As biologics modalities diversify and processes grow complex, the success of tech transfer depends on integrated execution rather than each procedural completion.

The post Executing Biologics Technology Transfer through Integrated Operating Models appeared first on MedCity News.

Creating adequate capacity for any therapeutic can be challenging, and the specialized technologies for manufacturing complex biologics require flexibility and agility in production processes. Here’s how contract development and manufacturing organizations (CDMOs) ensure that biopharmaceutical companies have a partner with the speed, flexibility, and expertise necessary for successful drug development and manufacturing.

The post Evolving Capacity to Meet Advanced Biologics Therapies appeared first on MedCity News.

Specialty drugs represent a growing share of overall pharmaceutical sales, and Omnicell is acquiring specialty pharmacy technologies company ReCept Pharmacy to enter this market. Omnicell is paying $100 million cash to buy ReCept.

The post With $100M ReCept M&A deal, Omnicell enters growing specialty pharmacy space appeared first on MedCity News.

The FDA has approved the first biosimilar that references the blockbuster Roche drug Lucentis. The Biogen and Samsung BioLogics joint venture that developed the biologic product have approval to treat three eye conditions that lead to vision loss.

The post Biogen and Samsung land FDA approval for biosimilar to blockbuster Roche drug appeared first on MedCity News.

This panel highlights how different organizations in the biopharma supply chain are addressing the inherent challenges of producing and delivering cell and gene therapies and biologics.

The post INVEST Precision Medicine Conference Video: Biologics and the Supply Chain Ballet appeared first on MedCity News.

Cell and gene therapy companies currently each have their own “cookie recipe” for manufacturing. But to scale, more standardization is needed, experts said.

The post Cell, gene therapies are highly personalized, but manufacturing needs to be standardized appeared first on MedCity News.

The rules are still more restrictive than the European Medicines Agency’s, which allow national governments to determine interchangeability. The FDA would require additional testing to demonstrate products can be freely substituted like generic pharmaceuticals.

The post A decade after biosimilars pathway’s creation, FDA issues final interchangeability rules appeared first on MedCity News.

Agency will create new review tools and other resources to encourage development of biosimilars.

The post FDA releases ‘Biosimilars Action Plan,’ aiming to accelerate innovation appeared first on MedCity News.

The post Biosimilars will lead to $110B in global healthcare savings by 2020 appeared first on MedCity News.

Building cost estimates for Biogen’s new Switzerland plant are $400 million higher than previously announced – despite the company’s 11 percent reduction in workforce last year.

The post Biogen breaks ground on $1.4B Switzerland plant appeared first on MedCity News.

The post Oncobiologics raising $50M for Avastin, Humira biosimilars appeared first on MedCity News.

The post Avitide nets $7.5M for its next-gen biologics manufacturing process appeared first on MedCity News.

The post Oncobiologics raises $31M to develop biosimilars as Humira, Avastin approach patent expiry appeared first on MedCity News.

The post Duchenne Muscular Dystrophy market to shoot up 100-fold in five years appeared first on MedCity News.

The post Gee whiz! Unchained Labs raises $25M, acquires platform to optimize biologics research appeared first on MedCity News.

The post Worldwide market for biosimilars at its tipping point appeared first on MedCity News.

The post FDA comes out with ‘Purple Book’ to catalog biologics and biosimilars appeared first on MedCity News.

The post New funding for next-generation fecal transplant company appeared first on MedCity News.

The post With a band of biotech collaborators, RuiYi sets sail developing new biologic drugs for China appeared first on MedCity News.

The post Biotech’s therapy to regenerate tissue, organs for chronic kidney disease, bladder cancer faces financial test appeared first on MedCity News.

The post Quiet Wisconsin startup raises $3 million for drug-discovery platform for biologics appeared first on MedCity News.

The post Once-monthly HGH replacement therapy gets $25 million VC boost for pediatric trial appeared first on MedCity News.

The post Big Pharma’s big pinch: a $50 billion “growth gap” and fierce M&A competition appeared first on MedCity News.

The post Report: Rapid development and adoption of biologic drugs will drive API market growth appeared first on MedCity News.