News from the World of Clinical Research

Ethics & GCP Presentations - April 2019

Presentations from the Ethics & GCP Forum held on 11th April 2019

Welcome Presentation 

MHRA Update - Kirsty Wydenbach

Update on HRA Approval & HRA Activity - Janet Messer

Ethics Committee Ins…

Call to end ban on producing immune therapy from UK blood

Eight-year-old Megan Steadman's immune system is like that of a newborn and needs a special treatment derived from blood plasma to strengthen it.

Production of immunoglobulins was banned in the UK in …

‘Concerning’ levels of non-alcoholic fatty liver disease among young people

A new study has shown an alarmingly high prevalence of non-alcoholic fatty liver disease (NAFLD) amongst young adults in the UK, including one in 40 who have already developed fibrosis.

Gene-silencing: 'New class' of medicine reverses disease porphyria

Doctors have used a new type of medicine called "gene silencing" to reverse a disease that leaves people in crippling pain.

The condition, acute intermittent porphyria, also causes paralysis and is fa…

More GP appointments available due to success of pilot scheme

An NHS scheme that has enabled GP practices to free up more time for doctors to see their patients is to be extended following a successful pilot.

NHS England said the Time For Care scheme, tried out …

'Female Viagra' keeps alcohol black box warning amid FDA dispute with Sprout

The dispute between Sprout and the FDA stems from competing interpretations of the post-marketing studies on Addyi (flibanserin​), testing whether taking the drug with alcohol led to cases of low bloo…

Measles: How a preventable disease returned from the past

Measles is one of the world's most infectious illnesses but until recently cases had been declining. So what's led to recent outbreaks?

Lyrica reclassified after being linked to 33 deaths

Pfizer's Lyrica (pregabalin) is to be reclassified following concerns over misuse.

On the back of a public consultation and advice from the Advisory Council on the Misuse of Drugs, the drug known on t…

Countess of Chester Hospital says no to Wales' patients

An English hospital has said it will no longer take in patients from Wales except emergencies and maternity cases.

Chemotherapy doses review after 14 NHS Tayside patients die

An independent review is to be carried out into chemotherapy given to 14 women who died after NHS Tayside gave lower doses than other Scottish health boards.

Brexit will have ‘minimal’ effect on R&D in UK, says expert

Despite Brexit uncertainties, the future for UK research and development (R&D), specifically clinical trials, is looking promising, heard delegates at the ‘Brexit: What's Next for Pharma?’ Pharmac…

Aimmune's peanut allergy drug finally gets an approval timeline

A peanut allergy drug developed by Aimmune Therapeutics has finally been accepted for review by the Food and Drug Administration, after delays caused by the 35-day U.S. government shutdown temporarily…

Advertising watchdog rules fake autism 'cure' adverts must stop

Advertising watchdog the Advertising Standards Authority (ASA) has ordered 150 homeopaths operating in the UK to stop claiming they can cure autism. Five of them face prosecution for advertising a tre…

Multi-drug approach found to attack resistance in bowel cancer

Combining three targeted drugs together could help block drug resistance in bowel cancer patients, as bowel cancer cells evolve resistance in response to two molecularly targeted cancer drugs through …

Gene therapy progress spurs competition in biotech buyouts

Drugmakers looking to buy their way into gene therapy are finding healthy competition for promising biotechs, regulatory filings from recent takeovers show, underscoring the renewed momentum behind a …

Making Pharma 2019

The ICR is proud to be taking part in Making Pharmaceuticals which will host over 2,000 visiting pharma professionals over two days, and 200+ exhibitors from across Europe who gather at the event to m…