Drug Discovery World

NOVEMBER 3, 2023

News round-up for 30 October – 3 November by DDW Editor Reece Armstrong My news highlights this week feature a variety of exciting clinical trial results and launches that are examining therapies for much-needed disease areas, new drug approvals and even a space mission with a pharma twist.

Drugs 52

Drugs Gene Therapy Clinical Trials Clinical Trials 52

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

Clinical Trials 100

Clinical Trials Clinical Trials Trials Clinical Research 100

FDA Law Blog

MAY 3, 2021

On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a). 42 C.F.R. §§ 11.10, 11.44(a).

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease. Malaria Vaccine Phase II Trial.

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Vaccination Vaccine Immune Response Trials 105

Drug Discovery World

FEBRUARY 20, 2023

Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, according to a recent report by analytics company Phesi. efficacy in symptomatic Covid-19 adults and 72% efficacy in Omicron cases in the Phase III trial VAT08 in over 13,000 patients.

Drug Trials 52

Drug Trials Trials Clinical Trials Clinical Trials 52

FDA Law Blog

MAY 3, 2021

Butler — On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a). 42 U.S.C. §

Clinical Trials 40

Clinical Trials Clinical Trials Trials Regulation 40

pharmaphorum

AUGUST 4, 2020

Rare diseases drugs have always faced challenges when it comes to HTA approvals, even as governments bring in more regulatory policies that make their path through assessment easier. The authors also note that orphan drug trials with higher p values and surrogate endpoints are often accepted for assessment in the country.

Drugs 96

Drugs Manufacturing Marketing Regulation 96

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. Takeda leads Finch-partnered Microbiome IBD drug.

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. Everyone I work with in pharma trials is painfully aware of the regulatory environment they work in.

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 ). Indian makers of Sputnik V may seek waiver for local Phase-3 trials ( Economic Times ). . Trump tax law cut what US drugmakers owed.

Trials 52

Trials Vaccination Vaccine Scientist 52