Title: 1 in 4 Hospitalized Newborns Gets Heartburn Drugs, Despite Risks
Category: Health News
Created: 4/27/2016 12:00:00 AM
Last Editorial Review: 4/28/2016 12:00:00 AM

Title: MS Patients Now Pay 20 Times More for Drugs Than a Decade Ago
Category: Health News
Created: 5/1/2019 12:00:00 AM
Last Editorial Review: 5/2/2019 12:00:00 AM

Title: Interest in Unproven COVID Drugs Soared After Trump Gave Thumbs Up
Category: Health News
Created: 4/29/2020 12:00:00 AM
Last Editorial Review: 4/30/2020 12:00:00 AM

Title: More Evidence That Trump-Touted Drugs Won't Curb COVID-19
Category: Health News
Created: 4/30/2020 12:00:00 AM
Last Editorial Review: 5/1/2020 12:00:00 AM

Title: Could ED Drugs Threaten Men's Vision?
Category: Health News
Created: 2/7/2020 12:00:00 AM
Last Editorial Review: 2/7/2020 12:00:00 AM

ABSTRACT

In the absence of a vaccine, multidrug-resistant Neisseria gonorrhoeae has emerged as a major human health threat, and new approaches to treat gonorrhea are urgently needed. N. gonorrhoeae pili are posttranslationally modified by a glycan that terminates in a galactose. The terminal galactose is critical for initial contact with the human cervical mucosa via an interaction with the I-domain of complement receptor 3 (CR3). We have now identified the I-domain galactose-binding epitope and characterized its galactose-specific lectin activity. Using surface plasmon resonance and cellular infection assays, we found that a peptide mimic of this galactose-binding region competitively inhibited the N. gonorrhoeae-CR3 interaction. A compound library was screened for potential drugs that could similarly prohibit the N. gonorrhoeae-CR3 interaction and be repurposed as novel host-targeted therapeutics for multidrug-resistant gonococcal infections in women. Two drugs, methyldopa and carbamazepine, prevented and cured cervical cell infection by multidrug-resistant gonococci by blocking the gonococcal-CR3 I-domain interaction.

IMPORTANCE Novel therapies that avert the problem of Neisseria gonorrhoeae with acquired antibiotic resistance are urgently needed. Gonococcal infection of the human cervix is initiated by an interaction between a galactose modification made to its surface appendages, pili, and the I-domain region of (host) complement receptor 3 (CR3). By targeting this crucial gonococcal–I-domain interaction, it may be possible to prevent cervical infection in females. To this end, we identified the I-domain galactose-binding epitope of CR3 and characterized its galactose lectin activity. Moreover, we identified two drugs, carbamazepine and methyldopa, as effective host-targeted therapies for gonorrhea treatment. At doses below those currently used for their respective existing indications, both carbamazepine and methyldopa were more effective than ceftriaxone in curing cervical infection ex vivo. This host-targeted approach would not be subject to N. gonorrhoeae drug resistance mechanisms. Thus, our data suggest a long-term solution to the growing problem of multidrug-resistant N. gonorrhoeae infections.

ABSTRACT

Transporters belonging to the chromosomally encoded resistance-nodulation-division (RND) superfamily mediate multidrug resistance in Gram-negative bacteria. However, the cotransfer of large gene clusters encoding RND-type pumps from the chromosome to a plasmid appears infrequent, and no plasmid-mediated RND efflux pump gene cluster has yet been found to confer resistance to tigecycline. Here, we identified a novel RND efflux pump gene cluster, designated tmexCD1-toprJ1, on plasmids from five pandrug-resistant Klebsiella pneumoniae isolates of animal origin. TMexCD1-TOprJ1 increased (by 4- to 32-fold) the MICs of tetracyclines (including tigecycline and eravacycline), quinolones, cephalosporins, and aminoglycosides for K. pneumoniae, Escherichia coli, and Salmonella. TMexCD1-TOprJ1 is closely related (64.5% to 77.8% amino acid identity) to the MexCD-OprJ efflux pump encoded on the chromosome of Pseudomonas aeruginosa. In an IncFIA plasmid, pHNAH8I, the tmexCD1-toprJ1 gene cluster lies adjacent to two genes encoding site-specific integrases, which may have been responsible for its acquisition. Expression of TMexCD1-TOprJ1 in E. coli resulted in increased tigecycline efflux and in K. pneumoniae negated the efficacy of tigecycline in an in vivo infection model. Expression of TMexCD1-TOprJ1 reduced the growth of E. coli and Salmonella but not K. pneumoniae. tmexCD1-toprJ1-positive Enterobacteriaceae isolates were rare in humans (0.08%) but more common in chicken fecal (14.3%) and retail meat (3.4%) samples. Plasmid-borne tmexCD1-toprJ1-like gene clusters were identified in sequences in GenBank from Enterobacteriaceae and Pseudomonas strains from multiple continents. The possibility of further global dissemination of the tmexCD1-toprJ1 gene cluster and its analogues in Enterobacteriaceae via plasmids may be an important consideration for public health planning.

IMPORTANCE In an era of increasing concerns about antimicrobial resistance, tigecycline is likely to have a critically important role in the treatment of carbapenem-resistant Enterobacteriaceae, the most problematic pathogens in human clinical settings—especially carbapenem-resistant K. pneumoniae. Here, we identified a new plasmid-borne RND-type tigecycline resistance determinant, TMexCD1-TOprJ1, which is widespread among K. pneumoniae isolates from food animals. tmexCD1-toprJ1 appears to have originated from the chromosome of a Pseudomonas species and may have been transferred onto plasmids by adjacent site-specific integrases. Although tmexCD1-toprJ1 still appears to be rare in human clinical isolates, considering the transferability of the tmexCD1-toprJ1 gene cluster and the broad substrate spectrum of TMexCD1-TOprJ1, further dissemination of this mobile tigecycline resistance determinant is possible. Therefore, from a "One Health" perspective, measures are urgently needed to monitor and control its further spread. The current low prevalence in human clinical isolates provides a precious time window to design and implement measures to tackle this.

Marissa Guale is like all too many Americans right now. Her husband and father of her two children, Raul, is on a ventilator in a hospital on Long Island, fighting for his life while sick with COVID-19. Raul, a 34-year-old nurse, likely caught the disease while working in a nursing home. When the National Institutes of Health announced an emergency use authorization for the experimental antiviral drug remdesivir, Marissa scrambled friends and family on Facebook to figure out how to get access for Raul, emailing hospital administrators, senators, and doctors. They pressed the Guale family’s case for a potentially lifesaving treatment on social media to anyone who would listen.

Her confusion about where and how to get access to the drug isn’t unique. All over the country, families, doctors, and hospitals are wondering how to get the drug and on what basis it’s being distributed. The Trump administration, which is in charge of allocation, hasn’t published any guidance on how it’s making decisions about the scarce supplies of the drug.

So who decides which hospitals get remdesivir? And what’s the most ethical way to prioritize access?

Read more at The Daily Beast.

Obese Europeans who are treated with cholesterol lowering drugs have not only lower values of blood LDL cholesterol and markers of inflammation but in addition a more healthy gut bacteria profile than those obese who are not prescribed statins.

A number of potential drugs for treating the coronavirus are in trials. There are some promising candidates but it’s unclear if they’ll help those who need them most

To fight the new coronavirus, researchers are investigating more than 60 drugs, including remdesivir and hydroxychloroquine and brand new ones. Here’s a breakdown of progress so far

A study suggests high blood pressure in people over 75 doesn't seem to raise the risk of death, leading researchers to question the use of medications for it in older people

People with rheumatoid arthritis often take medicines that can have damaging side-effects, but a system that uses red light to deliver drugs exactly where they are needed could help

Repurposing existing medicines focused on known drug targets is likely to offer a more rapid hope of tackling COVID-19 than developing and manufacturing a vaccine, argue an international team of scientists.

Intensive care units battling a tripling of demand during the coronavirus crisis are experiencing critically low supplies of vital drugs, NHS doctors have claimed.

Davidson is currently quarantining in his mother's basement

A NSW police officer is accused of "sloppy work" in an inquiry after she mistakenly inflated the quantity of drugs found on a reveller at Splendour in the Grass last year by nearly eight times.

Under the proposal, if a person is found with drugs they would be referred to a health service one of more than 100 recommendations to be delivered next month.

Given the rapid spread of COVID-19 and its relatively high mortality, filling the gap for coronavirus-specific drugs is urgent.

A clinical study led by Melbourne’s Doherty Institute aims to treat every patient hospitalised with coronavirus infection over the next 18 months, in a bid to keep them out of intensive care.

A clinical study led by Melbourne’s Doherty Institute aims to treat every patient hospitalised with coronavirus infection over the next 18 months, in a bid to keep them out of intensive care.

A clinical study led by Melbourne’s Doherty Institute aims to treat every patient hospitalised with coronavirus infection over the next 18 months, in a bid to keep them out of intensive care.

(MedPage Today) -- Patients hospitalized with COVID-19 who received a combination therapy with three antivirals -- protease inhibitor lopinavir-ritonavir (Kaletra), nucleoside analogue ribavirin, and injectable interferon beta-1b (Betaseron...

The search for existing drugs that may help treat coronavirus infections now has researchers testing the heartburn drug Pepcid, among others.

By: Daniel Dwyer and Daniel Logan On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. Law 116-136), which includes a comprehensive revision of the rules governing over-the-counter (OTC) drugs currently marketed under monographs published by the Food and Drug Administration (FDA).  This law

The post New Opportunities for OTC Monograph Drugs under the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP.

We are pleased to announce that KKB partners Dan Dwyer, Stacy Ehrlich, Peter Mathers, and Suzan Onel were selected for the annual Super Lawyers list for Washington, DC.  They make up more than 20% of the 18 DC attorneys listed in the “Food and Drugs” category.  In addition, for the sixth year in a row, KKB

The post KLEINFELD, KAPLAN & BECKER WELL REPRESENTED ON THE WASHINGTON, DC, 2020 SUPER LAWYERS LIST FOR “FOOD AND DRUGS” appeared first on Kleinfeld Kaplan & Becker LLP.

The genetic mutations that cause epilepsy don’t stop there. Praxis Precision Medicines CEO Marcio Souza says research also links these genes to other neurological conditions. The biotech startup is turning that research into new neuro drugs and it’s coming out of stealth to share details about its science and its pipeline, which already has two […]

The innate immune system has become a hot area for drug development, and for good reason. As the body’s first line of defense, its function (or dysfunction) plays a role in many diseases. The problem, says Ventus Therapeutics CEO Marcelo Bigal, is that drug developers have been working in the dark. Scientists don’t know the […]

Ayala Pharmaceuticals has two clinical-stage cancer drugs licensed from Bristol Myers Squibb. Now it has $55 million to take those drugs further than the pharmaceutical giant did. On Thursday evening, Ayala priced its IPO, which consisted of 3.7 million shares sold for $15 each. That price was the midpoint of the targeted $14 to $16 […]

In this video explainer, Christopher Robertson discusses the Right to Try Act and off-label use of pharmaceuticals with Alison Bateman-House.

The post Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson appeared first on Bill of Health.

This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Industry Update and COVID-19 Impact: PBMs & Payers.

Part D reform has faded from the policy debate. This rerun explains why it is still needed. FYI, this is my favorite article from 2020 (so far).

Click here to see the original post and comments from January 2020.

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Our high-list-price/high-rebate system remains a fundamental source of warped incentives and cascading problems within the Medicare Part D program.

For proof, check out the previously unpublished data below on market share for products that treat hepatitis C. Despite manufacturers offering products with lower list prices, Medicare Part D plans have rejected the therapeutically identical but lower-priced versions of these drugs.

List prices significantly affect seniors’ out of-pocket costs, so Part D plans are needlessly costing many of them thousands of dollars. The federal government's Medicare spending is also unnecessarily higher.

Anyone concerned about drug prices should pay close attention to this situation. Part D plans and seniors who don’t need specialty medications are benefiting, while seniors who need treatment with specialty medications are ripped off. Just another day inside the gross-to-net bubble!
Read more »

With substandard medicines already in wide circulation, fears are growing that coronavirus could create a lethal ‘parallel crisis’

When Joana Opoku-Darko’s daughter Anna was 18 months old, she came down with malaria, a disease common in Ghana and especially deadly for children.

She bought medication from a pharmacy in Ghana’s capital, Accra; when Anna’s fever didn’t subside she took her to a hospital, where they ran some tests.

The current focus on curbing Covid-19 spread means there is less focus on routine market surveillance

Related: Fight the fakes: how to beat the $200bn medicine counterfeiters | Helen Lock

Continue reading...

The ongoing spread of COVID-19 in Russia is leading to shortages of drugs against orphan diseases in…

Gilead made waves on Friday with its emergency FDA approval for remdesivir quickly on the heels of a controlled trial data release. But while it’s an important first step, other COVID-19 medicines will likely be coming down the line, analysts wrote.

The United States has filed a lawsuit to block KV Pharmaceutical Company, its subsidiaries, ETHEX Corp. and Ther-Rx Corp., and its principal officers from making and distributing adulterated and unapproved drugs. At the same time, KV agreed to the injunction in a consent decree.

Ethex Corporation, a wholly owned subsidiary of St. Louis-based drug manufacturer, KV Pharmaceutical Company, pleaded guilty to two felonies and was sentenced today in connection with the manufacturing of oversized prescription drug tablets.

Schwarz Pharma Inc. will pay $22 million to resolve False Claims Act allegations that the company failed to advise the Centers for Medicare and Medicaid Services (CMS) that two unapproved products did not qualify for coverage under federal health care programs.

Hazim Gaber, 22, of Edmonton, Canada, pleaded guilty today in Phoenix before U.S. Magistrate Judge Edward C. Voss to selling counterfeit cancer drugs using the Internet.

Three Pennsylvania men were charged today with conspiracy to possess and intending to distribute oxycodone, ecstasy and marijuana.

429 individuals in 16 states were arrested as part of Project Deliverance, which targeted the transportation infrastructure of Mexican drug trafficking organizations in the United States, especially along the Southwest border.

Hazim Gaber, 22, of Edmonton, Canada, was sentenced today in Phoenix by U.S. District Court Judge James A. Teilborg to 33 months in prison for selling counterfeit cancer drugs using the Internet.

"In every district, the Attorney General’s anti-violence strategy will require close coordination among state, local, and tribal law enforcement. In the Attorney General’s view – and I share his vision as well – fighting violent crime requires more than just putting offenders in jail. It also requires preventing crime before it occurs, and smoothing the transition of released prisoners back into society."

Approximately 1,985 individuals have been arrested on narcotics-related charges as part of a 20-month multi-agency law enforcement investigation known as “Project Delirium,” which targeted the La Familia Michoacana drug cartel.

Mississippi-based Cypress Pharmaceutical Inc., its subsidiary Hawthorn Pharmaceuticals Inc. and its CEO, Max Draughn, have agreed to pay $2.8 million to resolve civil allegations under the False Claims Act, the Justice Department announced today.

The Department of Justice announced the guilty plea and sentencing of Easley, S.C.-based Aletec Medical for engaging in a multi-million dollar prescription drug scheme. Altec Medical pleaded guilty in U.S. District Court in Miami to one count of conspiring to defraud the U.S. Food and Drug Administration (FDA) and to commit federal offenses in connection with a drug-diversion scheme that lasted from 2007 to 2009.