The White House today announced a COVID-19 response plan that includes a major effort to increase at-home rapid testing. President Joe Biden’s plan includes opening new federal testing sites to increase capacity and the distribution of 500 million at-home, rapid tests to Americans. The Biden administration plans to purchase a half-billion rapid tests this winter […]
Contract Manufacturing
Fareva, ApiJect ink 10-year licensing agreement on fill-finish production lines
Fareva and ApiJect Systems today announced a licensing agreement to fill-finish more than 500 million injectable drug doses per year. Under the agreement, Fareva intends to invest more than $56.5 million to install three blow-fill-seal production lines with support from the Government of France through the France Relance industry initiative, as well as the Investments for the […]
Integer completes $220M Oscor acquisition
Integer Holdings (NYSE: ITGR) announced today that it has completed its purchase of Oscor — a deal that expands the capabilities of what was already one of the world’s largest medtech contract manufacturers. Integer said the acquisition would cost $220 million when it first announced its plans in October. Get the full story on our […]
Fujifilm to expand vaccine production plant in England
Fujifilm (TSE:4901) is spending big to double the size of its United Kingdom-based vaccine manufacturing facility. According to a news release, Fujifilm is spending about $532.8 million (£400 million) to expand its Teesside (north-east England) plant making the Novavax COVID-19 vaccine. The expansion includes facilities specializing in antibody treatments and viral gene therapies. Fujifilm said […]
FDA clearance enables Outset Medical to streamline manufacturing
Outset Medical (NSDQ:OM) announced that a new sterilization method for its Tablo hemodialysis system received FDA 510(k) clearance. San Jose, California-based Outset’s new sterilization method for the cartridge — utilized in the Tablo system — enables the company to start cartridge production through a manufacturing partner in Mexico. The move facilitates the localization of cartridge […]
FDA says Philips knew about toxic foam for years before massive recall
The FDA said it observed potential violations of federal medical device safety rules when inspecting a Philips Respironics manufacturing facility connected to the Class I recall of more than 15 million respiratory devices. The FDA recently requested additional safety testing on replacement materials and issued a Form 483. The form details how Philips and its foam supplier were aware […]
BD breaks ground on pre-filled syringe manufacturing plant in Spain
BD (NYSE:BDX) announced today that it broke ground on its $200 million pre-filled drug delivery device manufacturing plant in Spain. Franklin Lakes, New Jersey-based BD announced in May that it would build the $201.5 million (€165 million) high-tech manufacturing facility in Zaragoza, Spain, with expectations of creating up to 600 jobs at the facility by 2030. Get […]
FDA requests safety testing of replacement foam in Philips sleep devices recall
The FDA said it has requested additional safety testing on the material used to repair Royal Philips (NYSE:PHG) sleep therapy devices recalled for foam that could harm patients using them. The Class I recall that started in June covers more than 15 million devices, after hundreds of complaints and more than 100 injuries from polyester-based […]
What is renal denervation? Medtronic Coronary and RDN President Jason Weidman explains
Medtronic (NYSE:MDT) continues clinical trials of its Symplicity Spyral renal denervation (RDN) system for treating hypertension. The hope now is to win FDA approval in 2023. To better understand the technology behind what Medtronic leaders expect to become a multibillion-dollar business, Medical Design & Outsourcing spoke with Jason Weidman, Medtronic SVP and president of the […]
HHS to invest $650M to increase access to rapid COVID-19 testing
The U.S. Dept. of Health & Human Services (HHS) today announced a further $650 million investment into rapid COVID-19 diagnostics. According to a news release, HHS will invest the $650 million from the American Rescue Plan to strengthen manufacturing capacity for rapid, point-of-care molecular COVID-19 tests and increase Americans’ access to the diagnostics. “Access to […]
World faces a shortage of up to 2 billion COVID-19 vaccine syringes
The World Health Organization (WHO) reportedly warned that a massive shortage of syringes for COVID-19 vaccines could be on the horizon. Reuters reported that WHO expert Lisa Hedman told a United Nations briefing that the potential shortage of 1 billion to 2 billion syringes could slow down routine immunizations and create issues with needle safety along […]