Mustang opens CAR-T manufacturing plant, with focus on lead candidates

By year's end, the biotech expects to start processing patient cells and file its first Investigational New Drug Application for one of its therapies.

By Jacob Bell • June 24, 2018

FDA pulls back biosimilar draft guide amid industry concern

The agency appears to be sympathetic to the cost concerns raised by biosimilar drugmakers, saying it will address them in future guidance.

By David Lim • June 22, 2018

Boehringer invests $268M to further build out biologics

Several expansions of the German pharma's biologics business reflect how the large-molecule drugs have beefed up its bottom line.

By Jacob Bell • June 22, 2018

Enthusiasm for GSK's Shingrix has supplies falling short

Despite a shortage, the 2018 supply will still be sufficient to vaccinate more patients than last year.

By Suzanne Elvidge • June 22, 2018

New drug shortages on the rise in 2017, after years of steady declines

A damaging hurricane season, along with manufacturing woes at a key plant, contributed to the uptick, even as the number of ongoing shortages dropped. 

By Suzanne Elvidge • June 21, 2018

Antibiotic supply chains in need of better management, report finds

Improved demand planning and sourcing strategies could help lower costs and improve distribution, according to a new white paper.

By Kate Patrick Macri • June 21, 2018

Emulate raises $36M to develop organ-on-chip tech

The cash will help broaden the functionality of Emulate's tech, which could reduce the numbers of animals used in drug experimentation.

By Suzanne Elvidge • June 21, 2018

Vertex opens doors to new research site in San Diego

Research at the new complex, which is one of three hubs for the biotech, will focus on cystic fibrosis as well as other therapeutic areas, including pain.

By Suzanne Elvidge • June 19, 2018

Recipharm to pay $60M for Sanofi manufacturing plant

All 450 staff employed at the Sanofi site will transfer over to the Swedish CDMO, which hopes to expand its contract business with the buy.

By Ned Pagliarulo • June 14, 2018

FDA hits Taiwan Biotech with warning letter

Taiwan Biotech was urged to call in a consultant to remedy the cGMP violations flagged by the FDA. 

By Suzanne Elvidge • June 14, 2018

Solving the challenges of high-viscosity biopharma mixing with effective design choices

Designing a processing system to handle high-viscosity BioPharma products can be a demanding process, and there are many challenges to consider. However, the better you understand the nature of these challenges, the better you will be able to optimize your quality and productivity. 

June 14, 2018

Phase 2: Big Pharma expands its blockchain experiment

Two drug distributors and four pharmas have signed onto the MediLedger Project, aiming to create a blockchain-based approach to product traceability.

By Edwin Lopez • June 14, 2018

Cambrex expands at Milan site

The generic API manufacturer will add a new lab in an effort to meet demand. 

By Suzanne Elvidge • June 13, 2018

Sun Pharma gets reprieve as FDA clears key Halol plant

India's largest generic drugmaker said the regulator had concluded violations found in a damaging 2015 warning letter to the facility were resolved.

By Ned Pagliarulo • June 12, 2018

WuXi Biologics plans first production facility in the US

The CMO will commit $60 million to build the plant, its latest project in a string of investments aimed at building a global manufacturing network.

By Suzanne Elvidge • June 11, 2018

Abeona opens commercial cell and gene manufacturing plant

The Elisa Linton Center in Ohio will manufacture cGMP-grade gene and cell therapies for clinical trials and commercialization.

By Suzanne Elvidge • June 7, 2018

How Fujifilm became a contract manufacturer

BioPharma Dive sat down with the head of Fujifilm Diosynth Biotechnologies at the BIO meeting to talk about manufacturing changes underway in the industry.

By Lisa LaMotta • June 7, 2018

TxCell turns to Lonza for CAR-T manufacturing

Anticipating increased demand, Lonza has been busy scaling up capacity to make cell and gene therapies for biotechs like TxCell.

By Suzanne Elvidge • June 7, 2018

UK launches new research institute tasked with improving drug discovery

The Rosalind Franklin Institute hopes to tap AI, robotics and new imaging techniques in a search for better methods to uncover new drug targets.

By Suzanne Elvidge • June 7, 2018

FDA working to mitigate critical drug shortages

Drug shortages can impede access to important drugs — something the agency aims to prevent in the future.

By Suzanne Elvidge • June 1, 2018

How to overcome drug sensitivity issues during development

By some estimates, 20-30% of drug formulations now have sensitivity issues. A glass container dedicated to biologics drugs has proven successful in de-risking switches from one container to another.

May 31, 2018

Ultragenyx taps Rentschler for Mepsevii commercial supply

The collaboration will give Ultragenyx access to fill and finish capabilities for its rare disease biologic.

By Suzanne Elvidge • May 31, 2018

GE Healthcare supports cell therapy scale-up

A partnership between DiscGenics, CCRM and GE Healthcare could help streamline manufacturing for the disc disease cell therapy.

By Suzanne Elvidge • May 31, 2018

Allergan recalls Taytulla contraceptive capsules

A packaging error could make the birth control ineffective and lead to unintended pregnancy.

By Suzanne Elvidge • May 30, 2018

EU refines IP rules to boost biosimilars and generics

The European Commission is loosening an IP law to improve the competitiveness of EU drugmakers in the global generic and biosimilar market.

By Suzanne Elvidge • May 29, 2018