, one or more of the following criteria should be fulfilled, the device must have a significant advantage over the presently available treatment or the treatment is in the best interest of the patients and that it will be used in treating patients with a serious life-threatening or debilitating disease or condition.

Important Facts About Heart Failure

From Visually.

 

Heart failure is a condition in which the heart is unable to pump enough blood to meet the needs of the body for oxygen and blood. Approximately 5.7 million people have heart failure. A few common causes of heart failure include diabetes and high blood pressure. Some of the symptoms are fatigue and swelling in the lower extremities that make daily activities difficult. A way to get around heart failure is to treat these underlying symptoms. To do so, doctors presently are prescribing medications such as angiotensin converting enzymes (ACE) inhibitors, beta blockers or angiotensin receptor blockers to reduce blood pressure and strain on the heart. They are also prescribing diuretics to prevent the build-up of fluids in the lungs and reduce swelling in ankles and feet. To treat patients better, FDA granted the Breakthrough Device designation to the Optimizer Smart system. It consists of a battery charger, implantable pulse generator, and software. The pulse generator is implanted subcutaneously in the upper right or left area of the chest and are connected to three leads that are implanted in the heart. The device is then programmed to deliver electrical impulses to the heart during regular heartbeats to help the heart’s squeezing capacity. The approval was based on the data from two randomized, multi-center clinical trials. It consisted of 389 patients with moderate-to-severe heart failure. Optimal medical therapy was common for all of them. 191 patients received an additional Optimizer Smart system implant. It was observed that those with the latter showed improvements in the distance that they were able to walk in the six-minute walking tests. They also showed improvements in the standard assessments to measure heart failure symptoms. The target group for the device, in general, is patients who have marked limitations in physical activity and those who haven’t reached adequate relief even after receiving optimal medical therapy. The Optimizer Smart system is thought to be useful for improving a six-minute walk distance, functional status of certain heart failure patients. These patients should also have a left ventricular ejection fraction of 25 to 45 percent, have a regular heart rhythm and should not be under a cardiac resynchronization therapy. The potential adverse effects include bleeding, infection, decreased heart failure or complications with the device such as fracture of the leads implanted in the heart etc.

“Patients with moderate-to-severe chronic heart failure have limited treatment options. And for those who are unable to be treated due to underlying conditions or who have not responded to available treatments, their quality of life may be impacted, with limits on the types of physical activities they can do,” said Bram Zuckerman, M.D., director of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. “The FDA recognized the unmet need for these patients and worked with the manufacturer through our Breakthrough Device Program to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness.”

 

FDA approves Zulresso for the treatment of postpartum depression (PPD).


FDA recently announced the approval of the first-ever drug for postpartum depression (PPD). Zulresso (brexanolone) injection will be administered intravenously in adult women with PPD [4]. FDA has granted a Priority Review and Breakthrough Therapy designation to this product of Sage Therapeutics Inc.

Postpartum depression (PPD) usually occurs after childbirth, but the symptoms of depression can initiate during the pregnancy period. This leads to depression, loss of interest in activities along with a continuous feeling of unhappiness. Some of the symptoms associated with PPD include feelings of worthlessness, suicidal tendencies, cognitive impairment. The intravenous injection, Zulresso is expected to bring relief under such conditions. For the time being it will only be available through a restricted program called Zulresso REMS program. It will be administered by a health care provider and in only certified health care facilities. For this, the patients have to be enrolled in the program before the administration of the drug. Zulresso is administered without a breakthrough IV infusion over a total of 60 hours. Patients will be monitored for sudden loss of consciousness, excessive sedation and have a continuous pulse oximetry monitoring (determining levels of oxygen in the blood), since all of these could lead to serious damages as mentioned in the Boxed Warning that is provided with prescribing information. The patients will be educated on the risks of the drug and that they might be monitored at a health care facility for 60 hours to determine effects of the medication. They will be advised not to drive, operate machinery etc. until their drowsiness from the treatment goes away completely. The approval was based on two clinical studies in which the participants received 60 hours of continuous IV of Zulresso or placebo and were then monitored for four weeks. One of the studies had patients with severe PPD and the other had those with moderate PPD. The efficiency was based on the mean change from baseline in depressive symptoms as measured by a depression rating scale. In both the studies, Zulresso was able to achieve superiority in the improvement of depressive symptoms at the end of the first infusion, when compared to the placebo. There was a similar improvement observed at the end of the 30-day follow-up period. The most common adverse effects associated with Zulresso in clinical trials included loss of consciousness and flushing, sleepiness and dry mouth. Those who experience a worsening effect on depression and develop suicidal thoughts and behavior should definitely consider changing the therapeutic regime and a healthcare provider must only execute it.

What is Postpartum Depression?

From Visually.

 

“Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option,” said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient.”

 

FDA announces the approval of Sunosi TM (solriamfetol) for excessive daytime sleepiness caused by Narcolepsy or Obstructive Sleep Apnea.


FDA recently announced the approval of Sunosi TM (solriamfetol), the first dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), to treat patients affected with excessive daytime sleeping associated with narcolepsy or obstructive sleep apnea (OSA) [5]. It is a product of Jazz Pharmaceuticals Plc. The approval of Sunofi is for a once-daily dose of 75 mg and 150 mg for patients with narcolepsy and doses of 37.5, 75 and 150 mg for patients with OSA. Sunosi is expected to be available within 90 days of FDA approval, i.e., following the final scheduling decision by the U.S. Drug Enforcement Administration.

When Rest Isn’t So Easy: Understanding Sleep Apnea Basics

From Visually.

 

Sleep apnea or Obstructive Sleep Apnea is a highly common disease with a higher occurrence in men, in which the patient exhibits excessive daytime sleepiness. The most common treatment for OSA is CPAP (Continuous Positive Airway Pressure) resulting in and an improvement in excessive daytime sleepiness. Often patients are unable to tolerate the CPAP treatment and in cases where they can undergo treatment, the procedure might not be adequate, and the symptoms might continue to exist even after the therapy. Narcolepsy, a debilitating, chronic, neurological disorder, has a similar excessive daytime sleepiness symptom. Additionally, these patients are also unable to regulate sleep-wake cycles normally. Based on the available data, about one in 2000 people in the U.S. is affected by Narcolepsy. In more than 50 percent of patients, it goes undiagnosed. The main symptoms of narcolepsy include sleep-related hallucinations, excessive daytime sleepiness, sleep disruption, cataplexy and sleep paralysis. Even though all patients experience excessive daytime sleepiness, the other symptoms may or may not be visible in all at one time. Sunosi, a dual-acting DNRI, is expected to improve the wakefulness in adults showing symptoms of OSA and narcolepsy, especially excessive daytime sleepiness. At present, Jazz Pharmaceuticals has the right for the global development, manufacturing and commercialization of the product, except a few in Asia. In the U.S., Sunosi has an orphan drug designation. FDA’s approval was based on data from a Phase 3 clinical program called TONES (Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness). It consisted of four randomized placebo-controlled studies aimed at demonstrating the superiority of Sunosi over placebo. Participants were 900 or more in number with excessive daytime sleepiness associated with OSA and narcolepsy. At week 12, an improvement was observed in all doses for the OSA patients and in those that received 150 mg for narcolepsy patients. There was an improvement in wakefulness when compared to placebo. Wakefulness was measured in test session 1 approximately 1 hour after the dose through 5, approximately nine hours after the dose by the maintenance of wakefulness test (MWT). Overall, using the Patient Global Impression of Change scale, it was observed that approximately 68-74 % of patients receiving 75 mg dose and about 78-90 % of people receiving 150 mg dose, showed improvement in their clinical condition and maintained it over a period of six months when compared to placebo. The most common adverse effects associated in both the diseased groups included nausea, headache, and a decrease in appetite.

“Excessive daytime sleepiness can negatively impact the daily lives of people living with narcolepsy or obstructive sleep apnea at work, at home or in daily activities. With this approval, a new, daytime medicine that can provide sustained wakefulness throughout the day will be available for patients,” said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. “The FDA approval of Sunosi also represents an important milestone for Jazz as we continue to offer new treatment options that address unmet needs for people living with chronic, and often debilitating, sleep disorders.” “We’re excited about this new therapeutic option for patients, and we are pleased with the information included in the Sunosi label as we believe it will give physicians the information needed to appropriately manage the vast majority of obstructive sleep apnea and narcolepsy patients with excessive daytime sleepiness,” said Daniel Swisher, president and chief operating officer of Jazz Pharmaceuticals.

 

FDA approves the marketing of a new device to help patients suffering from carbon monoxide poisoning.


FDA recently announced the approval for marketing of ClearMate, a new device expected to be used in an emergency room to treat patients suffering from carbon monoxide poisoning [6]. The device uses a novel method to increase the patient’s rate of breathing thus quickly removing carbon monoxide. ClearMate was reviewed under the De Novo premarket review pathway. This pathway is indicated for low-to-moderate risk devices of a new type and creates a regulatory classification such that following similar types of devices may go through FDA’s 501(k) premarket. Under the premarket process, devices can obtain marketing authorization by exhibiting significant similarity to a previous device. The approval was granted to Thornhill Research Inc.

Carbon monoxide is an extremely poisonous gas and nearly 500 people in the U.S. die each year with 20,000 visiting the emergency for unidentified exposure to the gas. The sources of carbon monoxide include gas-powered generators, gas stoves, and poorly-maintained heating systems. The most common adverse effects of carbon monoxide poisoning are weakness, dizziness, headache vomiting, and chest pain. Carbon monoxide when inhaled reduces the oxygen transport to the brain and other tissues since it binds to hemoglobin in the blood instead of oxygen leading to the poisoning. The most common form of treatment for patients is to inhale 100 percent oxygen using a mask. Hyperbaric chambers can be used in severe cases in which oxygen gets delivered under a higher than normal pressure. ClearMate is a new device that functions by delivering both 100 percent oxygen and a mixture of oxygen and carbon dioxide resulting in the patient breathing faster and faster elimination of carbon monoxide from the body. The increase in the breathing rate allows carbon monoxide to be replaced by oxygen for more efficient transportation. The approval of ClearMate was based on data from multiple clinical trials which tested the effectiveness in 100 patients. It was concluded that the combination of oxygen and carbon dioxide was able to eliminate carbon monoxide at a faster rate than by 100 percent oxygen alone but was not quicker than the hyperbaric oxygen therapy. No device-related complications were visible in patients during the clinical study of the efficacy of the device.

Carbon Monoxide Poisoning: Facts and Figures

From Visually.

 

“Carbon monoxide poisoning is a serious issue, affecting thousands of people each year,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices in the FDA’s Center for Devices and Radiological Health. “While the current standard treatment of administering 100 percent oxygen through a mask can be done anywhere, hyperbaric treatment, which is necessary for severe carbon monoxide poisoning, is less accessible because there are only 60 medical centers with hyperbaric units in the entire U.S. Moreover, those medical facilities are seldom in rural areas, so treatment in those areas could be delayed considerably due to transport time. Today’s marketing authorization provides patients with access to a simple, yet lifesaving device that may minimize the delay of getting vital treatment, especially in severe cases of carbon monoxide poisoning.”

 

Biogen and Eisai decide to discontinue Phase 3 trials, ENGAGE and EMERGE of Aducanumab in Alzheimer’s disease.


Eisai Co., Ltd and Biogen recently announced their decision to stop ENGAGE and EMERGE, the 2 Phase 3 trials, targeted at determining the safety and efficacy of aducanumab in patients with mild cognitive impairment caused due to Alzheimer’s disease and mild dementia caused due to the same reason [7]. The decision was not based on safety concerns. Instead, it was based on a futility analysis conducted by an independent monitoring committee. According to them the trials, after completion, were not able to meet the primary endpoints.

Aducanumab an investigational drug was investigation for its effectivity in the treatment of early Alzheimer’s disease. It is a monoclonal antibody derived from a de-identified B-cells library derived from healthy older adults with no cognitive impairment or with cognitively impaired elderly people with prolonged cognitive decline. This was done using Neurimmune’s technology platform, Reverse Translational Medicine (RTM). Biogen was able to license Aducanumab from Neurimmune under a collaborative development agreement. Biogen and Eisai have been collaborating on the global development and commercialization of aducanumab since 2017. FDA had also granted a Fast Track designation for it, which is usually given to drugs that have the potential of treating serious conditions and unfulfilled medical needs. ENGAGE and EMERGE are two Phase 3, global, multicenter, randomized, double-blinded, placebo controlled, parallel-group trials. The aim was to determine the safety and efficacy of the drug and to assess the efficiency of aducanumab in slowing functional and cognitive impairment when compared to the placebo. This was measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score. The secondary aim was to determine the effect of monthly doses on clinical progression and was measured by Mini-Mental State Examination (MMSE), AD Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL-MCI) and AD Assessment Scale-Cognitive Subscale (ADAS-Cog 13). The long-term extension of the PRIME Phase 1b study of aducanumab and the Phase 2 EVOLVE study of the safety will also be discontinued. Based on the data assessment from ENGAGE and EMERGE trials, a decision will be made regarding the initiation of aducanumab Phase 3 secondary prevention trial.

Alzheimer

From Visually.

“This disappointing news confirms the complexity of treating Alzheimer’s disease and the need to further advance knowledge in neuroscience.  We are incredibly grateful to all the Alzheimer’s disease patients, their families and the investigators who participated in the trials and contributed greatly to this research,” said Michel Vounatsos, Chief Executive Officer at Biogen. “Biogen’s history has been based on pioneering innovation, learning from successes and setbacks.  Driven by our steadfast commitment to patients and our strong business foundation, we will continue advancing our pipeline of potential therapies in Alzheimer’s disease and innovative medicines for patients suffering from diseases of high unmet need.”

 

Alcon announces the acquisition of PowerVision Inc., a company focused on creating fluid-based intraocular lens implants.


Alcon, a division of Novartis and a global leader in eye care recently announced their acquisition of PowerVision Inc. PowerVision is a US-based medical device development company that specializes in creating fluid-based intraocular lens implants for cataract surgery patients. Based on the agreement, PowerVision received 285 million USD from Alcon with additional payments pertaining to commercial milestones and specified regulatory milestones starting in 2023. Alcon will still maintain its 2023 financial outlook that it provided in the fourth quarter of 2018 at the Capital Markets Days.

The History of Contact Lenses

by MainPath.

From Visually.

Alcon has been focused on enhancing the innovation in advanced technology intraocular lenses (AT-IOLS) to cater to the needs of the cataract surgery patients who need desired spectacle independence. Cataract is defined as the clouding of the natural eye lens which in turn becomes hard and cloudy, scatters light rays and allows less light to pass through, causing difficulty in vision. A cataract usually develops with age. But certain steroids, diabetes, radiation exposure and eye injury may accelerate the development of cataract. It can also be hereditary and congenital and so in certain cases, may appear very soon after birth. In adults 55 years and older, cataract is considered to be the leading cause of preventable blindness in the U.S. As high as 20 million people above the age of 40 are usually diagnosed with cataract. It is surgically removed and replaced with intraocular lens (IOL). The cataract surgery has a very high success rate. Most patients return home to normal activities within 24 hours of the surgery. PowerVision, Inc., specializes in developing fluid-based accommodating intraocular lenses for cataract surgery patients. The company uses the eye’s natural accommodating response to transport fluid in the intraocular lens which is implanted in the eye’s capsule bag. PowerVision makes a fluid-based design that creates variable monofocal lenses which uses the natural eye muscle contraction function. Patients can then focus on objects providing them with a natural and continuous vision. Alcon is a global leader in the IOL share and estimates a significant growth in AT-IOLs, based solely on innovations.

“As the industry leader in cataract surgery, we’re eager to accelerate development of this potentially breakthrough accommodating lens technology,” said Michael Onuscheck, President of Global Business and Innovation. “By treating cataracts and restoring natural, continuous range of vision, this intraocular lens may be the preferred IOL for cataract surgery patients who desire spectacle independence.” “We’re thrilled to officially join Alcon and its pioneering history of launching new innovation in the field of ophthalmology,” said Barry Cheskin, President and CEO and Co-Founder of PowerVision. “We look forward to bringing this innovative IOL technology to eye care providers and customers in the years ahead.”

 

References:

  1. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633255.htm.
  2. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633479.htm.
  3. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634103.htm.
  4. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633919.htm.
  5. https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-us-fda-approval-of-sunosi-solriamfetol-for-excessive-daytime-sleepiness-associated-with-narcolepsy-or-obstructive-sleep-apnea-300816081.html.
  6. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633533.htm.
  7. http://investors.biogen.com/news-releases/news-release-details/biogen-and-eisai-discontinue-phase-3-engage-and-emerge-trials.
  8. https://www.novartis.com/news/media-releases/alcon-announces-acquisition-powervision-inc.

About the Author:

Esha Sehanobish

She is presently a Postdoctoral research fellow at Albert Einstein college of medicine, NY and works on characterization of enzymes that could act as potential therapeutic targets against tuberculosis. She is an enzymologist with a doctoral degree from the University of Central Florida in 2016. She loves using her communication skills to raise awareness about the importance of science in general by using social media. When she is not doing “science”, she loves designing and painting as a way of expressing ones thoughts through graphics and color.

Editor and Blog Design:

Abhi Dey

Abhi graduated from the Molecular Biophysics Unit of IISc (Bangalore, India) in 2011. As a Biomedical Scientist, he has worked with all three life-forms in his 13-year research career, viz., particulate, unicellular and multicellular. Currently, he is a Lead Scientist at MicroCures Inc. (New York, NY). Previously, he served as an Assistant Scientist at Emory University (Atlanta, GA) studying mechanisms of tumor recurrence in kids with brain tumors. As a postdoctoral fellow, he was the recipient of two Young Investigator Awards from Alex Lemonade Stand Foundation (Philadelphia, PA) and Rockland Immunochemicals. His research has been funded by Northwestern Mutual Foundation (Milwaukee, WI), CURE Childhood Cancer Foundation (Atlanta, GA) and American Association for Cancer Research (AACR).  When he is not on the bench you will find him spending time with his family or exploring the world through traveling and blogging.

Image Sources: Wikipedia and Twitter

Cover image: “Confocal micrograph showing the connections of the visual system in a four-day-old zebrafish embryo. Staining of the neurons, glia and optic nerve illustrate the connections between the retina and the brain. The retina is a multi-layered structure of retinal neurons that processes light information in the eye. The ganglion cell layer is closest to the bulb of the eye moving out towards the layer that contains the light sensitive cells – the rods and cones – towards the back of the retina. Both the retinal ganglion cell layers and photoreceptor cell layers are shown in cyan. The glial cells are shown in purple. The optic nerve (cyan) transmits information from the eye to the brain. The point at which the optic nerves meet is known as the optic chiasm.” Source

The contents of Club SciWri are the copyright of PhD Career Support Group for STEM PhDs {A US Non-Profit 501(c)3}. (PhDCSG is an initiative of the alumni of the Indian Institute of Science, Bangalore. The primary aim of this group is to build a NETWORK among scientists, engineers and entrepreneurs).

This work by Club SciWri is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

Disclaimer: The authors and editors for Medness Plus declare no financial benefits or remuneration from the sponsors. The sponsorships support the non-profit organization PhD Career Support Group (PhD CSG). The research conducted by authors and editors is a voluntary effort to popularize science for the public on behalf of PhD CSG. The sponsors do not have any influence on the nature or kind of the news/analysis reported in Medness Plus. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Club SciWri or PhD CSG. Examples of analysis performed within this article are only examples. They should not be utilized in real-world analytic products as they are based only on very limited and dated open source information. Assumptions made within the analysis are not reflective of the position of anyone volunteering or working for Club SciWri or PhD CSG. This blog is strictly for news and information. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

SHARE THIS

The contents of Club SciWri are the copyright of Ph.D. Career Support Group for STEM PhDs (A US Non-Profit 501(c)3, PhDCSG is an initiative of the alumni of the Indian Institute of Science, Bangalore. The primary aim of this group is to build a NETWORK among scientists, engineers, and entrepreneurs).

This work by Club SciWri is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

Tags

Related articles

Latest from Club SciWri