Fresenius (NYSE:FMS) business group Fresenius Kabi said today that it plans to invest more than $100 million over the next five years in a Wilson, N.C.-based manufacturing site. The company’s expansion project is designed to boost the facility’s capacity to produce generic medicines in pre-filled syringes, Fresenius reported. The expansion is also slated to increase the […]
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Dexcom, Lilly ink deal to combine CGM into smart insulin delivery device
Dexcom (NSDQ:DXCM) said today that it inked a development deal with Eli Lilly (NYSE:LLY) to include its continuous glucose monitor in the insulin-maker’s connected delivery devices. The pair plans to start clinical trials by the end of this year, adding that they hope to position the combination of their technologies as a comprehensive solution for people with […]
Aridis uses human antibodies to fight against “time bomb” of antibiotic resistance
Although antibodies have gained plenty of ground in recent years as vehicles for cancer therapies, Aridis Pharmaceuticals wants to use them as nature intended – to fight infection. “These are human monoclonal antibodies being investigated as anti-infectives to treat bacterial infections associated with pneumonia,” founder & CEO Vu Truong told Drug Delivery Business News, referring to […]
Milestone Scientific plans launch for Botox injection device
Milestone Scientific (NYSE:MLSS) said today that it plans to launch a cosmetic injection instrument designed to deliver botulinum toxin. The company’s new drug delivery instrument is slated to include an integrated electronic record-keeping feature, as well as improved needle placement compared to its dental injection device. “There is a large and growing market for botulinum toxin […]
Orexo nabs regulatory win for fast-dissolving opioid dependence therapy
Orexo (STO:ORX) said today that the European Medicines Agency granted marketing authorization for its Zubsolv rapidly-disintegrating treatment for opioid dependence. The buprenorphine and naloxone sublingual tablet is the first to be approved in Europe with six different strengths, according to the Sweden-based company. “Our ambition is to make Zubsolv available to patients outside the US, and this […]
FDA approves Kaleo’s allergy auto-injector designed for infants
The FDA has approved Kaleo‘s Auvi-Q epinephrine auto-injector designed to treat life-threatening allergic reactions in infants and small children, according to the privately-held biopharma company. The device, which Kaleo touts as the first of its kind, was given priority review by the FDA. The 0.1 mg Auvi-Q auto-injector has a shorter needle and a lower […]
After FDA nod, Flexion launches osteoarthritis injection
Flexion Therapeutics (NSDQ:FLXN) today launched its Zilretta therapy designed to help patients manage pain associated with osteoarthritis of the knee. The Burlington, Mass.-based company’s extended-release intra-articular injection combines a commonly administered, short-acting corticosteroid with a polylactic-co-glycolic acid matrix using Flexion’s microsphere technology. The FDA approved Zilretta last month after granting it fast track status in 2015. […]
Amgen launches Enbrel Mini single-dose cartridges with reusable auto-injector
Amgen (NSDQ:AMGN) announced today the U.S. launch of its Enbrel Mini single-dose prefilled cartridges, which are delivered using a reusable AutoTouch auto-injector. The drug-device combination was designed with a needle that stays hidden during injection and a sensor to detect placement on the skin. Amgen’s latest product uses a new drug formulation of Enbrel, an injectable […]
Here’s what the FDA is doing about IV fluid shortages following hurricanes Maria, Irma
Nine weeks after hurricanes Maria and Irma brought devastation to Puerto Rico, FDA commissioner Dr. Scott Gottlieb says hospitals across the U.S. are reporting shortages of IV fluids – medical products that are often sourced from Puerto Rico. Hospitals are specifically noting that 0.9% injection bags of saline, used to inject drugs intravenously, are of […]
JDRF touts win after Anthem decides to cover artificial pancreas systems
JDRF said today it successfully persuaded Anthem to cover artificial pancreas systems, after meeting the health insurer as part of its Coverage2Control campaign. America’s 25 largest health insurers now cover Medtronic‘s (NYSE:MDT) MiniMed system, according to the organization. “This is a great victory for the T1D community. By taking this tremendous step, Anthem is giving […]