Clinical Trials: Page 2

Lilly builds case for COVID-19 drug cocktail with new data

A low-dose combination of Lilly antibodies for COVID-19 reduced deaths and hospitalizations in a Phase 3 trial, a finding that could boost its use.

By Kristin Jensen • March 10, 2021

Novartis bid to bring rare disease drug to lung cancer hits a roadblock

Promising signs from a cardiovascular trial had led the Swiss firm to test canakinumab, a drug for rare immune diseases, in lung cancer. But the first test of that theory has failed.

By Jonathan Gardner • March 09, 2021

Merck gives an early peek at COVID-19 drug results

Initial results from a mid-stage study indicate the antiviral drug, molnupiravir, is safe. But whether it's hitting the study's main goal remains unclear.

By Jacob Bell • March 08, 2021

Crucial data on AstraZeneca's vaccine are coming. Here's what we may learn.

Results from previous trials have raised questions about the vaccine and how well it works. Data from a large U.S. study could help clear up the confusion. 

By Ben Fidler • March 08, 2021

Sponsored by Clinical Ink

What's new in ePRO, the customer service behind it, and how you can benefit

A single deployment now allows users to input ePRO on their device of choice, wherever they may be.

Lilly says diabetes shot outperformed rival Novo drug in study

The results are a boost for Lilly's drug, tirzepatide, which is being prepared for regulatory submissions later this year. But long-term heart data won't be available for some time.

By Jonathan Gardner • March 04, 2021

Galapagos reports long-awaited safety data for inflammation drug

The data show similar declines in sperm counts among patients on the Belgian biotech's drug, filgotinib, or a placebo. But it's unclear whether that finding will appease the FDA, which surprisingly rejected filgotinib last year.

By Jacob Bell • March 04, 2021

Lilly drug regrows hair in autoimmune disease study, but safety questions linger

The results could help baricitinib become the first treatment for alopecia areata, a leading cause of hair loss. Safety concerns have diminished the drug's prospects in arthritis, however.

By Ben Fidler • March 03, 2021

A closely watched schizophrenia drug fails key test

Though a mid-stage study read out negative, Neurocrine still sees a path forward for the drug, which it licensed from Takeda last summer.

By Jacob Bell • March 02, 2021

A play-by-play of the FDA meeting on J&J's vaccine

FDA advisers expressed growing comfort with the authorization process, offering unanimous support for J&J's shot. But the meeting also gave a window into debates likely to play out in the coming weeks and months.

By Ben Fidler , Ned Pagliarulo , Jonathan Gardner • UPDATED: March 1, 2021 at 1:31 p.m.

Moderna, Pfizer ready multi-pronged plans for coronavirus variants

Moderna has delivered a modified version of its vaccine to NIH scientists, while Pfizer has begun testing of an additional booster shot in a clinical trial, both precautionary steps against emerging strains.

By Jonathan Gardner , Ben Fidler • UPDATED: Feb. 25, 2021 at 10:29 a.m.

Icon to buy contract researcher PRA Health for $12B

The cash-and-stock deal gives PRA shareholders roughly one-third ownership of the new company, which will be one of the larger providers of contract research support.

By Kristin Jensen • Feb. 24, 2021

FDA review supports safety, efficacy of J&J coronavirus vaccine

In their review, agency scientists provided new details on the shot's protection against severe COVID-19 and different virus variants as well as its potential to reduce transmission.

By Ned Pagliarulo , Jonathan Gardner • UPDATED: Feb. 24, 2021 at 11:45 a.m.

FDA lays out shortened path for testing vaccines against new coronavirus variants

Lengthy trials won't be needed for updating shots against emerging viral strains, the agency told developers in newly published guidance.

By Ned Pagliarulo • Feb. 22, 2021

Sanofi and GSK start trial of upgraded coronavirus vaccine after first version disappoints

The companies think a new formulation will yield better results than their first attempt. But with several vaccines available, testing may be more challenging.

By Ben Fidler • Feb. 22, 2021

Sponsored by Medidata, a Dassault Systèmes company

Accelerating virtual clinical trials

Leveraging the guidance and support of trial virtualization professionals with experience in key areas of a trial's lifecycle will undoubtedly impact overall success.

Why this week's FDA meeting on J&J's coronavirus vaccine will be important

The FDA is widely expected to authorize the drugmaker's one-dose shot. But the advisory committee meeting beforehand will offer a window into debate over several key issues.

By Ben Fidler , Ned Pagliarulo • UPDATED: Feb. 23, 2021 at 9:28 p.m.

10 biotechs become 1: Centessa launches with $250M to prove unorthodox R&D model

The new company will be led by Saurabh Saha, a former Bristol Myers executive, and Moncef Slaoui, who until recently led the U.S. government's coronavirus vaccine program.

By Ned Pagliarulo • Feb. 16, 2021

Sponsored by Ethical

eReconciliation tool: A new software to facilitate Safety Data Reconciliation between clinical and safety databases

Simplify serious adverse events reconciliation operations with a customizable and GxP validated platform solution.

By Eleanor S. Segal, Luca Morbelli, Simone Suriano & Beat Widler • Feb. 16, 2021

AstraZeneca plans for adapting vaccine to coronavirus variants, but offers longer timeline than rivals

The drugmaker says between six to nine months are needed to ramp up production of an adapted shot. South Africa recently stopped using the vaccine due to its reduced potency against a common strain there.

By Jonathan Gardner • Feb. 11, 2021

Gilead, Galapagos halt development of experimental drug, denting research alliance

Independent reviewers found the benefits of the lung disease drug didn't outweigh its risks, marking a second major setback in six months for the companies' partnership.

By Kristin Jensen • Feb. 11, 2021

In surprise finding, Roche arthritis drug cuts risk of COVID-19 death in large UK study

U.K. researchers running the sprawling RECOVERY trial showed that adding Actemra to standard treatment can save lives, a powerfully positive result in a long-running debate about the drug's utility in COVID-19.

By Ben Fidler • Feb. 11, 2021

Small biotech gets big win on treatment for rare swelling disorder

An oral hereditary angioedema treatment from KalVista Pharmaceuticals looks similarly effective to standard injectables, which could threaten big-selling drugs from Takeda and others.

By Jonathan Gardner • Feb. 09, 2021

New data on AstraZeneca vaccine add to worries over coronavirus variant from South Africa

South Africa will use other shots in its immunization campaign after AstraZeneca's offered "minimal protection" against the variant that's spread throughout the country.

By Ben Fidler • Feb. 08, 2021

Sponsored by PSI CRO

On target, on-time enrollment, even in a global pandemic

Completing enrollment of a phase 3 trial on-time, even through the height of COVID-19