FDA Panel Votes to Recommend Johnson & Johnson’s Coronavirus Vaccine for Emergency Authorization

The Food and Drug Administration’s vaccine advisory panel voted Friday evening to recommend Johnson & Johnson’s coronavirus vaccine for emergency approval, clearing the way for its authorization, distribution and administration nationwide.

The vote followed hours of the panel live-streaming its process of scouring over data from the pharmaceutical company in order to reaffirm that the vaccine was safe for the millions of Americans who will receive it. The FDA also released the vaccine’s clinical trial data on Wednesday showing that the vaccine was effective in fighting the virus itself.

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Coronavirus Vaccines Can Guard Against New, More Contagious UK Strain, Experts Say

The two coronavirus vaccines that have been approved for emergency use authorization in the U.S. will be able to combat a new, more contagious strain of the virus in the U.K., experts said Monday.

Vaccines made by pharmaceutical companies Pfizer and Moderna will be effective against the new strain, which is “very similar” to previous strains at the genetic level, University of Washington’s Institute for Health Metrics and Evaluation affiliate assistant professor Vin Gupta told CNBC. The Food and Drug Administration has approved both vaccines for emergency use authorization after large-scale human trials showed efficacy of more than 90%.

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FDA Grants Moderna’s Coronavirus Vaccine Emergency Authorization

The FDA approved Moderna’s coronavirus vaccine for emergency use Friday, making the United States the first country to have approved two safe and effective vaccines against COVID-19.

Its approval follows a key FDA panel’s overwhelming vote Thursday to endorse the vaccine’s safety and efficacy. The Moderna vaccine’s approval means that its distribution could begin within hours, providing hospitals and long-term care facilities across the country thousands of much-needed doses.

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FDA Authorizes First Over-the-Counter Home Coronavirus Test

The Food and Drug Administration approved the first over-the-counter, at-home coronavirus test Tuesday.

The test, developed by the Australian company Ellume Limited, is a rapid antigen test that can deliver results in approximately 20 minutes, and works on any patient older than two years of age, the FDA said in its announcement.

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FDA Review Reaffirms Moderna Coronavirus Vaccine’s Safety, Efficacy

The FDA released data Tuesday reaffirming that Moderna’s coronavirus vaccine is safe and effective in preventing severe cases in adults.

The release is a sign that the vaccine is likely to be granted emergency use from the FDA in the coming days, public health officials said, a critical step in ensuring that millions of Americans can be vaccinated as soon as possible. The FDA released similar data regarding Pfizer’s vaccine just days before it was given emergency approval as well.

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Governor Mike DeWine Warns Ohioans to Watch Hospital Capacity as Health Director Mulls Outpatient Treatments for COVID-19

During the Thursday COVID briefing, Ohio Governor Mike DeWine said that he “took an oath to do everything to protect the lives and wellbeing of fellow Ohioans” and that the next three weeks will be the most critical in battling COVID.

DeWine then stressed the importance of Ohioans understanding and keeping an eye on hospital capacity in their respective communities.

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FDA Grants Pfizer Coronavirus Vaccine Emergency Authorization, Launching Nationwide Distribution and Vaccination Effort

The FDA approved Pfizer’s coronavirus vaccine for emergency use Friday, officially beginning a nationwide mass vaccination effort in an attempt to overcome the coronavirus pandemic.

Its approval follows a key FDA panel’s overwhelming vote to endorse the vaccine’s safety and efficacy. President Donald Trump called for the agency to approve Pfizer’s earlier Friday, telling its director, Dr. Stephen Hahn, to “get the dam vaccines out” as soon as possible.

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FDA Advisory Panel Approves Pfizer Coronavirus Vaccine, Clearing Way for Final Authorization and Distribution

The FDA’s vaccine advisory panel voted 17-4 to approve Pfizer’s coronavirus vaccine for use, clearing the way for its approval and distribution nationwide.

After scouring over Pfizer’s data during the multi-hour meeting Thursday, the panel ensured that it was safe for the hundreds of million Americans expected to receive it in the coming months and voted to recommend approval. Though the panel’s decision is merely an advisory one, the FDA is expected to heed its recommendation and approve Pfizer’s vaccine as early as Friday.

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Moderna Asks FDA for Emergency Approval of COVID-19 Vaccine, Second Company to Pass Milestone

Pharmaceutical company Moderna announced Monday that it will submit its coronavirus vaccine to the federal government for emergency use authorization approval.

Moderna said it would ask the Food and Drug Administration (FDA) for approval after its large-scale human trial concluded and showed the company’s vaccine to have an overall efficacy of 94.1%, according to NBC News. The vaccine was found to be 100% effective in preventing severe cases of coronavirus, according to Moderna.

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FDA Has Delayed Approval Process for Promising Cancer Drug for Months Because of COVID

A promising immunotherapy drug for patients battling non-Hodgkin’s lymphoma may fail to gain federal approval due to COVID-19 precautions, according to company executives and a quarterly report.

Liso-cel, manufactured by Bristol-Myers Squibb, originally had its Food and Drug Administration (FDA) application accepted in February, but has yet to have one of its contracted manufacturing sites undergo FDA inspection due to the coronavirus pandemic. Not only is the drug’s approval contingent on the facility inspections from the FDA, according to multiple company executives, but its application expires on Nov. 16, meaning that if the plant is not inspected in the coming days Bristol-Myers may have to completely resubmit the drug’s application as a result.

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AstraZeneca, Johnson and Johnson Resuming U.S. Tests of COVID-19 Vaccines

Two drugmakers announced Friday the resumption of U.S. testing of their COVID-19 vaccine candidates.

Testing of AstraZeneca’s vaccine candidate had been halted since early September, while Johnson & Johnson’s vaccine study was paused at the beginning of last week. Each company had a study volunteer develop a serious health issue, requiring a review of safety data.

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Governor DeWine Predicts ‘Very, Very Heavy’ COVID Storm

Ohio now has 29 counties colored red by the Ohio Public Health Advisory System, according to remarks made by Ohio Governor Mike DeWine during his press briefing on Thursday.

That total represents 65% of Ohio’s population of just under 11.7 million, according to the Governor.

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White House to Block FDA Vaccine Guidelines That Would’ve Delayed Approval Past Election

The White House blocked new vaccine guidelines proposed by health officials within the Trump administration, which likely would have pushed the approval of a coronavirus vaccine past the election.

The Food and Drug Administration (FDA), which is in charge of approving vaccines, proposed the guidance on Sept. 21, according to The New York Times. White House chief of staff Mark Meadows raised concerns with one provision of the guidelines which said vaccine trial subjects should be examined for two months following their final dose, a senior administration official told the Times.

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NIH: Halted Vaccine Study Shows ‘No Compromises’ on Safety

The suspension of a huge COVID-19 vaccine study over an illness in a single participant shows there will be “no compromises” on safety in the race to develop the shot, the chief of the National Institutes of Health told Congress on Wednesday.
AstraZeneca has put on hold studies of its vaccine candidate in the U.S. and other countries while it investigates whether a British volunteer’s illness is a side effect or a coincidence.

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Commentary: Lowering the Cost of Prescription Medicines for Seniors Is Not Impossible

Earlier this year James Payne, a 73-year-old retired attorney in Utah, was so fed up with the high cost of a blood thinner medication he takes, he researched prices in Canada, where he found it was cheaper.

“Under Medicare, I am now paying $225 for a three-month supply,” Payne explained. “That’s $25 more than I was paying last year. Under my employer’s insurance I was only paying $20.” Payne says he is not sure why the costs are so much higher and continue to climb under Medicare, but he thinks there must be ways to make life-saving medications more affordable.

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President Trump Announces Plasma Treatment Authorized for COVID-19

President Donald Trump announced Sunday the emergency authorization of convalescent plasma for COVID-19 patients, in a move he called “a breakthrough,” one of his top health officials called “promising,” and other health experts said needs more study before it’s celebrated.

The announcement comes after days of White House officials suggesting there were politically motivated delays by the Food and Drug Administration in approving a vaccine and therapeutics for the disease that has upended Trump’s reelection chances.

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Trump’s Sunday Presser Forces Hand of Ohio’s Dept of Health and Governor DeWine

President Donald J. Trump announced the Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for convalescent plasma as a therapeutic treatment in COVID patients Sunday.

Convalescent plasma is the liquid part of the blood that contains COVID antibodies. Convalescent plasma given to COVID patients during research conducted since April by the Mayo Clinic has resulted in a 35% decrease in the incidence of death in the patients receiving the plasma, according to FDA Director Stephen Hahn.

The announcement is significant in Ohio where Republican Governor Mike DeWine has hinted for months at his hesitation to allow Ohioans to return to normal life until there is a vaccine.

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Ohio Regulators Ban, Then Un-Ban ‘Controversial’ COVID Drug

The Ohio Pharmacy Board (OPB) implemented – then quickly reversed – a ban on the use of hydroxychloroquine Thursday. The move followed a revocation of the emergency use authorization by the FDA earlier this month. Previously, President Trump said the decades-old drug could be used as a preventative treatment for a deadly symptom of the disease that causes the lungs to lose function.

As of today, a new rule is set to go into effect regarding the drug, hydroxychloroquine. The OPB published a memo on the rule change stating “in general, the rule prohibits the use of hydroxychloroquine and chloroquine for the treatment or prevention of COVID-19.”

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FDA Revokes Emergency Use of Malaria Drugs to Treat Coronavirus, Cites ‘Potential Risks’

U.S. regulators on Monday revoked emergency authorization for malaria drugs promoted by President Donald Trump for treating COVID-19 amid growing evidence they don’t work and could cause deadly side effects.

The Food and Drug Administration said the drugs hydroxychloroquine and chloroquine are unlikely to be effective in treating the coronavirus. Citing reports of heart complications, the FDA said the drugs’ unproven benefits “do not outweigh the known and potential risks.”

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Commentary: Progressive Woke Orthodoxy Obscures the Truth About the Virus

Americans are acquainted with predictable but ultimately failed progressive efforts to suppress free expression by preemptive invective and politically correct finger-pointing.

To believe that U.S. Supreme Court Justice Brett Kavanaugh’s accusers revealed too many contradictions, too many lacunae, too many episodes of timely amnesia, and too many unsubstantiated accusations in their testimonies was chauvinistically to attack/smear/silence all women’s voices – at least until the same sort of memory-repressed accusations focused on handsy Joe Biden.

To express skepticism that current global temperatures are uniformly rising almost entirely due to human carbon emissions, that this state of affairs poses catastrophic dangers that may end civilization as we know it, and that this emergency can only be addressed by the radical restructuring of global economies is to be rendered a denialist, a crank, a fool.

But these parameters of censorship have a logic and predictability, given their race/class/gender/environmental orthodoxy.

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DeWine Thanks President Trump for Approving Plan for Battelle to Sterilize Hundreds of Thousands of Protective Masks

Ohio Governor Mike DeWine and Lt. Governor Jon Husted on Sunday thanked President Trump and Dr. Stephen Hahn of the U.S. Food and Drug Administration (FDA) for approving a plan to sterilize N95 masks to fight the coronavirus.

Earlier Sunday, DeWine called an emergency press conference to express his “deep disappointment” with the FDA for limiting the use of the new technology, The Ohio Star reported.

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FDA Issues Emergency Authorization Of Anti-Malaria Drugs As Doctors Herald Results For Coronavirus Patients

The United States Food and Drug Administration issued an emergency use authorization for donated anti-malaria drugs hydroxychloroquine sulfate and chloroquine phosphate as doctors say the drugs are showing positive results for coronavirus patients.

The FDA issued the authorization to allow doctors to distribute and prescribe the anti-malaria drugs to hospitalized teen and adult patients who have coronavirus, the Department of Health and Human Services said in a press release. Doctors may distribute and prescribe the drugs “as appropriate, when a clinical trial is not available or feasible.”

The emergency authorization was issued to the Assistant Secretary for Preparedness and Response’s Biomedical Advanced Research and Development Authority, which is working with the National Institute of Health to plan clinical trials of the drugs.

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FDA Allows Ohio Company to Make Unlimited Use of Face Mask Sterilizer After Trump, DeWine Intervene

Ohio Gov. Mike DeWine called an emergency press conference Sunday to express his “deep disappointment” with the Food and Drug Administration for limiting the use of a new technology to sterilize face masks.

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Mayo Clinic Says It Can Now Perform Up to 4,000 COVID-19 Tests Daily

Mayo Clinic announced last week that it can now test up to 4,000 clinical samples for SARS-CoV-2, the virus that causes COVID-19, on a daily basis.

Mayo officials said they now have the capacity to process COVID-19 test samples at all Mayo Clinic sites and have started processing test samples from their clients across the state, including eight major health systems.

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FDA Authorizes New 45 Minute Coronavirus Test for Release Next Week

A California-based molecular diagnostics company announced Saturday they will ship a point-of-care test next week that they say can detect SARS-CoV-2, the virus causing COVID-19 in 45 minutes.

Officials at the U.S. Food and Drug Administration gave that company, Cepheid, Emergency Use Authorization to do so, company officials said in a press release.

Called the Xpert Xpress SARS-CoV-2, the test is designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems worldwide, with a detection time of less than one hour.

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President Trump Says FDA Has Approved Testing of Anti-Malaria Drug Chloroquine for Treating Coronavirus

President Donald Trump announced during a Thursday press briefing that the anti-malarial drug chloroquine was approved by the Food and Drug Administration as a possible treatment for the coronavirus.

The announcement comes the day after Breitbart News reported that the medical establishment has known about chloroquine’s effectiveness in treating the virus since at least the 2005 SARS coronavirus outbreak.

“Clinical trials are already underway for many new therapies and we’re working on scaling these to allow many more Americans to access different drugs that have shown really good promise,” President Trump said.

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Trump Administration Ends Contract Supplying Fetal Tissue for Research

by Rachel del Guidice   The Trump administration has ended the government’s contract with a bioscience company that provided human fetal tissue from elective abortions for testing purposes. The Food and Drug Administration no longer will obtain the fetal tissue from California-based Advanced Bioscience Resources Inc., the Department of Health…

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Despite Growing Support for Hemp Legalization, Ohio Government Cracks Down

As the Ohio Senate considers legalizing hemp and hemp byproducts in the Buckeye State, the Ohio Department of Health, along with the Food and Drug Administration (FDA), is simultaneously cracking down on any form of sale of the substance. Currently, hemp is trapped in a complicated legal limbo and while state legalization will alleviate many of…

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FDA: More Blood Pressure Drugs May Have Shortages After Recalls

by Reuters   Additional shortages of blood pressure drugs in the United States are possible following recent recalls related to traces of a probable carcinogen found in some versions a particular class of hypertension medicines, the U.S. Food and Drug Administration said Friday. The drugs, including valsartan, belong to a…

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Ohio Medical Board Tightens Rules for Opioid Prescriptions

Long overdue limits on opioid prescriptions are finally being introduced to the Buckeye State. As of Wednesday, the State Medical Board of Ohio has enacted new requirements that must be met for the prescribing and continuing use of opioids. The rules will affect both short term and long term prescriptions.…

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Dr. Carol M. Swan Commentary: Congress’s Role in Creating America’s Healthcare Crisis

by Dr. Carol M. Swain   In 2017, President-elect Donald Trump sent pharmaceutical stocks into a nosedive by speaking an important truth. Drug companies, he said, are “getting away with murder” with their pricing of lifesaving drugs. True to his word, the president, since his election, has pushed for needed reforms  aimed at…

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Dr. Carol M. Swain Commentary: Congress’s Role in Creating America’s Healthcare Crisis

by Dr. Carol M. Swain   In 2017, President-elect Donald Trump sent pharmaceutical stocks into a nosedive by speaking an important truth. Drug companies, he said, are “getting away with murder” with their pricing of lifesaving drugs. True to his word, the president, since his election, has pushed for needed reforms  aimed at…

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Promise Kept: President Trump’s Landmark ‘Right to Try’ Legislation Curbs Government’s Monopoly on Medicine for Terminally Ill Patients

Trump right to try

In a signing ceremony on Wednesday, President Trump fulfilled another campaign promise by signing legislation nicknamed “Right to Try” that will expand seriously ill patients’ access to experimental treatments that could extent or even save their lives. Mr. Trump called the measure a “fundamental freedom” for people with terminal conditions to…

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Trump Is Following Through On His Pledge To Lower Drug Prices, Here’s The Plan

by Steve Birr   The Trump administration released its blueprint for lowering skyrocketing prescription drug prices Friday, a strategy that has already saved patients nearly $9 billion. President Donald Trump, along with Health and Human Services Secretary Alex Azar, outlined their four-pronged approach to making medications more affordable during an afternoon press…

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President Trump Faces Institutional Obstacles to Overcome U.S. Drug Pricing Fiasco

President Trump is scheduled to deliver his first speech Friday to introduce an overarching plan to confront high drug prices. As a candidate, where he railed against the pharmaceutical industry and accused it of “getting away with murder.” The populist rhetoric appears to be giving way to a more nuanced strategy focused…

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