With safety a concern, Merck, Gilead pause study of HIV drugs

Out of an "abundance of caution," the companies halted enrollment in a trial evaluating the combination of Merck's islatravir and Gilead's lenacapavir.

By Jacob Bell • Nov. 24, 2021

A worrisome safety signal slows Merck's HIV ambitions

After a study raised safety concerns, Merck has paused development of one of its experimental drugs and will keep a close eye on another that's critical to its plans in HIV.

By Jacob Bell • Nov. 19, 2021

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

FDA approves Merck's Keytruda as first immunotherapy for early kidney cancer

Immune-boosting drugs like Keytruda are increasingly being tested, and proven effective, alongside surgery before tumors spread widely.

By Ben Fidler , Ned Pagliarulo • Nov. 18, 2021

Cortexyme plans path forward for Alzheimer's drug that failed study

Detailed trial results presented last week are "interesting," one Alzheimer's expert said, but there are still "many challenges and uncertainties" with Cortexyme's unorthodox approach to treating the disease.

By Ned Pagliarulo • Nov. 12, 2021

Detailed Roche study results muddy another Alzheimer's hypothesis

Data presented at an Alzheimer's meeting raised more questions about the seeming benefit of Roche and AC Immune's drug semorinemab, which they claim is the first of its kind to slow deterioration of memory.

By Jonathan Gardner • Nov. 11, 2021

Mirati gives first look at KRAS drug combination in lung cancer

Study results for Mirati's drug combined with Keytruda have been much anticipated, as the San Diego biotech aims to challenge Amgen and its rival KRAS-blocking drug Lumakras.

By Ned Pagliarulo • Updated Nov. 8, 2021

Clinical trials face increasing challenges

The COVID-19 pandemic emerged at a time when the clinical trial landscape had reached a peak in complexity. Global trials are now commonplace as drug makers seek to establish efficacy in diverse populations.

By Hussein Pirbhai, Operations Director for UK and Europe, Yourway • Nov. 8, 2021

Pfizer pill for COVID-19 shows dramatic benefit in major study finding

The drugmaker, which on Oct. 29 won FDA clearance of its vaccine in younger children, plans to quickly ask the agency for emergency authorization of the drug in high-risk patients.

By Jonathan Gardner • Nov. 5, 2021

Cortexyme drug fails in Alzheimer's trial, but company sees validation of unorthodox approach

Cortexyme shares lost more than three-fourths of their value after the the biotech's therapy, which is designed to work differently than drugs like Aduhelm, missed both primary goals in a late-stage study.

By Ned Pagliarulo • Oct. 26, 2021

Novartis hits another setback in plan to repurpose rare disease drug in lung cancer

Canakinumab, which is approved as Ilaris, didn't slow progression or improve survival when used as a lung cancer treatment. Novartis still hopes it might work alongside surgery.

By Ned Pagliarulo • Updated Nov. 8, 2021

Biogen's closely watched ALS drug comes up short in late-stage study

Though the study's primary goal was missed, Biogen claimed there were some signs its drug, tofersen, could slow the disease's progression. The company is now engaging with regulators to discuss tofersen's future.

By Jacob Bell • Oct. 18, 2021

Why prescreening is the missing piece in a successful participant pipeline

Too often, optimized prescreening is overlooked in favor of the status quo. Here's why that's a mistake—and why prescreening is the great missed opportunity for modern-day trial enrollment. 

Oct. 18, 2021

CRISPR touts new results as fresh questions surround 'off-the-shelf' CAR-T

The biotech's lymphoma treatment initially seems as potent as earlier cell therapies, but its effects waned, adding to doubts about off-the-shelf CAR-T.

By Jonathan Gardner • Updated Oct. 13, 2021

Sarepta outlines final push for Duchenne gene therapy

The biotech still believes a speedy approval filing for the closely watched treatment is possible, but expects to have to wait for the results of the recently launched Phase 3 trial, CEO Doug Ingram said on a conference call. 

By Ben Fidler • Oct. 11, 2021

eCOA clinical trials: A simple, cost-effective approach to study build

This new data capture model gives clinical trial sponsors control over study build. 

Oct. 11, 2021

Relay’s targeted cancer drug could be safer than its competitors. Is it more effective?

Initial study results for Relay's experimental treatment offer some support for the biotech's protein motion technology, but raise some questions, too. 

By Ned Pagliarulo • Oct. 8, 2021

Allogene cell therapy trials halted by FDA after unexpected safety finding

Researchers found evidence of a "chromosomal abnormality" in one patient treated with Allogene's CAR-T cell therapy, spurring the clinical hold and an investigation.

By Ben Fidler • Updated Oct. 8, 2021

Takeda halts studies of touted sleep disorder drug over safety concern

The drugmaker suspended dosing in two mid-stage studies of its experimental narcolepsy treatment after a "safety signal" emerged.

By Ned Pagliarulo • Oct. 6, 2021

Collins to step down as NIH head in transition for research agency

After 12 years in the top job, the veteran director says a new scientist should assume leadership of the world's largest biomedical research institution.

By Jonathan Gardner • Oct. 5, 2021

J&J heats up RSV race with new vaccine data

The company's candidate is one of two to enter late-stage testing for a respiratory virus that causes hundreds of thousands of hospitalizations a year.

By Jonathan Gardner • Oct. 4, 2021

Sarepta embarks on late-stage clinical trial of Duchenne gene therapy

Initiation of the Phase 3 trial is an important milestone for the biotech after earlier setbacks, as well as for patients with the inherited muscle disease.

By Shoshana Dubnow • Oct. 4, 2021

Merck says antiviral pill effective against COVID-19, lifting hopes for first oral drug

The drugmaker, along with partner Ridgeback Biotherapeutics, plan to ask the FDA for emergency authorization "as soon as possible" following results so striking that testing was stopped early. 

By Ben Fidler • Oct. 1, 2021

After long wait, Editas reveals first data for CRISPR gene editing treatment

Early study results offer some hopeful signs but were difficult to interpret. Shares in the biotech slid by nearly 20% in response on Wednesday. 

By Ned Pagliarulo • Sept. 29, 2021

Sanofi claims positive early data for mRNA COVID shot, but pivots to flu instead

With Pfizer's and Moderna's vaccines broadly used, Sanofi says it will focus on its protein-based coronavirus candidate. The French pharma sees more promise for its mRNA work in influenza.

By Jonathan Gardner • Sept. 28, 2021

As FDA scrutinizes immunotherapy approvals, Merck says Keytruda extends survival in liver cancer trial

Phase 3 results showed Merck's drug improved overall survival versus placebo, which should lessen pressure for a market withdrawal in the indication.

By Jonathan Gardner • Sept. 27, 2021