FDA Roundup of the Week: October 13
Catch up on all the past week's action in US Food and Drug Administration rulings and decisions.
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FDA Committee Backs Gene Therapy Candidate
An advisory committee gave unanimous support to Luxturna, 3 months prior to its BLA ruling.
FDA Approves First 7 Tesla MRI Device
The approval of Magnetom Terra more than doubles the maximum MRI strength in the field.
FDA Requests More Pain Medication Data
AcelRx Pharmaceutical's New Drug Application for DSUVIA was rebuffed, pending more safety and use data.
FDA Approves LivaNova Epilepsy Device
SenTiva is capable of detecting and responding to seizures in patients — before they even begin.
Eravacycline Improves Regimen for Oral, IV Treatment of cUTI
Treated in hospital settings, cUTI has been traditionally treated with quinolones due to a patient’s ability to transfer from IV to oral form when they’re discharged.
California Passes Drug Price Transparency Law
Drug manufactures will have to explain any raise of at least 16% over a 2-year span.
FDA Approves Implantable Sleep Apnea Device
The Remedē System stimulates the phrenic nerve during sleep to retain normal breathing in patients.
How HCV Drug Makers Hit a Wall
National reports show less treated patients and less spending in a field that major developers are now leaving.
FDA Approves Zika Virus Blood Test
This was the first FDA approval of such a detection test for screening national blood supplies.
Gilead Gives UN Organization Licensing Rights to HIV Drug
As a result the Medicines Patent Pool will have sub-license rights to generic drugmakers in India, China, and South Africa for the integrase stand inhibitor drug.
NIH Institute Grants $122 Million to Research Minority Institutes
NIMHD, a part of the National Institutes of Health, supports scientists at institutions historically committed to training populations underrepresented in science.
The "Universal Flu Vaccine" Undergoes 2,000-patient Trial
Developed by Oxford University researchers, the vaccine could possibly be administered in 5-year intervals.
Copaxone Generic Approved for Multiple Sclerosis
At the time of the approval, Mylan is awaiting decision on another 225 ANDAs submitted to the FDA.
FDA Approves BOTOX Cosmetic for Third Indication
After previous indications in 2002 and 2013, the drug received its third indication for temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity
Merck Ends 2 HCV Drug Trials Due to "Evolving Marketplace"
The pharmaceutical company follows Johnson & Johnson's pursuit of fields outside of hepatitis C.
Breakthrough: CTE Biomarker Could Lead to Treatments
There's a growing chance that living patients can be tested for the neurodegenerative disease most linked to tackle football.
MD Magazine's Top 10 Stories of September
Catch up on our biggest headlines you missed before the end of the month!
A Damaged Car: Experts Discuss the Next Healthcare Bill Moves
Organized by the Harvard T.H. Chan School of Public Health, a panel of experts projected a foggy future for the ACA.
AbbVie, Amgen Settle on Humira Biosimilar Litigation
Amgen biosimilar Amgevita may be on US markets in about 7 years.
Lefamulin Returns Positive Phase 3 Results for Pneumonia
The investigational monotherapy has potential to be taken in multiple forms by CABP patients.
Advanced Heart Failure Device Approved by the FDA
The HVAD System, a left ventricular assist device, assists patient’s hearts in pumping and increasing blood flow through the body.
Expert: MS Treatments Are Improving Towards NEDA Potential
Therapy for both relapsing and progressive forms of multiple sclerosis have progressed in recent years.
Graham-Cassidy Healthcare Bill Fails to Reach Senate Vote
The last of multiple majority leader attempts to repeal the Affordable Care Act lacked confident support.
Howard Weintraub, MD, on Useful Patient Prognoses to Address Diabetes
The New York University clinical professor of medicine also shared his thoughts on the future of cardiovascular disease medicine.
The Connected Clinician: Top Stories of the Week for September 22
Stay connected and up-to-date in health care news with the Connected Clinician top stories of the week for the week of September 22.
After Trelegy Ellipta Approval, GSK Looks to More COPD Treatments
“We are constantly looking for new molecules with which to treat COPD patients.”
Generational Care: The History of Tardive Dyskinesia Treatment
"The frequency of causing tardive dyskinesia is lesser, but it’s not zero."
Dupixent for Atopic Dermatitis Aims for EU Approval
Dupixent, combined with topical corticosteroids significantly improved measures such as disease severity, skin clearing, itching, and overall quality of life in patients.
PBC Treatment Linked by FDA to At Least 19 Deaths
According to the FDA, Ocaliva has been identified in 19 cases of death and 11 cases of serious liver damage, and has been excessively dosed in some adult patients with moderate to severe decreases in liver function.