Merck KGaA invests $166M in biotech manufacturing

German Merck's most recent manufacturing investment will focus on expanding biologic capacity at its plant in Aubonne, Switzerland.

By Suzanne Elvidge • April 1, 2019

Thermo Fisher's pharma head talks Brammer Bio and future M&A

Michel Lagarde, who leads Thermo Fisher's pharma services unit, explained to BioPharma Dive why the life science giant chose to enter gene therapy via a $1.7 billion deal for Brammer Bio.

By Andrew Dunn • March 28, 2019

Bluebird opens cell and gene therapy plant in North Carolina

The site, which Bluebird bought in November 2017, will make the lentiviral vectors needed to produce the biotech's experimental treatments.

By Suzanne Elvidge • March 26, 2019

Masthercell to build cell and gene therapy plant in Belgium

Expected to become operational in 2021, the new plant should triple the CDMO's manufacturing capacity.

By Andrew Dunn • March 26, 2019

Thermo Fisher to buy Brammer Bio for $1.7B, expanding gene therapy offerings

The life sciences giant grows its ambitions in the pharma CDMO space with another acquisition, this time focused on viral vector production.

By Andrew Dunn • March 25, 2019

Abeona readies manufacturing ahead of Phase 3 trial

The biotech plans to begin Phase 3 study of cell therapy by mid-2019, a step made possible by ongoing development of its manufacturing capabilities.

By Kristin Jensen • March 21, 2019

FDA's Gottlieb defends agency response to valsartan contamination

Responding to questions at an event this week, the outgoing FDA chief also pointed to forthcoming regulations aimed at improving oversight of manufacturing process changes.

By Ned Pagliarulo • March 21, 2019

Merck KGaA to invest 1 billion euros in German HQ

The agreement comes out of negotiations between management and employee representatives, and solidifies Darmstadt as German Merck's main hub. 

By Andrew Dunn • March 21, 2019

In 'golden age' for CDMOs, Thermo Fisher invests $150M in pharma services

The lab and instruments giant has expanded in the contract pharma and biotech markets following a multi-billion dollar deal for Patheon two years ago.

By Andrew Dunn • March 20, 2019

FDA approves valsartan generic amid probe into impurities

The agency is prioritizing generic applications for the commonly used high blood pressure drug to counteract a shortage caused by manufacturer recalls.

By Suzanne Elvidge • March 13, 2019

Biogen sells biologics plant to Fujifilm in $890M deal

After acquiring the site, Fujifilm will become Biogen's supplier, producing the biotech's multiple sclerosis drug Tysabri.

By Ned Pagliarulo • March 12, 2019

Cellectis to bring CAR-T manufacturing in-house with new plants

The cell therapy biotech, best known for its allogeneic ambitions, currently relies on contract manufacturers for its clinical trial supply.

By Suzanne Elvidge • March 8, 2019

FDA flags manufacturing shortcomings at Actavis plant

The warning letter comes as Teva, Actavis' parent, works to close or divest nearly a dozen manufacturing sites this year.

By Suzanne Elvidge • March 7, 2019

Accenture to buy Irish manufacturing services firm ESP

ESP will join Accenture's digitally focused unit and bring along its clients, which include 17 of the top 20 global pharmas. 

By Kristin Jensen • March 7, 2019

Biogen avoids heavy manufacturing lift in latest gene therapy deal

Nightstar's therapies target the eye, which means delivery of the DNA-based treatments is less onerous than it would be in other tissues, Biogen argues.

By Jacob Bell • March 5, 2019

FDA urges move from stop-start to continuous manufacturing

The agency is pushing for more continuous manufacturing, but the industry has seemed reluctant thus far.

By Suzanne Elvidge • Feb. 28, 2019

Akorn's Amityville plant draws critiques from FDA

Inspectors from the agency flagged maintenance, testing and record-keeping issues at the New York plant, adding to the company's recent woes.

By Kristin Jensen • Feb. 28, 2019

In unusual step, FDA pushes back against reports on questionable generic drug quality

A statement from agency chief Scott Gottlieb and CDER head Janet Woodcock defended their oversight of generic drugs imported from abroad.

By Ned Pagliarulo • Feb. 22, 2019

FDA to accept drug plant inspections by Poland, Slovenia

So far, the regulator has recognized health authorities in 22 EU countries, trusting information those agencies gather through GMP inspections.

By Ned Pagliarulo • Feb. 21, 2019

Allogene inks lease for new cell therapy manufacturing facility

The 118,000-square-foot space should help the biotech be less reliant on its contract manufacturer and its partner Pfizer. 

By Jacob Bell • Feb. 21, 2019

AveXis adds new jobs in gene therapy manufacturing expansion

More jobs and money are on the table for an AveXis plant in North Carolina, showing acquirer Novartis' interest in building out its gene therapy capabilities.

By Suzanne Elvidge • Feb. 21, 2019

AstraZeneca adjusts supply chain for no-deal Brexit

The pharma will change some product packaging, duplicate batch testing and build inventory ahead of the impending Brexit deadline. 

By Matt Leonard • Feb. 19, 2019

Teva set to shed 11 manufacturing sites in 2019

The drugmaker's plans are part of a broad cost-cutting drive aimed at shrinking its spending base amid ongoing challenges in its generics business.

By Ned Pagliarulo • Feb. 14, 2019

Jazz set to lose rights to Erwinaze after partner cancels deal

While the lost rights would be a hit to Jazz's revenues, the company has a recombinant version of drug that analysts believe could cushion the blow. 

By Kristin Jensen • Feb. 13, 2019

Immunomedics, still searching for first approval, discloses forthcoming FDA re-inspection

The agency will re-inspect a New Jersey manufacturing facility as part of a regulatory resubmission for the company's lead drug candidate.

By Andrew Dunn • Feb. 8, 2019