EpiPen shortage tied to Pfizer manufacturing issues

The FDA added the epinephrine auto-injector to its list of drugs currently in shortage due to production issues.

By Lisa LaMotta • May 9, 2018

Lonza expands key New Hampshire biologics plant

The Swiss manufacturer will also add cell therapy suites to the site, further bolstering its push into the fast-growing field. 

By Suzanne Elvidge • May 7, 2018

Fremanezumab approval by mid-June unlikely, Teva says

Issues at Teva's contract manufacturer appear to have tripped up the migraine drug's application, although the generics giant still expects an OK by year-end.

By Ned Pagliarulo • May 3, 2018

WuXi steps outside China with Ireland plant plans

The biologics manufacturer will invest $390 million into building a huge single-use bioreactor plant in pharma's favorite home for drug production. 

By Suzanne Elvidge • May 1, 2018

3 FDA warning letters issued for GMP hitches

Inspectors from the U.S. regulator flagged violations at production plants in China, Mexico and Florida. 

By Randi Hernandez • April 30, 2018

Zoetis doubles down on animal vaccines

The animal health spinout will beef up its manufacturing footprint in China with two new facilities that will focus on vaccines, particularly for farmed fish. 

By Randi Hernandez • April 27, 2018

Shionogi dives into Japan's growing CMO sector

Seeing local demand for contract manufacturing, the Japanese pharma plans to set up a new unit to produce drugs developed by others as well as its own.

By Randi Hernandez • April 26, 2018

Shire, tight-lipped on Takeda, focuses on portfolio's potential

Investors craved details on a potential takeover, but Shire instead harped on Xiidra pickup, Cinryze stock and the resiliency of its hemophilia business.

By Jacob Bell • April 26, 2018

Noven resolves FDA warning for Miami facility

After receiving a close-out notice from the FDA, the company can now move past a 2016 warning letter. 

By Suzanne Elvidge • April 26, 2018

Avid Bioservices expands facility, process development capabilities

New capital investments supporting facility growth are part of Avid's transformation into a dedicated CDMO.

By Randi Hernandez • April 25, 2018

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

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

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

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