Startup Cellares adds $255M as investors pour cash into cell therapy production

Bristol Myers Squibb is among those backing the company, which claims the manufacturing capacity at its New Jersey plant can surpass that of conventional CDMO facilities. 

By Kristin Jensen • Aug. 24, 2023

5 ways experience matters in gene therapy manufacturing

By partnering with an accomplished CTDMO, gene therapy innovators can benefit from guidance and support.

Aug. 21, 2023

Explore the Trendline➔

The BioPharma Dive Outlook on 2023

Against a stormy backdrop, 2022 did bring bright spots in Alzheimer’s, obesity, breast cancer and rare disease. Dig in to BioPharma Dive’s 2023 outlook for what’s in store this year. 

By BioPharma Dive staff

Bruker to buy PhenomeX and its cell research tools for $108M

The company said PhenomeX’s technology will help its customers speed development and manufacturing of cell and gene therapies.

By Susan Kelly • Aug. 18, 2023

FDA won’t hold advisory meeting for Bluebird’s sickle cell gene therapy

The decision stands in contrast to the agency’s plans for a would-be rival gene editing treatment from Vertex Pharmaceuticals and CRISPR Therapeutics that is also under a regulatory review. 

By Kristin Jensen • Aug. 16, 2023

Precision sells lymphoma drug to Imugene in retreat from cell therapy research

The struggling biotech also plans to offload other cell therapy assets, including a multiple myeloma therapy, and focus exclusively on gene editing medicines.

By Ben Fidler • Aug. 16, 2023

HIV cell therapy startup Addimmune heads to Wall Street via blank-check merger

The deal will help fund a cell-based treatment that completed Phase 1 testing last year and is designed to provide a “functional cure” for patients with HIV infections.

By Ben Fidler • Aug. 10, 2023

Regeneron ups genetic medicine investment with Decibel buyout

Third Rock-founded Decibel, which has shed much of its value since a 2021 IPO, expected to run out of money within a year.

By Jonathan Gardner • Aug. 9, 2023

Sarepta offers early look at closely watched gene therapy launch

One patient received its Duchenne gene therapy, Elevidys, this week and a handful more could follow shortly, surprising some analysts and raising near-term sales expectations.

By Ben Fidler • Aug. 3, 2023

A once buzzy gene therapy startup lays off staff and shuts down

Intergalactic, a developer of non-viral gene therapies built by ex-Biogen executive Michael Ehlers, is folding less than two years after its launch. 

By Kristin Jensen • Aug. 2, 2023

Vertex taking ‘flexible’ approach to payment talks for experimental CRISPR therapy

The company is discussing various reimbursement models for its sickle cell treatment with government and commercial insurers ahead of an FDA approval decision later this year.

By Ned Pagliarulo • Aug. 2, 2023

AstraZeneca buys Pfizer’s early gene therapy work for up to $1B

The British pharma is deepening its investment in genetic medicine through a deal for a group of Pfizer’s gene therapy delivery tools, while the New York giant cuts back. 

By Ben Fidler • July 28, 2023

Kincell spins out of cell therapy biotech, joining wave of manufacturing startups

The company is the latest to emerge with plans to make production of cell-based medicines easier for researchers and biotechs.

By Ben Fidler • July 26, 2023

Gene therapy biotech Kriya adds $150M in fresh funds

Led by Vivek Ramaswamy's brother, Kriya has now raised over $600 million to fund gene therapy research spanning ophthalmology, neurology and metabolic disease.

By Kristin Jensen • July 26, 2023

Editas names Biogen veteran as top scientist in latest executive change

Linda Burkly’s appointment follows the exit of CSO Mark Shearman, whose departure Editas announced alongside layoffs earlier this year.

By Gwendolyn Wu • July 24, 2023

Cell and gene therapy is coming of age

Outsourcing in the cell and gene therapy industry is booming and no longer considered just a “trend.”

July 24, 2023

A cancer biotech’s collapse gives Neurogene a path to Wall Street

The startup, a developer of gene therapies for brain diseases like Rett syndrome, will bypass an IPO by merging with struggling drugmaker Neoleukin.

By Delilah Alvarado • July 18, 2023

Avrobio halts gene therapy research and considers a sale

The decision to explore “strategic alternatives” comes about six weeks after the company sold its most advanced treatment to Novartis for nearly $90 million.

By Ned Pagliarulo • July 12, 2023

Astellas buys rights to 4D Molecular’s technology in latest gene therapy deal

The licensing agreement for the biotech’s viral vector platform follows recent Astellas agreements with Taysha Gene Therapies and Kate Therapeutics.

By Delilah Alvarado • July 10, 2023

Overcoming AAV manufacturing challenges

Overcome issues with AAV vector scalability and reproducibility. Enable a wider application of gene therapies in a cost-effective and sustainable way.

July 10, 2023

Pfizer backs CRISPR biotech Caribou in latest cell therapy investment

Five years after helping launch Allogene Therapeutics, Pfizer is backing another developer of “off-the-shelf” cell therapies in a deal that gives the drugmaker the chance to acquire a multiple myeloma treatment. 

By Kristin Jensen • July 6, 2023

Sarepta sells FDA fast pass earned from Duchenne gene therapy approval

The deal enables Sarepta to quickly cash in on the clearance of Elevidys, with $102 million in new funds to help bankroll its drug research.

By Jonathan Gardner • July 5, 2023

With FDA approval in hand, BioMarin lays out plan to sell $2.9M gene therapy

The agency granted a long-awaited clearance last Thursday, but unexpected aspects of the hemophilia treatment’s label had some investors worried about its commercial prospects.

By Jacob Bell • June 30, 2023

BioMarin finally secures FDA approval of hemophilia gene therapy

After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the rare bleeding disorder.

By Jacob Bell • June 29, 2023

With new data, Nkarta battles doubts facing ‘off-the-shelf’ cell therapies

Though a newer regimen showed promise in patients with acute myeloid leukemia, earlier remissions haven’t held up as well as the company hoped.

By Ben Fidler • June 27, 2023

Pfizer’s hemophilia B gene therapy inches closer to regulatory approval

The treatment could become Pfizer’s first marketed gene therapy, an area the pharma has poured significant resources into in recent years.

By Delilah Alvarado • June 27, 2023