Halozyme Therapeutics today announced positive endpoint results from its phase III intravenous chemotherapy trial. Genentech's FeDeriCa study used Halozyme's Enhanze drug-delivery technology for subcutaneous administration of a fixed-dose … [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
Abbott wins FreeStyle Libre reimbursement in Ontario, Quebec
Abbott (NYSE:ABT) said today that it has won public reimbursement in Ontario and Quebec for its FreeStyle Libre sensor-based glucose monitoring system — the first of its kind listed by any provincial health plan in Canada. FreeStyle Libre is … [Read More...]
FDA approves ready-to-use liquid glucagon from Xeris
Xeris Pharmaceuticals (NSDQ:XERS) said yesterday that the FDA has approved its Gvoke glucagon injection for the treatment of hypoglycemia. Gvoke is a ready-to-use, room-temperature, stable liquid glucagon designed to treat severe hypoglycemia in … [Read More...]
Cook Regentec launches blood filtration trial for critical limb ischemia
Cook Medical's Regentec division today announced the launch of a clinical trial to evaluate its HemaTrate blood filtration system to treat patients with critical limb ischemia (CLI) due to peripheral arterial disease (PAD). Indianapolis-based Cook … [Read More...]
Dance Biopharm, DarioHealth partner up on smart inhaler
Dance Biopharm said today that it has partnered with DarioHealth (NSDQ:DRIO) to integrate Dance's smart inhaler into DarioHealth's digital therapeutics program. Durham, N.C.-based Dance Biopharm's smart inhaler includes vibrating mesh designed to … [Read More...]
Cook Medical touts paclitaxel-coated stent PAD study results
Cook Medical today touted five-year data from a study into the use of its Zilver PTX paclitaxel-coated stent for peripheral arterial disease (PAD). The study concluded that there was no increase in long-term all-cause mortality due to paclitaxel … [Read More...]
Medtronic lands reimbursement for MiniMed 670G pump in Germany
Medtronic (NYSE:MDT) said today it has secured reimbursement for its MiniMed 670G insulin pump system from regulators in Germany. The German Federal Association of the Statutory Health Insurances (GKV-SV) granted reimbursement for the smart … [Read More...]
Satsuma Pharmaceuticals registers $75m IPO
Satsuma Pharmaceuticals has registered an initial public offering, seeking to raise $75 million, according to a regulatory filing. The South San Francisco-based company is working on STS101, a nasal powder version of dihydroergotamine for … [Read More...]
Frequency Therapeutics registers $100m IPO
Frequency Therapeutics has registered an initial public offering of common stock worth $100 million. Woburn, Mass.-based Frequency Therapeutics did not disclose the number of shares it seeks to sell or the price range of the offered units. The … [Read More...]
Report: Dexcom shares drop in response to ‘headwinds’ comment
Shares in Dexcom (NSDQ:DXCM) dropped nearly 6.8% this morning following comments by a company executive that the company is facing "headwinds" that could hamper third-quarter results, according to a report by SeekingAlpha. EVP and CFO Quentin … [Read More...]
Medtronic’s In.Pact AV DCB meets endpoints in trial
Medtronic (NYSE:MDT) said last week that its clinical study comparing the In.Pact AV drug-coated balloon to percutaneous transluminal angioplasty (PTA) met primary safety and effectiveness endpoints. The study pitted the In.Pact AV DCB against PTA … [Read More...]
In case you missed it
- Clearside Biomedical, Regenxbio ink sales deal for gene therapy microinjector
- Senseonics touts BCBS reimbursement wins
- Insulet prices $700m offering
- Flowonix warns on software anomaly with Prometra pump
- Concept Medical wins FDA breakthrough nod for MagicTouch AVF drug-coated balloon
- Senseonics touts long-term safety data on home-use Eversense
- Surmodics reaps $10m from Abbott on SurVeil balloon milestone
- Whistleblowers accuse Fla. VA hospital of ignoring Alaris recall
- Dexcom claims win in patent war with AgaMatrix unit WaveForm
- Senseonics touts real-world CGM data
- Enable Injections inks deal with Genentech
- FDA wants more on new manufacturing process from Clearside Biomedical
- Baxter foundation, Direct Relief ink diabetes pact
- Adherium inks digital health deal with Summatix
- Study: No difference between Biotronik, Medtronic or Boston Scientific stents
Clinical Trials
Halozyme-Genentech breast cancer pivotal meets endpoint
Halozyme Therapeutics today announced positive endpoint results from its phase III intravenous chemotherapy trial. Genentech’s FeDeriCa study used Halozyme’s Enhanze drug-delivery technology for subcutaneous administration of a fixed-dose combination of pertuzumab (Perjeta) and trastuzumab (Herceptin), in combination with intravenous chemotherapy. The results showed non-inferior levels of Perjeta in the blood compared to standard IV infusion […]
FDA approves ready-to-use liquid glucagon from Xeris
Xeris Pharmaceuticals (NSDQ:XERS) said yesterday that the FDA has approved its Gvoke glucagon injection for the treatment of hypoglycemia. Gvoke is a ready-to-use, room-temperature, stable liquid glucagon designed to treat severe hypoglycemia in pediatric and adult patients with Type 1 diabetes aged two years old or above. Chicago-based Xeris’ Gvoke may be administered with a pre-filled […]
Cook Regentec launches blood filtration trial for critical limb ischemia
Cook Medical’s Regentec division today announced the launch of a clinical trial to evaluate its HemaTrate blood filtration system to treat patients with critical limb ischemia (CLI) due to peripheral arterial disease (PAD). Indianapolis-based Cook Regentec said the HemaTrate system is designed to produce an autologous, peripheral blood-derived total nucleated cell (TNC) concentrate for intramuscular […]
Cook Medical touts paclitaxel-coated stent PAD study results
Cook Medical today touted five-year data from a study into the use of its Zilver PTX paclitaxel-coated stent for peripheral arterial disease (PAD). The study concluded that there was no increase in long-term all-cause mortality due to paclitaxel after treatment using the Zilver PTX stent compared to traditional angioplasty or a bare-metal stent, according to a […]
Satsuma Pharmaceuticals registers $75m IPO
Satsuma Pharmaceuticals has registered an initial public offering, seeking to raise $75 million, according to a regulatory filing. The South San Francisco-based company is working on STS101, a nasal powder version of dihydroergotamine for migraine. It intends to use the money to fund its Phase 3 safety and efficacy clinical trials for STS101, manufacturing costs, […]
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