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Xarelto similar to aspirin in pediatric Fontan procedure study

Janssen (NYSE:JNJ) has announced that its blockbuster blood thinner Xarelto (rivaroxaban) had a similar safety profile to aspirin in pediatric patients a Phase 3 study. The trial focused on pediatric patients who underwent the Fontan procedure, a type of open-heart surgery intended to correct single ventricle anomalies in the heart.

Physicians have traditionally relied on aspirin (acetylsalicylic acid) to reduce the risk of thrombotic events following the Fontan procedure. Such thrombotic events are associated with significant morbidity and mortality.

The data, collected in the Phase 3 UNIVERSE trial, has been published in the Journal of the American Heart Association. The study concluded that “participants who received rivaroxaban for thromboprophylaxis [thrombosis prevention] had a similar safety profile and fewer thrombotic events, albeit not statistically significant, compared with those in the [acetylsalicylic acid] group.”

This summer, the Raritan,…

Paratek Pharmaceuticals wins more funding from BARDA

Antibiotic specialist Paratek Pharmaceuticals (NSDQ: PRTK) has secured additional funding from the Biomedical Advanced Research and Development Authority (BARDA) to develop the antibiotic Nuzyra (omadacycline) for anthrax.

Specifically, the latest funding will support Paratek’s program to develop the tetracycline-class antibiotic Nuzyra as a post-exposure prophylaxis and pulmonary anthrax treatment.

The latest BARDA funding will support studies valued at approximately $19 million. Overall, the BARDA contract now has a total value of $340 million.

Last week, Paratek released data related to Nuzyra for treating pneumonia and skin infections.

“Paratek has been studying Nuzyra against select biothreat pathogens for over a decade, and we are excited to build on the promising in vitro and in vivo animal data and advance the pulmonary anthrax development program for treatment and PEP,” said Randy Brenner, chief development and regulatory officer of Parat…

Pfizer launches Phase 2/3 trial of COVID-19 oral antiviral cocktail

Pfizer (NYSE:PFE) has announced the launch of the Phase 2/3 EPIC-PEP study to test its oral antiviral candidate PF-07321332 as a post-exposure prophylaxis.

The EPIC-PEP study, whose name is an acronym of “Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis,” will test the efficacy of PF-07321332 with low-dose ritonavir to prevent COVID-19 infection.

PF-07321332 and ritonavir are both protease inhibitors. AbbVie’s Ritonavir (Norvir) initially won FDA approval as an HIV treatment in 1996.

Molecular structure of PF-07321332. Image from Wikipedia.

Trial participants must be 18 or older and live in the same household as an individual with laboratory-confirmed symptomatic SARS-CoV-2 infection.

The study will enroll up to 2,660 participants.

“Given the continued emergence and evolution of SARS-CoV-2 variants and their immense impact, we continue to work diligently…

Medtronic CFO offers supply chain update as medical device industry concerns mount

Medtronic CFO Karen Parkhill [Photo courtesy of Medtronic]Medtronic (NYSE:MDT) was among the participants in a White House semiconductor summit last week to address the continuing global shortage of electronic chips, but CFO Karen Parkhill says the world’s largest medical device manufacturer is not in same dire straits as chip buyers in other industries.

Medtronic’s supply chain is “holding up OK, but we’re seeing pressures like everybody else,” Parkhill said Friday in an interview with Medical Design & Outsourcing.

Get the full story at our sister site, Medical Design & Outsourcing.

Medtronic CFO offers supply chain update as medical device industry concerns mount

Medtronic CFO Karen Parkhill [Photo courtesy of Medtronic]

Medtronic (NYSE:MDT) was among the participants in a White House semiconductor summit last week to address the continuing global shortage of electronic chips, but CFO Karen Parkhill says the world’s largest medical device manufacturer is not in same dire straits as chip buyers in other industries.

Medtronic’s supply chain is “holding up OK, but we’re seeing pressures like everybody else,” Parkhill said Friday in an interview with Medical Design & Outsourcing.

“Semi-conductors are an issue. Resins are an issue,” she said. “I think it helps that we’re a medical device manufacturer that’s producing life-saving technology … because when push comes to shove, I think we’re more important than new cars coming off the line, for example. We haven’t necessarily pulled that card, but I do think that that could help if…

Ambys Medicines opens cell therapy manufacturing facility, presents data on liver cell data

Privately-held Ambys Medicines has announced that it has opened a 52,000-ft² facility dedicated to hepatocyte manufacturing. The facility is certified to current Good Manufacturing Practices (cGMP) regulations.

The company, based in South San Francisco, California, also presented data on its novel bioreactor manufacturing at the Joint Congress of the International Xenotransplantation Association, IXA-CTRMS-2021.

Focused on developing novel treatments of severe liver disease, Ambys says it expects its lead program to enter the clinic in early 2023.

“The concept of hepatocyte transplantation with donor cells has been explored in academic settings for over 20 years,” said Dr. Ron Park, CEO of Ambys Medicines, in a statement. “These past efforts showed that mature hepatocytes were active and that the approach was safe, but further progress has been limited by the inability to generate adequate quantities of high-quality hepatocytes sufficient to drive clinic…

SeaSpine warns of COVID-19 hit to surgical revenue

SeaSpine Holdings (NSDQ:SPNE) is the latest medical device maker warning that the SARS-CoV-2 Delta variant wave is hurting its business.

Carlsbad, California–based SeaSpine filed an update for investors with the Securities and Exchange Commission on Friday, citing “ongoing uncertainty regarding the duration and severity of COVID-19 and/or staffing shortages on spine surgery procedure volumes throughout the United States.”

Get the full story at our sister site, MassDevice.

Women may have more adverse events with left atrial appendage occlusion devices than men

Left atrial appendage occlusion (LAAO) devices on the market include Abbott’s Amplatzer Amulet (left) and Boston Scientific’s Watchman (right). [Images courtesy of Abbott and Boston Scientific]Women appear more likely than men to experience adverse events or lengthened hospital stays from left atrial appendage occlusion (LAAO) devices, the FDA announced today.

In a letter to health care providers, the FDA said researchers have yet to determine the reason for the difference — and that it is working with device makers to understand the cause.

Get the full story on our sister site Medical Design & Outsourcing.

Women may have more adverse events with left atrial appendage occlusion devices than men

Left atrial appendage occlusion (LAAO) devices on the market include Abbott’s Amplatzer Amulet (left) and Boston Scientific’s Watchman (right). [Images courtesy of Abbott and Boston Scientific]

Women appear more likely than men to experience adverse events or lengthened hospital stays from left atrial appendage occlusion (LAAO) devices, the FDA announced today.

The FDA in its letter to health care providers said that researchers have yet to determine the reason for the difference — and that it is working with device makers to determine the cause.

For now, FDA officials still think that the benefits outweigh the risks when it comes to using LAAO devices such as Abbott’s Amplatzer Amulet and Boston Scientific’s Watchman and Watchman FLX to prevent people with atrial fibrillation from experiencing strokes.

The FDA advised health providers to continue monitoring people with LAA…

Gottlieb: Delta wave could burn out by Thanksgiving

Scott Gottlieb

Pfizer board member Dr. Scott Gottlieb has predicted that the COVID-19 Delta surge could mark a high-water mark of the pandemic.

“This may be the last major wave of infection,” said Gottlieb, who served as the FDA commissioner from 2017 to 2019.

In an interview with CNN, Gottlieb predicted that the pandemic in the U.S. would transition from pandemic to endemic phase in the relatively near future.

Get the full story on our sister site, Pharmaceutical Processing World.

Gottlieb: Delta wave could burn out by Thanksgiving

Dr. Scott Gottlieb. FDA file photo from 2017.

Pfizer board member Dr. Scott Gottlieb has predicted that the COVID-19 Delta surge could mark a high-water mark of the pandemic.

“This may be the last major wave of infection,” said Gottlieb, who served as the FDA commissioner from 2017 to 2019.

In an interview with CNN, Gottlieb predicted that the pandemic in the U.S. would transition from to endemic phase in the relatively near future.

Gottlieb did, however, suggest that the U.S. would see ongoing pockets of high caseloads as the Delta wave shifts from affecting predominantly Southern states to other regions. For example, Montana, Wyoming and West Virginia are current hot spots of infection.

Gottlieb also acknowledged that a new variant could potentially emerge that resists natural or vaccinated immunity.

The Delta wave, however, will likely dissipate by Thanksgiving in Gottlieb’s es…

Former Theranos lab director takes the stand, says Elizabeth Holmes was ‘nervous’ amid blood test inaccuracy concerns

Former Theranos CEO Elizabeth Holmes leaves after a hearing at a federal court in San Jose, Calif., on July 17, 2019. [Image courtesy of Reuters/Stephen Lam]A former Theranos lab director testified on Friday in the Elizabeth Holmes federal fraud trial that the company was aware of the multiple concerns raised by physicians and Theranos employees prior to the Walgreens launch.

Adam Rosendorff, a Theranos lab director from 2013 until late 2014, testified that Holmes and other top executives were pushing him to validate tests that he was not confident in, CNBC reports. The former lab director testified that he sent an email to Holmes in August 2013 that said that the blood-testing device was not ready for a launch in Walgreens stores. He also raised issues related to the training and staffing in the laboratory.

Rosendorff also spoke directly with Holmes, who had a countdown of the days until the Walgreens launch posted on her office window, regarding the concerns spe…