News from the World of Clinical Research

FDA rejects two China-developed cancer drugs

The Food and Drug Administration has refused to approve two cancer treatments developed by Chinese drugmakers, citing trial design in one rejection and manufacturing issues in the other.

University launches hub for pregnant women with pre-existing medical conditions

Norfolk and Norwich University Hospitals Foundation Trust opens centre to increase survival rate among pregnant women managing other conditions

Roche cancer immunotherapy fails another trial, casting doubt on emerging drug class

• A drug combination including Roche’s experimental immunotherapy tiragolumab failed one of two main goals in a Phase 3 trial in a common form of lung cancer, a setback that casts doubt on the potenti…

With 200M unused doses, AstraZeneca's COVID vaccine partner Serum Institute halts production

About 200 million doses of COVID-19 vaccine are gathering dust in warehouses of the world’s largest vaccine manufacturer as global demand ebbs.

How a surprise finding made an Alnylam study one of biotech’s most ‘polarizing’ trials

The outcome, no longer seen as a sure bet, could influence how future drugs for a deadly heart disease are developed.

DNA analysis uncovers new cancer treatment clues

Researchers were able to detect specific combinations of genetic alterations which may hold key to the growth of cancers

Troubling data leads a biotech to pull its prized drug from market and FDA review

• The New York-based biotechnology company TG Therapeutics has decided to pull its only approved medicine from the market, after recent clinical trial data showed a potentially increased risk of death…

ISA Pharmaceuticals announce new trial testing technology for cancers

Trial of Amplivant will begin in a number of cancer patients including those with ovarian cancer

Inflation is forcing prioritization of healthcare spending — are you ready?

If you're a pharmaceutical marketer, you're about to face a challenge no US-based marketer has seen since the early 1990s: inflation.

UK patients granted early access for radioligand therapy in advanced prostate cancer

Advanced Accelerator Applications (AAA), a Novartis company, has announced that eligible patients in the UK have been granted early access for radioligand therapy in advanced prostate cancer, a diseas…

A seasonal COVID-19 booster shot? Don't count on it in the US or Europe

People in the U.S. and Europe hoping to receive COVID-19 vaccine booster shots every four to six months are in for a rude awakening.

Hundreds of urothelial cancer patients to receive new treatment

NICE recommends avelumab as treatment for adults with locally advanced or metastatic urothelial cancer

In major shake-up, Novartis combines pharma and oncology units, leaving 3 top execs without jobs

Novartis CEO Vas Narasimhan is giving the Swiss pharma a huge makeover ahead of a possible spinoff of generics unit Sandoz, pushing out three C-level executives and preparing for layoffs.

Yet another gene therapy developer turns to layoffs

• A Dallas-based gene therapy developer with a lengthy list of research projects has decided to prioritize two moving forward and, in doing so, will reduce its workforce by approximately 35%, joining …

Boehringer goes bold with 'unwearable' fashion to spotlight patients' rare skin disease pain

It feels like a paper cut, but multiplied by 10,000. Or being stabbed with a bunch of knives over and over again.

Stalicla completes phase 1b trials into precision medicine for autism spectrum disorder

STP1 has demonstrated good safety and tolerability profiles, while also showing positive results for neurological function

Swiss clinical stage biotech company, Stalicla, has announced the highly suc…

UK’s first digital health training programme for all NHS frontline staff

The Digital Health Academy – which aims to help build the UK’s first digital-ready frontline workforce – is now open to health and care staff across the UK. All NHS and social care staff will have fre…

NHS contacting five million people for fourth COVID-19 vaccination

The NHS will begin giving a second booster vaccination to around five million people who are at a higher risk from COVID-19. Those who are aged over 75-years-old, care home residents and the immunocom…

Omicron BA.2 variant triggers COVID-19 surge in England

The new sub-variant, named Deltacron, combines mutations from both Omicron and Delta. The variant has been detected in multiple areas of France, and cases have doubled in China and tripled in parts of…

How Merck's 'puzzling' results could impact immunotherapy's role in early lung cancer

An immunotherapy from Merck & Co. is the latest drug of its kind to slow the return of lung cancer in clinical testing, though mixed results in the large study supporting its benefit add to questi…

Course Postponements Due to Covid

All of our delegates and members who had course places postponed over the last two years due to covid restrictions/illness have now been contacted directly by the Secretariat. If you had a place booke…