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.
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.
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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.
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.
The home care industry is booming. As Baby Boomers age and more families seek in-home solutions for loved ones, demand for home care services is at an all-time high.
Agency will create new review tools and other resources to encourage development of biosimilars.
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.
At a time when AI is reshaping pharma, Reverba Global CEO Cheryl Lubbert explained in an interview why empathy, context, and ethics still require a human touch.
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.
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 […]