European Pharmaceutical Review

AUGUST 2, 2024

The US Food and Drug Administration (FDA) has granted accelerated approval for the cell therapy TECELRA ® (afamitresgene autoleucel) to treat adults with unresectable or metastatic forms of the disease. The post FDA approves innovative engineered cell therapy appeared first on European Pharmaceutical Review.

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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.

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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.

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pharmaphorum

AUGUST 2, 2024

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

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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.

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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.

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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.

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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).

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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%

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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.

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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.

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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.

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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.

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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?

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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.

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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.

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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?

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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?

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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.,

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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.

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Pharmaceutical Technology

APRIL 17, 2023

argenx engineers antibodies for therapeutic use in its Immunology Innovation Program (IIP). Argenx also has three Fc engineering technologies (NHANCE, ABDEG and POTELLIGENT) that it uses to expand its antibody portfolio. Vyvgart is also the first FDA-approved neonatal Fc receptor (FcRN) antagonist.

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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.

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Pharma Marketing Network

APRIL 9, 2025

Face-to-face HCP visits dwindled, patients turned to search engines for symptom answers, and telehealth became the norm. SEO and Content Strategy Search engines remain a key source of medical information. Pharma brands were forced to adapt rapidly. Now, there’s no turning back. Transparency and fair balance remain non-negotiable.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Legacy MEDSearch

AUGUST 22, 2022

Food and Drug Administration (FDA) has granted 510(k) clearance to the MedWand,” shared MedWand CEO and Co-Founder, Robert Rose. “As With FDA clearance, clinicians and patients everywhere can trust MedWand’s vitals and remote examination tools, and experience telemedicine on an entirely new level.” MedWand Solutions, Inc.

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Pharma Leaders

JUNE 27, 2023

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) submitted by Pfizer for haemophilia B gene therapy, fidanacogene elaparvovec.

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European Pharmaceutical Review

OCTOBER 17, 2023

Authorisation by the EMA was preceded by the US FDA approving the treatment in June 2023. It is engineered to have one region that binds to CD3 and two regions that bind to CD20. It also suggests that glofitamab can provide patients with longer survival time and have longer before the disease progresses. What is glofitamab?

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PharmExec

NOVEMBER 9, 2023

Adzynma is the first approved genetically engineered protein product for the treatment of patients with congenital thrombotic thrombocytopenic purpura.

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