ABSTRACT
Artificial intelligence is creating another new frontier in real-world evidence gathering and analysis. AI's algorithms can approximate-and maybe even surpass-human cognition and judgment in the analysis of complex medical data. Sure, humans will sign off, but AI software will do the heavy lifting.
Subject(s)
Algorithms , Artificial Intelligence , Managed Care Programs , HumansABSTRACT
Effective treatment has helped curb the epidemic, but practical cures have been elusive. Now being tested: a "sterilizing cure" that eradicates HIV from the body, and a "functional cure" that effectively reduces the viral load so it cannot be transmitted or progress to AIDS.
Subject(s)
Acquired Immunodeficiency Syndrome , HIV Infections , HIV , HumansABSTRACT
The FDA's approval criteria require a biosimilar to be highly similar to its original biologic and show "no clinically meaningful differences." But mere similarity is not close enough for many clinicians and some patients; it makes biosimilars seem riskier than the original biologics.
Subject(s)
Biosimilar Pharmaceuticals , Drug Approval , Humans , United States , United States Food and Drug AdministrationABSTRACT
Companies with originator biologics on the market have used a variety of regulatory and legal tricks to fend off biosimilars and keep the revenue generated by their products pouring in. The most common approach has been for the "originators" to take legal action to assert or defend the patents attached to their products.
Subject(s)
Biosimilar Pharmaceuticals , Drug Costs , United StatesABSTRACT
Pharma says rebates are a primary driver of high drug prices because drug companies raise prices in response to payers' demands for rebates in exchange for preferred placement on their formularies. PBMs and payers object. They say the rebates they get from drugmakers are largely passed on to health plans and patients and save consumers billions of dollars in the form of lower premiums and copays.
Subject(s)
Drug Industry , Insurance Carriers , Insurance, Pharmaceutical Services , Negotiating , Drug Costs , Health Expenditures , Politics , United StatesABSTRACT
Sanofi and Regeneron's Dupixent (dupilumab)-which is already approved for atopic dermatitis-has an FDA action date of October 20 for its asthma indication. It will join Nucala, (mepolizumab), Cinqair (reslizumab), and Fasenra (benralizumab) as a monoclonal antibody approved as a treatment for the type 2 inflammation phenotype in severe asthma.
Subject(s)
Antibodies, Monoclonal/economics , Antibodies, Monoclonal/therapeutic use , Asthma/drug therapy , Drug Industry/economics , Antibodies, Monoclonal, Humanized , Dermatitis, Atopic/drug therapy , Economic Competition , HumansABSTRACT
But the adoption of new technology is rarely smooth; learning curves create jagged edges. The gee-whiz factor of technology can easily get ahead of true utility and effectiveness. And, of course, there's the expense. Hospitals and other providers need to be ready to plow millions in new machines.
Subject(s)
Cardiovascular Diseases/diagnostic imaging , Computed Tomography Angiography , Humans , Imaging, Three-Dimensional , United StatesABSTRACT
Aimovig (erenumab-aooe), codeveloped by Amgen and Novartis, has been recently approved for the prevention of migraines. Its mechanism of action is different than other migraine medications. But perhaps more interestingly, it is the first drug recently developed specifically for migraine prevention.
Subject(s)
Antibodies, Monoclonal/therapeutic use , Calcitonin Gene-Related Peptide Receptor Antagonists , Drug Costs , Migraine Disorders/prevention & control , Antibodies, Monoclonal, Humanized , Drug Approval , Humans , United States , United States Food and Drug AdministrationABSTRACT
They take the brakes off the immune system so it attacks cancer cells. But many people don't respond to checkpoint inhibitors, so researchers are looking for ways to defeat the resistance.
Subject(s)
Antibodies, Monoclonal/therapeutic use , Cell Cycle Checkpoints/drug effects , Cell Cycle Checkpoints/immunology , Immunotherapy/methods , Disease Progression , Drug Approval , Humans , United States , United States Food and Drug AdministrationABSTRACT
The direct-acting virals revolutionized the treatment of hepatitis C. They also ushered turbocharged pricing. At least patients-and society-got a major health benefit in return.
Subject(s)
Antiviral Agents/economics , Benzimidazoles/economics , Drug Industry/economics , Fluorenes/economics , Hepatitis C/drug therapy , Uridine Monophosphate/analogs & derivatives , Humans , Sofosbuvir , United States , Uridine Monophosphate/economicsABSTRACT
The randomized controlled trial reigns supreme, but the FDA is working on ways to incorporate real-world evidence into its approval processes.
Subject(s)
Evidence-Based Medicine , United States Food and Drug Administration , Organizational Objectives , United StatesABSTRACT
In theory, this approach could help untangle some knotty cost and quality concerns about medications as they move from clinical trials and into clinical use. But there's a credibility issue: The perception that much of the research is biased and that the studies are designed so the results serve the interests of the sponsors.
Subject(s)
Clinical Trials as Topic , Drug Evaluation , Evidence-Based Medicine , Decision Making , Drug Industry , Humans , Insurance, Health, Reimbursement , Quality ControlABSTRACT
Some say gene editing platforms like CRISPR are a truer version of gene therapy because they are designed to home in on a particular genomic location.
Subject(s)
Gene Editing , Genetic Therapy/methods , Receptors, Antigen, T-Cell/genetics , Clustered Regularly Interspaced Short Palindromic Repeats/genetics , Drug Approval , Humans , Transcription Activator-Like Effector Nucleases/genetics , United States , United States Food and Drug Administration , Zinc Finger Nucleases/geneticsABSTRACT
The credibility of cannabis as a source of a legitimate pharmaceutical ingredient in prescription medications took a major step forward in 2018 when the FDA approved Epidiolex (cannabidiol) for two types of severe seizures. Epidiolex was a stellar candidate for approval. It reduced convulsive seizures by about 40% and has a good safety profile.
Subject(s)
Anticonvulsants , Cannabidiol , Cannabis , Health Policy , Legislation, Drug , United States , United States Food and Drug AdministrationABSTRACT
Opioids remain the go-to products because they target the mu opioid receptor, which has been shown to be the most effective pathway to reduce pain. The holy grail for drug developers is an agent that stifles pain without producing the euphoria and addiction of opioids.
Subject(s)
Analgesics, Opioid/chemistry , Drug Industry/trends , Opioid-Related Disorders/prevention & control , Pain Management/trends , Drug Design , Humans , United States , United States Food and Drug AdministrationABSTRACT
Seven biosimilars have crossed the FDA-approval finish line. The FDA has largely held to the abbreviated pathway it laid out originally. The big change is that the rest of the world is starting to understand it. Approvals are based upon "the totality of evidence," "analytic similarity," and clinical performance with much less emphasis placed on phase 3 trials.
Subject(s)
Biosimilar Pharmaceuticals , Drug Approval , Humans , United States , United States Food and Drug AdministrationABSTRACT
Otezla-the generic name is apremilast-also exploited a new mechanism of action as the first inhibitor of phosphodiesterase 4 (PDE4) that results in increased expression of both anti-inflammatory proteins and reduced expression of their pro-inflammatory counterparts.
Subject(s)
Phosphodiesterase 4 Inhibitors/therapeutic use , Psoriasis/drug therapy , Thalidomide/analogs & derivatives , Administration, Oral , Humans , Phosphodiesterase 4 Inhibitors/adverse effects , Phosphodiesterase 4 Inhibitors/economics , Thalidomide/adverse effects , Thalidomide/economics , Thalidomide/therapeutic use , United StatesABSTRACT
Truvada is getting a new lease on life as a preventive agent. It is the only drug approved to prevent HIV infections, and Truvada is the key pharmaceutical component of pre-exposure prophylaxis, which is aimed at preventing, rather than treating, HIV infection and transmission.
Subject(s)
Adenine/analogs & derivatives , Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination/administration & dosage , HIV Infections/drug therapy , Reverse Transcriptase Inhibitors/administration & dosage , Adenine/administration & dosage , Alanine , Drug Therapy, Combination , Humans , Tenofovir/analogs & derivatives , Treatment OutcomeABSTRACT
Some industry observers wonder why the wunderkind hasn't done more wonderfully on the market. As a brand name drug, Entresto costs substantially more than the generic ACE inhibitors and ARBs. GoodRx reports the average cash price for uninsured patients for Entresto is $504 per month, compared with $44 for enalapril.
Subject(s)
Aminobutyrates/economics , Drug Costs , Drugs, Generic , Tetrazoles/economics , Biphenyl Compounds , Drug Combinations , ValsartanABSTRACT
The link between diabetes and cardiovascular disease has been clear for decades, but until 2015 no clinical trial had convincingly demonstrated a link between medications that lower blood glucose and cardiovascular risks. Enter SGKT2 inhibitors and GLP-1 agonists.