FDA Delays Ruling on Heplisav-B
The investigational hepatitis-B drug has been rejected for approval twice in the past 3 years, but creator Dynavax Technologies still hopes for an early 2018 US commercial release.
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FDA Approves Mavyret for Chronic HCV
The fixed-dose combination therapy is an 8-week, once-daily treatment option for all HCV genotype diagnoses.
Chronic Pain Device Stimpod NMS460 Gets FDA Approval
The device provides hybrid pulsed radio frequency waveforms that create electromagnetic effects, offering immediate chronic intractable pain relief.
Opioid Use Disorder Injection Drug Gets FDA Priority
RBP-6000, a injectable buprenorphine for adult moderate-to-severe OUD patients, was submitted for new drug application in May with major consideration to a phase 3 efficacy and safety study.
Study Reveals T Cells' Aggression Against Parkinson's Effects
Extracted immune cells show a stronger proclivity to attacking alpha-synuclein protein in Parkinson's patients than healthy patients.
FDA Committee Supports Safety Data of Hepatitis B Vaccine
HEPLISAV-B reported favorable marks for its lighter use — two doses every month — but was twice previously denied its marketing application in the past 3 years.
HIV Latency Reversal Could Lead to Infection Removal
Researchers at the University of North Carolina are beginning to combine a latency reversal agent with treatments that would destroy latent forms of HIV.
Potential COPD Treatment Revefenacin Returns More Positive Phase III Results
The proposed once-daily nebulized bronchodilator for COPD returned reports of generally positive toleration, with no new safety issues, in a study of 1,055 patients.
Type 1 Diabetes Cell Therapy Study Shows Promise in Pediatrics
The Sanford Project: T-Rex Study has reached its midway point through a Phase II, fast-tracked trial.
FDA Accepts Application for CIDP Treatment Hizentra
Hizentra prevents neuromuscular disability and impairment relapse in patients with CIDP, a rare immune-mediated disorder of the peripheral nerves.
Senate Healthcare Bill Rejected Again, Republican Leaders Look to ACA Repeal
The Better Care Reconciliation Act revision lost majority favor Monday night. On Tuesday night, majority leaders turned to a new plan.
"Immediate Priority": The FDA's Revamped Opioid Regulation
How the FDA has bolstered its policies and rulings on opioid products in just 2 months under commissioner Scott Gottlieb.
Senate Republican Leaders Propose Revised Healthcare Bill
The revisions to the Better Care Reconciliation Act 2017 come after majority party dissent and withdrawal in late June.
PRO 140 Results for HIV Suppression Nearing Announcement
The monoclonal antibody — a once-weekly injection endorsed by actor Charlie Sheen — has been undergoing current clinical phases for over 2 years.
Sanofi Purchases Protein Sciences for $650 Million
The to-be-acquired Protein Sciences had received US Food and Drug Administration approval for their Flublok Quadrivalent Influenza Vaccine in October 2016.
Eluxadoline Reports IBS-D Symptom Treatment Efficacy and Safety
Eluxadoline — a twice daily, oral medication used to treat adults with IBS-D — is a mu- and kappa-opioid receptor agonist and a delta-opioid receptor antagonist.
FDA Approves Oral Powder for Sickle Cell Disease
L-glutamine is the first SCD treatment approved for pediatric patients, and the first adult treatment approved in nearly 20 years.
Endo International Pulls Opioid Treatment from Market
The decision came one month after the first-ever FDA recommendation for a drug withdrawal on the grounds of opioid abuse.
Autism in Children May Be Measured By Blood Protein
Two blood proteins have shown a combined 82% accuracy in diagnosing ASD in a group of pediatric patients.
FDA Approves Seizure Device for Young Children
VNS Therapy was previously approved as a drug-resistant epilepsy treatment in seizure patients ages 12 and older.
Q&A: Medical Marijuana for Multiple Sclerosis
Allen Bowling, MD, PhD, explains the benefits and roadblocks of alternative medicine for MS.
Q&A on Betrixaban, the First Preventive VTE Treatment
Karol Watson, MD, shares her professional and personal perspective on what a prophylaxis means for especially older VTE patients.
Liraglutide, and the Link Between Diabetic and Cardiovascular Care
What the Type 2 diabetes treatment could do if approved for cardiovascular events, according to Karol Watson, MD.
Latent Form of HIV Capable of Reproducing in Immune Cells
The discovery of ART-resistant latent HIV indicates problems for finding a cure for the virus.
HIV Found to Persist in Infected Macrophages
The discovery means the virus is capable of persisting beyond the body's T cells — and future treatment must address that.
The Road to Finding an HIV Cure
With major progress in daily treatments, one expert believes a cure could be a decade away.
Link Found Between AMD and Myeloproliferative Neoplasms
Researchers analyzed 20 years of Danish healthcare registries to uncover a correlation.
Modified Starch Found in Foods Prevents Diabetes in Early Studies
High-amylose maize starch with chemical add-ons prevented diabtes in susceptible mice in an Australian study.
FDA Announces Changes to Improve Generic Drug Options
The changes are intended to improve treatment available at affordable market prices.
The Top 10 Stories of June 2017
A look back at what studies, headlines, and news caught our readers' eyes most throughout the month.