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 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.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
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 and gene therapy companies currently each have their own "cookie recipe" for manufacturing. But to scale, more standardization is needed, experts said.
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.
Agency will create new review tools and other resources to encourage development of biosimilars.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
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.
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 company is raising $50 million, on top of some $43 million it's raised this year, according to regulatory filings.
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.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
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.
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 […]
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 […]
Worldwide growth in the biosimilars market is hitting its tipping point, analysts say. Sales are projected to hit $25 billion by 2020, according to the folks over at BioWorld who put together a new report, “Biosimilars: A Global Perspective of a New Market.” This is pretty impressive projected growth, considering that total global sales of drugs approved […]
In a move that heralds greater momentum toward regulating biosimilars, the Food and Drug Administration has published its first-ever “Purple Book” – a list of all FDA-licensed biologics and the biosimilars that can be used in their stead. It’s meant to be equivalent to the FDA’s “Orange Book” – the go-to list for physicians, regulatory agents and […]