Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out.
The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination.
Get the full story at our sister site, Pharmaceutical Processing World.
Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out.
The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination.
In a news release announcing the extension of the shelf life of J&J’s COVID-19 vaccine, the FDA confirmed the allowance of two batches from the Emergent facility (The New York Times reported that those batches total about 10 million doses). However, the FDA mentioned that it “determined several other batches are not suitable for use, but additional batches are still under review,” likely referring to the 60 million or so doses as reported by The New York Times.
This comes as the latest blow to Emergent and J&J after news broke in April that a factory error…
TransMedics (NSDQ:TMDX) announced that the FDA confirmed that it will review its premarket approval application next month.
Andover, Mass.-based TransMedics said the FDA scheduled a public advisory committee meeting to review the PMA application for the OCS Liver System, an organ transplant transportation platform, for July 14, 2021.
In the committee meeting, the FDA’s Gastroenterology & Urology Devices Panel of the Medical Devices Advisory Committee will discuss the platform, make recommendations and vote on a recommendation for approval of the OCS Liver System, according to a news release.
“We are looking forward to presenting the OCS Liver PROTECT data to the advisory committee panel in support of our PMA for the OCS Liver System,” TransMedics president & CEO Dr. Waleed Hassanein said in the release. “This is another important milestone to bring TransMedics closer to having all of our three organ platforms approved by F…
A high magnification micrograph of histomorphologic changes in a lymph node resulting from systemic lupus erythematosus (SLE). Image from Wikipedia.
In the past half-century, scores of investigational drugs for lupus have seemingly failed in clinical trials. GSK’s Benlysta (belimumab) is unique in winning approval from the FDA and European regulatory authorities.
Anifrolumab from AstraZeneca, which would be a first-in-class type I interferon inhibitor, is one of the most promising investigational drugs for treating systemic lupus erythematosus (SLE). SLE is the most common form of lupus. The PDUFA date for anifrolumab is September 30, 2021, according to the Antibody Society.
A fully human monoclonal antibody, anifrolumab binds to subunit 1 of the type I interferon receptor, potentially calming the impact of pro-inflammatory cytokines involved in lupus.
Anifrolumab has shown promise in SLE patie…
Image courtesy of Wikipedia
The theme of myocarditis and pericarditis following mRNA vaccination emerged in today’s Vaccines and Related Biological Products Advisory Committee meeting, which reviewed preliminary safety data of Pfizer-BioNTech vaccine in children aged 12 to 15. The risk, however, appears to be small.
As of May 31, there were 116 reports of myocarditis or pericarditis after the first dose of Pfizer-BioNTech vaccine. There were 100 for the first dose of Moderna vaccine. The problem, however, appears to be more common after the second dose. The government has collected 372 reports of myocarditis or pericarditis after the second dose of Pfizer-BioNTech vaccine and 201 for the Moderna vaccine.
Early data suggests a connection between the mRNA vaccines and myocarditis and pericarditis. Out of 2.3 million doses administered to 16-to-17-year-olds, the VAERS database lists 79 cases of myocardit…
FDA’s decision to conditionally approve Biogen’s Aduhelm (aducanumab) continues to cause controversy.
Three members of FDA’s Peripheral and Central Nervous System Drugs Advisory Committee have resigned. The most recent include David S. Knopman, a neurologist at the Mayo Clinic (Rochester, Minn.) and Aaron Kesselheim, a professor at Harvard University (Cambridge, Mass.)
Last November, eight committee members disagreed that there was sufficient clinical trial evidence to suggest that the drug was effective against Alzheimer’s. Another was undecided.
The first to resign was Joel Perlmutter, a neurologist at Washington University (St. Louis).
The three have not gone quietly.
In a letter to acting FDA Commissioner Janet Woodcock, Kesselheim called the aducanumab approval the “worst drug approval decision in recent U.S. history.”
Knopman told The Washington Post that he did not “wish to be part of a sham process.”
Perlmutter was mor…
Fridley, Minn.-based Medtronic touts the Vanta INS as having a device life of up to 11 years, which stands as more than twice the device life of competitive primary cell devices, according to a news release.
Additionally, Vanta uses Medtronic’s proprietary AdaptiveStim technology that adapts to the patient’s movement or body position through a built-in accelerometer. The platform can automatically adjust stimulation to maintain each patient’s optimal dose.
Vanta represents a 10% increase in longevity when compared to Medtronic’s previous generation of recharge-free device, the PrimeAdvanced. Its design marks a 20% decrease in size compared to PrimeAdvanced, with a more rounded, ergonomic contouring for enhanced comfort, the medtech giant said.
The platform can access Medtronic’s pr…
Cardinal Health (NYSE:CAH) announced today that the FDA approved its Lymphoseek injection for pediatric use.
Dublin, Ohio-based Cardinal Health touts Lymphoseek, which it acquired from Navidea Biopharmaceuticals (NYSE:NAVB) in November 2016, as the first and only radiopharmaceutical agent specifically designed for targeted lymphatic mapping nad guiding sentinel lymph node biopsies (SLNB).
Get the full story at our sister site, Drug Delivery Business News.
Glaukos (NYSE:GKOS) announced today that it completed enrollment for a Phase 3 clinical program for its iDose TR sustained-release travoprost implant.
San Clemente, Calif.-based Glaukos’ iDose TR implant contains a novel formulation of travoprost, a prostaglandin analog used to reduce intraocular pressure (IOP) through a design that continuously releases therapeutic levels of the medication for at least one year. Once all travoprost is released, the implant can be removed and replaced with a new iDose TR as an alternative to daily eye drop treatment.
Get the full story at our sister site, Drug Delivery Business News.
A member of the FDA’s expert panel for nervous system therapies reportedly resigned over the decision to authorize an Alzheimer’s therapy.
The FDA controversially authorized Aduhelm (aducanumab) from Biogen on Monday, making it the first novel Alzheimer’s drug treatment in 18 years despite drug companies pumping billions of dollars into more than 400 clinical trials.
STAT News reported yesterday that Joel Perlmutter, a neurologist at Washington University (St. Louis) and a member of the FDA’s expert panel for nervous system therapies, told the outlet that he quit the committee on Monday “due to this ruling by the FDA without further discussion with our advisory committee.”
In March, three FDA advisory committee members — none of them Perlmutter — published an editorial in JAMA expressing reservations about aducanumab’s clinical trial data. The FDA’s approval of the drug is conditional, with Biogen required to run a confirmatory clinical…
Synopsys announced today that it launched a new software version to update the Simpleware ScanIP Medical program with FDA 510(k) clearance.
According to Synopsys, the new software includes 3D medical printing and point-of-care 3D printing, making Simpleware ScanIP Medical one of just a handful of software programs to garner such clearance with 3D-printed models created through the program suitable for diagnostic uses.
The software allows for processing medical imaging data into 3D models for pre-surgical planning and 3D printing, generating watertight STLs for direct export to 3D printing applications, according to the company’s website.
Synopsys’ platform offers patient-specific images through the combination of the image and CAD data for evaluating implant positions, while the tools on hand allow for the visualization and measurement of medical image data.
The company touts the platform as easy to learn and use with an intuitive inte…
Amazon subsidiary STS Lab Holdco received FDA emergency use authorization (EUA) for the direct-to-consumer sale of its COVID-19 test.
The FDA authorized the test with indications as a direct-to-consumer product for testing individual anterior nasal swab specimens self-collected at home with the Amazon COVID-19 test collection kit DTC by any individual 18 years or older, according to an FDA letter.
STS Lab Holdco previously won EUA in March for the real-time PCR test without the direct-to-consumer sale option. The current indication includes those without symptoms or other reasons to suspect COVID-19 infection and is limited to authorized laboratories.
Authorization extends to pooled samples containing up to five individual anterior nasal swab specimens per pool that are self-collected in individual vials containing transport medium, the letter reads.
Test results from specimens collected with the Amazon COVID-19 test collection kit DTC can be deli…