The sNDA was granted Priority Review and accepted under the agency's Real-Time Oncology Review pilot program, which aims to make the review of oncology drugs more efficient by allowing the FDA access to clinical trial data before the information is formally submitted to the agency.
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During the featured session at Asembia’s Specialty Pharmacy Summit 2019, “Specialty Industry Outlook: What’s Next,†speakers Adam Fein, PhD, CEO of the Drug Channels Institute; Lisa Gill, managing director of J.P. Morgan Securities; and Doug Long, vice president of industry relations at IQVIA, explored the radical changes that could be on the horizon from potential legislation that would dramatically alter the health care industry.
Matt Farber, MA, Senior Director of Patient Care and Advocacy at Walgreens provided insight into new areas of technology that pharmacists can use to help improve care when treating patients with cancer.
Matt Farber, MA, Senior Director of Patient Care and Advocacy at Walgreens, discussed the role of specialty pharmacists in working to manage the cost burden of cancer care.
Since the growth of specialty pharmacies, genetically acquired bleeding disorders such as von Willebrand disease (VWD) have been among the most common conditions addressed at these practice locations.
At the Asembia Specialty Pharmacy Summit 2019, Scott Gottlieb, MD, 23rd commissioner of the FDA discussed the agency's role in rewriting the modern rules of new regulatory paradigms for a number of recent advancements in medicine.
Patients taking beta interferons for at least 6 months had a reduced mortality risk compared with patients who did not take the drug.
The drug application was granted the FDA’s Priority Review designation, as well as a Tropical Disease Priority Review Voucher under a program intended to encourage development of new drugs and biologics for the prevention and treatment of certain tropical diseases.
Top news of the week from Specialty Pharmacy Times.
Matthew Malachowski, PharmD, BCPS, supervisor of specialty pharmacy services at UAB Health System, discusses opportunities to improve the patient experience.
Most Americans have never heard of hereditary transthyretin amyloidosis (hATTR), which speaks to its very low incidence rate in the population.
The study authors believe that the modification of teriflunomide and the development of new DHODH inhibitors is urgent for drug-resistant epilepsy patients
Partnerships like the UC College of Pharmacy and Walgreens offer opportunities for experience with complex disease states, such as cancer, multiple sclerosis, HIV, and Crohn’s disease, that many students will see after they graduate.
The oncology drug pipeline has experienced rapid growth over the past decade, driven by innovation in cell therapies, immunotherapy, and precision medicine, according to a specialty pipeline update presentation at the Asembia Specialty Pharmacy Summit 2019.
Co-pay accumulator programs are the latest cost management initiative resulting from the constant push and pull between payers, pharmacy benefit managers, and manufacturers to reduce drug spend.
Mouthwash containing diphenhydramine, lidocaine, and antacids found to significantly reduce pain from oral mucositis in patients with head and neck cancer administered chemotherapy.
Treatment for inflammatory bowel disease has the best outcomes when patients partner with their medical teams.
Why health system specialty pharmacies are uniquely positioned to provide valuable data and superior care to the patients they serve.
Amber Draper, PharmD, BCOP, clinical pharmacist at Winship Cancer Institute discussed how biomarkers are used to make informed decisions in colorectal cancer treatment.
The specialty lite platform leverages the current infrastructure of specialty pharmacies with efficient services and emerging technological solutions that focus on ensuring prescription fulfillment with economic feasibility.
This drug was previously approved, in 2017, to treat HCV in adults.
The preclinical data was presented by Beam Therapeutics, Monday at the American Society of Gene and Cell Therapy (ASGCT) 22nd Annual Meeting in Washington, DC.
Study finds cannabidiol may act as a Trojan horse to transport molecules into the brain.
Experts emphasized the need for clinicians to use every available tool when patients need PCSK9 inhibitors but face access barriers.
During a session on Monday at Asembia’s Specialty Pharmacy Summit 2019, experts discussed specialty pharmacy’s potential to improve outcomes for patients with pulmonary arterial hypertension.
Diagnostic delay tends to be a challenge for patients with hereditary angioedema, a rare but serious condition affecting 1 in 50,000 individuals.
During the week of the summit, you’ll find shows unique to the city that are sure to make lifelong memories.
Alison Duffy, PharmD, BCOP, from UM Greenebaum Comprehensive Cancer Center, talks about some of the emerging agents in the chronic lymphocytic leukemia treatment landscape.
This new offering provides an end-to-end digital prescription process with nationwide access through more than 25,000 retail pharmacies.