Outset Medical hemodialysis system cartridge wins FDA clearance

[Image from Outset Medical]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 includes starting cartridge production through a manufacturing partner in Mexico, facilitating the localization of the cartridge in addition to the Tablo console, in North America.

According to a news release, FDA clearance allows for the new location to reduce the need for expensive and capacity-constrained air freight delivery of the cartridges, simplifying distribution and logistics for Outset, its customers and its patients.

Outset said another benefit to the FDA clearance is the ability to start using an eco-friendly cartridge sterilization method through E-beam non-ionizing technology. E-beam can be produced on-demand and does not involve toxic or potentially explosive chemicals, the…

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AMF Medical wins breakthrough nod for insulin management system

[Image from AMF Medical]AMF Medical announced today that it received FDA breakthrough device designation for its Sigi insulin management system.

Ecublens, Switzerland-based AMF Medical’s Sigi (for diabetes mellitus treatment) can be programmed to deliver basal and bolus insulin at both set and variable rates.

Get the full story at our sister site, Drug Delivery Business News.

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Pfizer bolsters COVID-19 antiviral manufacturing capacity

Although Pfizer (NYSE:PFE) has yet to receive emergency use authorization for its Paxlovid COVID-19 therapy, it plans to manufacture 80 million courses of the drug by the end of 2022. Pfizer had initially planned on making 50 million courses of Paxlovid (PF-07321332/ritonavir) in the same time frame.

An interim analysis of the Phase 2/3 EPIC-HR study found the drug to be 89% effective at reducing hospitalization or death. Pfizer announced the launch of a Phase 1 study of PF-07321332 in March.

Pfizer has inked a $5.29 billion Paxlovid deal with the U.S. government.

One course of oral Paxlovid therapy would consist of two daily 150-mg doses for five days.

Meanwhile, molnupiravir, the antiviral from Merck (NYSE:MRK) and Ridgeback Biotherapeutics, has lost some of its luster. New data suggests the drug led to an absolute risk reduction against hospitalization or death of 3% compared to placebo. Furthermore, the drug led to a relative risk reduction of…

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Pfizer-BioNTech COVID-19 vaccine 100% effective in adolescents 12 to 15

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) shared new data from their Phase 3 study of the Comirnaty vaccine, concluding that two 30-µg doses were 100% effective against COVID-19 between seven days and four months after the second dose.

The safety profile of the vaccine in the study was broadly consistent with other clinical safety data. In addition, clinical trial investigators reported no serious safety concerns in participants in the six months following receipt of the second dose.

Data from 2,228 individuals were included in the analysis.

In the U.S., the Comirnaty vaccine is available under emergency use authorization for adolescents 12 to 15. The FDA approved the vaccine for individuals at least 16 years of age in August. In late October, the companies received emergency use authorization for the vaccine in children 5 to 11.

Pfizer and BioNTech plan on including the recent data in a planned supplemental Biologics License Application (sBLA) t…

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Janssen shares positive Phase 2 Tremfya data in Crohn’s

Johnson & Johnson’s Janssen division (NYSE:JNJ) has released topline results from the Phase 2 GALAXI 1 clinical study testing the potential of TREMFYA (guselkumab) in patients with moderately to severely active Crohn’s disease (CD).

The study found that nearly two-thirds (65%) of TREMFYA (guselkumab) recipients achieved clinical remission at week 48. The trial used the Crohn’s Disease Activity Index [CDAI]<150) to verify that benchmark.

The study provided the first long-term data testing guselkumab as a potential CD treatment in the U.S.

Guslkumab selectively inhibits the p19 subunit of interleukin IL-23.

Guselkumab is now FDA approved for moderate-to-severe plaque psoriasis and active psoriatic arthritis, but not yet for Crohn’s disease.

Tremfya (guselkumab) won FDA approval for adult patients with active psoriatic arthritis in 2020.

The placebo-controlled double-blind stu…

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GSK touts DREAMM clinical trial headway in multiple myeloma

GlaxoSmithKline (NYSE:GSK) will present 11 abstracts on Blenrep (belantamab mafodotin blmf) at the American Society of Hematology (ASH) Annual Meeting and Exposition on December 11–14. Presentations will include new data from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial program and two collaborative studies focused on Blenrep.

The drug won FDA approval on August 5, 2020, for adults with relapsed or refractory multiple myeloma who have received at least four prior therapies.

Featured presentations at ASH includes poster #2738, which will describe outcomes of regimen of belantamab mafodotin with the chemotherapies bortezomib and lenalidomide plus the steroid dexamethasone in transplant-ineligible patients with recently diagnosed multiple myeloma.

Another presentation will detail results from the BelaRd trial (poster #2736) from Hellenic Society of Hematology in collaboration with GSK exploring a similar cocktail mentione…

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FDA grants breakthrough device designation for Theradaptive’s spinal fusion implant

Theradaptive announced today that it received FDA breakthrough device designation for its Osteo-Adapt SP spinal fusion implant.

Frederick, Maryland-based Theradaptive designed the Osteo Adapt SP implant for transforaminal lumbar interbody spinal fusion to treat degenerative disc disease, spondylolisthesis or retrolisthesis.

According to a news release, the company touts its regenerative implants as best-in-class with designs to permit precise tissue regeneration for a variety of tissue types and clinical indications.

Cleveland Clinic’s Dr. George Muschler said in the release that the technology may provide “several significant advantages” over current state-of-the-art offerings in spinal fusion and musculoskeletal repair, including improved safety and more consistent outcomes.

“This designation is a major milestone for Theradaptive as we aspire to change the practice of medicine by enabling precise tissue regeneration in a …

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FDA says cardiac perforation problems appear more severe with Medtronic’s Micra

The FDA earlier this week issued a letter highlighting certain complications associated with leadless pacemaker implantation, including with Medtronic’s (NYSE:MDT) Micra platform.

In the letter, the FDA noted that the overall risk of cardiac perforation associated with leadless pacemaker implantation appears similar to the risk associated with traditional transvenous pacing systems. Still, premarket clinical studies of Medtronic’s Micra have suggested that major complications related to cardiac perforation appeared more severe for patients with a leadless pacemaker compared to those with a transvenous one.

Real-world data suggest that cardiac perforations associated with Micra pacemakers are more likely to be associated with serious complications, including cardiac tamponade or death, when compared to traditional pacemakers, FDA said.

“Since the Micra Transcatheter Pacing System (TPS) received premarket approval in 2016, Medtronic has w…

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Datar Cancer Genetics wins FDA breakthrough nod for breast cancer detection blood test

[Image from Datar]Datar Cancer Genetics announced today that it received FDA breakthrough device designation for its TriNetra blood test.

The company designed its TriNetra blood test to detect early-stage breast cancer using proprietary technology that detects circulating tumor cells (CTCs) specific to breast cancer.

According to a news release, TriNetra can detect even Stage 0 (DCIS) and Stage 1 cancers with high accuracy, requiring just 5 mL of blood. Its indication covers asymptomatic women above the age of 40 with a physician’s prescription.

Datar’s test already holds CE mark and is available in Europe.

“We are pleased that the FDA has recognized the potential of TriNetra for the detection of early-stage breast cancer. We believe that TriNetra will offer definitive advantages for breast cancer screening once it receives marketing authorization from the FDA,” Datar Executive Director Dr. Vineet Datta said in the release. …

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Small Pharma Inc. plans Phase 2b trial of DMT for depression

Small Pharma Inc. (TSXV:DMT) is prepping a Phase 2b clinical study to test the use of its lead candidate, SPL026, an N, N-dimethyltryptamine (DMT) in treating major depressive disorder (MDD).

DMT is present in Ayahuasca, a South American psychedelic brew.

The company has announced that it has had positive discussions with FDA regarding the planned trial.

“Importantly, the FDA’s feedback facilitates a path forward to prepare for the inclusion of U.S. sites in our Phase 2b clinical trial, which we anticipate will also be conducted across sites in Europe and the UK,” said Dr. Carol Routledge, chief medical and scientific officer of Small Pharma. “We believe that Small Pharma is conducting the first clinical trials of a DMT-assisted therapy for patients with MDD, with the potential to provide a much-needed alternative treatment for patients suffering from this debilitating condition.”

The company Small Pharma chose its name as a reaction to the phrase…

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FDA gives Bexson pre-IND guidance for ketamine formulation delivered by wearable pump

Bexson is developing a wearable infusion pump with Stevanato Group. [Image from Bexson]Bexson Biomedical announced today that it received pre-investigational new drug guidance from the FDA for its ketamine compound therapy.

Santa Barbara, California-based Bexson develops the patented BB106 formulation, a ketamine therapy delivered through a wearable, subcutaneous patch pump in development with Stevanato Group.

Get the full story at our sister site, Drug Delivery Business News.

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Cardialen gets FDA IDE nod for low-energy AFib treatment

Cardialen announced today that it received FDA investigational device exemption (IDE) approval for its MultiPulse therapy platform.

Minneapolis-based Cardialen designed its MultiPulse therapy (MPT) to treat paroxysmal and persistent AFib through a sequence of low-energy electrical pulses that restore abnormally rapid heart rates to a normal rhythm.

According to a news release, the low-energy method of electrical pulse delivery provides treatment in a manner that can potentially be less painful for the patient.

Cardialen’s IDE trial builds on a previous study conducted by the company along with a companion study currently enrolling patients across seven medical centers in Australia, the company said.

The study’s principal investigator, Dr. John Hummel, said in the release that he believes MPT has the potential to improve heart failure outcomes in AFib patients receiving a cardiac resynchronization therapy defibrillator (CRT-D) implant. …

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