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 … [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
FDA clears Propeller Health sensor to work with Symbocort inhaler
Propeller Health announced that it received FDA 510(k) clearance for connecting patients using its Symbicort Inhaler to its digital health platform. The Madison, Wis.-based company’s digital health platform already connects to inhalers used by … [Read More...]
Baxter wins CE Mark for EVO IQ syringe system
Baxter (NYSE:BAX) announced that it received regulatory approval in Europe and Australia for its Evo IQ syringe infusion system. With CE Mark approval in Europe and a nod from Australia’s Therapeutic Goods Administration (TGA), the company expects … [Read More...]
Ocular Therapeutix commences public offering
Ocular Therapeutix (NSDQ:OCUL) announced that it commenced an underwritten public offering of an undisclosed amount of its common stock. The Bedford, Mass.-based eye condition therapy developer filed with the SEC to confirm the offering with the … [Read More...]
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 … [Read More...]
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 … [Read More...]
AbbVie gains U.S. nod for $63B Allergan takeover
Pharmaceutical giant AbbVie (NYSE:ABBV) has won U.S. antitrust approval for its purchase of Allergan (NYSE:AGN) for $63 billion in cash and stock. The purchase is seen as a hedge against the impending expiration of U.S. patents on AbbVie’s … [Read More...]
Tandem Diabetes Care posts wider-than-forecast losses in Q1
Tandem Diabetes Care (NSDQ:TNDM) posted first-quarter results that beat the revenue consensus on Wall Street but missed on earnings. The San Diego-based company — maker of insulin pumps and other diabetes management devices — reported losses of … [Read More...]
Dexcom shares up on Street-beating Q1 results
Dexcom (NSDQ:DXCM) posted first-quarter results today that beat the consensus forecast on Wall Street but dropped its financial guidance for the year. The San Diego-based company reported profits of $19.9 million, or 21¢ per share, on sales of … [Read More...]
Soligenix soars on COVID-19 vaccine licensing agreement with Boston Scientific
Soligenix (NSDQ:SNGX) skyrocketed up 89% in premarket trading this morning after announcing today that it entered into an exclusive worldwide licensing agreement with Boston Scientific (NYSE:BSX) for its CoVaccine HT novel vaccine adjuvant for … [Read More...]
B. Braun lands FDA EUA for use of infusion pumps with nebulizers to treat COVID-19
B. Braun Medical announced that it received FDA emergency use authorization to use its infusion pumps with nebulizers to treat patients with COVID-19. The Bethlehem, Pa.-based company’s authorization win includes its Perfusor space syringe … [Read More...]
In case you missed it
- Clinical trials ramping up for potential coronavirus-fighting drugs
- FDA approves Cipla’s generic albuterol inhaler
- Qosina touts single-use bioprocessing components for coronavirus response
- OncoSec, Inovio testing COVID-19 vaccines
- Nemaura Medical repurposes its CGM to spot coronavirus fevers
- DHS warns on Insulet Omnipod
- Nemaura Medical enters non-binding agreements for its SugarBeat platform
- Companion Medical wins FDA nod for InPen diabetes management system
- Insulet down after hours on Q4 sales beat, bottom-line slide
- BD warns on some ambulatory syringe pumps
- Insulet partners with Abbott and Dexcom on automated insulin delivery
- These ‘smart’ bandages could heal chronic wounds
- Could this handheld 3D bioink printer improve wound healing?
- Insulet’s Omnipod Dash Personal Diabetes Managers have a glitch
- Wearable insulin delivery device maker Valeritas files for Chapter 11, selling company
Clinical Trials
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 […]
Fauci: Hundreds of millions of COVID-19 vaccine doses could be ready in January
Dr. Anthony Fauci said this morning that hundreds of millions of doses of a vaccine for COVID-19 could be ready by January. In an interview on the Today Show, the director of the National Institute of Allergy and Infectious Diseases said that a vaccine candidate is in the first phase of a clinical trial. If the second […]
Clinical trials ramping up for potential coronavirus-fighting drugs
Bausch Health (NYSE:BHC) announced today that it initiated a clinical trial program in Canada to investigate the use of Virazole for treating COVID-19. With today’s announcement, Bausch joins Eli Lilly (NYSE:LLY) and Care Access Research, which both announced clinical testing of coronavirus therapies last week. Bausch’s Virazole is currently approved in the U.S. and Canada, among other […]
OncoSec, Inovio testing COVID-19 vaccines
OncoSec Medical (NSDQ:ONCS) and Inovio Pharmaceuticals (NSDQ:INO) announced that they are testing potential COVID-19 vaccines after the latter received investigational new drug clearance from the FDA. Inovio received an IND nod, while OncoSec’s is pending, but both companies are pursuing a first-in-human Phase 1 clinical trial for their vaccines, according to separate news releases. OncoSec is using […]
