Novartis division Sandoz has partnered with Chinese manufacturer Gan & Lee to bring biosimilar insulins to the US and EU. The agreement will see China’s Gan & Lee supply Sandoz with insulin glargine, lispro and aspart products for use in patients with type 1 and type 2 diabetes for commercialization in Europe and the US, along with other key markets. “After conducting a significant review, Sandoz decided to collaborate with Gan & Lee, the third largest insulin distributor headquartered in…
How many of the big 2018 news stories do you remember? Try BioProcess Insider’s quiz and have a great Christmas and New Year. Are you a bioprocessing expert or a newbie to this industry? Eitherway, our funtime festive fiesta of a quiz can help you swot up on the industry. See how much of the news from 2018 you remember and we will see you in 2019. Who knows what will take place next year, but you can be assured…
Rentschler Biopharma will produce recombinant hemophilia A product Obizur for Shire after acquiring the Milford facility. German contract development and manufacturing organization (CDMO) Rentschler has entered into an agreement to buy Shire’s Milford, Massachusetts manufacturing facility. The facility makes Shire’s approved product Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence], and under terms of the deal Rentschler will take over production and supply directly to Shire from the plant. Financial details have not been disclosed. “Milford is a specialized site that focuses…
MabPlex has opened a facility in Yantai, China with up to 24,000 L of single-use capacity to serve the growth in biomanufacturing demand. MabPlex International, a contract development and manufacturing organization (CDMO) focused on monoclonal antibodies and antibody-drug conjugates (ADCs), has expanded its global offering through the opening of a commercial plant in Yantai, China. The ribbon cutting ceremony took place in September and according to the firm, the expansion helps feed the global demand in biologics services. “The demand…
Launched in June 2018, the BioProcess Insider digital information portal delivers the latest financial and business news and expert insider views influencing the commercialization of biopharmaceuticals. Here are just a few recent stories edited for our space limitations in print. For more discussion and in-depth analysis, check out the website at www.bioprocessinsider.com. Every edition provides expert and insider perspectives on current financial movements and deal-making; the newest technology purchases and capacity investments; regulations affecting the bioprocessing sector; global market actions…
In earlier issues of BPI we published a few “Elucidation†closers that we called “Defining Moments.†Since then, we have tried to distinguish key confusable terms from one another. Those presented (and sometimes “elucidatedâ€) have been analytical and bioanalytical, spectroscopy and spectrometry, and biosimilars and biobetters. They are just a few of the many confusable terms in the biopharmaceutical industry. For example, when someone says “drug delivery,†a formulator will think of a syringe or transdermal patch, but a logistics…
Sanofi will see its short-acting follow-on insulin Admelog be regulated as a biosimilar from 2020 under US FDA plans to promote competition. But the need for additional studies to show interchangeability could delay any impact, the firm says. The US Food and Drug Administration (FDA) has been actively pursuing efforts to increase adoption of biosimilar products over the past year. In July, the Agency published a ‘Biosimilars Action Plan’ aimed at promoting access to lower-cost biosimilar drugs while maintaining a desire…
An investigating has begun into alleged accounting irregularities between Celltrion Inc. and its affiliate Celltrion Healthcare. Meanwhile, Samsung BioLogics has recommenced share trading a month after being hit by its own accountancy problems. South Korea’s Financial Supervisory Services (FSS) is looking into the business dealings of drugmaker Celltrion Inc and its wholesaler and marketing affiliate Celltrion Healthcare, according to Korean news outlet YTN. The article claimed Celltrion Healthcare violated accounting rules by selling the domestic distribution rights of biological medicines…
Business is up and proposal requests are increasing, but planned sequential maintenance shutdowns of both Avid’s manufacturing facilities hit the CDMO’s second quarter revenues. For the second quarter FY19, Avid Bioservices reported manufacturing revenue of $10.2 million (€9 million), down 20% on the same period last year. The firm – which became a pureplay contract development and manufacturing organization (CDMO) in January 2018 – attributed the drop to planned sequential maintenance shutdowns of both its Californian production plants. The Franklin…
Contract research organization (CRO) PPD will expand its biologics capabilities in Athlone, Ireland to include cell and gene therapy analytical testing. The 41,000 square foot Athlone facility will have a further 6,000 square feet of lab space added to it to feed the demand for biologics testing and to mirror expansions being made at PPD’s facility across the pond in Middleton, Wisconsin. “The Athlone facility enables us to partner closely with a wide variety of both European and global clients…