Biotech

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 at 9:55 a.m.

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

Explore the Trendline➔

Trendline

Inside the race to bring coronavirus vaccines to the world

More than a dozen shots are cleared for use in some fashion around the world. Producing enough supply and addressing the spread of coronavirus variants are the next challenges. 

By BioPharma Dive staff

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. 08, 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. 07, 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. 07, 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. 07, 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. 06, 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. 06, 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. 04, 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. 04, 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

Sponsored by SGS

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

Incyte eczema drug wins FDA OK, but with safety warning

A topical cream formulation of the drug in Incyte's top-selling product could help the company expand. The black box warning, though, might limit use.

By Kristin Jensen • Sept. 22, 2021

Deep Dive

'This is the time to double down': Top Vertex executives defend research plan as pressure builds

A series of setbacks has led to criticism of the storied biotech's bid to diversify. But Vertex intends to stay the course, its CEO and top scientist say.

By Ben Fidler • Sept. 22, 2021

ESMO21: Mirati sets new KRAS bar, AstraZeneca's breast cancer data and Keytruda challengers line up

Mirati's KRAS-blocking drug looks to have an edge over Amgen's, while AstraZeneca and Daiichi reported impressive data for their drug Enhertu.

By Ned Pagliarulo • UPDATED: Sept. 21, 2021 at 10:59 p.m.

Sponsored by Nuvolo

Calibrate and connect your equipment in the cloud

Calibration is too important to do on spreadsheets or paper. See how you can improve your calibration activities with a cloud-based solution.

Biogen says experimental pain drug helps neuropathy patients in mid-stage trial

With Aduhelm approved but struggling to gain traction, Biogen is talking up its pipeline. Mixed trial results, however, may make it challenging to design a larger study that can persuade regulators to approve the pain drug.

By Jonathan Gardner • Sept. 17, 2021

Theravance to lay off 75% of employees alongside larger restructuring

The move, which will affect an estimated 270 positions, follows a review by the company's board, and comes just weeks after one of its most advanced drugs failed a key test.

By Jacob Bell • Sept. 15, 2021

After talks with FDA, a biotech prepares to submit its closely watched ALS drug

Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will soon ask for approval of AMX0035 — a change of plans from earlier this year. 

By Jacob Bell • Sept. 15, 2021

CureVac scales back mRNA manufacturing for coronavirus vaccine

The German biotech, which announced disappointing results for its shot in June, said the move was done in response to reduced demand. 

By Shoshana Dubnow • UPDATED: Sept. 15, 2021 at 5:29 p.m.

Biotech funder Lightstone raises another $375M for life sciences investing

The venture firm, which previously invested in LocanaBio, Catamaran Bio and Tizona Therapeutics, said its third fund surpassed its target.

By Jacob Bell • Sept. 14, 2021

Fourth trial volunteer dies in Astellas gene therapy study

The study, which was suspended following three deaths last year, had been restarted in February after Astellas lowered the treatment dose used. 

By Ned Pagliarulo • Sept. 14, 2021