FDA Approval Archives - Amazing Health Advances

Breakthrough UC San Diego Brain Recording Device Receives FDA Approval for a Clinical Trial

The AHA! Team — Fri, 02 Aug 2024 08:21:00 +0000

University of California San Diego via Newswise – The Federal Drug Administration approved a clinical trial to test the effectiveness of an electronic grid that records brain activity during surgery, developed by engineers at the University of California San Diego. The device with nanoscale sensors records electrical signals directly from the surface of the human brain in record-breaking detail. The grid’s breakthrough resolution could provide better guidance for planning and performing surgeries to remove brain tumors and treat drug-resistant epilepsy. The grid’s higher resolution for recording brain signals could improve neurosurgeons’ ability to minimize damage to healthy brain tissue. During epilepsy surgery, the novel grid could improve the ability to precisely identify the regions of the brain where epileptic seizures originate for safe and effective treatment. The new brain sensor array, known as platinum nanorod grid (PtNRGrid) features a densely packed grid of a record-breaking 1,024 embedded electrocorticography (ECoG) sensors. The device rests on the surface of the brain and is approximately 6 microns thin–smaller than one tenth of the human hair–and flexible. As a result, it can both adhere and conform to the surface of the brain, bending as the brain moves while providing high-quality, high-resolution recordings of brain activity. In contrast, the ECoG grids most commonly used in surgeries today typically have between 16 and 64 sensors. These grids are rigid, stiffer and more than 0.5 mm in thickness and do not conform to the curved surface of the brain. The PtNRGrid was invented by Shadi Dayeh, a Professor in the Department of Electrical and Computer Engineering at the University of California San Diego and members of his team. Over the years, the team developed the PtNRGrid technology in collaboration with neurosurgeons and medical researchers from UC San Diego, Massachusetts General Hospital (MGH) and Oregon Health & Science University (OHSU). “This accomplishment ushers in a new era of clinical neuroscience and neuromonitoring,” Dayeh said. “We are very excited to receive the FDA approval to apply our groundbreaking PtNRGrid in a clinical setting. It is a credit to the hard work of my team members who worked tirelessly to meet the quality criteria mandated by the FDA. I am also grateful to my clinical partners, the support of the NIH, and to the campus leadership that fostered an impactful ecosystem across engineering and medicine to transform the future of healthcare.” The FDA approved an investigational device exemption (IDE) for a “pivotal study [titled] “Systematic Evaluation of Platinum Nanorod Grids (PtNRGrids) for Intraoperative Mapping and Neurophysiological Monitoring (IONM) During Brain Surgeries.” Specifically, the clinical trial is designed to demonstrate the effectiveness of the PtNRGrid device to map both normal and pathological brain activity. During the trial, UC San Diego engineers will partner with clinician-scientists: Drs. Sharona Ben-Haim and Eric Halgren at UC San Diego, Dr. Sydney Cash at MGH, and Dr. Ahmed Raslan at OHSU. In a first phase, surgeons will implant the PtNRGrid in 20 patients, then measure and compare the grid’s performance with the present state-of-the-art. The PtNRGrid will be deployed in surgeries to remove brain tumors and to remove tissue that causes epileptic seizures. Record-breaking density Dayeh’s team has pioneered human brain and spinal cord mapping with thousands of channels since 2019, and has reported early safety and efficacy results in a series of articles published in Science Translational Medicine in 2022 in human subjects. PtNRGrid is the only device with thousands of channels to demonstrate in peer-reviewed publications that it can map motor and language brain activity, as well as epileptic discharges, by producing panoramic videos of brain waves over 10 square centimeters of the brain’s cortex while maintaining resolution at a microscopic level. Currently, Dayeh’s research group holds the world record of recording brain activity from a single cortical grid with 2,048 channels on the surface of the human brain published in Science Translational Medicine in 2022. The device was used in the operating room of Dr. Ahmed Raslan of the OHSU. Since then, the team has increased the number of recording channels to 4,096 and continues to work on increasing the number of channels in the grid to monitor brain activity in even higher resolution. Pending success of this staged trial, the team will transition to the next crucial step of making the PtNRGrid available for commercial use at scale. Demonstrating that ECoG grids with sensors in the thousands of channels record brain activity with high fidelity also opens new opportunities in neuroscience for uncovering a deeper understanding of how the human brain functions. Basic science advances, in turn, could lead to improved treatments grounded in enhanced understanding of brain function. “Our goal is to provide a new atlas for understanding and treating neurological disorders, working with a network of highly experienced clinical collaborators at UC San Diego, MGH, and OHSU,” Dayeh said. Dayeh’s work toward the FDA approval is supported by an NIH BRAIN® Initiative award # UG3NS123723. To read the original article click here.

The post Breakthrough UC San Diego Brain Recording Device Receives FDA Approval for a Clinical Trial appeared first on Amazing Health Advances.

FDA: Merck COVID Pill Effective, Experts Will Review Safety

AHA Publisher — Wed, 01 Dec 2021 08:00:16 +0000

Matthew Perrone via CBN News – Federal health regulators say an experimental COVID-19 pill from Merck is effective against the virus, but they will seek input from outside experts on risks of birth defects and other potential problems during pregnancy. The Food and Drug Administration posted its analysis of the pill ahead of a public meeting next week where academic and other experts will weigh in on its safety and effectiveness. The agency isn’t required to follow the group’s advice. The FDA scientists said their review identified several potential risks, including possible toxicity to developing fetuses and birth defects that were identified in studies of the pill in animals. Given those risks, the FDA will ask its advisers next Tuesday whether the drug should never be given during pregnancy or whether it could be made available in certain cases. Under that scenario, the FDA said the drug would carry warnings about risks during pregnancy, but doctors would still have the option to prescribe it in certain cases where its benefits could outweigh its risks for patients. Given the safety concerns, FDA said Merck agreed the drug would not be used in children. Other side effects were mild and rare, with about 2% of patients experiencing diarrhea. Regulators also noted that Merck collected far less safety data overall on its drug than was gathered for other COVID-19 therapies. “While the clinical safety database was small, there were no major safety concerns identified,” FDA reviewers concluded. Additionally, the FDA flagged a concern that Merck’s drug led to small changes in the coronavirus’ signature spike protein, which it uses to penetrate human cells. Theoretically, FDA cautioned, those changes could lead to dangerous new variants. FDA will ask its independent advisers to discuss all those issues and then vote on whether the drug’s overall benefits outweigh its risks. All COVID-19 drugs currently authorized by the FDA require an injection or IV and can only be given by health professionals. If authorized, Merck’s drug would be the first that U.S. patients could take at home to ease symptoms and speed recovery. It is already authorized for emergency use in the U.K. The meeting marks the first time regulators have publicly reviewed a new drug for COVID-19, reflecting the intense interest and scrutiny of a pill that could be soon used by millions of Americans. The drug, molnupiravir, has been shown to significantly cut the rate of hospitalizations and deaths among people with mild-to-moderate coronavirus infections. Merck’s drug uses a novel approach to fight COVID-19: it inserts tiny mutations into the coronavirus’ genetic code to stop the virus from reproducing. But that genetic effect has raised concerns that in rare cases the drug could cause birth defects or even spur more virulent strains of the virus. Pregnant women were excluded from Merck’s study, and both women and men in the study were instructed to use contraception or abstain from sex. For its part, Merck says results from two company studies in rodents show the drug does not cause mutations or damage to DNA at the doses studied. FDA reviewers also confirmed previously reported interim results from Merck that the pill cut the rate of hospitalization and death by about half among patients with early symptoms of COVID-19 who faced increased risk due to health problems. However, on Friday morning Merck announced updated results from the same study that showed a smaller benefit from the drug. The FDA said it is still reviewing the updated data and would present a new assessment of the drug’s effectiveness next Tuesday. Among more than 1,400 adults in a company study, molnupiravir reduced the combined risk of hospitalization and death by 30%, less than the 50% initially reported based on incomplete results. Nearly 7% of patients who received Merck’s drug within five days of COVID-19 symptoms ended up in the hospital and one died. That compared to 10% of patients hospitalized who were taking the placebo and nine deaths. Merck didn’t study its drug in people who were vaccinated for COVID-19. But the FDA will ask advisers to recommend which patients may stand to benefit the most from the drug, based on vaccination status and underlying health problems. While Merck’s drug is likely to be the first pill for coronavirus in the U.S., more are expected to follow. Rival drugmaker Pfizer has submitted its own antiviral for FDA review after initial study results showed it cut the combined rate of hospitalization and death by nearly 90%. Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns that have been raised with Merck’s drug. To read the original article click here.

The post FDA: Merck COVID Pill Effective, Experts Will Review Safety appeared first on Amazing Health Advances.

FDA Allows Emergency use of Antibody Drug President Trump Received

AHA Publisher — Mon, 23 Nov 2020 08:00:26 +0000

Associated Press via CBN News – U.S. health officials Saturday agreed to allow emergency use of a second antibody drug to help the immune system fight COVID-19, an experimental medicine that President Donald Trump was given when he was sickened last month. The Food and Drug Administration authorized use of the Regeneron Pharmaceuticals Inc. drug to try to prevent hospitalization and worsening disease from developing in patients with mild-to-moderate symptoms. The drug is given as a one-time treatment through an IV. The FDA allowed its use in adults and children 12 and over who weigh at least 88 pounds (40 kilograms) and who are at high risk of severe illness from COVID-19 because of age or certain other medical conditions. Emergency authorization allows use of the drug to start while studies are continuing to establish safety and effectiveness. Early results suggest the drug may reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression, the FDA said. Regeneron said that initial doses will be made available to roughly 300,000 patients through a federal government allocation program. Those patients will not be charged for the drug but may have to pay part of the cost of giving the IV. Initial supplies will likely be vastly outstripped by demand as the U.S. has surged past 12 million reported cases, with the country facing what health experts say will be a dark winter due to the uncontrolled spread of the virus. Antibodies are proteins the body makes to target and help eliminate viruses, but it can take weeks for the best ones to form after an infection occurs. The drugs are concentrated versions of ones that proved best able to do this in lab and animal tests, and in theory, help the body start to fight the virus right away. The Regeneron drug is a combo of two antibodies to enhance the chances it will prove effective. Earlier this month, the FDA gave emergency authorization to a single-antibody drug from Eli Lilly that also is still being studied. There’s no way to know whether the Regeneron drug helped Trump recover; he received a host of treatments and most COVID-19 patients recover on their own. FDA regulators authorized the Regeneron drug using their emergency powers to quickly speed the availability of experimental drugs and other medical products during public health crises. In normal times the FDA requires “substantial evidence” to show that a drug is safe and effective, usually through one or more large, rigorously controlled patient studies. But during public health emergencies, the agency can lower those standards and require only that an experimental treatment’s potential benefits outweigh its risks. The emergency authorization functions like a temporary approval for the duration of the COVID-19 pandemic. To win full approval, Regeneron will have to submit additional research to fully define the drug’s safety and benefit for patients. The White House cast the decision as a victory for Trump’s efforts “to deliver cutting-edge treatments with highly promising results to protect the health and safety of the most vulnerable Americans,” according to a statement from spokesman Michael Bars. To read the original article click here. For more articles from CBN News click here.

The post FDA Allows Emergency use of Antibody Drug President Trump Received appeared first on Amazing Health Advances.

Pfizer to Seek Approval for COVID Vaccine ‘Within Days’

AHA Publisher — Fri, 20 Nov 2020 08:00:11 +0000

Tré Goins-Phillips, Faithwire via CBN News – The pharmaceutical giant Pfizer announced Wednesday it will seek regulatory approval for its COVID-19 vaccine “within days.” Working in partnership with the German group BioNTech, Pfizer has completed its Phase 3 trial and has deemed the vaccination 95% effective at preventing COVID-19 infections, NBC News reported, up from 90% last week. Former Food and Drug Administration Commissioner Dr. Scott Gottlieb, who serves as an independent member on Pfizer’s board of directors, described the development as a “game change,” adding the successes in vaccine development “could effectively end the U.S. epidemic next year.” To date, there have been no serious side effects for the 41,135 adults who received two doses of the Pfizer vaccine. The most common reaction among trial participants were that 3.7% experienced fatigue and 2% had headaches. Only eight of those who received the Pfizer vaccination fell ill to COVID-19. By comparison, 162 of those who received the placebo became sick. “The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Pfizer Chairman and CEO Dr. Albert Bourla said in a statement. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.” The companies — Pfizer and BioNTech — announced their joint plan to seek emergency use authorization from the FDA “within days.” The groups are also sharing their findings with regulators in Europe. Pfizer’s data shows the vaccination 95% effective against future infections beginning 28 days after the first two doses. The immunization’s effectiveness was found to be consistent across all age and race demographics. Furthermore, its side effects wore off “shortly after vaccination,” and among older adults, they tended to be “fewer and milder.” News of Pfizer’s rapidly evolving vaccine comes just a couple days after the biotech company Moderna announced its COVID-19 vaccine is 94.5% effective against infection. Moderna President Dr. Stephen Hogue described the development as a “really important milestone,” adding he’s reassured by the fact that Pfizer has released similar findings. “That should give us all hope that actually a vaccine is going to be able to stop this pandemic and hopefully get us back to our lives,” he added. Both the Moderna and Pfizer vaccines were developed using messenger RNA, tiny pieces of genetic code injected into the body to trick the immune system into producing a response to fend off COVID-19 without actually having to inject actual bits of the virus. Anything Else? This week, CNN’s Jake Tapper and Dr. Sanjay Gupta praised President Donald Trump’s administration for its work to facilitate the production of a COVID-19 vaccine at breakneck speed. “It’s important that people working so hard — Monsef Slaoui and the others — get credit for this, and President Trump was the one who OK’d it,” Tapper said. Gupta agreed, adding, “No doubt. The pace of medical innovation has been forever changed. I mean, three months, Jan. 11 is when they got the sequence of this virus. By March 16, two months later, shots were going into arms as part of these clinical trials. I couldn’t believe it when I saw that pace. It typically takes, you know, years to really get these vaccines approved. It’ll be done within a year. That is worth celebrating, and now we have some early data to be very optimistic about.” “So all of the scientists, everyone behind this, all the way up to President Trump and Vice President Pence, congratulations on this great accomplishment,” said Tapper. Trump, for his part, thanked Tapper and Gupta for their comments. To read the original article click here. For more articles from CBN News click here.

The post Pfizer to Seek Approval for COVID Vaccine ‘Within Days’ appeared first on Amazing Health Advances.

FDA Approves First COVID-19 Drug: Antiviral Remdesivir

AHA Publisher — Mon, 26 Oct 2020 07:00:56 +0000

Associated Press via CBN News – US regulators on Thursday approved the first drug to treat COVID-19: remdesivir, an antiviral medicine given to hospitalized patients through an IV. The drug, which California-based Gilead Sciences Inc. is calling Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the U.S. National Institutes of Health. It had been authorized for use on an emergency basis since spring, and now becomes the first drug to win full Food and Drug Administration approval for treating COVID-19. President Donald Trump received it when he was sickened earlier this month. Veklury is approved for people at least 12 years old and weighing at least 88 pounds (40 kilograms) who are hospitalized for a coronavirus infection. For patients younger than 12, the FDA will still allow the drug’s use in certain cases under its previous emergency authorization. The drug works by inhibiting a substance the virus uses to make copies of itself. Certain kidney and liver tests are required before starting patients on it to ensure it’s safe for them and to monitor for any possible side effects. And the label warns against using it with the malaria drug hydroxychloroquine, because that can curb its effectiveness. “We now have enough knowledge and a growing set of tools to help fight COVID-19,” Gilead’s chief medical officer, Dr. Merdad Parsey, said in a statement. The drug is either approved or has temporary authorization in about 50 countries, he noted. Its price has been controversial, given that no studies have found it improves survival. Last week, a large study led by the World Health Organization found the drug did not help hospitalized COVID-19 patients, but that study did not include a placebo group and was less rigorous than previous ones that found a benefit. The FDA’s approval statement noted that, besides the NIH-led one, two other studies found the drug beneficial. Gilead charges $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries, and $3,120 for patients with private insurance. The amount that patients pay out of pocket depends on insurance, income, and other factors. So far, only steroids such as dexamethasone have been shown to cut the risk of dying of COVID-19. The FDA also has given emergency authorization to using the blood of survivors, and two companies are currently seeking similar authorization for experimental antibody drugs. To read the original article click here. For more articles from CBN News click here.

The post FDA Approves First COVID-19 Drug: Antiviral Remdesivir appeared first on Amazing Health Advances.