pharmaphorum

MAY 26, 2022

Racial disparities are still commonplace in many clinical trials with white-ethnic groups often overrepresented amongst trial participants. Inadequate clinical trial representations of all populations can therefore leave underrepresented groups vulnerable due to the lack of subgroup-specific data.

Clinical Trials 138

Clinical Trials Clinical Trials Trials Medicine 138

pharmaphorum

OCTOBER 28, 2020

Data defines modern therapeutics, but this is almost uniquely confined to the clinical trial stages of drug development. Identifying, recruiting, retaining and monitoring patients during this part of the cycle is estimated to cost pharma US$19 billion a year as companies seek to harvest patient experiences. The way back.

Medicine 119

Medicine Pharma Companies Vaccination Vaccine 119

pharmaphorum

DECEMBER 21, 2020

A year ago, the names Moderna and BioNTech were known mainly to those who followed biotech and pharma dealings. But the tragic events of 2020 have meant these companies have become household names as their trailblazing mRNA vaccines became the first to be approved by regulators against the COVID-19 scourge.

Vaccination 91

Vaccination Vaccine Doctors Doctor 91

Drug Discovery World

MARCH 29, 2023

Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care). What are the rNPV effects of forcing pharma companies to pursue new indications requested by third parties, and of opening up the authorisation process to third parties?

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

Drug Discovery World

APRIL 20, 2023

Regulators are therefore used to seeing cognitive data as primary or secondary outcomes in clinical trials, and are familiar with the instruments and methodological nuances of such data. However, to invest in drug development for this condition, a number of methodological issues will need to be addressed. depression).

Development 98

Development Drugs Clinical Trials Clinical Trials 98

Drug Discovery World

MAY 6, 2024

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. The city is host to many innovative biotech companies, including relative newcomers Orexa, a company that recently launched its first Phase II clinical trial.

Drugs 59

Drugs Life Science Gene Editing Gene 59

XTalks

DECEMBER 29, 2022

In 2022 alone, the US regulator approved four new gene therapies, showing the high interest in getting these therapies to market. It has also been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the US regulator for both SCD and TDT.

Life Science 52

Life Science Gene Therapy Gene Manufacturing 52

Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines.

Packaging 52

Packaging Packaging Drugs Containment 52

pharmaphorum

APRIL 1, 2021

In the past couple of years, Turbine worked with a number of big pharma companies, including Bayer, and has also started building its own pipeline, including a target delivering new biological insight in PARP inhibitor resistance. “We There’s not really a well-developed ecosystem of biotech funding and spin-out companies.

Bioinformatics 103

Bioinformatics Drugs Development Scientist 103

pharmaphorum

AUGUST 4, 2020

Shares in Redx Pharma were soaring this morning after it licensed its preclinical fibrotic disease drug RXC006 to AstraZeneca. The company’s shares were valued as high as 95p on the London Stock Exchange following the announcement, the highest they had been since 2015.

Drugs 90

Drugs Clinical Trials Clinical Trials Pharma Companies 90

pharmaphorum

DECEMBER 7, 2020

Bureaucracy, political upheaval, and lack of regulations continue to make Latin America a difficult market for European and North American pharma to enter – and COVID-19 has only worsened these issues. For example, price regulations are becoming more common in Latin America, often being based on models such as NICE’s.

Marketing 90

Marketing Regulation Production Medicine 90

XTalks

SEPTEMBER 5, 2023

Investigation of the possibility of VAED is crucial during clinical trials for decision-making on vaccine licensing by regulatory agencies. In the majority of cases, the risk of VAED is brought to light during preclinical stages or early clinical trial phases.

Vaccination 96

Vaccination Vaccine Development Clinical Trials 96

pharmaphorum

MAY 21, 2021

It builds on the company’s four partnership projects: two with the generics and biosimilars firm Hikma, one with US biotech Inhibrix and another with an unnamed biosimilars partner. Regulators may not require the large phase 3 trials needed to approve completely new drugs, as safety is proven.

Insulin 52

Insulin Drugs Production Marketing 52

XTalks

MARCH 22, 2023

While not a record-breaking deal at $17 billion, the buyout strengthened Pfizer’s injectables business unit with the company reporting an 11 percent increase in revenue the following year. In addition, these drugs can be more complex to develop and push through the clinical trials process, causing R&D costs to add up quickly.

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

The Pharma Data

DECEMBER 30, 2020

The reason for this is still not understood and many regulators may want it to be explained before authorizing it for broader use. In early December 2019, they presented full data at the 12th Clinical Trials on Alzheimer’s Disease (CATD) conference. Johnson & Johnson’s COVID-19 vaccine.

Vaccination 52

Vaccination Vaccine Gene Therapy Trials 52