Pfizer to test COVID pill in children as vaccinations in US plateau

Supplies of the drug, called Paxlovid, have become more available for adults in the U.S., which recently began rolling out a "test-to-treat" initiative likely to make use of Pfizer's pill. 

By Kristin Jensen • March 9, 2022

Bluebird's CFO resigns as cash woes raise doubts about its future

The gene therapy developer's top financial executive, Gina Consylman, is stepping down amid concerns the company needs to raise additional cash to survive for more than a year.  

By Jonathan Gardner • March 7, 2022

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

Gilead says breast cancer drug succeeded in key study, but offers few details

The study is an important test of whether the drug, called Trodelvy, can live up to expectations set by Gilead's $21 billion deal to acquire it.

By Jacob Bell • March 7, 2022

Roche, nearing major trial readouts, starts new Alzheimer's drug study

As Aduhelm sputters on the market, Roche aims to prove its experimental medicine can work better. A large, multi-year trial is part of that bet.

By Jonathan Gardner • March 3, 2022

Intellia presses forward with new results for pioneering CRISPR drug

The findings build on early evidence that gene editing inside the body could safely and effectively treat disease, and suggest the effects of Intellia's medicine might last. 

By Ben Fidler • Updated Feb. 28, 2022

FDA rejects Reata drug for rare kidney disease

While expected, the decision raises questions about the treatment's prospects in other settings. Reata may have better luck with another drug it's submitting to the FDA for a movement disorder.

By Jonathan Gardner • Feb. 28, 2022

Engaging patients for the duration: 3 ways to improve retention in oncology studies

Tangible strategies to maximize the benefits and decrease the burdens of participants staying active and compliant in an oncology study.

Feb. 28, 2022

Moderna bets on booster demand, advancing new 'bivalent' COVID-19 shot

The biotech will start trials in the U.S. and U.K. of a vaccine that targets both the original coronavirus strain and the omicron variant. 

By Jonathan Gardner • Feb. 24, 2022

Allogene, slipping in 'off-the-shelf' CAR-T race, prepares for key trials

Allogene, once the clear leader in development of a more convenient option to personalized cancer cell therapies, now is competing with CRISPR Therapeutics and other fast-emerging rivals.

By Ben Fidler • Feb. 24, 2022

Sanofi and GSK, after delays, to seek clearance for COVID-19 vaccine

The companies' vaccine provided strong protection against severe illness in a large clinical trial, a long awaited result that could position it as a booster for people who have received other shots.

By Jonathan Gardner , Ben Fidler • Feb. 23, 2022

Kodiak crashes on negative trial results for would-be Eylea competitor

Data from a Phase 3 trial showed Kodiak's experimental treatment didn't match up to Eylea in wet AMD, spurring questions from analysts about its potential.

By Kristin Jensen • Feb. 23, 2022

AstraZeneca, Daiichi press rivals with new results for breast cancer drug

Positive study results for the companies' drug Enhertu in patients whose only remaining option is chemo could open up a new treatment use, pressuring competitors Roche and SeaGen.

By Ben Fidler • Updated Feb. 23, 2022

Citing safety signal, GSK pauses some trials of new RSV vaccine

As RSV vaccine development heats up, the drugmaker said it will delay work on its shot for pregnant women, although separate studies in older adults remain on track.

By Jonathan Gardner • Feb. 18, 2022

Sage claims new data show depression drug works, but doubts remain

Study results indicate the company's fast-acting medicine may help patients already on existing drugs. But its limited effects may curb its potential, Wall Street analysts said.

By Ben Fidler • Feb. 16, 2022

Califf confirmed as FDA chief in close vote, ending protracted vacancy at health agency

Several Democratic lawmakers opposed Califf over his industry ties and the FDA's past policies on opioid painkillers, drawing out the confirmation process and making the final vote close.

By Jonathan Gardner • Updated Feb. 15, 2022

Amgen sees potential for KRAS drug in treating pancreatic cancer

Early study results suggest some efficacy for Amgen's KRAS-targeting drug in the tough-to-treat cancer type. The biotech plans to expand testing as a result. 

By Ned Pagliarulo • Feb. 15, 2022

EMA follows FDA in scrutinizing safety of certain immune drugs

The European regulator began a safety review of so-called Janus kinase inhibitors from Pfizer, AbbVie, Eli Lilly and Galapagos, citing worrisome data from a study of Pfizer's drug Xeljanz.

By Ned Pagliarulo • Feb. 14, 2022

ProQR eye drug comes up short in key study, surprising company and investors

The biotech's treatment did not improve vision in the Phase 2/3 trial, a significant setback that sent shares down by 75%.

By Ned Pagliarulo • Feb. 11, 2022

Pfizer aims to restart late-stage trial of Duchenne gene therapy following safety setback

Safety concerns, including the recent death of a patient in an early study, led the FDA to place a hold on the therapy and Pfizer to redesign its Phase 3 trial.

By Ned Pagliarulo • Feb. 10, 2022

Pressure rises as Gilead awaits important study results for top cancer drug

Gilead expects data from a late-stage trial of Trodelvy, a medicine it acquired via its largest ever acquisition, next month. The results have come to be viewed as a key test of the company's ambitions in oncology.

By Jacob Bell • Updated Feb. 14, 2022

The pipeline of new antibiotics is drying up. A bill in Congress aims to change that.

Despite the growing threat of drug-resistant bacteria, few new antibiotics are reaching the market because of hurdles that biotech executives and experts say stand in the way.

By Jonathan Gardner • Feb. 1, 2022

Madrigal adds to safety data for NASH drug

The biotech's drug is one of the few NASH treatments that has advanced to late-stage testing, as the disease has proven difficult for drugmakers to crack.

By Jacob Bell • Jan. 31, 2022

Regeneron, Sanofi are latest to withdraw a cancer drug application

The partners pulled their request after disagreeing with the FDA on post-approval studies for their immunotherapy Libtayo in cervical cancer. Incyte made a similar decision earlier this week.

By Jonathan Gardner • Jan. 28, 2022

Moderna follows Pfizer in beginning trial of omicron vaccine

The study will test a version of the biotech's COVID-19 shot that's tailored to the infectious variant. New data, meanwhile, help affirm the benefit of a third dose of Moderna's current vaccine.

By Jonathan Gardner • Jan. 26, 2022

Cortexyme to shift focus after FDA places hold on experimental Alzheimer's drug

While a recent trial of Cortexyme's drug had failed, the biotech was planning to move ahead with another study. Now the company is cutting costs and prioritizing an earlier-stage therapy.

By Ned Pagliarulo • Jan. 26, 2022