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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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. There are no shortcuts in drug development, and nor should there be.

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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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Food and Drug Administration Engineering Food Medical 97

European Pharmaceutical Review

AUGUST 1, 2022

The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team. The US Food and Drug Administration (FDA) recently published a new draft guidance to support companies in enrolling more ethnically diverse trial populations. .

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Food and Drug Administration Medical Medicine Engineering 122

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

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

Legacy MEDSearch

NOVEMBER 15, 2022

Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. “Our product design and engineering team developed a superior method for staple implantation that enhances surgical efficiency.

Medical 98

Medical FDA Food and Drug Administration Engineering 98

Legacy MEDSearch

FEBRUARY 13, 2023

Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care.

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Food and Drug Administration FDA Recruitment Medical 98

European Pharmaceutical Review

OCTOBER 20, 2022

An essential part of the manufacturing of drug products is the use of water of different degrees of purity. In particular, purified water and WFI are critical when producing sterile pharmaceutical drug products. The difference is that purified water can be used for non-parenteral drugs, while WFI must be used for parenteral drugs.

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Food and Drug Administration Pharma Manufacturing Pharmaceutical 98

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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Pharmaceutical Technology

FEBRUARY 14, 2023

It will also support smaller dose vials development, selection of strain as per the US Food and Drug Administration (FDA) recommendations, and transition to the commercial market. It was developed using the recombinant nanoparticle technology of Novavax.

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Food and Drug Administration Government FDA Engineering 64

Pharmaceutical Technology

MARCH 8, 2023

The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products. Currently, there are six CAR T cell therapies that received approval from the US Food and Drug Administration (FDA) and approximately 560 programmes in ongoing studies.

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Food and Drug Administration Manufacturing Engineering Food 97

European Pharmaceutical Review

JULY 11, 2023

This news follows the US Food and Drug Administration (FDA)’s approval of the anti-cancer treatment last month. The T-cell-engaging BsAb is engineered to have one region that binds to CD3 and two regions that bind to CD20, which can be healthy or malignant.

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Food and Drug Administration Engineering FDA Food 75

Pharmaceutical Technology

APRIL 20, 2023

Biopharmaceutical company Abdera Therapeutics has raised $142m in combined Series A and B financing to engineer and advance antibody-based radiopharmaceuticals to treat cancer. The Series A financing round was led by Amplitude Ventures and Versant Ventures, with Northview Ventures, AbCellera and adMare BioInnovations as participants.

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Food and Drug Administration Engineering Food Leads 52

Pharmaceutical Technology

JUNE 21, 2023

In the past year, Hemgenix has been granted approval by the US Food and Drug Administration (FDA) and has received conditional marketing authorisation from the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

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Patients Food and Drug Administration Sales Marketing 98

Pharmaceutical Technology

JUNE 5, 2023

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. Social engineering attacks will rise, in addition to phishing, smishing and deepfake attacks.

Pharma 110

Pharma Food and Drug Administration Insurance Pharmaceutical 110

Legacy MEDSearch

JANUARY 10, 2023

Food and Drug Administration (FDA). GENOSYL DS is a tankless and portable system engineered with redundant backup features, which delivers a constant concentration of inhaled nitric oxide gas to patients with an easy-to-use interface and portability features. About GENOSYL ® DS.

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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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Food and Drug Administration FDA Safety Engineering 52

European Pharmaceutical Review

AUGUST 31, 2023

In addition, radionuclide therapy has the potential to achieve high efficacy rates since the administered drugs spare surrounding healthy tissue, thus, reducing the burden on the patient. 1-4 Besides these drug products, several companies worldwide are developing radiotheranostics in clinical trials built on various radionuclides.

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Food and Drug Administration Manufacturing Safety Transportation 97

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. Lecanemab is a humanised antibody generated using protofibrils engineered from Aβ harbouring genetic mutations that cause familial AD.

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Food and Drug Administration Safety Medicine Pharmaceutical 96

European Pharmaceutical Review

OCTOBER 27, 2022

Taysha develops and commercialises drug therapies for rare and large-market indications such as monogenic central nervous system (CNS) diseases. These innovative drugs offer potential for better, more effective treatments for Rett syndrome and GAN. It is in Phase I/II clinical development and awaiting regulatory feedback.

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Food and Drug Administration Engineering FDA Food 52

European Pharmaceutical Review

FEBRUARY 24, 2023

The risks linked to contamination have led regulatory bodies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to implement strict requirements on process characterisation and validation. 1 eg, emicizumab uses this ART-lg platform. eg zenocutuzumab (MLCA-128).

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European Pharmaceutical Review

JULY 26, 2024

More about the gene therapy The one-time gene therapy contains a “bio-engineered adeno-associated virus (AAV) capsid and a high-activity variant of human coagulation FIX gene”, Pfizer shared. DURVEQTIX was approved by the US Food and Drug Administration (FDA) for haemophilia B as BEQVEZ TM in April this year.

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Food and Drug Administration Engineering Food Patients 52

European Pharmaceutical Review

JULY 18, 2024

What are antibody-drug conjugates and why do they hold potential over other treatment modalities? Antibody drug conjugates (ADCs) are an emerging technology adding significant value to the oncology treatment landscape. Antibody drug conjugate: the “biological missile” for targeted cancer therapy. References Fu et al.

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European Pharmaceutical Review

MAY 4, 2023

Why are bispecific monoclonal antibody drugs such as amivantamab promising for this indication? 2, 3 The treatment was engineered to simultaneously bind with high affinity and inhibit both EGFR and MET, which are two important pathways in NSCLC development and progression. What are the current trends in antibody therapeutics?

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Food and Drug Administration Safety Patients Medicine 98

Pharmaceutical Technology

NOVEMBER 29, 2022

These viruses are engineered genetically for killing cancer. The researchers plan to seek the US Food and Drug Administration approval to commence clinical trials of the viral platform comprising chemokines and cetuximab, in humans. GBMs are called “cold” tumours as they lack helpful immune cells.

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Food and Drug Administration Engineering Food Medical 52

Pharmaceutical Technology

JUNE 9, 2023

The US Food and Drug Administration (FDA) has granted approval to commence commercial production at Bristol Myers Squibb’s new advanced cell therapy manufacturing facility in Devens, Massachusetts. Each engineered T cell batch is manufactured separately and infused back into the cancer patient.

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Food and Drug Administration FDA Manufacturing Engineering 52

Pharmaceutical Technology

SEPTEMBER 22, 2022

The merged business will focus on the advancement of Charisma's cell therapy platform, which leverages engineered macrophages and monocytes to transform the way cancers and other serious ailments are treated. . Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Food and Drug Administration Engineering Food Leads 52

Legacy MEDSearch

SEPTEMBER 11, 2023

Food and Drug Administration has cleared the Zeta Cranial Navigation System, its mixed reality surgical navigation system. Zeta’s computer vision engine ensures maintained accuracy by automatically registering multiple times a second, accounting for patient movement. To learn more, visit: www.zetasurgical.com.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

JUNE 30, 2023

Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). ” CHG leverages Cresilon’s in-house manufacturing capabilities, advanced engineering, and focused research teams. CHG is for prescription use only.

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FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

NOVEMBER 2, 2023

Food and Drug Administration (FDA) to market the SOLACE Sacroiliac Fixation System with proprietary NANOACTIV surface technology and compatibility with StealthStation ® Navigation. The SOLACE Sacroiliac Fixation System consists of 3D printed, threaded implants ranging 10.5mm or 12.0mm in diameter and 30mm to 115mm in length.

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Medical FDA Food and Drug Administration Recruitment 52

Pharmaceutical Technology

FEBRUARY 28, 2023

It was engineered with an Fc-silent IgG1 isotype to avoid activation of Fc-receptor-mediated non-specific immune. Biocytogen Pharmaceuticals president and CEO Dr Yuelei Shen said: “Chipscreen Biosciences and Chipscreen NewWay have extensive experience in clinical drug development and commercialisation.

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European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. What are three current key trends in data integrity? Ensuring data integrity in the life science industry is crucial for regulatory compliance.

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Legacy MEDSearch

MAY 30, 2023

Food and Drug Administration (FDA). About Sagentia Innovation Sagentia Innovation is a science and engineering R&D consultancy based in Cambridge, U.K. THINK Surgical, Inc., The TMINI system includes a wireless robotic handpiece that assists surgeons in performing total knee replacement.

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Legacy MEDSearch

JULY 21, 2023

Food and Drug Administration). Food and Drug Administration (FDA) for UroActive. Designed by urologists and collaborating scientists and engineers, UroActive intends to provide a new standard of care combining safety, efficacy, durability and ergonomics fitting any individual’s lifestyle and anatomy.

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Food and Drug Administration Patients Safety Recruitment 52

European Pharmaceutical Review

NOVEMBER 15, 2022

Since their outset the GAMP guides have promoted using a balanced risk-based pragmatism to achieve compliance and the July 2022 release of GAMP 5 second edition strongly encourages the use of critical thinking to support that.

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Manufacturing Pharma Food and Drug Administration Safety 98

Pharmaceutical Technology

APRIL 5, 2023

More than a decade after the first patient was treated with a CAR-T therapy, six therapies relying on the same principles have been approved by the US Food and Drug Administration (FDA) and marketed to thousands of patients. Exa-cel is almost certainly going to the first CRISPR engineered product [to be approved].

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