FDA Archives - Page 52 of 103 - Medical Design Sourcing

Pfizer and BioNTech win EUA for booster for individuals 16 and older

Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) have received emergency use authorization for BNT162b2 mRNA COVID-19 vaccine for individuals at least 16 years old.

To coincide with the announcement, CDC Director Dr. Rochelle Walensky recommended that everyone 16 and older receive a booster. “Although we don’t have all the answers on the Omicron variant, initial data suggests that COVID-19 boosters help broaden and strengthen the protection against Omicron and other variants,” Walensky said. Recipients need to wait at least six months after completing the primary vaccination series.

The Pfizer-BioNTech is now the only COVID-19 vaccine to win authorization for adolescents between 16 and 17.

“Today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our COVID-19 vaccine is a critical milestone as we continue to stay vigilant in addressing the virus,” said Albert Bourla, Pfizer CEO, in a press release.<…

FDA authorizes COVID-19 antibody cocktail for younger children

The FDA will allow the use of Lilly’s (NYSE:LLY) bamlanivimab and etesevimab antibodies for younger pediatric patients, including newborns.

The revised expanded emergency use authorization (EUA) specifically includes children with mild-to-moderate COVID-19 who face a high risk of disease progression.

The EUA previously covered children at least 12 years of age who weigh at least 40 kilograms.

The FDA will now allow the use of the antibody cocktail as post-exposure prophylaxis (PEP) to prevent COVID-19 in all pediatric patients with a high risk of progressing to severe COVID-19.

Bamlanivimab and etesevimab image courtesy of Lilly.

The expanded authorization is not intended to provide an alternative to vaccination, said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “Vaccines remain our best tool in the fight against the virus, an…

Report: Insulet expects delays in FDA review for Omnipod 5 with launch pushed back

The Insulet Omnipod 5 [Photo courtesy of Insulet]The highly anticipated launch of the Insulet (NSDQ:PODD) Omnipod 5 may not come as soon as thought as an FDA review drags on.

SeekingAlpha reported that Insulet CEO Shacey Petrovic, speaking at the Nasdaq Investor Conference, said the regulatory agency will likely not complete its review of the next-generation Omnipod 5 before the end of the year, meaning the launch projected for the fourth quarter of 2021 is now expected for the first quarter of 2022.

Get the full story at our sister site, Drug Delivery Business News.

FDA clears CoreLink’s CentraFix midline fixation system

[Image from CoreLink]CoreLink announced today that it won FDA 510(k) clearance for and commercially launched its CentraFix midline fixation system.

St. Louis-based CoreLink designed CentraFix as a posterior thoracolumbar pedicle screw for less invasive spinal fixation, often used with a medial-to-lateral approach known as cortical bone trajectory (CBT).

According to a news release, that technique allows for maximum contact of the pedicle screw with cortical bone with the aim of reducing incision size, limiting muscular and vascular injury and improving initial fixation.

CentraFix also features modular cobalt chrome tulip heads and titanium alloy screw shanks in various lengths and diameters for allowing screw placement in denser cortical bone, CoreLink said. he tulip heads minimize tissue disruption and simplify distraction without compromising strength.

“The CentraFix System provides unmatched intraoperative visualization and surgical flexib…

FDA’s Woodcock reassures about COVID-19 tests, vaccines under Omicron

FDA Acting Commissioner Dr. Janet Woodcock

Acting FDA Commissioner Dr. Janet Woodcock thinks many COVID-19 tests will continue to work with the new Omicron variant — with information coming soon on vaccine efficacy.

In a statement posted yesterday, Woodcock said she thought the agency is well-positioned to work with companies to address the potential impact of viral mutations on COVID-19 tests, therapeutics, and vaccines.

“Getting vaccinated or receiving a booster with one of the currently available vaccines is the best thing that you can do right now (in addition to standard precautions like wearing a mask) to help protect yourself, your family and friends,” Woodcock said.

Get the full story on our sister site Medical Design & Outsourcing.

FDA’s Woodcock reassures about COVID-19 tests, vaccines under Omicron

Acting FDA Commissioner Dr. Janet Woodcock

Acting FDA Commissioner Dr. Janet Woodcock thinks many COVID-19 tests will continue to work with the new Omicron variant — with information coming soon on vaccine efficacy.

In a statement posted yesterday, Woodcock said she thought the agency is well-positioned to work with companies to address the potential impact of viral mutations on COVID-19 tests, therapeutics, and vaccines.

“Getting vaccinated or receiving a booster with one of the currently available vaccines is the best thing that you can do right now (in addition to standard precautions like wearing a mask) to help protect yourself, your family and friends,” Woodcock said.

Get the full story on our sister site Medical Design & Outsourcing.

FDA’s Woodcock reassures about COVID-19 tests, vaccines under Omicron

Acting FDA Commissioner Dr. Janet Woodcock

Acting FDA Commissioner Dr. Janet Woodcock thinks many COVID-19 tests will continue to work with the new Omicron variant — with information coming soon on vaccine efficacy.

In a statement posted yesterday, Woodcock said she thought the agency is well-positioned to work with companies to address the potential impact of viral mutations on COVID-19 tests, therapeutics, and vaccines.

“Getting vaccinated or receiving a booster with one of the currently available vaccines is the best thing that you can do right now (in addition to standard precautions like wearing a mask) to help protect yourself, your family and friends,” Woodcock said.

Discovered in late November in South Africa, the Omicron variant has more than 30 changes to the SARS-CoV-2 spike protein. The variant has enough mutations to raise concerns worldwide, even though it is still un…

FDA clears Insightec Exablate Prostate device

Insightec announced today that it received FDA 510(k) clearance for its Exablate Prostate system for treating prostate tissue.

Haifa, Israel-based Insightec designed its Exablate Prostate system to use high-intensity focused ultrasound to ablate targeted tissue in the prostate. The procedure is performed under magnetic resonance imaging (MRI) guidance for high-resolution visualization of the patient’s anatomy for precise targeting and real-time temperature monitoring.

According to a news release, the treatment does not require incisions and is performed in a single session, allowing patients to quickly return to normal activity with minimal complications.

Clinical trial results demonstrated that the Exablate Prostate system resulted in minimal damage to adjacent structures with low rates of impact on potency and continence, Insightec said.

“Insightec remains focused on achieving strategic milestones and expanding into indications beyon…

FDA advisory committee votes in favor of COVID-19 pill molnupiravir

FDA’s Antimicrobial Drugs Advisory Committee narrowly concluded that the benefits of Merck’s (NYSE:MRK) COVID-19 pill molnupiravir outweigh the risks.

A total of 13 members of the panel voted in favor of the drug candidate, while 10 voted against it. There were no abstentions.

FDA generally follows the advice of its advisory committees.

“This was clearly a very difficult decision,” said Dr. Michael D. Green, a member of the advisory committee and professor at the University of Pittsburgh School of Medicine. “I would use it in high-risk non-vaccinated individuals,” Green said, adding he would consider the drug for people with obesity and multiple other risk factors. “For pregnancy, I would only use it if there’s no alternative therapy available, and I don’t think I would use it in the first trimester.”

Committee members who voted ‘no’ voiced several concerns.

Dr. Timothy Burgess of the Uniformed Services University cited the unconvincing cli…

Why Public Citizen is skeptical about the COVID-19 antiviral molnupiravir

Dr. Michael Carome, director of Public Citizen’s health research group, is concerned about Merck’s SARS-CoV-2 antiviral molnupiravir.

If it wins emergency use authorization (EUA), molnupiravir would be the first oral treatment for COVID-19. But Carome brought up several potential problems with molnupiravir during today’s public comment period of the FDA’s Antimicrobial Drugs Advisory Committee meeting.

First, Carome argued that the drug appeared to have modest efficacy, offering a relative risk reduction against hospitalization or death of 30% through day 29 of the MK-4482-002 Phase 2/3 study.

Additionally, subgroup analyses of the MK-4482-002 study showed that the drug’s potential benefits appeared to be “substantially lower” in patients infected with the SARS CoV-2 Delta variant when the drug was provided at the proposed dosage of 800 mg every 12 hours for five days.

“Subgroup analyses also found n…

FDA clears virtual reality surgical planning tool from PrecisionOS

[Image from PrecisionOS]PrecisionOS announced today that it received FDA 510(k) clearance for its InVisionOS virtual reality-based planning tool.

Vancouver, British Columbia-based PrecisionOS designed InVisionOS as a patient-specific planning tool that uses VR. The patented software allows surgeons to use an Oculus Quest 2 device to conduct preoperative surgical planning.

According to a news release, PrecisionOS expects InVisionOS to be made available commercially in early 2022.

Current offerings allow surgeons to view a simulated 3D image of the patient on a computer screen and carry the mental model to the operating room, Precision OS said, while its software automatically converts the patient’s computed tomography (CT) scan from any PACS system into a 3D reconstruction within seconds.

With the CT scan available through this software, surgeons can then use the Oculus Quest 2 to view, manipulate and isolate relevant anatomical areas before con…

FDA authorizes expansion of Fractyl’s pivotal clinical trial for diabetes reversal tech

Fractyl Health announced today that the FDA gave authorization to expand the Revitalize-1 pivotal clinical study of its Revita DMR system.

Lexington, Massachusetts-based Fractyl Health (formerly Fractyl Laboratories) can now increase the sample size of the Revitalize-1 trial (formerly Revita-T2Di trial) from 288 to 420.

Get the full story at our sister site, Drug Delivery Business News.