Moderna faces delay in plans to bring coronavirus vaccine to US teenagers, young kids

The FDA wants to better understand the risk of vaccine-associated myocarditis in 12- to 17-year-olds based on real-world use overseas, which will set back Moderna’s authorization plans in the U.S. 

By Ben Fidler • Nov. 1, 2021

Despite strong quarter, some wonder how long Gilead can rely on coronavirus drug

While other drugs in Gilead’s arsenal fell short, third quarter revenue from Veklury tripled what analysts had expected, reaching nearly $2 billion.

By Jacob Bell • Oct. 29, 2021

Explore the Trendline➔

Emerging biotech

New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.

By BioPharma Dive staff

John Maraganore, pioneering RNAi executive, to step down as Alnylam CEO

Alnylam shares fell 15% on the news, which surprised Wall Street analysts and ends Maraganore's 19-year run overseeing the company's journey from startup to a biotech worth nearly $20 billion.  

By Ben Fidler • Oct. 28, 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

Moderna vaccine safe and spurs immune response in kids, company says

The trial results should allow the company to ask the FDA for approval of its vaccine in younger children, just as Pfizer nears a crucial decision for its shot in 5- to 11-year olds.

By Jonathan Gardner • Oct. 25, 2021

Why natural language processing (NLP) is a critical part of your real world data strategy

The barrier to knowledge can be eliminated when pharmaceutical companies use natural language processing to analyze unstructured content.

By Hywel Evans, Director, IQVIA NLP Insights Hub • Oct. 25, 2021

With Merck blocking its path, a small biotech reroutes, to the dismay of investors

Shares of Agenus fell around 25% Friday, after the company said the FDA has recommended withdrawing an approval application for its cancer immunotherapy balstilimab.

By Jacob Bell • Oct. 22, 2021

Biogen's Alzheimer's drug is struggling, and a turnaround might not be coming soon

Sales of Aduhelm during the third quarter totaled only $300,000, falling well below expectations amid controversy over its approval and physician reluctance to prescribe it.

By Jacob Bell • Oct. 20, 2021

Atea, Roche change plans for oral COVID-19 drug after trial setback

A closely watched competitor to Merck's molnupiravir failed a Phase 2 study, prompting its makers to change their strategy in a move that could delay an answer on the drug's efficacy until late next year.

By Ben Fidler , Jonathan Gardner • Oct. 19, 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

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

CureVac scraps its first COVID-19 vaccine and pivots to a second

The German biotech has abandoned plans to seek approval of the shot in Europe, citing tough competition, waning demand and the progress of a second candidate it's developing with GlaxoSmithKline. 

By Ben Fidler • Oct. 12, 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

Under pressure to share technology, Moderna to build vaccine factory in Africa

The biotech company expects to make its coronavirus vaccine and mRNA shots for other diseases at the planned plant, into which it will invest $500 million.

By Kristin Jensen • Oct. 7, 2021

Intergalactic Therapeutics launches with $75M to build a new type of gene therapy

Founded by former Biogen executive Michael Ehlers and backed by Apple Tree Partners, Intergalactic aims to create non-viral gene therapies delivered via an advanced form of electroporation.

By Ned Pagliarulo • Oct. 7, 2021

Armed with half a billion dollars, a startup aims to change how brain drugs are made

Neumora Therapeutics launched Thursday with $100 million from Amgen and another $400 million from a long list of venture capital firms, including Arch, which is taking another shot at building a neuroscience company.

By Jacob Bell • Oct. 7, 2021

Gene therapy developer gets chance at a comeback with Pfizer deal

Voyager Therapeutics recently scrapped much of its pipeline and replaced top executives. Now, a Pfizer deal on new technology gives investors hope.

By Jonathan Gardner • Oct. 6, 2021

Biohaven migraine drug sales again top Wall Street forecasts

The neuroscience-focused biotech continues to win market share in a battle with some of the industry's largest companies.

By Kristin Jensen • Oct. 6, 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

How a busy year for biotech IPOs measures up at the three-quarter mark

Drugmaker initial public offerings could break records set just a year ago. But valuations and stock performance have slipped from historic highs.

By Ben Fidler • Oct. 4, 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

FDA lifts hold on GeneTx, Ultragenyx study of Angelman therapy

The hold, which was put in place during the fourth quarter last year, came after five patients in an early trial experienced muscle weakness following treatment.

By Shoshana Dubnow • Sept. 27, 2021

Biohaven's pipeline takes a hit as drug for rare neurological disease falls short in trial

After success with the migraine drug Nurtec, Biohaven has been looking to prove the rest of its neuroscience research. Negative Phase 3 results in multiple system atrophy could close off one opportunity. 

By Ned Pagliarulo • Sept. 27, 2021

Charged aerosol detection: Chromatographer's magical tool to unravel the invisible in biologics

The discovery and development of next generation therapeutics will drive the availability and use of Biologics to meet the unmet medical needs, never imagined before.

By Yena Patel, Sahil Shah and Bart Byczynski • Sept. 27, 2021

Bluebird officially asks FDA to approve gene therapy for rare blood disorder

After several delays, Bluebird has completed an application to the agency to get beti-cel cleared as a treatment for beta-thalassemia.

By Jacob Bell • Sept. 22, 2021