Evolve Your Success

OCTOBER 31, 2023

In this episode, Blake Williams takes us on a wild journey through his career as a Field Clinical Engineer (FCE), shedding light on the incredible impact of neuromodulation on the lives of patients. I am a field clinical engineer. People come from sales, clinical, and engineers. Nursing to engineering.

Engineering 130

Engineering Sales Medical sales Medical 130

European Pharmaceutical Review

JULY 13, 2023

By re-engineering existing approaches that have already shown clinical promise, there is potential to bring further benefit to the patient community in its fight against cancer. Since then, several next-generation antibodies have been engineered with modifications that enable them to better engage with immune cells.

Engineering 98

Engineering Food and Drug Administration Patients Safety 98

pharmaphorum

AUGUST 2, 2024

FDA has approved Adaptimmune's Tecelra for synovial sarcoma, the first engineered T-cell therapy for solid tumours

FDA 105

FDA Engineering 105

pharmaphorum

SEPTEMBER 28, 2022

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

FDA 135

FDA Medical Healthcare Provider Engineering 135

PharmaVoice

APRIL 4, 2024

As its FDA filing approaches, Verastem Oncology CEO Daniel Paterson wants to go from “The Little Engine That Could” to a major oncology player.

Engineering 147

Engineering FDA 147

pharmaphorum

OCTOBER 4, 2022

The FDA has approved Swiss pharmaceutical company Roche’s first companion diagnostic for identifying those patients with HER2 low-metastatic breast cancer who are eligible for ENHERTU. The post Roche gets FDA approval for HER2 breast cancer diagnostic appeared first on. HER2 is a receptor protein that accelerates cancer cell growth.

FDA 105

FDA Engineering Patients Pharmaceutical 105

pharmaphorum

FEBRUARY 2, 2024

The FDA is due to decide by 4th August whether to approve Adaptimmune’s afami-cel engineered T-cell therapy for advanced synovial sarcoma.

FDA 81

FDA Engineering 81

Pharmaceutical Technology

MAY 10, 2023

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. SYNB1934 has also gained rare paediatric disease designation (RPDD) from the FDA and orphan drug designation from the European Medicines Agency (EMA).

Food and Drug Administration 104

Food and Drug Administration FDA Engineering Medicine 104

Pharmaceutical Technology

AUGUST 12, 2022

The US Food and Drug Administration (FDA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat unresectable or metastatic non-small cell lung cancer (NSCLC) in adults. According to the interim efficacy data from a pre-specified patient cohort, a 5.4 In the trial, 1.9%

Food and Drug Administration 105

Food and Drug Administration FDA Safety Engineering 105

European Pharmaceutical Review

JUNE 11, 2023

The US Food and Drug Administration (FDA) has approved commercial production at Bristol Myers Squibb’s newest cell therapy manufacturing facility in Devens, Massachusetts. Each batch of engineered T cells is manufactured individually and infused back to the original cancer patient.

Manufacturing 105

Manufacturing Food and Drug Administration FDA Engineering 105

Legacy MEDSearch

OCTOBER 18, 2022

Axoft, a neurotechnology company, launched and announced FDA Breakthrough Device designation for its brain-machine interface (BMI) to better treat neurological disorders. The company secured $8 million in capital to fund pre-clinical studies with the FDA and to scale up prototypes of its neural implants “as soft as the brain.”

FDA 98

FDA Engineering Electronics Recruitment 98

Legacy MEDSearch

NOVEMBER 15, 2022

Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. “We are pleased to receive another FDA clearance that extends our reach into the orthopedic device market with our ever-growing suite of cleared bone-fixation devices,” said Tyber Medical CEO and President Jeff Tyber.

Medical 98

Medical FDA Food and Drug Administration Engineering 98

European Pharmaceutical Review

JUNE 16, 2023

The first and only CD20xCD3 T-cell engaging bispecific antibody ( BsAb ) for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) that is given for a defined period of time has been approved by the US Food and Drug Administration (FDA). What did the trial data show?

FDA 98

FDA Food and Drug Administration Engineering Food 98

Pharmaceutical Technology

JUNE 24, 2022

The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain. Earlier this month, the US FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0 recommending the EUA grant for Novavax’s NVX-CoV2373 for individuals aged 18 years and above.

Food and Drug Administration 105

Food and Drug Administration FDA Engineering Food 105

Pharma Marketing Network

MARCH 26, 2025

Misinformation and Hallucinations : Generative AI platforms may create content that is inaccurate, outdated, or off-labelviolating FDA regulations. Regulatory Guidance and Gray Areas Currently, guidance from regulatory bodies like the FDA, FTC, and EMA around AI in pharma marketing is limited but growing.

Marketing 64

Marketing Pharma Government Training 64

Legacy MEDSearch

FEBRUARY 8, 2023

market with a breakthrough FDA-Class II medical device, TargetCool. ” TargetCool was created by award-winning South Korean mechanical engineer, Dr. Gun-Ho Kim, who specializes in thermal engineering. Recens, Inc. “We truly believe that TargetCool will change the face of cooling,” Dr. Kim stated. Are you hiring?

Management 98

Management Medical Marketing FDA 98

European Pharmaceutical Review

JUNE 13, 2024

In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa. In December 2023, the FDA granted OCU400 Regenerative Medicine Advanced Therapy (RMAT) designation.

Manufacturing 145

Manufacturing Food and Drug Administration Engineering Safety 145

Pharma Marketing Network

MARCH 20, 2025

Multi-Channel Retargeting : Using platforms like search engines, social media, and programmatic ad networks expands reach and improves conversion rates. Marketers must ensure that their campaigns adhere to FDA, HIPAA, and GDPR guidelines to avoid legal complications. Frequency Capping : Overexposing users to ads can lead to fatigue.

Pharma 52

Pharma Networking Marketing Media 52

PharmaTech

MAY 4, 2024

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

Manufacturing 52

Manufacturing Engineering FDA Medicine 52

Legacy MEDSearch

JANUARY 10, 2023

a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, announced FDA approval of the newest generation of its tankless inhaled nitric oxide (iNO) delivery system. . Food and Drug Administration (FDA). VERO Biotech Inc., About GENOSYL ® DS. VERO Biotech Inc. Are you hiring?

FDA 98

FDA Food and Drug Administration Recruitment Management 98

Legacy MEDSearch

AUGUST 15, 2022

This is a crucial first step in our path to make the Maestro Brain Model the ‘engine’ in our navigation system supporting multiple new applications in the future. The ClearPoint® Neuro Navigation System has FDA clearance, is CE-marked, and is installed in over 60 active sites in the United States, Canada, and Europe. Are you hiring?

FDA 98

FDA Recruitment Safety Patients 98

Legacy MEDSearch

FEBRUARY 13, 2023

the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. Hyperfine, Inc.,

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Medical 98

Pharma Marketing Network

FEBRUARY 27, 2025

Using FDA-approved messaging and ensuring transparent disclaimers are critical in avoiding regulatory issues. Brands must adhere to HIPAA, FDA, and GDPR guidelines when collecting and using patient data. Programmatic advertising helps target HCPs, payers, and patients based on their interests and behavior. However, compliance is key.

Pharma 52

Pharma Marketing Prescription Education 52

European Pharmaceutical Review

FEBRUARY 13, 2023

These T cells are engineered to be able to recognise cancer cells. The engineered cells are grown in large numbers. In the case of ide-cel, the T cells are engineered to recognise a protein called BCMA. A type of white blood cells called T cells are removed from the patient through a vein.

Food and Drug Administration 116

Food and Drug Administration Engineering Safety Patients 116

European Pharmaceutical Review

MARCH 14, 2023

It will leverage Pfizer’s protein engineering and medicinal chemistry capabilities to advance Seagen’s ADC technology to unlock potential novel target combinations and next-generation biologics. Seagen has four of the twelve total US Food and Drug Administration (FDA)-approved and marketed ADCs using its technology industry-wide.

Food and Drug Administration 119

Food and Drug Administration Medicine Engineering Food 119

European Pharmaceutical Review

JULY 17, 2023

The $82 million project is funded by the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research. The research team will work with the FDA to make sure the pilot-scale system aligns to current good manufacturing practices (cGMP) and informs regulatory strategies.

Manufacturing 98

Manufacturing Food and Drug Administration Engineering Biopharma 98

PharmaTech

JANUARY 4, 2024

The FDA's Office of Combination Products recently finalized guidance emphasizing the critical role of human factors engineering (HFE) in the development of combination medical products. Eurofins Human Factors MD highlights the importance of a robust HFE program, stressing its necessity rather than being optional.

Engineering 40

Engineering Medical Training FDA 40

Legacy MEDSearch

JANUARY 18, 2023

Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year. For more information, please visit www.cytovale.com. Press Release by: Cytovale. Are you hiring?

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Medical 98

Infuse Medical

OCTOBER 22, 2024

By creating lifelike, three-dimensional models, 3D visualization enables developers, engineers, and stakeholders to see and interact with a device before it ever reaches the production line. This approach allowed them to perfect the design in just 7-10 iterations, ultimately speeding up the process of gaining FDA approval.

Medical 130

Medical Engineering Manufacturing Competition 130

Pharma Marketing Network

MARCH 18, 2025

Brand Authority: By appearing at the top of search engine results, pharmaceutical companies increase brand credibility among HCPs. Follow FDA and Regulatory Guidelines Ensure all PPC ads adhere to FDA, EMA, or MHRA regulations. Non-compliance can lead to penalties, reputation damage, and ad disapprovals.

Pharma 52

Pharma Marketing Networking Healthcare 52

pharmaphorum

OCTOBER 25, 2022

Earlier this year, the FDA rejected AZ’s application for Fasenra (benralizumab) as a treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) with a request for more data. Photo by engin akyurt on Unsplash. “We will continue to analyse the complete data set to share with the scientific community,” he added.

FDA 111

FDA Sales Biopharma Engineering 111

Pharmaceutical Technology

APRIL 11, 2023

The finding was made as part of a study published in the journal Nature Biomedical Engineering. Kelley added: “Engineering-based tools allow you to do things that open up new areas of biology. CTRL Therapeutics will file an application with the US Food and Drug Administration (FDA) to advance the new platform into clinical trials.

Food and Drug Administration 97

Food and Drug Administration Engineering Food Medical 97

PM360

AUGUST 29, 2022

Food and Drug Administration (FDA) and their international peers protect us all from ineffective, substandard, and even dangerous compounds, whether produced willfully by shady actors or by accident by those of high repute. The hurdles are there for good reason, of course.

Marketing 105

Marketing Food and Drug Administration Pharma Manufacturing 105

Pharmaceutical Technology

JUNE 2, 2023

It has been engineered to remove certain sugar molecules generally expressed on the antibody. Last December, the US Food and Drug Administration (FDA) also granted approval to Briumvi to treat RMS in adult patients. The therapy targets a unique epitope on CD20-expressing B-cells.

Food and Drug Administration 98

Food and Drug Administration Engineering Food Patients 98

Pharmaceutical Technology

APRIL 26, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation to IN8bio’s INB-400 and INB-410 to treat a range of malignant gliomas, including newly diagnosed glioblastoma multiforme (GBM). This marks the first-ever designation for genetically modified gamma-delta T cell therapies.

Food and Drug Administration 52

Food and Drug Administration FDA Engineering Food 52

PM360

JANUARY 24, 2025

The most prominent among them include: AI misinterpretation of critical information: As an example, a team might ask ChatGPT to answer a question, and the AI engine may deliver an impressive volume of information, while misaligning with the core business, leading to conclusions that are either overvalued or flat-out wrong.

Marketing 64

Marketing Pharmaceutical Pharma Sales pitches 64

Pharma Marketing Network

MARCH 5, 2025

So how can pharma brands maximize their return on investment (ROI) while ensuring compliance with FDA and HIPAA regulations ? The answer is simple search engines and social platforms are where patients and HCPs find information. The key lies in data-driven strategies, precise audience segmentation, and high-performing ad placements.

Pharma 52

Pharma Networking Medical Healthcare 52