pharmaphorum

JANUARY 18, 2021

The need for diversity in clinical trial populations has been a topic of discussion across regulators and the industry in general for decades. Fundamental barriers and deeply rooted mistrust of medical research motives among communities of colour require a more thoughtful and deliberate approach to participant outreach.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drug Trials 52

Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Production 52

FDA Law Blog

MAY 3, 2021

The “responsible party” is the sponsor or principal investigator of the trial. An “applicable clinical trial” is generally defined to mean any clinical trial (other than a device feasibility trial or a phase I drug trial) to collect data to support an FDA premarket submission, such as a New Drug Application or 510(k) premarket notification.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

pharmaphorum

AUGUST 4, 2020

Germany had the highest approval rate of orphan drugs at 98% – however most of these recommendations (73%) were awarded a ‘non-quantifiable benefit’ rating, the automatic rating for an orphan drug, which shows the regulator did not see any benefit compared to comparator products (see graph 1).

Drugs 122

Drugs Manufacturing Marketing Regulation 122

Drug Discovery World

FEBRUARY 20, 2023

The approval was based on results from the PROpel Phase III trial, however, the drug was rejected by UK regulator NICE because it requires expensive genetic testing. The post What are the top disease areas for clinical drug trials? appeared first on Drug Discovery World (DDW).

Drug Trials 52

Drug Trials Trials Clinical Trials Clinical Trials 52

FDA Law Blog

MAY 3, 2021

The “responsible party” is the sponsor or principal investigator of the trial. An “applicable clinical trial” is generally defined to mean any clinical trial (other than a device feasibility trial or a phase I drug trial) to collect data to support an FDA premarket submission, such as a New Drug Application or 510(k) premarket notification.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Regulation 40

XTalks

APRIL 26, 2021

Given the success of Oxford’s Phase II trial, the study investigators are now gearing up for a Phase III licensure trial to assess large-scale safety and efficacy in 4,800 children aged 5 to 36 months across four countries in Africa. Developing an efficacious vaccine against malaria has been a huge challenge.

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

The Pharma Data

AUGUST 16, 2020

The Medical School Council (led by the heads of UK medical schools) and the regulator, the General Medical Council, say they are putting plans in place to improve the situation. Hundreds of other UK medical students have signed petitions demanding teaching that better reflects the diversity of the country. Life-or-death signs.

Doctors 52

Doctors Doctor Medicine Drug Trials 52

Delveinsight

AUGUST 12, 2021

LQTT has a portfolio of in-licensed compounds from Sanofi that prohibit serum/glucocorticoid-regulated kinase 1, or SGK1. That kinase plays a role in inappropriate sodium regulation, a hallmark of arrhythmias like Long QT Syndrome.

Trials 97

Trials Clinical Trials Clinical Trials Regulation 97

Placebo Control

JULY 31, 2013

Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “ fake fix ” that was being thoroughly “ignored” by the pharmaceutical industry. Pharma: breaking the law in broad daylight?

Pharma Companies 40

Pharma Companies Trials Compliance Clinical Trials 40

The Pharma Data

MAY 17, 2021

Regeneron resumes enrollment in lymphoma drug trials ( Reuters ). Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ). EU Medical Device Regulation May Spur Litigation Uptick ( Law360 ). Trump tax law cut what US drugmakers owed. BioPharmaDive ).

Trials 52

Trials Vaccination Vaccine Scientist 52