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

Lonza ups stake in Octane, furthering cell therapy bet

Octane's technology, which Lonza has collaborated on since 2015, is designed to manufacture cell therapies through a closed, automated system.

By Suzanne Elvidge • Nov. 1, 2018

Allergan axes expansion plan, but reiterates commitment to Waco plant

With generic competition for Restasis looming, Allergan is stepping back from previous plans to expand its Texas manufacturing facility.

By Suzanne Elvidge • Nov. 1, 2018

Supply shortages weigh on Pfizer's sterile injectables business in Q3

The pharma doesn't expect to see improvement until late 2019, leaving several quarters yet of ongoing manufacturing challenges.

By Suzanne Elvidge • Nov. 1, 2018

Astellas invests $257M in trans-Pacific manufacturing build-out

A major focus of the planned construction will be on building capacity for cell therapy and regenerative medicine development.

By Suzanne Elvidge • Nov. 1, 2018

Red pill or blue? It could be a billion-dollar decision

Viagra and Nexium ​underscore how marketers and manufacturers can use color to make a drug franchise more successful.

By Jacob Bell • Oct. 29, 2018

Endocyte deal showcases Novartis' complex manufacturing juggling act

Radioligands, CAR-T medicines, gene therapies: Novartis is working on all of them, creating some pretty substantial production challenges.

By Jacob Bell • Oct. 25, 2018

GSK opens new Ellipta plant in Scotland

Growing demand means greater investment needed in manufacturing for the franchise, set against a background of job cuts across the company.

By Suzanne Elvidge • Oct. 25, 2018

Merck KGaA expands manufacturing site at German HQ

The new production facility is 15,000-square-meters and is located in the German pharma giant's historic headquarters in Darmstadt.

By Suzanne Elvidge • Oct. 24, 2018