Catalent to help make Novartis' Zolgensma at Maryland site

The gene therapy is currently produced at an AveXis facility in Illinois, but Novartis is expanding its capacity in anticipation of growing demand.

By Ned Pagliarulo • July 18, 2019

FDA warns Indian drug manufacturer Strides about document shredding

In a July warning letter, the regulator criticized the generics manufacturer for shoddy investigation of impurities and deficient quality practices.

By Kristin Jensen • July 17, 2019

Drone delivers Merck vaccines between islands using AT&T tech

The drone, which carried temperature-sensitive Merck vaccines over a 24-mile route, could potentially be used to bring drugs to remote locations.

By Morgan Forde • July 16, 2019

Kite building out manufacturing as next cell therapy inches to market

A new facility will span 67,000 square feet and be located in Oceanside, California, tucked into an existing Gilead site for biologics.

By Jacob Bell • July 16, 2019

Nexus to build $250M manufacturing facility in Wisconsin

The privately-owned drugmaker is planning a 10-year, multi-phase project in Pleasant Prairie, Wisconsin.

By Kristin Jensen • July 11, 2019

Sandoz widens launch of EpiPen rival as shortage continues

Manufacturing issues have kept EpiPen in shortage for more than a year, opening a window for Sandoz to build share for Adamis' Symjepi. 

By Andrew Dunn • July 10, 2019

Federal court bars stem cell sales by Florida company in win for FDA oversight

FDA leaders Ned Sharpless and Peter Marks said the legal action "sends a strong message to others manufacturing violative stem cell products."

By Andrew Dunn • June 27, 2019

Catalent picks up Novavax facilities, 100 employees

The contract manufacturer will use the two sites to further its gene therapy push, complementing a recent buy of Paragon Bioservices.

By Ned Pagliarulo • June 27, 2019

FDA warns Akorn on issues at New Jersey plant

The warning letter is the second issued by the agency to Akorn this year, following a notice for violations at a facility in Decatur, Illinois.

By Kristin Jensen • June 27, 2019

Aiming for price transparency, Civica Rx hits snag with bundled payments

The payment model, often opaque on specific drug costs, affects many of the medicines the hospital-led group is targeting, according to its commercial chief.

By Jacob Bell • June 27, 2019

Axovant signs Yposkesi as manufacturing partner

The small gene therapy developer, with no manufacturing capacity of its own, looks to Yposkesi for large-scale production.

By Kristin Jensen • June 20, 2019

DHL invests $150M to expand pharma, medical supply chain

The life sciences logistics market is highly fragmented, driving third-party companies to invest in temperature-controlled supply chains and specialized facilities.

By Shefali Kapadia • June 20, 2019

Catalent to buy Bristol-Myers plant to grow biologics, European business

The deal also brings an assured customer, as Catalent agreed to continue manufacturing Bristol-Myers Squibb's products at the Italian site.

By Jacob Bell • June 19, 2019

Bluebird delays gene therapy launch to 2020, citing manufacturing tweaks

Following a conditional approval in Europe, Zynteglo's manufacturing process will have to be tightened before treating a commercial patient.

By Andrew Dunn • June 18, 2019

Gene therapy costs, manufacturing keeping CBER head 'up at night'

Lower costs and improved reproducibility would help advance the field, said FDA's Peter Marks in an interview with BioPharma Dive.

By Andrew Dunn • June 13, 2019

Former GSK site to be redeveloped as WeWork-styled life sciences center

Discovery Labs, a company formed by developer MLP Ventures, is the latest to try its hand at creating a science hub outside of Cambridge and the Bay Area.

By Ned Pagliarulo • June 6, 2019

Fresh off being bought, Apceth preps to supply Bluebird's gene therapy

Apceth, now a part of Hitachi Chemical, will serve as the commercial manufacturer in Europe for Bluebird's just-approved gene therapy, Zynteglo.

By Jacob Bell • June 6, 2019

Lonza to separate out specialty ingredients business

As part of the restructuring, Lonza is considering about 130 job cuts, including 50 in Switzerland and 35 in the U.S.

By Kristin Jensen • June 6, 2019

Aldevron to build out 14-acre gene therapy campus

New buildings at an existing site in North Dakota will be capable of making $1 billion worth of biologic products each year — according to the company, at least.

By Kristin Jensen • June 6, 2019

PE firm nabs Vibalogics, banking on demand for complex viral products

The deal brings 50 employees and a 27,000-square-foot manufacturing facility in Germany under the ownership of Ampersand Capital Partners.

By Jacob Bell • May 30, 2019

Iovance to invest $75M in cell therapy plant

A new site in Philadelphia, when complete, will be used to produce Iovance's tumor-infiltrating lymphocyte therapies. 

By Kristin Jensen • May 29, 2019

Biologics license application submission: finding expert help

How finding the right partner to provide expert help can move a company further along the drug-development journey.

May 28, 2019

Evotec to buy Just Biotherapeutics for up to $90M

The purchase offers Germany-based Evotec some new technology as well as a stronger foothold for U.S.​ growth.

By Kristin Jensen • May 23, 2019

WuXi Biologics building dedicated facility to supply 'global vaccine leader'

Though the Chinese company didn't name its latest partner, it did say the pair have in place a 20-year manufacturing contract worth more than $3 billion.

By Kristin Jensen • May 23, 2019

Could Novartis' gene therapy have more than one price?

Indication-based pricing may be possible for less severe patients, who would receive a smaller dose. Lower manufacturing costs would lessen the blow to Novartis too.

By Jonathan Gardner • May 23, 2019