Chinese pharma Henan Lihua hit with FDA warning letter

As a result, the company was subsequently placed on the FDA's import alert list — the eighth Chinese drugmaker to land on the list this year. 

By Suzanne Elvidge • July 5, 2018

Dr. Reddy's recalls generic cholesterol drug from US market

More than 236,000 bottles of atorvastatin, better known by its brand name Lipitor, are affected by the recall.

By Suzanne Elvidge • July 5, 2018

Catalent expands with $133M deal for Juniper

Acquiring the Boston-based company will hand Catalent a clinical development and manufacturing center in the U.K.

By Ned Pagliarulo • July 3, 2018

Sanofi expands China presence with new R&D hub

It's a bet on the growing role China looks set to play in global clinical trials of new medicines. 

By Ned Pagliarulo • July 2, 2018

WuXi strikes manufacturing collaboration with Harbour BioMed

It's the latest manufacturing partnership the Chinese CDMO has inked this year amid a major expansion of its global footprint.

By Suzanne Elvidge • June 28, 2018

Plasticell leads UK gene therapy manufacturing consortium

The biotech is working with academia to improve its manufacturing technology.

By Suzanne Elvidge • June 27, 2018

GE to spin off healthcare unit in latest restructuring

Moody's and investors applauded the move, which comes amid a reboot of the health division.

By Meg Bryant • June 27, 2018

Sanofi Pasteur on dengue and the changing vaccine landscape

The French pharma's vaccine unit has faced significant backlash, but remains a major player in the global market. The chief commercial officer of North America talked to BioPharma Dive about the business.

By Lisa LaMotta • June 25, 2018

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

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