News from the World of Clinical Research

Infex begins study of pseudomonas aeruginosa candidate RESP-X

Phase 1 research will evaluate tolerability and safety of therapy among healthy volunteers

Infex – a company focusing on anti-infectives specialist – has announced that the first patients have been d…

Pfizer, BioNTech start study testing next COVID-19 vaccine

• Pfizer and BioNTech on Thursday announced the start of a Phase 1 study of a new COVID-19 vaccine candidate designed to spur a broader and potentially more durable immune response. The study will enr…

With Sanofi as its marketing partner, Provention Bio grabs long-awaited FDA nod for diabetes drug

What a long, strange trip it’s been for teplizumab, a drug developed to combat juvenile diabetes—36 years to be exact.

Under FDA pressure, GSK limits use of ovarian cancer drug

GSK will stop selling the drug Zejula for some ovarian cancer patients whose disease is stable after a second line of chemotherapy, the company said Friday, following pressure from the Food and Drug A…

A new way to access scientific papers?

Many researchers are surprised to find that leaving university also means leaving behind something they didn’t expect—easy access to peer-reviewed literature. Especially for those who have gone to wor…

Trial failures end latest hope for Roche’s Alzheimer’s drug

An experimental Alzheimer’s disease medicine from Roche failed two large Phase 3 clinical trials, a major setback to the Swiss company’s yearslong effort to prove the drug might slow the progression o…

Healthcare Twitter influencers beam over Pfizer's RSV shot data: report

Move over, COVID: Shots to stop respiratory syncytial virus (RSV) are providing the new must-watch trial data on Twitter as healthcare influencers on the social media platform talk up the latest reado…

Galapagos to cut 200 jobs amid research revamp

The workforce reduction is part of a “new strategic direction” for Galapagos, which intends to stop developing drugs for fibrosis and kidney disease.

Eli Lilly, Boehringer Ingelheim bolster case for Jardiance to treat chronic kidney disease

With an FDA approval 19 months ago to treat chronic kidney disease, AstraZeneca’s Farxiga dominated the race against its primary SGLT2 rival—Eli Lilly and Boehringer Ingelheim’s Jardiance. And since t…

Pfizer planning steep price hike for COVID-19 vaccine

Pfizer is considering hiking the price of its COVID-19 vaccine by roughly four times what it currently charges as it prepares for sales in the U.S. to shift from government contracts to the private ma…

Cancer patients want pharma's support, but many aren’t getting it: survey

Education and support are critical to getting—and keeping—patients on appropriate therapy. But many oncology patients have gaps in their knowledge of their condition, treatment and existing support se…

ICR’s new study tracks disease progression in children with rare type of cancer

Blood tests could help guide the treatment of children with the cancer rhabdomyosarcoma (RMS), according to a new study led by scientists at the Institute of Cancer Research, London (ICR).

Novo Nordisk's Wegovy gets a surprise endorsement from Twitter's soon-to-be owner Elon Musk

How do you solve a problem like Elon Musk? Well, when it comes to his weight, there seems to be a simple answer: Novo Nordisk’s Wegovy.

GSK sets high bar with trial results for RSV vaccine

• GSK’s vaccine for respiratory syncytial virus proved strongly effective in a large Phase 3 trial, reducing cases of lower respiratory infection in people 60 years and older by 83% when compared to t…

Atara on verge of landmark approval for first allogeneic T-cell therapy

With a thumbs up from Europe’s Committee for Medicinal Products for Human Use (CHMP), Atara Biotherapeutics’ Ebvallo is poised to become the first allogeneic T-cell therapy approved in the world.

OPTIMA announce AstraZeneca and Mutabor as official partners

The companies will aim to improve treatment for patients with prostate, breast and lung cancer

The Innovative Medicines Initiative (IMI) – a joint undertaking of the European Union and the European F…

'The Top Line': Will Eisai's Alzheimer's med lecanemab sway the CMS, how Pfizer is upping its DTC ad push for its COVID shots

Eisai and Biogen's Alzheimer’s disease drug lecanemab did surprisingly well in a phase 3 trial. The results support the idea that an anti-amyloid drug like lecanemab could be a way to treat Alzheimer’…

BioMarin to lay off around 120 employees as part of restructuring plan

• BioMarin Pharmaceutical plans to lay off roughly 120 employees, or 4% of its global workforce, as part of a larger restructuring effort announced Thursday.

Keytruda taught Merck how to build a blockbuster. But manufacturing a 2nd lightning bolt is easier said than done

On the second night of the largest annual European cancer conference, some 100 Merck scientists packed into Champeaux, a classic French restaurant, to break bread and share clinical wisdom. 

MHRA appoints DEKRA to certify medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that DEKRA Certification UK has now joined the three current UK-approved bodies, increasing the UK’s capacity to process co…

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…