Discoveries/Innovations: Novartis, Amgen Breakthrough Migraine Drug Approved

Aimovig is the first migraine therapy of its kind to be approved by the FDA, a long-awaited milestone in treatment of this incapacitating disease. Migraines are the result of a poorly understood and often misinterpreted disease that affects millions of Americans. Sufferers deal with a stabbing headache, nausea, and inability to function that causes them to retreat to a dark room for nearly 15 days out of the month. While many believe that eliminating triggers like stress, worry, and other societal burdens are the only necessary treatment, Aimovig provides the first therapy that works to prevent migraines at their origin—like the episodic disease that it is. A 70 mg dose of Aimovig is self-administered once monthly via Amgen’s device, the SureClick autoinjector. The drug works to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R), which is believed to play a critical role in migraine.

“The FDA approval of Aimovig reflects the Novartis commitment to advancing neuroscience and marks an important moment in the fight against migraine,” Fabrice Chouraqui, U.S. President of Novartis Pharmaceuticals Corporation, said in a statement. “Migraine is a serious and misunderstood disease with significant gaps in the way it is both perceived and treated. In close partnership with Amgen, our goal in the U.S. is to bring meaningful therapeutic options to patients, while also helping them to overcome the personal, professional and clinical barriers that have long been associated with this stigmatized disease.”

This innovative drug is a result of a global collaboration between Novartis and Amgen started in 2015 to develop and commercialize Alzheimer’s and migraine treatments. Over the past five years, the 3,000 dedicated patients who participated in clinical trials found Aimovig provided nearly three-fold higher odds of cutting their migraine days by half or more compared to placebo, including those with difficult to treat cases.

The U.S. list price of Aimovig is $575 for once monthly 70 mg or 140 mg single-use prefilled SureClick autoinjectors, or $6,900 annually. Amgen and Novartis are also dedicated to ensuring patient access, creating The Aimovig Ally product support program to help patients navigate insurance coverage and identify potential resources for those who are uninsured or underinsured. The companies will continue their neuroscience partnership, next addressing how stigma against migraine manifests in the workplace: Migraine gets in between people and their careers, and in between employee and employer.

Medical Device: AI Device Changes View of Human Cells

Step-by-step cell structure labeling in 3D image

A new Artificial Intelligence (AI) device has simplified the complex task of studying all the interacting structures that change over time in a living cell. The Allen Integrated Cell, developed by the Allen Institute for Cell Science, is a machine-learning based tool that provides a real-time 3D image of cells with fluorescently labeled structures. This type of imagery previously involved fluorescently labeling the actual cells using an expensive microscope system that blasts the cells with lasers, which caused the cells to die over time so that scientists could only study changes affecting the cell over short periods of time.

This cheaper method creates 3D renderings with accurate predictions of changes with a simple two-step method. First, an algorithm studied the shape of plasma membranes, nuclei, and other structures to learn their spatial relationships from pictures of tens of thousands of these glowing cells taken from research using the previous fluorescence method. A model then uses what it learned from those images to find cellular structures in cells, but without those harmful, laser labels. This technology is freely available on their website for anyone to use.

DC Dispatch: U.K. Using AI to Reduce Cancer Deaths

Theresa May, U.K. Home Office

Using artificial intelligence to diagnose cancers, especially prostate, ovarian, lung, and bowel cancer, at earlier stages can reduce cancer death rates by 10% within 15 years according to U.K. Prime Minister Theresa May. In a speech addressing the direction and priorities of science, May set a target of 22,000 fewer deaths due to cancer annually by the year 2033 by dedicating research-power to the AI health sector. “Late diagnosis of otherwise treatable illnesses is one of the biggest causes of avoidable deaths,” May explains. “And the development of smart technologies to analyze great quantities of data quickly and with a higher degree of accuracy than is possible by human beings opens up a whole new field of medical research and gives us a new weapon in our armory in the fight against disease.”

May is throwing government support behind businesses in the industry who will work towards this goal, a model of state intervention proposed by Mariana Mazzucato, according to the Financial Times. Indeed, Bryan Williams, Director of the National Institute for Health Research University College London Hospitals Biomedical Research Centre and Director of Research at UCLH, announced in a statement that the UCLH NHS Foundation Trust will collaborate with the Alan Turing Institute “to harness the power of data science and artificial intelligence to support clinical decision making to make services safer, quicker, and more efficient.”

This rare scientific address from the British Prime Minister comes amidst a technological race between nations, with President Macron declaring France a new “startup nation” and China using its wealth of tech data and heavy U.S. support to make a push in the field of AI.

Brand Beat: Pharma TV Ads are Changing, But Maybe Not for the Better

Pharma TV commercials have gained feel-good mojo over the past decade, but research finds that they are no more informative than the ads aired in 2004. When PhD Professors Janelle Applequist and Jennifer Gerard Ball compared samples from 2004 and 2016, they found the 2016 ads to be about 15 seconds longer while containing less specific information, instead focusing on post-medication mood, health, and social benefits of the drug.

The DTC ads used as part of the study included 61 product ads for 35 different prescription drug brands ranging from GlaxoSmithKline’s respiratory therapy Breo to Shire’s dry eye drug Xiidra. Using the same coding to compare the commercials from each year, algorithms found markedly less “information related to the biologic nature, risk factors or causes, or prevalence of the condition” in the 2016 ads as compared to the 2004 sample set. What does this mean for consumers?

“Our results suggest that self-regulation has done little to improve the educational quality of DTC ads. If these advertisements are to fulfill a public health function in addition to a drug marketing function, policy makers will likely need to take further regulatory action to codify those expectations,” the authors explain in the Annals of Family Medicine. Many would push Congress to improve their methods of evaluating the effects pharma marketing has on the patient—and hold big pharma to a higher educational standard.

Therapeutic Talk: TB, Parkinson’s Link Sparks Improved Drugs

A protein that scientists have known to be responsible for clearing bacterial infections in our immune systems has been discovered to play a surprising role in Parkinson’s disease. The LRRK2 protein should help seek and destroy foreign bacteria in our bodies, but when these immune cells are infected with tuberculosis, they stop eliminating bacteria and allow it to spread.

Scientists from Francis Crick Institute, GlaxoSmithKline, and Newcastle University have found that mutations in the same LRRK2 protein cause it to act the same way in diseases such as Parkinson’s, Crohn’s, ulcerative colitis, and leprosy as it does in tuberculosis cases.

The researchers found that inhibiting the mutated LRRK2 cleared up the TB infection in mice and could work similarly for these other, currently irreversible, diseases. “We think that this mechanism might also be at play in Parkinson’s disease, where abnormal masses of protein called ‘Lewy bodies’ build up in neurons in the brain and cause damage,” Susanne Herbst, first author of the study at the Crick Institute, said in a statement. LRRK2 inhibiting drugs are now in development for Parkinson’s therapy and TB therapies for newly emerging resistant strains of the infection popping up worldwide.

FDA Update:

Drug Approvals

The FDA approved the first non-opioid drug therapy for the treatment of opioid withdrawal symptoms in adults. US WorldMeds LLC developed Lucemyra to help facilitate immediate discontinuation of opioids by mitigating withdrawal symptoms such as anxiety, agitation, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting, diarrhea, and drug craving. The oral medication can be used for up to 14 days as a safe component of a long-term treatment for a patient opioid use disorder.

AkaRx Inc. received approval for Doptelet, the first drug used to treat low blood platelet count, thrombocytopenia, in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. The drug safely increases platelet count in those who are at risk of bleeding profusely and requiring a platelet transfusion.

Liftique Blush is the latest method launched by the trademarked Liftique procedures that uses the safest FDA-approved technology to improve or eliminate symptoms such as urinary incontinence; recurrent UTIs; pain with intercourse; vaginal dryness; vaginal laxity; and any cosmetic concerns pertaining to a woman’s vaginal area after childbirth. With programs designed by Dr. Mickey Karram, Liftique Blush Pelvic Floor Health Services focuses on promoting the body’s natural ability for collagen synthesis, shrinking and tightening tissues while rehabilitating muscles in the reproductive area.

Medical Devices

The FDA approved the marketing of the CustomFlex Artificial Iris, a prosthetic eye iris made of thin, foldable medical-grade silicone. Clinical Research Consultants Inc. developed the device to treat congenital (genetic disorder in which the iris is completely or partially absent) and traumatic aniridia as well as iris defects due to other reasons or conditions, such as albinism or surgical removal after melanoma onset. The device is custom-made and can be sized and colored for each individual patient before being surgically inserted. The artificial iris functions just as the natural iris would by reducing the amount of light entering the eye.

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