FDA Archives - Page 72 of 103 - Medical Design Sourcing

Pfizer expands COVID-19 vaccine trial involving children under 12

Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ: BNTX) will proceed with a COVID-19 vaccine trial involving as many as 4,500 children. The trial will significantly reduce the 30-mg dose that adults and adolescents receive. Investigators will administer a 10-µg dose to children aged 5 to 11 and give those aged six months to five years old a 3-µg dose.

The company anticipates data from 5- to 11-year-olds in September and plans on filing for emergency use authorization shortly after that.

The company anticipates that data for the 6-month to 2-year-old cohort will be available in October or November.

In related news, Pfizer and BioNTech must contend with concerns that their BNT162b2 could be linked to myocarditis in adolescents.

[Related: 50 of 2020’s best-selling pharmaceuticals]

A recently published preprint in the journal Pediatrics describes seven male adolescents who developed myocarditis after receiving the vaccine. All seven pa…

Biogen’s stock pops nearly 40% after FDA’s Alzheimer drug approval, but questions remain

FDA has approved the Aduhelm (aducanumab) from Biogen, the first novel Alzheimer’s drug treatment, in 18 years despite drug companies pumping billions of dollars into more than 400 clinical trials.

The news caused Biogen’s share price to jump from $286.14 to $395.85 — a 38.34% increase.

It remains to be seen, however, just how big of a blockbuster Aduhelm will be. Some Alzheimer’s experts have stressed that they won’t prescribe aducanumab, citing a lack of convincing evidence that it is effective. Last November, an FDA advisory committee also expressed reservations about aducanumab’s clinical trial data. Three of those members explained their reasoning in a March editorial in JAMA.

But optimists stress that Aduhelm’s approval could also mark a turning point in treating Alzheimer’s disease (AD). “Aduhelm is the first therapy to target and affect the underlying disease process of AD,” said Alessio Brune…

FDA approves Medtronic’s SenSight directional lead system for DBS therapy

Medtronic (NYSE:MDT) announced today that it received FDA approval for its SenSight directional lead system used in deep brain stimulation therapy.

Fridley, Minn.-based Medtronic designed the SenSight directional lead system for DBS therapy to combine directionality and sensing to allow physicians to deliver precise, patient-specific DBS therapy for treating some symptoms associated with movement disorders including Parkinson’s disease, dystonia and essential tremor and medically refractory epilepsy, according to a news release.

The company touts SenSight as the first directional, sensing-enabled lead designed to improve the detection of local field potentials (LFPs). It can be paired with the Percept PC device to expand on Medtronic’s BrianSense technology to allow for the capturing and recording of enhanced directional LFP information from the implanted lead.

Multi-disciplinary teams at the University of Florida performed the first implants…

FDA approves Novo Nordisk’s semaglutide for weight management

FDA has approved Wegovy, the weekly semaglutide treatment for obesity from Novo Nordisk (CPH:NOVO-B).

The agency approved the use of semaglutide for type 2 diabetes in 2017. FDA approved an oral formulation for diabetes in 2019.

Semaglutide is a glucagon-like peptide (GLP-1) receptor agonist (RA) that continues to find wider use.

In clinical trials, Novo Nordisk people led to an average weight loss of 15% to 18% of body weight over 68 weeks in patients with obesity without diabetes.

In a clinical trial published in JAMA and The New England Journal of Medicine, semaglutide tripled weight loss for participants who received lifestyle management coaching.

Novo Nordisk continues to research new potential uses of the drug. It has launched clinical trials to test its use for conditions ranging from atherosclerosis to Alzheimer’s and Parkinson’s disease. A posthoc analysis involving three cardiovascular clinical trials found that participants recei…

Olaparib improved survival rates in patients with breast cancer subtype

AstraZeneca (LON: AZN) announced that its oncology drug olaparib (Lynparza) led to clinically meaningful improvements in a Phase 3 study. The study focused on patients with germline BRCA-mutated high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

Some 5% of breast cancer patients have BRCA1 and BRCA2 mutations.

Clinical trial investigators have repeatedly demonstrated that olaparib is effective against BRCA-related cancer.

NEJM recently published a summary of the study, known as OlympiA, whose primary endpoint was disease-free survival. The study had 1,836 participants.

After a median follow-up period of 2.5 years, the 3-year invasive survival-free survival rate for olaparib recipients was 85.9% compared with 77.1% in the placebo group.

For patients who had received local treatment and standard neoadjuvant or adjuvant chemotherapy, olaparib led to a 42% reduction in invasive breast can…

FDA shares guidance to protect the pharma supply chain

FDA has issued guidance documents to help pharmaceutical stakeholders identify illegitimate products and remove them from the supply chain. Two of the documents are final while another two are draft guidance.

“Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public. Illegitimate and unsafe products must be kept out of the U.S. drug supply chain,” said Donald D. Ashley, director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research, in a statement.

The FDA introduced the Drug Supply Chain Security Act (DSCSA) requirements to identify and weed out illegitimate products.

The recent documents include recommendations for complying with DSCSA requirements and how to provide enhanced drug distribution security at the package level to comply with requirements that go into effect in November 2023. After that da…

AstraZeneca could enlist Catalent to produce COVID-19 vaccines

After stopping the production of its COVID-19 vaccine at an Emergent Biosolutions facility in Baltimore, AstraZeneca (LON:AZN) is in negotiations with Catalent (NYSE:CTLT) to shift production to one of its plants in nearby Harmans, Md.

FDA has yet to authorize the AstraZeneca COVID-19 vaccine, although it has won full approval in Australia and Brazil and has received emergency use authorization (EUA) in 168 other countries.

As a majority of U.S. citizens have already received at least one COVID-19 vaccine dose, officials at AstraZeneca are reportedly mulling the option of pursuing full approval of its vaccine instead of EUA, according to The Wall Street Journal.

The U.S. government required Emergent Biosolutions to halt production of the AstraZeneca vaccine after a production error forced Emergent to discard 15 million COVID-19 vaccine doses. Emergent intended to produce AstraZeneca’s and Johnson & Johnson’s adenovirus-vectored vaccines in the same f…

Italian sterilization plants falsified records for years, FDA says

Device sterilized by ethylene oxide (EtO) (Image from the FDA)

An Italian medtech sterilization company falsified records of a variety of FDA-regulated products since 2016, the agency said today.

The company, Steril Milano, falsified graphs and parameters of sterilization certificates for devices processed at its Reggiolo and Monza ethylene oxide (EtO) plants, the FDA said.

Steril Milano on March 9, 2021, announced the temporary closure of the Monza and Reggiolo sites for further investigations following a review of operating procedures. The company said that it has taken steps to strengthen the quality control processes at its Biassonno site. Steril Milano’s certifying body has suspended the certification for its Italian sites, the company added.

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New FDA-backed initiative seeks to boost diversity in medtech

MedTech Color launched of a Collaborative Community on Diversity and Inclusion in Medical Device Product Development and Clinical Research.

The MedTech Color Collaborative Community aims to bring together public and private stakeholders and develop targeted strategies to up the awareness, understanding and participation of racial and ethnic minorities within the medtech industry, according to a news release.

“The FDA is committed to advancing diverse participation in trials to ensure that clinical studies better reflect the populations that will ultimately benefit from new and innovative health solutions,” director of the FDA’s Center for Devices & Radiological Health (CDRH) Dr. Jeff Shuren said in the release. “We are encouraged by MedTech Color’s active efforts to develop solutions to increase participant diversity and inclusion of minority health populations. We are also pleased to have FDA liaisons from CDRH and the Office …

FDA seeks more money, authority in budget request

The FDA wants more money from Congress for the coming fiscal year, and more power, too.

Out of its $6.5 billion total budget, the agency is asking $676.55 million for its medical device program. That includes $571 million for the Center for Devices & Radiological Health (CDRH) and $105.4 million for the Office of Regulatory Affairs (ORA).

The request includes $452 million that would come from Congress— up nearly $44 million from FY 2021 — and $224.5 million from user fees, a $4.9 million increase.

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Avicenna.AI’s triage system get regulatory nods

Avicenna.AI announced today that it received FDA 510(k) clearance and CE mark for its Cina Chest vascular condition triage system.

Marseille, France-based Avicenna.AI designed Cina Chest to leverage deep learning algorithms to offer automatic detection and triage capabilities for both pulmonary embolism (PE) and aortic dissection (AD) from CT-scan imaging, according to a news release.

Cina Chest offers rapid, automatic PE detection on CT chest angiography with accurate and real-time alerts, while it identifies acute AD cases that require urgent intervention on thoraco-abdominal CT angiography.

“At Avicenna, we specialize in the development of AI algorithms that can identify acute abnormalities, and Cina Chest is the latest application we’ve developed to enhance emergency room radiology,” Avicenna.AI co-founder & CEO Cyril Di Grandi said in the release. “Our PE and AD triage tools are the third and fourth algorithms we’ve…

Edwards’ low-BP prediction software gains FDA clearance

(Image courtesy of Edwards Lifesciences)

Edwards Lifesciences (NYSE:EW) has announced that its Acumen hypotension prediction index (HPI) software has received FDA 510(k) clearance.

Using data obtained from the Acumen IQ finger cuff, the software uses machine learning to alert clinicians of the likelihood a patient is trending toward hypotension, or low blood pressure. Until now, Acumen HPI software has only been available for patients using an invasive arterial line, according to Irvine, Calif.-based Edwards.

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