Clinical Trials

Sage, Biogen drug reduces tremors but side effects could limit potential

Early Phase 2 data for a pill from the two companies' alliance appeared promising. But most patients had to cut their drug dose due to drowsiness.

By Jonathan Gardner • April 12, 2021

5 takeaways from AACR, one of the year's top meetings on cancer drugs

The American Association for Cancer Research's virtual conference featured new data on an emerging immunotherapy target, a new kind of cell therapy and a KRAS reboot. 

By Ben Fidler , Ned Pagliarulo • April 12, 2021

Lilly gene-targeted drug shows potential for use across cancers

Study results presented at AACR showed Retevmo shrank tumors in nine different cancers, building a case for the type of tissue-agnostic label that only three other medicines have secured.

By Ned Pagliarulo • April 11, 2021

Researchers lay out hypothesis for rare side effect linked to AstraZeneca vaccine

The EMA has reiterated the benefits of the shot outweigh the risks, but the safety concerns are another hurdle to the vaccine's rollout in Europe. 

By Ned Pagliarulo , Ben Fidler • April 09, 2021

Lilly claims promising finding in failed study of COVID-19 drug

Baricitinib, an oral tablet already authorized to treat COVID-19, fell short of goal in a large Phase 3 study. But Lilly also reported treatment led to a substantial reduction in death.

By Ned Pagliarulo • April 08, 2021

New data push a biotech's muscle disease drug closer to a key test

An experimental medicine from Scholar Rock could complement a gene therapy from Novartis and other treatments for the disease, though its benefit needs to be proven in further study.

By Jacob Bell • April 06, 2021

Takeda, CSL to end alliance as plasma-based COVID-19 drug fails key test

An unusual partnership to develop a standardized plasma therapy for COVID-19 didn't succeed, but could be a model for collaborations should another public health crisis arise, the drugmakers said.

By Ben Fidler • April 05, 2021

Pfizer, BioNTech's vaccine protects 12- to 15-year-olds from COVID-19 in study

The positive finding should pave the way for broader use of the vaccine among adolescents, an important step for reaching herd immunity against the virus.

By Ben Fidler , Jonathan Gardner • March 31, 2021

A biotech shelves its Huntington's drugs after trial failures

Two drugs developed by Wave Life Sciences didn't appear to have an effect on disease-causing proteins, another setback for Huntington's research after disappointing results last week from Roche and Ionis.

By Jacob Bell • March 30, 2021

Sponsored by Parexel Biotech

How RWE can help Biotechs optimize the value of their asset

No matter the exit strategy, the use of Real-World Evidence (RWE) can provide a framework for Biotech companies to develop insights needed for the various stakeholders. 

Bristol Myers gets late-stage win in test of new type of immunotherapy

When given together with Opdivo, Bristol Myers' new drug kept skin cancers from progressing, a rare clinical victory for a combination of immunotherapies that puts the pharma a step ahead of several rivals. 

By Jonathan Gardner • March 25, 2021

AstraZeneca, under fire, tries to repair image with new vaccine data

Updated results show the vaccine is only slightly less effective than AstraZeneca originally reported. But an unusual break with a study committee may damage perception of the shot.

By Ben Fidler • UPDATED: March 25, 2021 at 2:15 p.m.

Regeneron joins Lilly in proving lower-dose antibody drugs can thwart COVID-19

The findings could help boost the supply and reach of Regeneron's COVID-19 antibody drug, which, despite limited use, is now backed by convincing data showing it can prevent hospitalization.  

By Kristin Jensen • March 24, 2021

Roche stops giving Huntington's disease drug in closely watched study

A disappointing recommendation from outside data reviewers raises doubts about the DNA-targeting drug's benefits and puts pressure on Roche's partner, Ionis Pharmaceuticals. 

By Jonathan Gardner • March 23, 2021

FDA won't review Novo diabetes drug in latest case of regulatory pushback

Novo Nordisk said the FDA requested more data before starting review for a high dose of the Danish company's treatment semaglutide, extending a string of recent setbacks for drugmakers in the U.S.

By Ned Pagliarulo • March 23, 2021

AstraZeneca may have used 'outdated' data to describe vaccine's efficacy, NIH says

The British drugmaker said it will release updated data from the large U.S. trial within 48 hours, but the puzzling episode is another communication misstep for the company.

By Ned Pagliarulo • March 23, 2021

Roche immunotherapy notches a win in early lung cancer, pressuring Merck

New results could make Tecentriq the first immunotherapy available in the post-surgery setting, adding pressure on Merck & Co.'s Keytruda to succeed as well.

By Jonathan Gardner • March 22, 2021

Sponsored by PSI CRO

Technological adoption and human connection. Finding the balance in clinical trials

While technology can push trials ahead, in-person interactions and site relationships are, and always will be, the key to success in delivering patient-centric trials on time.

Sponsored by Medidata, a Dassault Systèmes company

Adopting RBQM to ensure trial oversight in COVID and beyond

Now more than ever, a firm grasp of RBQM is needed for the success of all clinical trials.

With new results, Sarepta's 2nd gene therapy holds steady

Stung by a clinical trial miss in Duchenne muscular dystrophy, the biotech now has promising, if early, data to back a gene therapy for a different rare neuromuscular disease.

By Jonathan Gardner • March 19, 2021

A first-of-its-kind mRNA drug falls short in cystic fibrosis

A treatment that sprays synthetic messenger RNA into the lungs failed to help cystic fibrosis patients, a blow to efforts to use the technology for more than vaccines. 

By Ben Fidler • March 18, 2021

Gilead, still aiming at NASH, broadens an alliance with Novo

With positive safety data in hand, the partners will advance work pairing the diabetes medicine Ozempic with two experimental treatments to see if they can reverse the liver disease, which has proven a tough target for drugmakers.

By Jonathan Gardner • March 18, 2021

Lilly lays out 2-year plan to gain approval for Alzheimer's drug

Study results for donanemab showed signs of slowing disease progression, but the company believes the FDA won't review until another study confirms that apparent benefit.

By Jonathan Gardner • March 15, 2021

Sponsored by Koneksa Health

The Apple Watch in clinical trials: Current uses and future possibilities

Why the Apple Watch will likely be one of the top choices for use by sponsors, CROs and clinical trial teams wishing to use wearables in their trials.

Detailed Lilly data give mixed picture of Alzheimer's drug's benefit

Highly anticipated results from a Phase 2 study of donanemab showed treatment slowed disease progression on one measure, but mixed data on other scales could temper optimism in its potential.

By Jonathan Gardner • March 13, 2021