Spark looks at scale, manufacturing as gene therapy matures

Though Luxturna only recently hit the market, Spark is already at work validating new ways of scaling up manufacturing. 

By Jacob Bell • Jan. 10, 2019

Catalent to invest $200M in biologics manufacturing, creating 300 US jobs

The move follows a $14 million investment in Bloomington, Indiana, to boost packaging offerings.

By Kristin Jensen • Jan. 8, 2019

Sarepta inks deal to bolster gene therapy manufacturing

An agreement with Aldevron may help the biotech avoid setbacks like the short-lived clinical hold it received on a gene therapy candidate last year. 

By Suzanne Elvidge • Jan. 3, 2019

Our 10 best stories of 2018

Pharma boards, cell therapy, AI and cancer drug ads feature in BioPharma Dive's top articles of the past 12 months.

By Ned Pagliarulo • Dec. 21, 2018

Novartis seeks to acquire French CAR-T contract manufacturer

CellforCure already works with Novartis on clinical production of Kymriah, a therapy that has hit manufacturing hurdles in its rollout. 

By Ned Pagliarulo • Dec. 20, 2018

Recipharm considering closing UK plant, could affect 140 workers

The CEO said the facility in Greater Manchester, England, had "no likely prospect" to deliver "acceptable return in the medium term."

By Andrew Dunn • Dec. 20, 2018

Sen. Warren proposes government manufacture generics

Democratic Sen. Elizabeth Warren is pitching a radical way to cut drug prices for the U.S. budget — the government manufacturing its own generics.

By Suzanne Elvidge • Dec. 19, 2018

New education program to accelerate industry next-gen processing

Employee training is critical as organizations implement next-generation technologies to create new products and streamline their operations across departments.  

Dec. 17, 2018

Troubled Pfizer plant faces more criticism in Form 483

Despite Pfizer's talk of remediation and improvement, regulators have found a slate of repeat manufacturing violations at its Kansas facility.

By Suzanne Elvidge • Dec. 13, 2018

FDA keeps spotlight on GMP data integrity

New guidance from the FDA is aimed at helping manufacturers stay on the agency's good side when it comes to ensuring data are secure and accurate.

By Suzanne Elvidge • Dec. 13, 2018

Orchard to build gene therapy manufacturing plant in California

The planned investment comes months after Orchard struck a deal with GSK to take over development of the British pharma's gene therapy drugs.

By Kristin Jensen • Dec. 13, 2018

Chinese company at heart of valsartan investigation hit with warning letter

The FDA laid out its concerns with Zhejiang Huahai, putting the onus firmly on the Chinese manufacturer to clean up its act.

By Suzanne Elvidge • Dec. 12, 2018

Lonza bets on China biotech market with plans for new plant

A crop of emerging Chinese biotechs are pushing into novel drug development, increasing demand for CDMO services in a country long known for its API manufacturing. 

By Andrew Dunn • Dec. 10, 2018

J&J, Merck back new UK vaccine manufacturing center

The center, which should open in early 2022, aims to ensure a supply of emergency pandemic vaccines for the U.K.

By Suzanne Elvidge • Dec. 6, 2018

Novo Nordisk to invest $22M in North Carolina diabetes plant

Another round of investment will bring more jobs to the site, which is a central piece of the Danish drugmaker's operations in the U.S.

By Suzanne Elvidge • Dec. 6, 2018

Masthercell doubles capacity in production build-out

With the expansion, the CDMO aims to better support its cell therapy-focused clients as they advance candidates through testing. 

By Suzanne Elvidge • Dec. 6, 2018

In CAR-T, manufacturing a hurdle Novartis has yet to clear

In an interview, Novartis' cell and gene therapy head said the pharma's made "significant progress" addressing issues that have hampered Kymriah's roll-out.

By Ned Pagliarulo • Dec. 6, 2018

Catalent boosts biologics packaging with $14M investment at Indiana site

Following the 20th commercial drug approval from its recently acquired Bloomington plant, Catalent is planning a 15,000-square-foot expansion to beef up CDMO capabilities.

By Suzanne Elvidge • Dec. 5, 2018

Sun Pharma acquires two manufacturing plants in deal for Japanese company

Acquiring Pola Pharma won't cost the Indian generics maker much, and boosts its dermatology presence in Japan.

By Suzanne Elvidge • Nov. 29, 2018

GE Healthcare opens new manufacturing center in England

While a small addition, the increased footprint in Stevenage is yet another sign of the corporate giant's interest in biopharmaceuticals and complex therapies.

By Suzanne Elvidge • Nov. 29, 2018

Mylan taken to task for manufacturing failings at key plant

A warning letter issued by the FDA is the first received by the drugmaker for its Morgantown, West Virginia facility since the site was established in 1966.

By Ned Pagliarulo • Nov. 21, 2018

Cambrex acquires Avista in $250M deal

Analysts note the deal, which gives Cambrex facilities as well as new capabilities, will make the company more competitive in the CDMO space.

By Suzanne Elvidge • Nov. 21, 2018

Catalent bringing 2nd clinical supply facility to China

The contract manufacturer expects to invest $2.5 million in the facility and officially open it in early 2019.

By Suzanne Elvidge • Nov. 15, 2018

3D printing poised to disrupt healthcare

Health industry types are "100% convinced, and rightly so, that [3D printing] will be a core part of their business in five to 10 years," ISG's Michael Harmon said.

By Meg Bryant • Nov. 12, 2018

AmerisourceBergen's compounding site still on ice despite beefed-up oversight

Form 483s issued by the FDA have raised questions about PharMEDium's procedures to ensure quality control.

By Jacob Bell • Nov. 8, 2018