Lonza reports pharma strength as rest of business falters

The Swiss manufacturer kept its 2019 guidance in place as growth in its pharma and biotech business made up for headwinds elsewhere.

By Kristin Jensen • April 18, 2019

Catalent to buy Paragon for $1.2B as gene therapy demand grows

The deal follows close on the heels of Thermo Fisher's buy of Brammer Bio, a peer of Paragon in making the viral vectors needed for gene therapy. 

By Jacob Bell • April 15, 2019

GSK, AstraZeneca explore continuous manufacturing in partnership with CPI

The companies are establishing a continuous wet granulation plant for small-scale development of oral solid dosage pharmaceuticals.

By Suzanne Elvidge • April 11, 2019

FDA clears 40 impurity-free ARBs to ease antihypertensive shortages

Agency officials stressed the risk to patients is small and urged those on the heart meds to consult a doctor before discontinuing them.

By Suzanne Elvidge • April 11, 2019

Lonza's CEO on keeping up with microbiome, gene therapy boom

Marc Funk told BioPharma Dive manufacturing has been an obstacle for microbiome drugmakers, something the Swiss CDMO hopes to solve with a new joint venture. 

By Ned Pagliarulo • April 11, 2019

Novo ramping up hemophilia drug production with $100M investment in Danish site

Currently producing diabetes drugs, the upgraded facilities will also make the active ingredients for NovoSeven and future hemophilia products.

By Suzanne Elvidge • April 3, 2019

Lonza launches joint venture to supply microbiome field

Together with the Danish company Chr. Hansen, Lonza is betting biotech and pharma companies developing bacteria-based therapies will need a partner.

By Kristin Jensen • April 3, 2019

AveXis buys its 4th US plant in preparation of Zolgensma launch

The six-building campus in Longmont, Colorado, gives the Swiss biotech nearly 700,000 square feet of additional space for biologic drug manufacturing.

By Jacob Bell • April 2, 2019

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