Legacy MEDSearch

SEPTEMBER 11, 2023

Zeta’s computer vision engine ensures maintained accuracy by automatically registering multiple times a second, accounting for patient movement. ” About Zeta Surgical Zeta Surgical is a digital surgery company focused on improving the accuracy, safety, and accessibility of image guided procedures. Are you hiring?

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

European Pharmaceutical Review

MARCH 4, 2024

Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5 The emergency use approval from the FDA of lipid nanoparticle- (LNP-) based mRNA vaccines during the COVID-19 pandemic attested the significance of LNPs.

Food and Drug Administration 90

Food and Drug Administration Transportation FDA Medical 90

Legacy MEDSearch

SEPTEMBER 29, 2023

The HYDR ogel A ugmentation F or I ntervertebral L umbar D iscs (HYDRAFIL-D) Study , is a multicenter, single-blinded, randomized, controlled trial to evaluate the safety and efficacy of the HYDRAFIL System for treatment of chronic low back pain due to degenerative disc disease. Vapotherm (NYSE:VAPO), and National Sleep Technologies.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

JULY 21, 2023

UroMems , a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive smart, automated artificial urinary sphincter (AUS) in a female patient. Food and Drug Administration (FDA) for UroActive. .

Food and Drug Administration 52

Food and Drug Administration Patients Safety Recruitment 52

Legacy MEDSearch

JUNE 19, 2023

The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with the potential to enhance diagnostic accuracy for patients with cardiovascular diseases and heart conditions. Itatani, MD, Ph.D., Cardio Flow Design Inc. Cardio Flow Design, Inc.

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

Legacy MEDSearch

JULY 27, 2022

Rapid Medical , a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER 13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting in Toronto. The ability to tailor each procedure can provide new safety levels for higher-risk thrombectomies.

Medical 52

Medical FDA Recruitment Physicians 52

European Pharmaceutical Review

MAY 8, 2024

2 Driven by the success of FMTs with clinical efficacy in several indications 3-6 and the first two FDA-approved donor-derived products on the market for recurrent Clostridioides difficile infections, 7,8 a new and promising trend is emerging that combines the ‘whole ecosystem’ of FMTs with rational consortia design.

Manufacturing 69

Manufacturing Safety FDA Patients 69

pharmaphorum

OCTOBER 26, 2022

And just as a family business thrives on its connection to the community, Chiesi is committed to connecting to the global patient community. We try to have a very long-term orientation because we believe that aligns our objectives very well with the objectives of society and the patients we serve, and it makes us a stable business.”.

Patients 77

Patients Pharma Consulting Transportation 77

European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed.

Food and Drug Administration 79

Food and Drug Administration Manufacturing Safety Transportation 79

Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The first patient had a total haemoglobin level of 16.4 The first patient had a total haemoglobin level of 16.4 g/dL and 45.4% g/dL and 45.4%

Food and Drug Administration 105

Food and Drug Administration Engineering Patients Food 105

European Pharmaceutical Review

MAY 4, 2023

Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). 4 Amivantamab targets the extracellular portion of the EGFR and MET receptors.

Food and Drug Administration 92

Food and Drug Administration Safety Medicine Patients 92

pharmaphorum

NOVEMBER 29, 2022

NT-I7 is a homeostatic T cell growth factor composed of a covalently linked homodimer of an engineered Interleukin-7 (IL-7), biologically fused with the proprietary long-acting platform – hyFc®. It is worth noting that patients with r/r PaC or r/r MSS-CRC have very limited treatment options. Several combinations being studied.

Safety 104

Safety Patients Engineering Recruitment 104

Legacy MEDSearch

SEPTEMBER 1, 2022

eCential Robotics, a French growth MedTech company that designs and produces a system unifying 2D/3D imaging, surgical navigation and robotics, announced FDA 510(k) clearance of its 3D imaging, navigation and robotics guidance system, securing the penetration of its unified robotic platform in the United States. Securing the U.S.

FDA 52

FDA Recruitment Marketing Medical 52

Legacy MEDSearch

NOVEMBER 29, 2022

engine acts as a second reader to radiological technologists at point-of-care for image quality on every mammogram. generated image quality assessments while the patient is still in the exam room, and supports reduced technical recalls and improved mammography quality. The intelliMammo A.I. ” About Densitas ®.

Recruitment 98

Recruitment FDA Engineering Management 98

Medgadget

SEPTEMBER 29, 2023

This layer of specialized endothelium significantly restricts which drug molecules can enter the brain, normally greatly limiting treatment options for patients with brain-based disease. In addition, it isn’t sustainable to have patients in-hospital for months at a time seeking this type of treatment.

Medicine 106

Medicine Distribution Specialization Medical 106

PM360

JULY 13, 2023

Using this flexible platform, Ambrx is developing engineered precision biologics with site-specific, homogenous, and stable conjugation to overcome limitations of traditional ADC technologies. Cellectis is pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients.

Patients 98

Patients Engineering Side effects Leads 98

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 86

Manufacturing Pharma Food and Drug Administration Safety 86

European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The US Food and Drug Administration (FDA) further estimates that 97 percent of online pharmacies are operating illegally. About the author.

Medicine 92

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 92

European Pharmaceutical Review

MARCH 12, 2024

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. Joseph S Boakai (JSB): The three current trends are as follows: Increased scrutiny by regulatory bodies. What is an effective solution?

Government 89

Government Pharma Ethics Training 89

European Pharmaceutical Review

MARCH 6, 2023

On 6 January, a milestone was achieved—lecanemab gained US Food and Drug Administration (FDA) approval via the Accelerated Approval pathway. The application was accepted by the European Medicines Agency (EMA) on 26 January, signalling another significant breakthrough for both patients and experts working to address the disease.

Food and Drug Administration 75

Food and Drug Administration Safety Medicine FDA 75

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. Treatment with the mAbs delayed cognitive decline by 2.6 months for lecanemab and 5.5

Food and Drug Administration 78

Food and Drug Administration Safety Patients Leads 78

Medgadget

OCTOBER 17, 2023

Additionally, NeoCast is solvent-free which eliminates concerns related to the use of a solvent requiring management of patient pain (such as general anesthesia) and catheter compatibility. It is a potentially life-saving intervention that can rapidly stabilize a patient and serve as a bridge to definitive surgery for patients.

Medical 69

Medical Specialization Engineering Leads 69

Legacy MEDSearch

AUGUST 11, 2022

launch and first commercial use of OSSIOfiber ® Suture Anchors, expanding patient access to the company’s growing portfolio of bio-integrative implants for use in foot/ankle, shoulder, knee, hand/wrist and elbow surgery. OSSIO , Inc., a fast-growing orthopedic fixation technology company, announced the U.S. Gregory Berlet, M.D.,

Recruitment 52

Recruitment Marketing Safety Medical 52

pharmaphorum

NOVEMBER 3, 2022

Food and Drug Administration’s (FDA) draft guidance, “ Digital Health Technologies for Remote Data Acquisition in Clinical Investigations ”. We see how digital measures of adherence ensure that sample size calculations hold and drug developers can accurately evaluate the safety and efficacy of new molecules.

Pharma 80

Pharma Medicine Education Recruitment 80

European Pharmaceutical Review

FEBRUARY 24, 2023

The removal/separation of impurities and ensuring the purity of biologics is essential to the safety and quality of the therapeutic. Not only can impurities lead to adverse effects in patients, but they can also introduce product variability. References Kitazawa T, Shima M.

Food and Drug Administration 87

Food and Drug Administration Engineering Specialization Food 87

Impetus Digital

JUNE 8, 2022

In recent years, the biotech industry has been trending toward personalized medicine, which is a form of treatment that is tailored specifically for each patient. It used to take years for a drug to progress from laboratory research to FDA approval. Personalized Medicine. Agricultural Biotech.

Medicine 52

Medicine FDA Leads Distribution 52

pharmaphorum

DECEMBER 6, 2022

Clinical trials are the engine for pharmaceutical innovation, but their means of capturing and communicating data are stuck in the past. This unlocks opportunities for more trial sites and patients to participate in research – and speeds the research process to get critical treatments in the hands of patients sooner.

Electronics 98

Electronics Patients Medical Marketing 98

Pharmaceutical Technology

APRIL 26, 2023

Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The role of primary packaging has extended beyond the primary objectives of sterility, physical and chemical protection, and security.

Manufacturing 52

Manufacturing Medical Food and Drug Administration Pharmaceutical 52

pharmaphorum

AUGUST 19, 2022

Since DiMe’s launch in October 2019, there has been a 929% increase in the number of digital endpoints being used by the life sciences industry for the safety and efficacy of new drug development. DiMe is ready to help get data out of the cloud and into the hands of those who need it to improve patients’ lives.

Medicine 52

Medicine Healthcare Healthcare Ethics 52

Medgadget

MARCH 2, 2023

Moreover, due to the different nature of healthy and cancerous tissue, alpha radiation produced by Alpha DaRT sources diffuses about a millimeter into healthy tissue while penetrating at a diameter up to about five millimeters into tumors, providing an automatic safety mechanism. The rest of the patients had partial responses.

Manufacturing 83

Manufacturing Leads Patients Medicine 83