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

How to go fast to IND: 3 tips to combine speed with quality

A survey of small-biopharma leaders on their plans and concerns for developing their molecules shows three issues of highest importance: getting their drugs to the clinic quickly, finding expert help and having adequate funding.

May 17, 2019

B. Braun invests $1B in IV fluid manufacturing to alleviate shortages

Weather events like Hurricane Maria have fueled an IV solution shortage B. Braun hopes to address by opening, updating and expanding production sites.

By David Lim • May 16, 2019

FDA highlights manufacturing quality efforts after recalls, regulatory criticism

An agency report found the industry's average inspection score didn't change much over the last two years, though there remain concerns about quality control in China and India.

By Kristin Jensen • May 16, 2019

Thermo Fisher to buy GSK drug plant in Ireland

GSK will receive about $100 million from Thermo for the site, which makes API for drugs that treat conditions like depression and Parkinson's disease.

By Kristin Jensen • May 16, 2019

Chemical suppliers take hits from both sides of the trade war

Chemicals produced in the U.S. suffer from higher cost of materials imported from China and the shrinking Chinese export market due to retaliatory tariffs.

By Emma Cosgrove • May 16, 2019

Bayer pumping $150M more into biologics

A new facility will focus on large-molecule therapies for oncology, cardiology and additional specialty care areas.​

By Jacob Bell • May 13, 2019

Catalent, hindered by Softgel weakness, sees stronger growth ahead

Revenues from January to March fell 2% year over year, as the CDMO works through an ibuprofen supply shortage and an accounting change.

By Ned Pagliarulo • May 9, 2019

Charles River sees minimal financial impact from cybersecurity breach

An incident disclosed last week likely won't result in significant costs, the company told investors.

By Kristin Jensen • May 9, 2019