Executing Biologics Technology Transfer through Integrated Operating Models
As biologics modalities diversify and processes grow complex, the success of tech transfer depends on integrated execution rather than each procedural completion.
Evolving Capacity to Meet Advanced Biologics Therapies
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.
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Survey on the Healthcare Financial Landscape Offers a Roadmap for Stakeholders
Zelis highlights how employers, payers, and consumers are integrating digital tools to manage healthcare costs.
With $100M ReCept M&A deal, Omnicell enters growing specialty pharmacy space
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.
Biogen and Samsung land FDA approval for biosimilar to blockbuster Roche drug
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.
INVEST Precision Medicine Conference Video: Biologics and the Supply Chain Ballet
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.
Cell, gene therapies are highly personalized, but manufacturing needs to be standardized
Cell and gene therapy companies currently each have their own "cookie recipe" for manufacturing. But to scale, more standardization is needed, experts said.
The Power Behind Enterprise EHR Software for Large Healthcare Systems
Enterprise EHR boosts scalability, interoperability, and governance for large healthcare systems.
A decade after biosimilars pathway’s creation, FDA issues final interchangeability rules
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.
FDA releases ‘Biosimilars Action Plan,’ aiming to accelerate innovation
Agency will create new review tools and other resources to encourage development of biosimilars.
Biosimilars will lead to $110B in global healthcare savings by 2020
Biosimilars compete directly with branded biologics that are now going off patent - and in five years, they'll account for 20 percent of the global pharmaceutical market.
Biogen breaks ground on $1.4B Switzerland plant
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 Hidden Administrative Tasks Draining Small Practices
Small practices play a critical role in healthcare delivery, but they cannot continue to absorb ever-increasing administrative demands without consequences.
Oncobiologics raising $50M for Avastin, Humira biosimilars
The company is raising $50 million, on top of some $43 million it's raised this year, according to regulatory filings.
Avitide nets $7.5M for its next-gen biologics manufacturing process
Avitide, a New Hampshire biotech startup, just raised a $7.5 million Series C for its lithe protein engineering platform that can purify and develop biologics and biosimilars.
Oncobiologics raises $31M to develop biosimilars as Humira, Avastin approach patent expiry
New Jersey biosimilar maker Oncobiologics just raised $31 million. It's developing biosimilars for 11 monoclonal antibody drugs that will soon go off-patent, such as Humira, Avastin and Herceptin.
Duchenne Muscular Dystrophy market to shoot up 100-fold in five years
As a whole host of new Duchenne Muscular Dystrophy therapies mature down the regulatory pathway, the global market for the degenerative disease is expected to expand at an incredible rate – from $8.2 million in 2014 to $990 million in 2019, or so says market research firm GlobalData. The present market’s got only paltry offerings to treat this […]
Gee whiz! Unchained Labs raises $25M, acquires platform to optimize biologics research
Two news items from Bay Area life sciences tools startup Unchained Labs: It just announced a $25 million Series A, and acquired a multiplex stability platform for biologics called Optim that will serve as the backbone of its business. With the funding, Unchained Labs plans to build on this Optim platform, and acquire more technologies to grow the biz […]