Lupin reeling after double whammy warning letter

Shares in the Indian drugmaker dropped by more than 15% on news the FDA flagged manufacturing violations at two facilities.

By Jacob Bell • Nov. 8, 2017

Shire moves Cinryze production in-house as manufacturing problems persist

A third-party manufacturer didn't supply enough of the hereditary angioedema drug during the third quarter, leading to slumped sales.

By Jacob Bell • Nov. 2, 2017

FDA to recognize GMP inspections by 8 EU drug regulators

The agreement marks a major step toward closer collaboration between the FDA and its European counterparts to regulate the production of medical products. 

By Ned Pagliarulo • Nov. 2, 2017

Mustang Bio secures CAR-T production site

Mustang will lease a facility in the UMass Medicine Science Park as it prepares for clinical production of its CAR-T candidates next year. 

By Suzanne Elvidge • Nov. 2, 2017

Sanofi passes on Parkinson's option, crushing Voyager's shares

While the biotech took a hit when its pharma partner exited, retaining U.S. rights for the gene therapy could be a silver lining with better economics.

By Jacob Bell • Oct. 31, 2017

India fights the 'lesser quality' taint in drug manufacturing

Indian drug manufacturers are looking to be bigger players in the global market, but quality control continues to be a challenge.

By Malorye Allison Branca • Oct. 30, 2017

Drug production in Puerto Rico still disrupted, FDA says

Despite positive updates from several large drugmakers, many facilities appear to be operating well below capacity.

By Ned Pagliarulo • Oct. 26, 2017

Recipharm's serialization push continues with Lisbon facility

The CDMO now has six sites with serialization capabilities, reinforcing its position as a key provider of the increasingly important regulatory service.

By Jacob Bell • Oct. 26, 2017

Lilly to spend $72M on upgrading insulin production

The Indianapolis pharma has earmarked $850 million for investments into its U.S. operations this year.

By Ned Pagliarulo • Oct. 26, 2017

Single-source contracting could speed drug development

Outsourcing to a single CMO rather than multiple for manufacturing support proved faster and less costly, a Tufts study found. 

By Suzanne Elvidge • Oct. 26, 2017

With generics market calling, Cambrex outfits Milan facility

The API and generics manufacturer sees an opportunity for growth as certain highly potent molecules near patent expiration. 

By Jacob Bell • Oct. 19, 2017

J&J says Puerto Rico plants returning to full operations

All of J&J's six manufacturing plants on the island are open, but the drugmaker couldn't rule out the possibility of intermittent supply shortages for certain drugs.

By Ned Pagliarulo • Oct. 19, 2017

CPhI Worldwide: Q&A on bilayer tablet manufacturing

Manufacturing bilayer tablets has its own unique challenges for CDMO's. Dr. Éanna Ó Maitiú, Technical Operations Manager, at AbbVie Cork, Ireland discusses the special considerations Abbvie takes into account regarding the manufacturing of these medications. 

By Dr. Éanna Ó Maitiú, Technical Operations Manager at AbbVie Cork, Ireland • Oct. 19, 2017

Novartis shuts Colorado generics facility, cutting 450 jobs

A tightening generics market in the U.S. has prompted the Swiss pharma to consolidate production and discontinue or sell several low-growth products. 

By Suzanne Elvidge • Oct. 19, 2017

MassBio: Massachusetts edges out California as #1 biotech hub

A recent report shows there are now more biopharma jobs in the Boston area than any other place in the U.S., while funding to the area continues to flow.

By Jacob Bell • Oct. 17, 2017

Pfizer sells off Colorado facility to CordenPharma

The Colorado site is one of several legacy Hospira sites that the pharma giant has sought to divest as it reshapes its manufacturing network.

By Ned Pagliarulo • Oct. 12, 2017

Biocon manufacturing problems stall another one of its biosimilars

The FDA rejected Biocon and Mylan's version of Neulasta as the agency awaits more chemistry, manufacturing and controls data for a recently modified facility.

By Jacob Bell • Oct. 12, 2017

Sanofi commits €170M to expand flu vaccines production

​Vaccines are a sizable and fast-growing business for the French drugmaker, which is one of the leading players in the space. 

By Ned Pagliarulo • Oct. 12, 2017

J&J invests $355M in Ireland, creates new jobs

Janssen Sciences Ireland is expanding its Country Cork facility, boosting manufacturing and creating new jobs.

By Suzanne Elvidge • Oct. 12, 2017

Is your API ready for scale-up? What to demand from your CDMO

A CDMO that can optimize your API synthesis process early during technology transfer will reduce the risk of project delay or failure. That will also help your molecule run more efficiently in their plant. And time is money.  

By Justin A. Divan, Manager, Project Management, Pfizer CentreOne • Oct. 11, 2017

Bio-Rad shutters Cambridge facility

The clinical diagnostics tool manufacturer is consolidating its research and development at a site in California. 

By Suzanne Elvidge • Oct. 10, 2017

Merck KGaA invests in Italian manufacturing site

The German company is putting money into a 25-year-old manufacturing site as it increases production of biotech drugs.

By Lisa LaMotta • Oct. 5, 2017

Lonza snatches Shire facility as biologics manufacturing rakes in returns

The drug developer expects the new site will complement operations from another mammalian manufacturing plant in the U.K.

By Jacob Bell • Oct. 5, 2017

Abeona breaks ground on gene therapy manufacturing site

Construction is starting on what could be Ohio's first commercial gene therapy manufacturing facility.

By Suzanne Elvidge • Oct. 5, 2017

With solid results in hand, Gilead inks manufacturing deal for HIV med

A combination including bictegravir showed non-inferiority in a late-stage trial of HIV patients, prompting Gilead to set contracts that allow the drug to be generically manufactured for low-income countries once approved.

By Lisa LaMotta • Oct. 4, 2017