Cover Design: Ipsa Jain
Hello everyone and welcome to MedNess: At the frontier of healthcare news. The month of April was pretty crucial for Gilead Sciences and Novartis. Read below to find out more.
Also, this issue of MedNess is special as we are covering a report on March for Science from Club SciWri’s “Reporting from the lab” led by Radhika Raheja, Ph.D. Why are we covering March for Science on MedNess? Science affects us; the scientists, science affects our decisions and perspectives..still need more reasons? Check out our section on March for Science.
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Gilead’s NASH candidate clears early proof concept study
Gilead Sciences presented the first clinical trial data for GS-0976, an acetyl–CoA carboxylase inhibitor in patients with non-alcoholic steatohepatitis (NASH) at the 2017 International Liver Congress. The results are very preliminary but hopeful.
Gilead acquired GS-0976 from Nimbus Therapeutics in a billion-dollar deal last year.
This chronic liver disease affects around 15 million Americans. It is manifested by fat deposition in the liver and can cause scarring and liver fibrosis leading to liver failure (FierceBiotech, SeekingAlpha).
The clinical trial consisted of only 10 patients treated with 20mg dose OD for 12-weeks. GS-0976 blocked the formation of new fat in the liver by 29% and reduced liver fat by 43%. There was also a statistically significant decline in liver stiffness, marker for liver fibrosis, from 3.4 to 3.1kPa.
MedNess: Although on Friday, April 21, 2017, we did not see Gilead stocks soaring after the news, based on 19 analysts polled by TipRanks, majority approve buying Gilead stock while 7 maintain a hold and 0 recommend selling (SmarterAnalyst).
FDA issues new warnings against the use of opioids in kids and nursing mothers
The Food and Drug Administration (FDA) issued a consumer safety alert on April 20, 2017, ordering major label changes on prescription drugs containing codeine and tramadol. Codeine is found in some prescription pain, and cough medicines and some over-the-counter cough medicines and tramadol is found in some prescription pain medicines. The opioid drugs are metabolized rapidly by children which can lead to breathing problems.
The FDA listed 15 medications and their generics that will be affected by this warning ranging from J&J’s Tylenol with codeine and Ultracet with tramadol, Vertical’s ConZip with tramadol, and Allergan’s migraine medication Fiorinol with codeine (FDA.gov)
FDA approves Roche’s Tecentriq as first line treatment for certain patients with advanced bladder cancer treatment
Roche’s Tecentriq gained accelerated approval from the FDA as a first-line treatment in patients with advanced bladder cancer who are ineligible for cisplatin chemotherapy. Tecentriq was earlier approved for treatment in patients with advanced or metastatic bladder cancer whose disease worsened within one year of standard chemotherapy.
MedNess: This immunotherapy was approved earlier for the treatment of non-small cell lung cancer (Roche.com). The current approval enables label expansion of this immunotherapy. As per Zacks ranking list, Roche stocks are strongly recommended for buying (Zack.com)
Novartis’ CAR-T CTL019 receives FDA “Breakthrough” Tag for the treatment of most common form of lymphoma
Novartis received the US Food and Drug Administration (FDA) Breakthrough Therapy designation for CTL019, an investigational chimeric antigen receptor T-cell (CAR-T) therapy. Last month, CTL109 received the breakthrough designation for the treatment of r/r B-cell acute lymphoblastic leukemia (ALL) in pediatric and young adult patients.
This is the second indication for which CTL019 has received this designation for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) for the treatment of adults who have failed two or more prior therapies.
The Breakthrough Therapy designation is based on data from the multi-center Phase II JULIET study. The results from JULIET study are expected to be presented soon (Novartis.com).
MedNess: Novartis is competing with Kite Pharma over CAR-T therapy. Kite already has breakthrough designations for DLBCL, transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma. After the announcement, Kites shares dropped by 1% and Novartis’s by 0.3% (FierceBiotech)
MedNess # March for Science by Radhika Raheja Ph.D
While we look at FDA approvals and how they affect pharmaceutical companies, it is important to acknowledge the science coming out of academic institutions that steers translational discoveries. Here is a brief report on how science impacts lives and why it is necessary to support scientific research.
Reporting from outside the lab – #marchforscience #Boston
This week we are not ‘Reporting from the lab” but from outside the lab where most of the excitement was happening. Thousands of scientists all over the world took to the streets to “March for Science” on April 22, usually observed as Earth Day.
Why do we march for science? We march for science because “ Science is real, denial is deadly”, “ No science, no beer”, “ Progress in science = progress in humanity”, “Climate change is real” and several other reasons. Here in Boston, the research community in the Longwood medical area marched under the motto “ Science is good for your health“. Our rally kick-started with a lineup of extremely eloquent speakers, faculty, students, patients and the Dean of Harvard Medical School (HMS) who spoke about the impact of science on our lives and the ramifications that reckless changes in science policy can have on all of us.
Why do we march for science? Science gives us the opportunity to give back to the community. The Dean for Students at HMS, Fidencio Saldana, emphasized that science affects all of us. “Science is for people who want to invest in the future of our children” he said, as science education creates awareness, teaches our children to think critically, ask questions and creates opportunities for them in the future. Fidencio Saldana ended by saying that there is, “too much at stake for us to remain silent anymore”. On a similar note, Senan Ebrahim, an MD-PhD student at the HMS reminded us, “to raise our voices and speak the truth, because we are blessed with knowledge and it is our responsibility to act on it and share it.” It is our duty to leave behind a legacy of advanced engineering, improved medical care and to safeguard the future for young and bright scientists.
Why do we march for science? Science gives us hope when we are afflicted with disease. This was further exemplified by the stories of patients and doctors on the innovative cures for various diseases including sickle cell anemia, acute lymphoblastic leukemia, neuroblastoma, lymphangioleiomyomatosis that have saved lives, thanks to fundamental scientific research conducted in laboratories within Boston and the nation. In order to continue fostering the promise of scientific discoveries, it is important to ensure our voices are heard. “Scientific research is one of the fundamental pillars of our society, … this is not a fight for our livelihoods, this is a fight for human lives “ said Elorm Avakame, an MD/MPH student at Kennedy School of Public Health.
Why do we march for science? “We march because we are facing a threat to humanity “. The proposed budget cuts within federal agencies like the National Institute of health itself will be dramatic as it has an annual budget of $32billion and propels scientific progress not only in the United states but in the world. “Such budget cuts, if applied, will have tragic consequences that will haunt us for generations, destabilize our economy and pose an existential threat to America’s preeminence as a world leader in biomedicine”, said George Daley, Dean of HMS. He also added that NIH funding supports over 380,000 jobs nationwide and over 31,000 jobs in the state of Massachusetts alone. Research funded by the NIH drives an economic activity of over $65 billion a year. “Scientific progress, scientific discovery is an enduring symbol of what is best and what is most noble about this great nation. Cutting biomedical research funding will eviscerate our ability to relieve suffering here and around the world. It threatens the very core of our mission”.
Boston plays a historic role in creating and nurturing some of the best scientists and physicians trained to alleviate human suffering caused by disease. Nearly half of new cancer drugs in the last 5 years emerged from the hard work and curiosity of scientists in the laboratories at Harvard University funded by grants from the National Institute of Health. In this era of phenomenal advancements in science, it is terrifying to envision the therapeutic landscape for various diseases without support for scientific research.
It was a cold, rainy day in Boston, with temperatures as low as 3oC (37oF) , yet this did not deter the spirit of the students, scientists, physicians, patients and people whose lives have been positively impacted by science to get out and stand up for science. We marched to reaffirm the importance of science and how it benefits our lives, our country, and our planet. We marched because science truly matters!
About the Authors:
Imit Kaur is a freelance medical writer, editor and an active science blogger. She pursued her PhD in Pharmaceutics and Pharmaceutical Chemistry from University of Utah. She is experienced in the field of oncology, hematology, pharmacology, nanotechnology and drug development.
Radhika completed her PhD from Cornell University and is currently a Postdoctoral fellow at the Brigham and Women’s Hospital. Her research interests have centered around oncology and neuroimmunology. Among other things, she is striving to effectively communicate scientific discoveries to the community.