FDA Signs Off On New Booster COVID-19 Vaccines

 

Great news!  With the threat of a new wave of COVID-19 coming, the Food and Drug Administration (FDA) has just signed off on two new booster shots, one from Moderna and one from Pfizer/BioNTech.  The mRNA vaccines have been updated to teach the body to fight the XBB.1.5 Omnicron subvariant of the coronavirus and other closely related strains that are circulating.  The Advisory Committee on Immunization Practices will make recommendations for their use—they are scheduled to meet tomorrow.  After the CDC director signs off on those recommendations, the vaccines can be administered.  Therefore, they could be available in pharmacies in just a few days. 

 

Diabetes Drugs In Short Supply

A person holding a hamburger in their hand.


Drugs like Ozempic are in short supply for diabetics as physicians have found new “off-label†uses for the drug such as weight loss.  Although the drug was not originally designed for the use of weight loss, this has become a very effective side effect and many weight loss clinics are aggressively pushing the off-label prescription drug.  “The clock is ticking to preserve kidney and heath health, and the longer patients are without these therapies, the more risks they are accruing,†Katherine Tuttle, Executive Director for Research at Providence Medical Research, told the Wall Street Journal.

FDA On The Offensive Regarding New Alzheimer’s Drug

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The Food and Drug Administration’s Commissioner Robert Califf has defended the agency’s approval of the new Alzheimer’s drug called Aduhelm.  This follows an investigation by House Democrats which found close cooperation between the drug’s sponsors and regulators.  The findings were made by the Oversight and Reform Committee and the Energy and Commerce Committee which found an unusual number of meetings between Biogen Inc. and the FDA.  The FDA also co-authored with the company a briefing document presented to outside advisors, which is very unusual.  Unfortunately, the drug was pulled off the market because Medicare refused to cover the expensive drug.

New Blood Pressure Reduction Device Requires No Medication

A stethoscope and heart on the table.


A Medtronic PLC medical device reduced the blood pressure of people with tough-to-treat hypertension in a new study.  However it missed its goal, producing an insignificant blood pressure result of only 2 points more than those in the study that didn’t have the procedure done.  Despite falling short of the study’s main efficacy goal, Medtronic is still moving forward with its application to the Food and Drug Administration to approve the device.  If the FDA approves it, the device could offer a new, non-medication treatment for people who have high blood pressure.  “This could be the biggest thing we’ve ever done because hypertension is the No. 1 contributor to death,†Medtronic CEO Geoffrey Martha told The Wall Street Journal.

FDA Rejects Two Cancer Drugs Developed In China

A doctor and patient looking at a book


The Food & Drug Administration has denied approval of two proposed new cancer drugs which were developed in China.  The FDA issued a letter to Hong Kong-based Hutchmed Ltd. denying permission to market the drug ufatinib, which is approved in the Chinese market to treat pancreatic and neuroendocrine tumors.  It also notified China-based Shanghai Junshi Biosciences Co. and its U.S.-based partner Coherus BioSciences Inc. that it denied its application to sell the drug toripalimab, which treats nasopharyngeal cancer.  The FDA asked the companies to change their quality-related processes at which time the FDA will reexamine the applications.  However, the FDA did note that two clinical trials Hutchmed conducted in China for ufatinib didn’t support approval so that company may have to go back to the drawing board on clinical trials as well.  FDA officials have commented publicly recently that they were not happy with the quality of drug studies conducted in China and that it was unclear whether the results would be applicable to U.S. patients.

 

Robert Califf Confirmed As FDA Commissioner

A man in white lab coat and tie.


In a close vote, The Senate voted 50 to 46 in favor confirming Robert Califf to lead the Food and Drug Administration (FDA).   Califf was opposed by some Republicans after being pressured by abortion-pill opponents as well as some Democrat’s because of Dr. Califf’s industry ties.  Six Republicans voted for confirmation while four Democrats and independent Senator Bernie Sanders voted against him.  As FDA Commissioner, Dr. Califf will play a key roll in overseeing the response to the coronavirus pandemic.

Eli Lilly Gets Bad News About Its New Lung Cancer Drug Tuvut

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In a 14:1 vote, a panel advising U.S. drug regulators said Eli Lilly & Company and its Chinese partner (Innovent Biologics) needs to conduct more studies on a proposed new lung-cancer drug called Tuvut before giving FDA approval.  The panel was concerned about the tests done on the drug in China and said it had significant shortcomings and its results were not applicable to U.S. patients who would use the drug.  This is due in part that the study participants didn’t reflect the diversity of the U.S. population and they also suggested that Innovent undercounted adverse events.

FDA officials have recently cited concerns about the quality of drug studies conducted largely in China and whether the results in Chinese patients are directly applicable to patients in the U.S.  The most recent recommendation by the panel advising the FDA isn’t just a setback to Eli Lilly, but is likely a shot over the bow to let U.S. drug companies know that they need to more carefully screen their Chinese partners or they may risk having important drugs see a long delay before gaining FDA approval or even being denied FDA approval altogether.

 

 

 

FDA Approves Two COVID-19 Vaccines

A vial of influenza vaccine next to two syringes.


At last, the FDA has approved both the Pfizer and the BioNTech vaccines.  They are no longer approved only for experimental use which will shoot down one of the last excuses that anti-vaxers have been using as an excuse not to get vaccinated.  This is where the rubber meets the road and those not getting vaccinated are going to have to try and come up with another excuse for doing what the majority of Americans have done—get vaccinated against the coronavirus.  Shortly after the approval, the Pentagon announced that it would require all active-duty military to be vaccinated (only 64% now are) and President Biden put the pressure on private companies to do the same.  “Today I’m calling on more companies in the private sector to step up with vaccine requirements that will reach millions to do that,†he said.  Johnson & Johnson and Moderna are expected to submit paperwork to get full approval by the end of the year.  This is definitely great news as hospitalizations from COVID-19 are surging as the Delta variant continues to spread.

https://www.wsj.com/articles/fda-approves-pfizer-biontech-covid-19-vaccine-for-people-16-and-older-11629726322?mod=djemwhatsnews

New Hope For Those With Alzheimer’s Disease

A purple square with the words " the end of alzheimer 's starts with me ".


The U.S. Food and Drug Administration (FDA) is set to rule soon on whether a promising drug by Biogen called aducanumab can be prescribed from those suffering from Alzheimer’s disease.  Although it has already been recommended by an FDA advisory panel of medical experts that the drug not be approved as two clinical trials had completely different results, Bloomberg Businessweek interviewed a man, Jeffrey Borghoff age 57, who was diagnosed with early-stage Alzheimer’s disease at 51.  He gave cudos to the drug, which he has been taking for years as part of an experimental drug trial.  :We’re fighting like hell to get this drug approved,†Borghoff told a reporter.  “Every day they are making progress in cancer and diabetes and other diseases.  We need something for Alzheimer’s disease,†he said.  Fingers crossed that the FDA approves the drug—they have until June 7 to make a decision.

Monterey, CA New Hope For Alzheimer’s Drug

A woman looking out of the window at her home.


The Food & Drug Administration FDA is taking another look at aducanumab, a potential new drug for treating Alzheimer’s Disease and dementia.  The drug candidate will undergo an additional three months of review after a panel of experts in November recommended against approving the drug.  Biogen and Eisai partnered on the development of the drug and delivered new data to the FDA, triggering the prolonged review time.  An independent committee of experts had criticism of both the drug’s merits and the interpretation of data by FDA scientists.  Biogen said the data from one clinical trial showed a slowing in cognitive decline compared to study participants who received a placebo.  In the second clinical trial, the drug failed to show a benefit.  However, Biogen says it is likely because fewer patients received the higher dosage.  Regular readers of my blog know that both my father and grandmother had this terrible disease when they passed away.  There are great people at our local chapter of Alzheimer’s Association in Ryan’s Ranch.  They also have a 24-hour hotline if you need support at 800-272-3900.

https://www.wsj.com/articles/fda-extends-review-of-biogen-eisais-alzheimers-drug-11611935425