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

Explore the Trendline➔

Neuroscience drug development

Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.

By BioPharma Dive staff

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

With new trial, Pfizer and BioNTech will test whether an omicron vaccine is needed

The trial, which will enroll nearly 1,500 people, could help determine whether a variant-specific shot is more effective than an additional booster of Pfizer's original vaccine.

By Ben Fidler • Jan. 25, 2022

Sierra Oncology records success in late-stage study of bone cancer drug

The biotech said it plans to soon submit the drug, which it acquired for cheap from Gilead three years ago, to the Food and Drug Administration for approval.

By Jacob Bell • Jan. 25, 2022

Roche sees cause for optimism with failed Huntington's disease drug. Others aren't so sure.

After halting a Phase 3 trial of the drug last year, Roche went digging for more data. What it found led to plans for another trial, but the pharma's hypothesis may rest on shaky ground.

By Ned Pagliarulo , Jacob Bell • Jan. 21, 2022

Alnylam, awaiting key study data, builds case for its next rare disease drug

New results show the effects of its next drug for transthyretin amyloidosis appear to hold up for a year and a half. But it's unclear whether treatment will help those with heart problems, a much larger market opportunity.  

By Ben Fidler • Jan. 21, 2022

EQRx builds case for cancer drug it hopes can disrupt market

Study results show EQRx's drug, which it means to position as a lower-cost alternative to widely used cancer immunotherapies, extended the lives of lung cancer patients. But it's unclear whether that will be enough to sway the FDA.

By Kristin Jensen • Jan. 19, 2022

Roche revives a closely watched Huntington's disease drug

Ten months after Roche stopped giving the drug to patients in a Phase 3 trial, the pharma is planning a new study on the belief the medicine may help younger adult patients with less advanced disease.

By Jonathan Gardner , Ben Fidler • Jan. 18, 2022

Leveraging print communications in support of clinical trial diversity

Ensuring clinical studies reflect the real-world patient populations as much as possible in terms of ethnicity, race, sex and age

Jan. 18, 2022

Medicare proposes to limit coverage of Biogen Alzheimer's drug

The program will only cover Aduhelm, which the FDA controversially approved last June, for patients enrolled in rigorous clinical trials, likely forestalling broader adoption of the treatment.

By Jonathan Gardner , Jacob Bell • Updated Jan. 11, 2022

Allogene cleared by FDA to resume 'off the shelf' cancer cell therapy trials

A "chromosomal abnormality" that led regulators to halt Allogene's trials was judged to be unrelated to its technology, a finding with important implications for the field of donor-derived cell therapies.

By Ben Fidler • Jan. 10, 2022