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Biogen will launch an expanded access program for its investigational amyotrophic lateral sclerosis (ALS) drug tofersen in July but that s likely too late for the patient whose quest to try the therapy has brought it into the spotlight.
In a community update posted to its website, Biogen said it will offer compassionate use to the most rapidly progressing patients starting in mid-July, once placebo patients in its phase III trial are transitioned to active therapy.
The company noted that this would be before the drug has been confirmed to be safe and effective. It defined rapidly progressing as SOD1-ALS patients with an ALS Functional Rating Scale-Revised (ALSFRS-R) slope decline greater than or equal to 2 points per month, and said access would be confirmed by a third-party organization in an anonymized manner.
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When Pfizer CEO Albert Bourla said people will likely need a COVID vaccine booster in 6 to 12 months, and that annual vaccines were possible, public health and infectious disease experts were quick to put on the brakes.
There aren t enough data yet to make that call, said Paul Offit, MD, a vaccine expert at Children s Hospital of Philadelphia. We ll have a better idea in about 1 year, Offit told
MedPage Today.
Experts have said they do believe it s likely that boosters will eventually be necessary. When that will be, how often they ll be needed, and whether that will vary by vaccine brand, or by differences in immune response, is still anyone s guess.
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A hospital in Jackson Hole, Wyoming will give its employees a bonus for getting vaccinated, a spokesperson told
MedPage Today.
Full-time employees at St. John s Health will get $600 if they re fully vaccinated by May 31, said chief communications officer Karen Connelly. That amount will be pro-rated for part-time employees who meet the deadline. Bonuses will be paid in June, she added.
About three-quarters (74%) of the hospital s 870 employees have already been vaccinated, but the hope is that the incentive will push that figure to 90% or higher, Connelly said.
The current rate is far higher than the state average of 40%, according to data from the Wyoming Department of Health.
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When Neil Shneider, MD, PhD, got results back that Lisa Stockman Mauriello s amyotrophic lateral sclerosis (ALS) was driven by a
SOD1 mutation, enrollment in the VALOR study had just closed.
The phase III trial is testing Biogen s investigational antisense oligonucleotide (ASO) aimed at knocking down levels of the mutant protein thought to play a major role in contributing to ALS in the 2% of patients with
SOD1 mutations.
Shneider, an investigator on the VALOR trial at Columbia University who has long worked on therapies targeted to specific mutations in ALS, figured he d be able to go the route of expanded access (also called compassionate use ) instead. He requested access from Biogen for the 51-year-old mother of three on Feb. 4.
email article NPR s Kansas City affiliate.
In 2018, Brovont filed a suit claiming he was fired after raising concerns about staffing issues at Overland Park Regional Medical Center in Kansas. Brovont repeatedly sounded the alarm that EmCare staffed only one physician on the night shift to cover both the regular and the pediatric emergency department at the hospital, which is owned by HCA Healthcare.
A jury awarded Brovont $29 million in October 2018, which included almost $3 million in economic damages, $6 million in pain and suffering, and $10 million in punitive damages against each of the defendants, KS-I Medical Services and MO-I Medical Services (both are EmCare subsidiaries, the former in Kansas and the other in neighboring Missouri).