The pharma supply chain: What you need to know

Drug development is no easy feat. But even when manufacturing is perfected, getting treatments from plants to patients remains a hurdle.

By Jacob Bell • April 24, 2018

FDA bans Cantrell from manufacturing, distributing sterile drugs

An April consent decree filed by the Department of Justice on behalf of the FDA prohibits Cantrell from operating in any capacity until it corrects the "substandard" conditions at its Arkansas facility.

By Randi Hernandez • April 24, 2018

Pharma supply chains could use a tech reboot

While more prosaic than drug R&D, supply chains are increasingly important as the industry moves toward personalized medicine. 

By Kate Patrick Macri • April 23, 2018

Mylan cuts workforce at West Virginia plant by 15%

The announcement leaves approximately 3,000 employees at the Morgantown location, a site that is primarily dedicated to production of oral drugs.

By Randi Hernandez • April 23, 2018

As India, China drug industries mature, FDA scrutiny an overhang

Rising numbers of warning letters have put production quality in focus, just as both countries turn further toward novel drug R&D. 

By Ned Pagliarulo • April 23, 2018

The Drug Supply Chain Security Act: A progress report

Five years in and one enforcement extension later, pharmaceutical companies still have a long way to go to fulfill the goal of true traceability. 

By Edwin Lopez • April 23, 2018

Top challenges facing drug supply chains

Issues like GMP compliance and cold-chain shipping are just two of the hurdles that must be overcome for medicines to travel from drugmakers to patients. 

By Ned Pagliarulo , Edwin Lopez • April 23, 2018

CAR-T ups challenges in pharma supply chain

New technology made it viable to ship the cell therapies. Now, stakeholders are pushing for more innovation to meet looming commercial demands.

By Jacob Bell • April 23, 2018

Astellas sells Agensys facilities to Gilead

Ownership of the California sites will be transferred to Gilead's Kite unit, which has a nearby plant for the production of its CAR-T therapies.

By Ned Pagliarulo • April 19, 2018

J&J reshaping its supply chain around therapies of the future

Newer technologies like those used in biologics and CAR-T development are spurring the overhaul, as are hundreds of millions in potential cost savings.

By Jacob Bell • April 19, 2018

GE brings antibody know-how to viral vector production

The corporate giant aims to adapt its manufacturing tech for the cell and gene therapy world, a GE exec tells BioPharma Dive. 

By Randi Hernandez • April 19, 2018

Top trends impacting your pharma packaging decisions

Biological drugs and wearable devices are growing in tandem with an aging, longer-living population. Glass containers are an important solution to the challenges of stabilization and administration these drugs present. 

April 19, 2018

DEA seeks to more strictly manage opioid manufacturing

A proposed rule would allow the agency to consider drug misuse when setting the annual quotas that govern production of the painkillers. 

By Ned Pagliarulo • April 18, 2018

Amgen chooses location for $160M biomanufacturing plant

Coming to Rhode Island, the facility is first of its kind in the U.S., according to Amgen, and will feature primarily single-use systems and a modular design.

By Randi Hernandez • April 12, 2018

Lonza makes gene therapy ambitions clear with Texas plant

Banking on surging demand for the biologic components of gene therapy, Lonza has constructed what it claims is the world's largest dedicated facility for production of the complex treatments.

By Ned Pagliarulo • April 12, 2018

Maker of Pfizer med warned for continued testing issues

Tris Pharma has for years ruffled feathers at the FDA for not adequately investigating drug product failures.

By Jacob Bell • April 12, 2018

Sanofi boosts vaccine supply capabilities with Toronto investment

The Toronto site is the exclusive producer of the five-component pertussis, an antigen used to make pertussis combination vaccines.

By Randi Hernandez • April 12, 2018

Celltrion acknowledges CRLs in potential hurdle for Teva

Rejection by the FDA of the two biosimilar candidates Celltrion develops with Teva could also prove a headache for the Israeli drugmaker's migraine therapy.

By Randi Hernandez • April 9, 2018

Autolus pairs up with Miltenyi to manufacture T-cell therapies

Autolus aims to automate its cell processing steps utilizing Miltenyi tools, which could in theory make the complex manufacturing process more reproducible.

By Randi Hernandez • April 5, 2018

AGC in new expansion as biologics production heats up

With the industry's focus shifting more to large-molecule drugs, contract manufacturers are building out capacity to meet demand.

By Jacob Bell • April 5, 2018

Corning to build NC facility in pharma packaging expansion

The manufacturer plans to invest $200 million in the plant, which will produce the company's Valor Glass packaging.

By Ned Pagliarulo • April 5, 2018

Alnylam taps Agilent for commercial API supply

The five-year deal will help support Alnylam's planned market launch of its RNAi therapeutic patisiran.

By Ned Pagliarulo • April 4, 2018

Proposed China tariffs target dozens of medical products

Insulin products, vaccines and certain active pharmaceutical ingredients imported from China could face a new 25% tariff under the Trump administration's proposed plan. 

By Ned Pagliarulo • April 4, 2018

Eisai partners with Nichi-Iko in generics pact

Under the deal, Eisai will transfer ownership of its generics unit to Nichi-Iko, supplying its new partner with API from a manufacturing plant in India.

By Ned Pagliarulo • March 29, 2018

Fujifilm lays down $800M for Irvine Scientific

Snapping up niche bioprocessing companies furthers Fujifilm's goal of improved pharma manufacturing, and it's on the hunt for more buys.

By Randi Hernandez • March 29, 2018