Inovio Pharmaceuticals (NSDQ:INO) announced that it received $71 million from the U.S. Defense Dept. to support its Cellectra 3PSP smart device. Funding from the DoD is set to support large-scale manufacturing for the Cellectra 3PSP and the … [Read More...]
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Are You Prepared for the Upcoming Blanket No Change Certification Reporting Period? Learn more from Reed Tech
Listen to the recording of Reed Tech’s ‘Blanket No Change Certification webinar’ to learn about annual No Change Certification submission requirements for drug product listings and what steps are … [Read More...]
Featured Posts
BREAKING: Thermo Fisher drops bid for Qiagen
Thermo Fisher Scientific (NYSE:TMO) announced today that its offer to acquire Qiagen (NYSE:QGEN) in an $11.5 billion deal has lapsed. According to a news release, more than 107.5 million shares of Qiagen (47.02% of the issued and outstanding … [Read More...]
Medtronic to acquire Companion Medical, expands diabetes business
Medtronic (NYSE:MDT) today said it would acquire insulin pen manufacturer Companion Medical for an undisclosed amount. Companion Medical's product portfolio includes the InPen FDA-cleared smart insulin pen system that is paired with an integrated … [Read More...]
Report: Will Dr. Hahn crack under political pressure?
Many jobs have come with increased stress levels during the coronavirus pandemic, from ICU staff to Walmart greeters. Now officials who’ve been keeping tabs on FDA commissioner Dr. Stephen Hahn are wondering whether he can weather the strain of … [Read More...]
3M lays off another 1,700 workers, many related to former drug delivery business
3M (NYSE:MMM) laid off another 1,700 workers during its second-quarter — with many of the jobs related to the company's divested drug delivery business. The layoff — announced as part of an SEC filing on July 28 — comes after the Maplewood, … [Read More...]
Insulet up on Street-beating Q2, raised guidance
Insulet (NSDQ:PODD) shares ticked up today on second-quarter results that topped the consensus forecast. The Acton, Mass.-based wearable insulin delivery system developer posted profits of $14.4 million, or 22¢ per share, on sales of $226.3 … [Read More...]
Tandem Diabetes posts $27m Q2 loss, reinstates earlier guidance
Tandem Diabetes Care (NSDQ:TNDM) posted Street-beating second-quarter sales and missed badly on earnings, but reinstated its earlier full-year 2020 guidance. The San Diego-based company — maker of insulin pumps and other diabetes management … [Read More...]
Inovio to scale up production of smart delivery device for potential COVID-19 vaccine
Inovio Pharmaceuticals (NSDQ:INO) announced that it received $71 million from the U.S. Defense Dept. to support its Cellectra 3PSP smart device. Funding from the DoD is set to support large-scale manufacturing for the Cellectra 3PSP and the … [Read More...]
Thermo Fisher rises on COVID-19 response-driven Q2
Thermo Fisher Scientific (NYSE:TMO) shares got a boost today on second-quarter results that came in well above the consensus forecast. The Waltham, Mass.-based company posted profits of $1.2 billion, or $2.90 per share, on sales of $6.9 billion … [Read More...]
Smiths Medical lands major vaccine-related contract
Smiths Medical announced today that it has landed a federal contract to produce more than 78 million syringe-and-needle units and $20 million in federal funding to expand its Keene, N.H. plant to produce them. The Plymouth, Minn.-based company … [Read More...]
Teva launches connected inhaler for asthma, COPD
Teva (NYSE:TEVA) announced today that it has launched a Bluetooth-enabled version of its ProAir albuterol sulfate rescue inhaler. The ProAir Digihaler's sensors connect to a companion mobile app to provide inhaler-use information to healthcare … [Read More...]
In case you missed it
- Medtronic, Tandem Diabetes Care bury the hatchet on potential IP disputes
- MIT researchers think they’ve found a way to get more particles through a syringe
- U.S. investing $42m to boost BD syringe and needle production
- Thermo Fisher projects 10% increase in Q2 sales
- Abbott, Tandem seal deal to combine CGM, insulin delivery tech
- Tandem Diabetes Care acquires Sugarmate mobile app
- Lantheus, Progenics complete merger
- HHS spending $347m to boost supply of COVID-19 vaccine, treatment vials
- Tandem Diabetes Care wins expanded FDA indication for insulin pump
- Pandemic forces Proteus into bankruptcy
- Medtech manufacturers must add warning label to drug-eluting PAD devices
- Abbott, Medtronic go head-to-head at ADA conference
- Medtronic touts results of latest MiniMed studies at ADA
- Former Eli Lilly researcher joins Bigfoot Biomedical as chief medical officer
- Medtronic lands CE Mark for MiniMed 780G insulin pump
Clinical Trials
Inovio to scale up production of smart delivery device for potential COVID-19 vaccine
Inovio Pharmaceuticals (NSDQ:INO) announced that it received $71 million from the U.S. Defense Dept. to support its Cellectra 3PSP smart device. Funding from the DoD is set to support large-scale manufacturing for the Cellectra 3PSP and the procurement of Cellectra 2000 devices, which are used to deliver Inovio’s INO-4800 COVID-19 vaccine candidate directly into the skin. […]
Abbott, Medtronic go head-to-head at ADA conference
Major medtech companies vied for the biggest news splash at this year’s annual meeting of the American Diabetes Association, announcing promising results from studies of patients who used their latest diabetes technology. The virtual 80th Annual American Diabetes Association Virtual Scientific Sessions, which runs through Tuesday, so far has featured news out of Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) and several smaller […]
Medtronic touts results of latest MiniMed studies at ADA
The latest generation of the Medtronic (NYSE:MDT) MiniMed insulin pump met both safety and glycemic endpoints in a study presented today at the American Diabetes Association’s virtual annual conference. The MiniMed 780G closed-loop system is indicated for treating Type 1 diabetes in people aged 7 to 80 years old. It is designed to automate the delivery of […]
Moderna reports positive early data out of COVID-19 vaccine trial
Moderna today touted positive interim clinical data from trials for its mRNA-1273 vaccine candidate against coronavirus (SARS-CoV-2). The Phase I study, led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), recorded positive early results from the first eight people tested, each of whom received two […]
FDA clears Nanobiotix to start cancer treatment trial
Nanobiotix (PAR:NANO.PA) announced that the FDA designated its cancer treatment trial with the University of Texas MD Anderson Cancer Center as “safe to proceed.” The trial, co-developed by Nanobiotix and MD Anderson, is set to evaluate the safety and feasibility of NBTXR3 activated-by-radiation therapy for patients with locally advanced (LAPC) or borderline resectable (BRPC) cases of […]
