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.

Food and Drug Administration 77

Food and Drug Administration Manufacturing Safety Transportation 77

European Pharmaceutical Review

JUNE 29, 2023

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. 1 Nitrosamines are not new or unknown impurities.

Food and Drug Administration 84

Food and Drug Administration Manufacturing Food Medicine 84

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). Why are bispecific monoclonal antibody drugs such as amivantamab promising for this indication?

Food and Drug Administration 90

Food and Drug Administration Safety Patients Medicine 90

European Pharmaceutical Review

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Tanzini et al.

Food and Drug Administration 71

Food and Drug Administration Manufacturing Pharma Pharmaceutical 71

European Pharmaceutical Review

DECEMBER 22, 2022

The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category” The term ‘mRNA’ has become commonplace globally. The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category.

Medicine 104

Medicine Food and Drug Administration Transportation Distribution 104

Pharmaceutical Technology

JUNE 8, 2023

While the company previously shared interim biomarker and safety data from the Phase I/II AEROW trial (NCT05248230) in November 2022, the update features further results detailing the drug’s effects on quality-of-life and spirometry-measured outcomes in a limited set of patients.

Patients 98

Patients Food and Drug Administration Food Safety 98

European Pharmaceutical Review

JUNE 27, 2023

difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. This followed results from a large metagenomics study published in November 2022, in which gut microbiome was identified as a key part of Parkinson’s pathogenesis.

Food and Drug Administration 97

Food and Drug Administration Manufacturing Medicine Pharma 97

Legacy MEDSearch

JULY 21, 2023

This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration). Food and Drug Administration (FDA) for UroActive. Aurélien Beaugerie and Dr. Christophe Vaessen.

Food and Drug Administration 52

Food and Drug Administration Patients Safety Recruitment 52

Pharmaceutical Technology

APRIL 13, 2023

Overview of last year’s DCT activity North America dominates DCT landscape Analysis by GlobalData [3] shows that North America dominates industry and non-industry DCTs, with a total of 4,117 trials as of September 2022. Values for North America are particularly high due to the highest revenue pharmaceutical corporations being based in the US.

Food and Drug Administration 52

Food and Drug Administration Electronics Healthcare Healthcare 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. Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 84

Manufacturing Pharma Food and Drug Administration Safety 84

Nixon Gwilt Law

APRIL 22, 2024

The rule aims to regulate and enhance the transparency, effectiveness, and safety of predictive DSIs used in healthcare settings, ensuring that these technologies are developed and managed responsibly. In a recent blog post, the FTC illustrated how an AI company’s TOUs and PPs might lead to enforcement action.

Healthcare 52

Healthcare Healthcare Training Food and Drug Administration 52

European Pharmaceutical Review

JANUARY 16, 2023

This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. Regulation, particularly Annex 1, was identified as a key focus for 2022.

Pharmaceutical 126

Pharmaceutical Food and Drug Administration Manufacturing FDA 126

Pharmaceutical Technology

SEPTEMBER 14, 2022

This week, at the European Society of Medical Oncology (ESMO) Congress 2022 researchers presented encouraging updates on immunotherapies in the field of cervical cancer. Opdivo is a programmed cell death receptor-1 (PD-1) inhibitor approved by the US Food and Drug Administration (FDA) for the treatment of several cancers.

Food and Drug Administration 59

Food and Drug Administration Patients FDA Pharmaceutical 59

European Pharmaceutical Review

MAY 4, 2023

Adjuvanted vaccine Arexvy has been approved by the US Food and Drug Administration (FDA). In November 2022, GSK announced the European Medicines Agency (EMA) had validated a marketing authorisation application (MAA) under accelerated assessment for its RSV vaccine. percent.

Food and Drug Administration 85

Food and Drug Administration Safety FDA Food 85

European Pharmaceutical Review

JULY 13, 2023

A new therapeutic antibody class, bispecific antibodies, was engineered to build on the classic antibody design and bind to two different proteins, demonstrating how incremental changes in protein design can lead to entirely new therapies. 3 The CARs recognise and bind to proteins on the surface of cancer cells, effectively killing them.

Engineering 86

Engineering Food and Drug Administration Safety Patients 86

European Pharmaceutical Review

JANUARY 25, 2023

Clinical trials for exa-cel The ongoing Phase I/II/III open-label trials, CLIMB-111 and CLIMB-121, are designed to assess the safety and efficacy of a single dose of exa-cel, the CRISPR-based medicine, in patients ages 12 to 35 years with TDT or with SCD, respectively. Costs and profits worldwide are shared with CRISPR Therapeutics.

Medicine 102

Medicine Food and Drug Administration FDA Pharmaceutical 102

European Pharmaceutical Review

FEBRUARY 14, 2023

A key benefit of mRNA therapeutics is that manufacturing time is fast compared to antibodies or protein-based drugs. 2 Yet according to a 2022 report by GlobalData, it is difficult to achieve high quality and highly pure mRNA via scalable manufacturing.

Food and Drug Administration 89

Food and Drug Administration Medicine Safety Consulting 89

Legacy MEDSearch

MARCH 13, 2023

Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal ® Closure Device System. and Europe.

Medical 98

Medical FDA Food and Drug Administration Recruitment 98

Pharmaceutical Technology

DECEMBER 11, 2022

The US Food and Drug Administration (FDA) has granted Fast Track designation for Pfizer and BioNTech’s messenger ribonucleic acid (mRNA)-based combination vaccine candidate against Covid-19 and influenza. The vaccine is intended to prevent two respiratory ailments through a single injection. 5 Omicron sublineages spike proteins.

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FDA Food and Drug Administration Food Safety 115

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. No serious adverse events were reported.

Food and Drug Administration 88

Food and Drug Administration Manufacturing Safety Pharmaceutical 88

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.

Food and Drug Administration 76

Food and Drug Administration Safety Patients Leads 76

Evolve Your Success

MAY 17, 2022

You know when they are trying to push a drug and white-knuckling it. You ask the hospital administrators to figure out the financial aspects of that side of it. What drugs are we using? This office or rep prescribed this drug and this is what I want you to know about this drug.”. You do not even have to say it.

Medical sales 52

Medical sales Medical Sales Patients 52

pharmaphorum

JANUARY 30, 2023

One of the reasons is the most evident: the winter months often lead to greater need for antibiotics, and that can lead to shortages. For its part, the US Food and Drug Administration (FDA) posted its drug shortage list , which contains various formulations of amoxicillin that are limited in supply.

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Food and Drug Administration Medicine Manufacturing Pharmaceutical 92

Medico Reach

OCTOBER 17, 2022

from 2022 to 2030. However, this can lead to several issues, such as: Implantation resistance due to reactionary metabolism Allergic reactions to the nickel component found in stainless steel composites Widespread bone destruction due to immunological responses to cobalt particles. The US-based Enovis is leading this new development.

Medical 98

Medical Food and Drug Administration Healthcare Healthcare 98

European Pharmaceutical Review

DECEMBER 16, 2022

The gene therapy was recently approved by the US Food and Drug Administration (FDA). The trial is an ongoing, multinational, open-label, single-arm study evaluating the safety and efficacy of etranacogene dezaparvovec. IU/yr/participant (from lead-in period to months 13-18). Summer 2022 haemophilia trial update.

Food and Drug Administration 83

Food and Drug Administration Safety Patients Leads 83

Medico Reach

OCTOBER 17, 2022

from 2022 to 2030. However, this can lead to several issues, such as: Implantation resistance due to reactionary metabolism Allergic reactions to the nickel component found in stainless steel composites Widespread bone destruction due to immunological responses to cobalt particles. The US-based Enovis is leading this new development.

Medical 52

Medical Food and Drug Administration Healthcare Healthcare 52

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. Proteus’s profile grew considerably; it was soon valued at $1.5

Food and Drug Administration 122

Food and Drug Administration FDA Medicine Patients 122

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. Being a cellular therapy that involves cell manipulation and molecular transfection – and above all, being a living drug – makes CAR T-cell therapy a somewhat challenging immunotherapy to manufacture in‑house.

Manufacturing 82

Manufacturing Food and Drug Administration Patients Pharma 82

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted Centessa Pharmaceuticals’ activated Protein C (APC) inhibitor SerpinPC a fast track designation for treating haemophilia B. SerpinPC causes the inhibition of coagulation factor XIV, which leads to an increase in thrombin production, speeding up the clot formation process.

FDA 59

FDA Food and Drug Administration Prospecting Food 59

Pharmaceutical Technology

APRIL 25, 2023

A few months later, the board of the nonprofit Vaccine Alliance Gavi approved an initial investment of nearly $160 million, to be given between 2022 and 2025, to support the rollout of the malaria vaccine in GAVI-eligible countries. However, making sure the vaccine reaches everyone can be challenging due to the storage requirements.

Food and Drug Administration 69

Food and Drug Administration Government Prospecting Food 69