Insufficient Evidence for Anti-CGRP Treatment Guideline for Migraine
The European Headache Federation (EHF) recently sought to create an expert- and evidence-based guideline for the treatment of migraine with monoclonal antibodies that target the calcitonin gene-related peptide (CGRP). However, in reviewing available research, the EHF found that there was not enough evidence to provide a guideline based on the Grading of Recommendation, Assessment, Development, and Evaluation approach.
FDA Expands Patient Inclusion Criteria for Cancer Clinical Trials
In an effort to increase patient accrual, broaden patients’ access to cancer clinical trials, and lead to trial results that better represent treatment effects in the real world, the FDA published 4 draft guidances and 1 final guidance to promote the inclusion of pediatric patients and patients with comorbidities that can occur alongside cancer.
5 Things to Know About Medicare for All
“Medicare for Al” refers to a bill originally introduced to Congress in September 2017 by Senator Bernie Sanders, I-Vermont, with 16 Democratic cosponsors that would create a single, federal, government-administered program to provide healthcare to all US residents. In February 2019, Representative Pramila Jayapal, D-Washington, introduced the Medicare for All Act of 2019, with 106 cosponsors. This bill builds upon the legislation that Sanders introduced, with a few key differences. Here are 5 things to know about the bills.
Fedratinib Earns Priority Review Status for Myelofibrosis From FDA
Earlier this week, the FDA granted priority review to a new drug application for fedratinib for the treatment of myelofibrosis. The drug had previously been awarded an orphan drug designation for the treatment of primary and secondary myelofibrosis.
Should Fecal Microbiota Transplants Be Regulated as Drugs or Organ Donations?
The FDA is anticipated to release a finalized guidance document any day now around the regulation of fecal microbiota transplants for the treatment of Clostridium difficile infection. The outcome will dictate how they’re priced, who oversees their use, and who can make money off the treatment.
CHMP Recommends First Treatment of FCS for Marketing Approval
The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion that an orphan drug, volanesorsen (Waylivra), receive a conditional marketing authorization. The drug would be the first medication approved for the treatment of the familial chylomicronemia syndrome (FCS).
Pharma Executives Call for Reforms to Medicare, Rebate System in Senate Hearing
During the hearing on drug pricing held yesterday before the US Senate Committee on Finance, 7 pharmaceutical executives gave testimony in an effort to explain rising drug costs in the United States and offer solutions to lower them.
Study Finds 74% Long-Term Survival Rate for Patients With Myelofibrosis
The only curative treatment for myelofibrosis (MF) continues to be allogeneic hematopoietic stem cell transplant (HSCT). Occasionally, adverse events posttransplantation can occur and usually present within the first 2 years after posttransplant. Researchers recently sought to analyze the outcome of 2-year disease-free survivors in a systematic review published in Haematologica.
Personalized Medicines Account for 42% of All Drug Approvals in 2018
More than one-third of the therapies the FDA approved in the last 2 years includes information on the label identifying patients would benefit the most or experience fewer side effects, found a recently published report from the Personalized Medicine Coalition.
Real-World Study Finds Better Outcomes in MS After Early Intensive Therapy
Due to continued uncertainty around how aggressively to treat early multiple sclerosis (MS), a group of researchers recently analyzed long-term outcomes in a population-based cohort according to initial treatment strategy.
Greater Diet Drink Consumption Heightens Stroke Risk in Postmenopausal Women
While diet soft drinks may seem like a healthier option, the effects of the drinks given the amount of artificial sugar and flavorings haven’t yet been fully studied. Researchers recently sought to evaluate the association between self-reported consumption of artificially sweetened beverages (ASBs) with stroke and its subtypes, coronary heart disease, and all-cause mortality in postmenopausal US women.
Continuous Fingolimod Treatment Leads to 50% Reduction of ARRs
In a recent study, researchers looked to assess the real-world durability of reduction in annualized relapse rates (ARRs) among patients with multiple sclerosis who continuously received fingolimod (Gilenya) therapy over a longer-term period of follow up.
Is Immunotherapy the Future of Glioblastoma Treatment?
Immunotherapy has seen great success in the treatment of numerous cancers, from melanoma to lung, breast, colorectal, kidney, and even some brain cancers. But thus far, despite several attempts, the devastating brain disease glioblastoma has not been among the immunotherapy success stories. In fact, glioblastoma researchers have had few advances in more than a decade.
Careful Observation of Ovarian Cysts Safe Alternative to Surgery
Once identified, ovarian tumors are usually surgically removed due to the presumed risk of complications associated with the diagnosis. Researchers recently looked to evaluate the incidence of cyst complications and malignancy during the first 2 years of follow-up after the tumors were classified as benign.
5 Updates and Actions Taken in the Fight to Stop Teen Vaping
Teen nicotine use drastically increased in 2018, largely due to the popularity of e-cigarette products. The FDA has taken a number of recent steps to address the epidemic that has been said to have created a new generation of nicotine addicts. Here are 5 of the latest updates and actions in the fight against teen vaping.
AJMCtv® Interviews, January 2019
AJMC®TV interviews let you catch up on what’s new and important about changes in healthcare, with insights from key decision makers—from the clinician, to the health plan leader, to the regulator. When every minute in your day matters, AJMC®TV interviews keep you informed. Access the video clips at ajmc.com/interviews.