European Pharmaceutical Review

FEBRUARY 24, 2023

Figure 1 : Use of net charge differences between the target molecule and impurity over a range of pH to accomplish separation using AEX. Figure 1 illustrates the use of net charge differences between the target molecule and impurity over a range of pH conditions to accomplish separation using AEX. 2020;111(1):20-30.

Food and Drug Administration 85

Food and Drug Administration Engineering Specialization Food 85

pharmaphorum

JULY 8, 2022

A variety of digital and sensor technologies have been developed for use in clinical trials to allow the collection of high-quality, reproducible data and provide trialists with real-time insights (Table 1). Table 1: Digital and sensor technology available for use in clinical trials. About the author.

Pharma 74

Pharma Patients FDA Marketing 74

European Pharmaceutical Review

MARCH 14, 2023

CJEU ruling in the Bristol Myers Squibb case (CJEU judgment of 11 July 1996 in joined cases C-427/93, C-429/93 and C-436/93) 1 is noteworthy. About the authors Andrzej Siwiec is Attorney-at-Law, Partner at DBS Law Firm, Kraków, Poland. Case C-224/20 Merck Sharp & Dohme BV and Others v Abacus Medicine A/S and Others [2022].

Medicine 82

Medicine Marketing Distribution Pharmaceutical 82

European Pharmaceutical Review

FEBRUARY 23, 2023

This may represent an area where regulatory requirements could be swiftly developed with dual impact to industry and health authorities. Regulatory agencies and health authorities may start to encourage greater end-to-end automation in the near future. 1 Concurrently, the field of microbial systematics continues to change.

Pharmaceutical 94

Pharmaceutical Management Manufacturing Recruitment 94

European Pharmaceutical Review

JANUARY 16, 2023

Regulation, particularly Annex 1, was identified as a key focus for 2022. Clearly the number one challenge in 2022, as mandated by the EU GMP Guidelines for the Manufacture of Sterile Medicinal Products Annex 1 1 , is the development of a Contamination Control Strategy (CCS),” Tony Cundell noted.

Pharmaceutical 126

Pharmaceutical Food and Drug Administration Manufacturing FDA 126

Pharmaceutical Technology

NOVEMBER 22, 2022

Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. The live attenuated vaccine was authorized by the EMA and FDA five years later in 2019 — half the time than normal. Devex’s global COVID-19 funding dashboard recorded $172 million invested in vaccine research between 1 January 2020 and 27 June 2020.

Manufacturing 52

Manufacturing Government FDA Safety 52

European Pharmaceutical Review

FEBRUARY 14, 2023

Initially developed to treat viral infections, mRNA vaccines deliver a piece of genetic material that instructs the body to make a protein fragment of a target pathogen (such as a virus), which the immune system recognises and remembers 1 to respond to when exposed to the pathogen in the future. Internet], Ethris, [cited 2023Jan].

Food and Drug Administration 90

Food and Drug Administration Medicine Safety Consulting 90

World of DTC Marketing

DECEMBER 10, 2020

Its authors, from Memorial Sloan Kettering and the Oregon Health and Science University, used annual financial disclosures from the Securities and Exchange Commission for companies that had only one cancer drug approved but had on average three or four other drugs in development. Only two drugs had research costs over $1 billion.

Insurance 181

Insurance Pharma Manufacturing Retail 181

European Pharmaceutical Review

DECEMBER 11, 2023

1 However, research related to RNA therapeutics has also consistently reinforced limitations that drug developers are steadfastly working to address – primarily that delivery of most RNA therapies has thus far been limited to the liver and unable to target other tissues in the body. He has previously held roles at Genentech, Merck & Co.,

Pharmacology 83

Pharmacology Safety Engineering Medical 83

Clarivate

OCTOBER 7, 2021

KEYNOTE-716 shows a clinical benefit with adjuvant immunotherapy in resected stage IIB-C malignant melanoma 1. Context: In August 2021, Merck & Co. Treatment-related adverse events commonly associated with anti-PD-1 therapy occurred, with the vast majority being immune-related adverse events (endocrine toxicities).

Patients 91

Patients Safety Marketing Physicians 91

European Pharmaceutical Review

FEBRUARY 28, 2024

The implementation of the EU’s Health Technology Assessment Regulation (HTAR) 1 will play a key role in shaping the patient access pathway for ATMPs such as cell and gene therapies. Prior to that, he worked at Merck Serono, Kyphon (now known as Medtronic) and spent several years with the Italian HTA agency Agenas.

Patients 77

Patients Ethics Healthcare Healthcare 77

European Pharmaceutical Review

NOVEMBER 10, 2022

Complex medicines will become as important as traditional small molecule drugs in the coming years, with market values of hundreds of billions of pounds 1. Figure 1 ). Figure 1 ). Figure 1 : The proposed Medicines Discovery Catapult classification of complex medicines. About the authors.

Medicine 96

Medicine Distribution Engineering Electronics 96

Clarivate

DECEMBER 1, 2021

50% in the EMPEROR-Preserved clinical trial 1. 50% (considered “True HFpEF” by many clinicians, according to the study authors), reducing the risk of the primary endpoint (a composite of CV death or hospitalization for heart failure [HHF]) by 17% (P = 0.0244).

Safety 52

Safety Patients Management Marketing 52

pharmaphorum

NOVEMBER 6, 2022

Here are a few examples on how companies are using AI in diverse ways to accelerate antibody discovery: 1) Generate Biomedicine : Founded in 2018, it is a flagship pioneering company based in Boston and has raised $420M so far. About the Author. In August 2021, Genentech acquired Prescient Design.

Biopharma 105

Biopharma Pharma Training Leads 105

pharmaphorum

JULY 8, 2022

Now, it’s turning its attention to other big pharma groups, including Abbott Laboratories, Merck & Co and reportedly also Bristol-Myers Squibb. The authors take aim at what they claim is 27 price rises for the drug since it was introduced, resulting in a 470% hike in the annual cost to almost $78,000.

Sales 57

Sales Pharma Distribution Prescription 57