OncoCyte Corporation announced the initiation of the company’s Analytical Validation study of DetermaVu Lung, its liquid biopsy test for lung cancer. Having recently achieved very positive results from its R&D Validation study, OncoCyte is now working to complete the remaining development studies required for commercialization of DetermaVu, including Analytical Validation, CLIA Validation and Clinical Validation. Assuming positive results from these studies, the company remains on-track to make its DetermaVu lung cancer assay commercially available in the second half of 2019.
https://thefly.com/landingPageNews.php?id=2873991
Monday, March 4, 2019
PDL BioPharma announces U.S. launch of authorized generic of Tekturna
PDL BioPharma announces the U.S. commercial launch of an authorized generic of Tekturna, aliskiren hemifumarate 150 mg and 300 mg tablets. The authorized generic has the same drug formulation as Tekturna. The launch is being carried out by Prasco, LLC, d/b/a Prasco Laboratories, under an agreement with PDL’s wholly owned subsidiary, Noden Pharma USA. Noden will continue to manufacture and commercialize prescription aliskiren products under the Tekturna and Tekturna HCT brands in the United States, and the Rasilez and Rasilez HCT brands in international markets. The authorized generic launch does not include Tekturna HCT.
https://thefly.com/landingPageNews.php?id=2873995
https://thefly.com/landingPageNews.php?id=2873995
Early feedback on Intuitive Surgical’s SP largely positive, says Piper Jaffray
After speaking with call with a physician from Hackensack University Medical Center, one of the early adopters of the company’s SP robotic system, Piper Jaffray analyst JP McKim reiterates an Overweight rating on Intuitive Surgical with a $625 price target. Early feedback was largely positive, McKim tells investors in a research note. He says that while SP will be more cannibalistic in urology, it will “open up the door into new specialties like ENT and fuel additional growth to General Surgery.” The analyst believes that if SP can get the same clinical outcomes as multiport systems, patients are going to be drawn to its single incision surgery.
https://thefly.com/landingPageNews.php?id=2873997
https://thefly.com/landingPageNews.php?id=2873997
Inspire Medical says five new BCBSA healthcare plans issue positive coverage
Inspire Medical Systems announced that five new Blue Cross Blue Shield Association healthcare plans have issued positive coverage policies of Inspire therapy. These plans include: Independence Blue Cross; Blue Cross Blue Shield of Louisiana; Wellmark; HealthNow New York; and BCBS of Kansas City, which, in the aggregate, provide coverage for approximately 8.5M members.
CVS to close retail audiology centers ahead of over-the-counter regulations
- CVS Health is set to shut down its foray into audiology services at the end of March as it positions itself to take advantage of the forthcoming over-the-counter hearing aid category of devices, Hearing Health & Technology Matters first reported. Fourty-nine standalone audiology centers in CVS retail locations and about 100 employees will be impacted by the decision.
- FDA is scheduled to issue a proposed rule outlining how it plans to implement the OTC hearing aid regulations in November, according to the Unified Agenda. It is required to issue the proposal by 2020 by the FDA Reauthorization Act of 2017, and then finalize the proposal within 180 days of the comment period closing.
- The decision by CVS may signal audiologist practices could face stiff headwinds when FDA issues its proposal. Hearing aid manufacturers such as Starkey Hearing Technologies have been lobbying the federal government in an effort to protect the industry.
FDA has made it clear it believes consumers should be able to take a more active role in managing hearing loss. In October, the agency authorized the first self-fitting hearing aid from Bose that consumers can program without assistance from a healthcare provider.
CVS Pharmacy started piloting audiology centers in 2015 at certain retail locations, but with new regulations on the horizon, the company is pivoting away from the experiment. The company said the decision was prompted by lower-cost devices entering the market in the “near future” that will “enable self-serve hearing testing and care.”
“We are shifting our audiology strategy to better position CVS Pharmacy as a leader in offering clinically effective, lower priced hearing devices once the new over-the-counter category is approved by the FDA,” CVS spokesperson Michael DeAngelis confirmed to MedTech Dive. “To help prepare for this shift, we are closing the standalone audiology centers in our retail locations, effective March 30, 2019.”
The employees affected by the decision to close the centers will be paid through April 5 and be offered the opportunity to apply for other CVS positions, according to DeAngelis. Those that do not stay with the company will be “eligible for a transition package.”
FDA announced in February it is planning to exempt certain hearing aidsfrom 510(k) requirements in forthcoming rulemaking and will exercise enforcement discretion until such regulations are formally implemented.
Hearing aid manufacturers argue audiologists are a critical component of hearing care to maintain patient safety, but reports from the National Academies of Science, Engineering and Medicine and former President Barack Obama’s President’s Council of Advisors on Science and Technology argue OTC hearing aids will lower costs and expand consumer access.
Japan okays research using human cells in animals
Japan has given the green light to a controversial research process involving implanting animals with human stem cells that could eventually help grow human organs for transplant inside animal hosts.
The decision by the education and science ministry Friday to revise its guidelines means Japanese researchers can now apply for permits to carry out studies employing the technique, a ministry official told AFP.
The process involves implanting embryonic animals, likely first pigs, with human “induced pluripotent stem” (iPS) cells, which can transform into the building blocks of any part of the body.
The idea is for the iPS cells to grow into transplantable human organs inside the animal embryos.
Japan had previously required researchers to terminate animal embryos implanted with human cells after 14 days “due to ethical concerns over the vague line between human beings and animals,” the official said.
The old regulations also prevented researchers from placing the embryos into animal wombs to allow them to develop.
But the ministry has dropped both restrictions “as we have concluded that there is technically zero risk of producing a new organism mixing human and animal elements under the research,” the official added.
Researchers will now, for instance, be allowed to create animal embryos with a human pancreas and transplant it into the womb of a pig, which could in theory result in the birth of a baby pig with a human pancreas.
In practice, where similar research has been carried elsewhere, the embryos have been terminated before delivery, avoiding the thorny moral issues raised by creating creatures that contain both human and animal cells.
Research involving the hybrids sometimes called “chimeras”—after the monster in Greek mythology with a lion’s head, goat’s body and dragon’s tail—has been controversial elsewhere too.
Ethical questions have been raised about the status of animals containing human cells, and whether human iPS cells implanted into animals could develop into brain matter or reproductive organs.
But a shortage of transplantable human organs means researchers around the world are racing to create mixed human-animal embryos.
Apellis resumes phase 3 AMD trials after addressing safety issue
Apellis Pharmaceuticals has resumed dosing in phase 3 trials of its treatment for an advanced form of age-related macular degeneration (AMD). The resumption follows modifications to the production process to cut the risk of the noninfectious inflammation that triggered the halt.
Dosing in the phase 3 geographic atrophy program began in September only to stop in October after reports of eight cases of noninfectious inflammation in patients who received Apellis’ APL-2. The two phase 3 trials are designed to show APL-2 reduces the area of geographic atrophy lesions by binding to C3 and C3b and thereby inhibiting the complement cascade. But the adverse events put the brakes on those plans.
Apellis suspected the adverse events were isolated to a single lot of APL-2 and voluntarily stopped the study and initiated an investigation to confirm its thinking. Apellis originally targeted a 2018 restart for the trials.
That goal came and went as the investigation led Apellis to modify its manufacturing processes to eliminate an impurity it thinks was introduced during scale-up. Apellis fingered the impurity as the likely cause of the inflammation and took action to prevent its production.
Investigators in a phase 1b geographic atrophy trial have given the resulting APL-2 products to 10 patients without incident. The lack of adverse events encouraged Apellis to resume dosing in the phase 3 using the stockpile of APL-2 it has accrued. Apellis thinks it has enough APL-2 made using the new process to cover the rest of the phase 3 program.
The two 600-patient trials in the phase 3 program are on track to be fully enrolled around this time next year. With the primary endpoint assessing patients at 12 months, the timeline means Apellis is still some way from having phase 3 data. But recent events have put it in a better position to make the hike toward the pivotal readout.
News of the resumption of the phase 3 program comes days after Apellis struck a deal with SFJ Pharmaceuticals, a drug development shop backed by Blackstone Life Sciences and Abingworth. The novel deal secured Apellis $60 million upfront and up to $60 million in near-term milestones to fund development of APL-2 in paroxysmal nocturnal hemoglobinuria, enabling it to continue advancing on multiple fronts without raising money from investors.
Shares in Apellis rose 30% in the days following news of the SFJ agreement.
Subscribe to:
Posts (Atom)