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The first generic naloxone nasal spray gets approved by the FDA to treat opioid overdose.


In the last few years, FDA has taken many initiatives to combat the ever-growing problem of opioid overdose. The last few months itself has seen multiple approvals from the federal agency to bolster the fight against this crisis. To add to the list, the FDA recently granted the final approval for the first generic naloxone hydrochloride nasal spray to treat opioid overdose crisis [1]. The spray commonly known as Narcan, functions either by preventing or reversing the harmful effects of opioid overdose. Teva Pharmaceuticals was granted the approval to market the generic naloxone nasal spray. The FDA tentatively approved this generic drug product on June 8, 2018. FDA is also making efforts to expedite the process which include generic drug application that could possibly treat opioid overdose. The sponsors will receive faster review deadlines, shorter aim dates and a faster and efficient communication between the agency and the sponsor. There will be similarity to the generic Drug User Fee Act in terms of expanded agency engagements that will lead to pre-submission and mid-cycle meetings.

The statistics provided by the Centers for Disease Control and prevention for death from opioid overdose is shocking and qualifies it to be a genuine crisis by which the society is now plagued. More than 130 Americans die each day with almost 400,000 already dead from opioid overdose from 1999-2017. These include prescription medications such as oxycodone, hydrocodone, fentanyl, and morphine along with other illegal drugs such as heroin. Often the problem encountered during the overdose is the reduced ability of the affected, to breathe, which then leads to death. A naloxone nasal spray used under such circumstances, could be counter the effects within a few minutes. This of course, needs to be followed by immediate medical attention, but could provide some buffering time. Generic naloxone injectable products have existed for many years now, but the drawback was that it could only be used in a healthcare setting. The present approval of the nasal spray allows it to be used in a community setting by people without medical training. Another brand-name naloxone spray had been previously approved by the FDA which is used with an auto-injector. The use of the naloxone nasal spray has been made very easy and could be used for children or adults and with no prior medical. There is no need to assemble it and if used following the directions, a correct and consistent dose will be administered with each use. The drug is usually administered through one nostril while the patient is lying on their back and the process could be repeated if required. The adverse effects of naloxone spray for opioid-dependent patients include extreme withdrawal symptoms such as fever, abdominal cramps, increased blood pressure, increased heart rate, dizziness, diarrhea etc.

The Scope Of The Opioid Crisis

From Visually.

 

“In the wake of the opioid crisis, a number of efforts are underway to make this emergency overdose reversal treatment more readily available and more accessible. In addition to this approval of the first generic naloxone nasal spray, moving forward we will prioritize our review of generic drug applications for naloxone. The FDA has also taken the unprecedented step of helping to assist manufacturers to pursue approval of an over-the-counter naloxone product and is exploring other ways to increase the availability of naloxone products intended for use in the community, including whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “All together, these efforts have the potential to put a vital tool for combatting opioid overdose in the hands of those who need it most – friends and families of opioid users, as well as first responders and community-based organizations. We’re taking many steps to improve availability of naloxone products, and we’re committed to working with other federal, state and local officials as well as health care providers, patients and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction.”

 

FDA approves the marketing of the first medical device for the treatment of ADHD.


FDA recently approved the marketing of the first prescription-only medical device called the Monarch external Trigeminal Nerve Stimulation System (eTNS), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [2]. It is the first non-drug treatment for ADHD to be approved by the FDA. The authorization has been granted to NeuroSigma and will be used for those not under any other prescription medication and are between the ages of 7 and 12 years. The de novo review pathway was used for this approval under which the FDA considers all low-to moderate-risk devices. Because of the use of this pathway, subsequent devices of similar type and with similar aims may now undergo the FDA’s 510(k) premarket process by which devices can be granted marketing authorization just by showing significant equivalence to one that has already been approved.

Free Infographic: What is ADHD

From Visually.

 

ADHD is a disorder that causes a person to become inattentive and prevents them from controlling impulsive disorders [3]. The person may become restless and be in a state of constant motion. Even though the symptoms for this disorder is usually seen in childhood, ADHD can continue to exist throughout adolescence and adulthood. The symptoms may reduce overtime, but problems like being disorganized and inattentiveness may last beyond childhood. The approval for the Monarch eTNS System was based on the study of efficacy as shown in a clinical trial that included the eTNS system as the sole treatment, as monotherapy or relative to a placebo device. 62 children with moderate-to-severe ADHD participated in the study and used either the placebo or the eTNS therapy for four weeks at home. Clinicians usually use an ADHD rating scale (ADHD-RS) to determine the intensity of the symptoms. Typically, they are based on questions from the daily lives of the patient which includes if they are having problems to concentrate and whether they have difficulty in paying attention. The improvement in this ADHD-RS was considered to be the primary endpoint of the trial. Based on the data from the trial, the average score decreased from 34.1 percent at baseline to 23.4 percent for the eTNS system and went from 33.7 percent to 27.5 percent for the placebo group. Lower values indicate improvements in the ADHD symptoms. The most common adverse effects include increase in appetite, headache and fatigue etc. Even though the detailed mechanism is not known, the eTNS system is supposed to work by increasing the activity of the regions in the brain responsible for generating attention, behavior and emotions, as has been determined from the neuroimaging studies. The system generates a low-level electrical pulse and is connected to a small patch on the forehead of a patient through a wire. Low-level electrical stimulations then branch out and reach the trigeminal nerve which apparently send out impulses to the parts of the brain responsible for ADHD. The eTNS system should only be used under the supervision of healthcare professionals and caregivers during sleep. It takes approximately 4 weeks for responses to be evident at which stage healthcare professionals should assess the efficiency of the technique.

“This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” said Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “Today’s action reflects our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their unique needs.”

 

FDA approves the filing and Priority Review of brolucizumab (RTH258) for patients with wet age-related macular degeneration (AMD).


The Biologics License Application (BLA) submitted by Novartis on behalf of their candidate, brolucizumab (RTH258), was recently approved by the FDA [4]. It is indicated for the treatment of wet age-related macular degeneration (AMD) also referred to as neovascular AMD or nAMD. The company has used a Priority Review voucher to expedite the availability of the drug as early as the end of 2019, if approved finally.

nAMD or neovascular AMD occurs when unusual blood vessels form below macula, the area attributed to central sharp vision. It is the most common cause of blindness in patients above the age of 65 years in Europe, North America, Asia and Australia. Based on the estimates available, a total of 1.5 to 1.75 million people in the US will be affected by the disease by the year 2020. Typically, the blood vessels become fragile and they ultimately damage the macula. This is a gradually debilitating disease. If left untreated, a patient could lose complete vision and would be unable to do daily activities and recognize familiar faces. In this disorder, the cell degradation continues to increase with time. Hence, immediate diagnosis and treatment after detection is required. Some of the early symptoms include metamorphopsia or distorted and unclear vision. RTH258 or brolucizumab is an advanced humanized single-chain antibody fragment. Development of such antibodies have attracted attention due to their properties of tissue penetration because of its small size, their rapid delivery and clearance to and from the system. An increased signaling through the VEGF pathway leads to retinal edema and pathologic ocular angiogenesis. Brolucizumab functions by inhibiting the VEGF signaling pathway as it blocks the binding of ligand to its receptor. The approval was based on 2 Phase III randomized, double-masked, multicenter trials called HAWK and HARRIER. These were the only two trials that were conducted globally in a head-to-head basis in patients with wet AMD, to demonstrate efficacy at week 48 starting with a 12-week dose regimen. Various primary and secondary endpoints demonstrated a reduction in the number of patients with the disease activity for those on brolucizumab.

Causes Of Age-Related Macular Degeneration

From Visually.

 

“Reaching this milestone is an important step in our efforts to reimagine the treatment journey for people with wet AMD and their caregivers,” said Fabrice Chouraqui, President, Novartis Pharmaceuticals Corporation. “We are looking forward to the potential of a new option for patients with wet AMD, who often have to navigate considerable physical and emotional difficulties caused by deteriorating vision.” “Wet AMD robs people of their precious sight and takes a major toll on the lives of millions of people who face not only vision loss, but also the burden of frequent injections into their eyes,” said Dawn Prall George, executive director, The Support Sight Foundation. “We are always excited about potential new treatment options and hopeful they may help people manage this devastating disease.”

 

FDA approves the use of SKYRIZITM, for the treatment of patients with moderate-to-severe plaque psoriasis.


Abbvie, a research-based global pharmaceutical company recently announced the approval of SKYRIZITM (risankizumab-rzaa), for the treatment of patients with moderate-to-severe psoriasis [5]. These are adults who are in-line for phototherapy or systemic therapy. Based on the approval, SKYRIZI can be administered in a medical care setting or could be self-administered, upon training. The recommended and legitimate dose is 150 mg. It should be administered subcutaneously, twice, every 12 weeks, after two initiation doses at week 0 and week 4. Abbvie is responsible for the development and global commercialization of SKYRIZI, a collaboration product between Abbvie and Boehringer Ingelheim.

Psoriasis is a chronic, debilitating condition, that is immune-mediated with skin and certain systemic manifestations [6]. It affects more than 125 million throughout the world and is prevalent in both women and men. The manifestation can be at any age, but the onset takes place between the age of 18 and 39 years. Plaque psoriasis is the most common form of the disease and is characterized by red patches covered with dead cells. These plaques are most often observed on elbows, knees, scalp and lower back. Some of the symptoms include, itching, burning and soreness [7]. SKYRIZI, is an IL-23 (interleukin-23) inhibitor. IL-23 is thought to be involved in a number of immune-mediated and immune-related diseases. The inhibitor binds to the p19 subunit of IL-23, thus inhibiting it. The approval was based on data from global Phase 3 Psoriasis program, conducted by Abbvie, to determine the safety and efficacy of the medication. The adults involved in the four randomized, placebo and/or active-controlled pivotal studies, were patients with moderate-to-severe psoriasis. The four studies were ultIMMa-1, ultIMMa-2, IMMhance and IMMvent. The data obtained were assessed on Psoriasis Area and Severity Index (PASI) and static Physician Global Assessment (sPGA). PASI 90 indicates 90 percent reduction in PASI scoring and PASI 100 indicates that the patients have been completely resolved of the disease. In the ultIMma-1 and 2 studies, at the 16 weeks stage, 75 percent of those treated with SKYRIZI achieved PASI 90 as compared to 5 and 2 percent in placebo, and 36 and 51 percent of those treated with SKYRIZI achieved PASI 100 as compared to 0 and 2 percent of those with placebo. All those who achieved PASI 90 and PASI 100 at week 16, maintained it throughout the next one year. Some of the more common adverse effects include upper respiratory infections, headache, fatigue, tinea infections and injection site reactions. A screening for TB is required before the prescribing SKYRIZI and if observed, one should report any corresponding symptoms.

A Patient’s Guide to Psoriasis

From Visually.

 

“The approval of SKYRIZI is an important advance in the treatment of adults with plaque psoriasis who are seeking high levels of durable skin clearance that can be maintained over time,” said Michael Severino, M.D., vice chairman and president, AbbVie. “SKYRIZI builds on AbbVie’s legacy in immunology, expanding our portfolio to help meet the evolving needs in psoriatic disease and reinforcing our continued pursuit of innovations that improve care for people living with immune-mediated conditions.” “People living with plaque psoriasis can be profoundly impacted by their disease both physically and emotionally,” said Stacie Bell, Ph.D., vice president of research and medical affairs, National Psoriasis Foundation. “The approval of a new therapy represents an important step forward in the treatment of psoriasis, offering dermatologists another option to help patients achieve their treatment goals.”

 

Eli Lilly and Pfizer announce the results from the Phase 3 study of Tanezumab, to treat patients with osteoarthritis.


Pfizer and Eli-Lilly recently announced the results from their Phase 3 study of 2.5 and 5 mg of Tanezumab to treat patients with osteoarthritis. It is a member of an investigational group of non-opioid chronic pain medication [8]. The motive of the study was to compare the 16-week efficacy and long-term joint safety to the existing NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). The patients under consideration were those who have moderate-to-severe osteoarthritis of the hip or knee.

Osteoarthritis is a chronic condition of the joint, where the cartilage slowly disintegrates thus getting rid of the cushion between the bones and the joints. This leads to inflammation, pain and stiffness [9]. Tanezumab, as mentioned, belongs to the family of nerve growth factor (NGF) inhibitors. It is an investigational monoclonal antibody that binds to NGF and inhibits their functions thus preventing the pain signals arising from muscles and skin from reaching the spinal cord and brain. From the data available till now, tanezumab hasn’t shown any risk of addiction or misuse. Hence research about its working mechanism is an area of interest. It was granted a Fast Track Designation in June 2017, for the treatment of chronic low back pain and osteoarthritis. The study (A4091058) was a randomized, double-blind, parallel-group, multicenter, study for 56 weeks comparing the safety and efficacy for tanezumab and NSAIDs for 56 weeks. It was a global study on patients with moderate-to-severe osteoarthritis who had inadequate responses to the other available medications or those who were not keen on taking opioids. 3021 patients were randomized in a 1:1:1 Ratio. They received either 2.5 mg every 8 weeks, 5 mg every 8 weeks or oral NSAIDs twice daily for a period of 56 weeks. There was a 24-week safety follow-up period for a total of 80 weeks of observation. Two of the three co-primary efficacy endpoints were met with for the 5 mg tanezumab treatment. At the 16-week period, there was a statistically significant improvement in the physical function and pain compared to the NSAIDs. The overall assessment of their osteoarthritis was not significantly different from the NSAIDs. The same results were not observed for the 2.5 mg dosage group. There was a higher and statistically significant rate of joint safety events in tanezumab as compared to NSAIDs at 80 weeks. The joint safety profile was determined from outcomes of rapidly progressive osteoarthritis (RPOA) type 1 or type 2, osteonecrosis or pathological fracture and subchondral insufficiency fracture.

Dealing with Osteoarthritis

From Visually.

 

“Lilly and Pfizer recognize the significant unmet needs for patients living with osteoarthritis,” said Christi Shaw, president, Lilly Bio-Medicines. “We are committed to understanding these results for people who suffer from chronic pain.” “We are analyzing these findings in the context of the recent Phase 3 results as we assess potential next steps for tanezumab,” said Ken Verburg, tanezumab development team leader, Pfizer Global Product Development. “We plan to review the totality of data from our clinical development program for tanezumab with regulatory authorities.”

 

Janssen Pharmaceuticals announces positive results from the Phase 3 study of INVOKANA.


The Janssen Pharmaceutical companies of Johnson and Johnson recently announced the results from their Phase 3 study of INVOKANA (canagliflozin) [10]. The study was done to demonstrate the safety and efficacy of INVOKANA when used in addition to the usual treatment, in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). The study was published in the New England Journal of Medicine and was presented at the International Society of Nephrology (ISN) 2019 World Congress of Nephrology. Based on the present study, if INVOKANA gets a nod from the FDA, then it would be the first diabetes medicine to treat both T2D and CKD and will provide relief to many patients throughout the world. The CREDENCE data was used back in March 2019, to submit a supplemental New Drug Application for INVOKANA to reduce renal or cardiovascular deaths for adults with T2D and CKD and to reduce the risk of end-stage kidney disease (ESKD).

INVOKANA is a prescription medication used for lowering the blood sugar levels in patients with T2D and for reducing the risk of cardiovascular events in such patients. It is a sodium glucose co-transporter 2 (SGLT2) inhibitor that functions by blocking the transporter which is responsible for the majority of renal glucose absorption. It is not indicated to be used for type 1 diabetes mellitus and diabetic ketoacidosis [11]. CREDENCE was a placebo-controlled study were the safety and efficacy of INVOKANA in context of T2D and CKD, was compared to that of placebo. The primary endpoint was a combination of progression to doubling of serum creatinine, renal or cardiovascular death and ESKD. It was observed that there was a 30 percent reduction in the risk of the endpoint. There was a 32 percent reduction in the risk of end-stage kidney disease. It also showed a 20 percent reduction in the secondary endpoints of the Major Adverse Cardiovascular Effects (MACE) which comprised of nonfatal stroke, CV deaths, nonfatal myocardial infarction (MI). there was a 39 percent reduction in the risk of hospitalization because of heart failure and a 31 percent reduction in the risk of CV death and hospitalization for heart failure. Even the adverse effects and the serious ones had lower incidence rate for INVOKANA when compared to placebo. INVOKANA is not suggested to be used in patients with ESKD and in those with severe renal impairment.

Type 2 Diabetes: Facts & Statistics

by Healthline.

From Visually.

 

“Diabetes is the leading cause of kidney failure for millions of people worldwide, and this clear need for a new treatment option was the motivation for initiating the CREDENCE study. Today, we are pleased to share study results that potentially could establish INVOKANA® as the only medicine to safely reduce the risk of renal failure in this high-risk patient population when added to current standard of care,” said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. “We are working closely with the U.S. FDA and health authorities worldwide to bring this important medicine to those living with these life-threatening conditions.” “At Janssen, we tackle some of the world’s most challenging and burdensome diseases, both by exploring the ability of our established medicines to meet unmet patient needs and by leveraging the cutting edge of science to develop entirely new medicines,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “The CREDENCE clinical trial results demonstrate our commitment to helping patients and bring us one step closer to treating the comorbidities associated with type 2 diabetes and meeting the unmet needs of the millions of people living with chronic kidney disease.”

 

Teva announces the discontinuation of the clinical development of Fremanezumab, for treating Episodic cluster headache.


Teva Pharmaceuticals Industries Ltd. recently announced their decision on the clinical development of fremanezumab, indicated for the treatment of Episodic cluster headache [12]. Based on a pre-specified futility analysis of a Phase III study in the episodic cluster headaches, it is unlikely that fremanezumab will reach the study’s primary endpoint which involved mean change from baseline in the weekly average number of cluster headache attacks during a period of 4-week treatment. Hence the company has decided to discontinue its development in the study of episodic cluster headaches.

Humanized monoclonal antibody, fremanezumab, functions by binding to the calcitonin gene-related peptide ligand and prevents it from binding to its receptor. It is an investigational drug studied for potential treating abilities for cluster headache or post-traumatic headache and hasn’t received any approval for these so far. Based on the results from the study, ENFORCE, Phase III clinical trial will now be discontinued. This trial also included a long-term safety study. Teva shall continue to investigate the use of fremanezumab in the treatment of post-traumatic headache, which is currently in the Phase II trial stage.

“We’d like to thank the patients and investigators for their immense contributions to this study. Despite these results, we are continuing the evaluate if fremanezumab treatment can provide clinical benefits in additional diseases where anti-calcitonin gene-related peptide (CGRP) therapy may play a role in its pathophysiology,” said Tushar Shah, M.D., Senior Vice President, Head of Global Specialty Clinical Development at Teva.

 

Avidity Biosciences and Eli Lilly and company announce their decision of a global research and licensing collaboration.


>
Avidity Biosciences and Eli Lilly recently announced their decision of entering into a global licensing and research collaboration [13]. This will be aimed at developing, discovering and marketing new drug targets in the area of immunology and some others.

Based on the terms of agreement, there will be an upfront $20 million payment to Avidity, along with an investment of $15 million. The company will also be eligible to payments from the development, regulatory and commercialization milestones of up to approximately $450 million per target. They will also receive tiered royalties ranging from mid-single to low-double digits on product sales. This collaboration will be subjected to clearance under the customary closing conditions. Based on the terms of the collaboration, Avidity’s technology platform will be utilized to progress new therapeutic approaches towards the development and marketing. This would include the use of tissue selective monoclonal antibodies and oligonucleotide-based therapeutics. The aim is to overcome the obstacles in the delivery of oligonucleotides to target the genetic causes of diseases.

“This collaboration with Lilly provides an exceptional opportunity to leverage Avidity’s proprietary AOC platform in order to generate new therapeutic targets in disease areas that have been challenging to pursue using oligonucleotide-based approaches,’ said Kent Hawryluk, Avidity’s chief business officer. “Lilly’s extensive research, development, regulatory, and commercial capabilities make them an ideal partner, and we look forward to a long and productive relationship.” “We are excited to expand our oligonucleotide research and development efforts through this strategic collaboration with Avidity,’ said Andrew C. Adams, Ph.D., chief scientific officer for RNA therapeutics at Lille. “Their expertise in studying the combination of monoclonal antibodies and oligonucleotide-based therapies represent a promising avenue of research toward development of new RNA-based medicines.”

References:

  1. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636333.htm.
  2. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636379.htm.
  3. https://www.nimh.nih.gov/health/publications/attention-deficit-hyperactivity-disorder-adhd-the-basics/index.shtml.
  4. https://www.novartis.com/news/media-releases/novartis-announces-fda-filing-acceptance-and-priority-review-brolucizumab-rth258-patients-wet-amd.
  5. https://news.abbvie.com/news/press-releases/abbvie-expands-immunology-portfolio-in-us-with-fda-approval-skyrizi-risankizumab-rzaa-for-moderate-to-severe-plaque-psoriasis.htm.
  6. https://www.nature.com/articles/nrdp201682.
  7. https://www.psoriasis.org/about-psoriasis/types/plaque.
  8. https://investor.lilly.com/news-releases/news-release-details/pfizer-and-lilly-announce-top-line-results-long-term-phase-3.
  9. https://www.arthritis.org/about-arthritis/types/osteoarthritis/.
  10. https://www.jnj.com/invokana-canagliflozin-significantly-reduces-the-risk-of-renal-failure-in-patients-with-type-2-diabetes-and-chronic-kidney-disease-in-the-landmark-phase-3-credence-study.
  11. http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INVOKANA-pi.pdf.
  12. https://www.tevapharm.com/news/teva_announces_update_on_fremanezumab_clinical_development_for_use_in_episodic_cluster_headache_04_19.aspx.
  13. https://investor.lilly.com/news-releases/news-release-details/lilly-and-avidity-biosciences-announce-licensing-and-research.

 

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: “Colorized scanning electron micrograph showing psoriasis (an inflammatory skin disorder) of the tongue. This condition on the tongue causes rough, scaley and bumping texture to the surface.” Source

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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.

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