European Pharmaceutical Review

MARCH 9, 2023

There are emerging trends in oncology, with new chemical entities (NCEs) and antibody-drug conjugates (ADC) leading to increased demand for HPAPI manufacturing capabilities. Based on the latest report and data, HPAPI market size is expected to reach $32 billion by 2028. What training is required for employees to handle HPAPIs safely?

Safety 98

Safety Pharmacology Training Manufacturing 98

European Pharmaceutical Review

NOVEMBER 28, 2024

This dual-layer certification process can create significant delays, as each framework involves extensive assessments for safety and performance under separate requirements specific to medical device and AI-specific criteria.

Government 105

Government Medical Safety Management 105

European Pharmaceutical Review

NOVEMBER 1, 2023

It is one of the leading causes of death associated with AMR globally. Using this approach, our lead programme – RVX 001, a protein-based vaccine against invasive pneumococcal disease – has been designed with antigens common to all pneumococcus serotypes. AMR has the potential to be just as devastating for the world as COVID-19.

Safety 115

Safety Marketing Manufacturing Leads 115

European Pharmaceutical Review

FEBRUARY 14, 2023

Robust analytical methods are needed to establish safety, potency, and purity of mRNA therapeutics in large-scale manufacturing. Sarah Bundra, Pharmaceutical Analyst at GlobalData also warned about patient safety: “introducing mRNA carries the risk of activating the immune system.”

Food and Drug Administration 105

Food and Drug Administration Medicine Safety Consulting 105

Medico Reach

OCTOBER 17, 2022

million by 2028. 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

Pharmaceutical Technology

AUGUST 16, 2022

In 2019, Daiichi Sankyo entered a global development and commercialisation agreement with AstraZeneca for Daiichi Sankyo’s lead antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), in a deal worth $6.9bn. GlobalData estimates that global annual sales for datopotamab deruxtecan in the NSCLC setting will exceed $500m in 2028.

Food and Drug Administration 59

Food and Drug Administration Sales Patients Food 59

Pharmaceutical Technology

DECEMBER 16, 2022

GnRH antagonists have an improved safety and efficacy profile compared to the marketed GnRH agonists, which have significant side effects that are unappealing to patients. This therapy is currently in Phase II development and is expected to launch in the US and 5EU in 2027 and 2028, respectively.

Marketing 59

Marketing Side effects Sales Safety 59