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.

---

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.

Victory Pharma Inc., a specialty pharmaceutical company headquartered in San Diego, has agreed to pay $11,420,743 to resolve federal civil and criminal liability arising from its marketing of the pharmaceutical products Naprelan, Xodol, Fexmid and Dolgic, the Justice Department announced today. Under the agreement announced today, Victory entered into a deferred prosecution agreement and paid a criminal forfeiture of $1.4 million to resolve federal Ant-Kickback Statute allegations, and paid $9,938,310 to resolve False Claims Act allegations.

Lina Rodriguez, 34, was sentenced today in the U.S. District Court for the Southern District of Florida to serve 72 months in prison, followed by 24 months of supervised release, for operating and facilitating the operation of an Internet-pharmacy business that illegally shipped over $1.5 million of pharmaceuticals since July 2007 to U.S. and overseas purchasers.

The Justice Department announced today that the United States has filed a second civil false claims lawsuit against Novartis Pharmaceuticals Corp. involving alleged kickbacks paid by the company to health care providers.

Michael P. Jackson, 40, of Carmi, Ill., was sentenced today in the U.S. District Court for the Southern District of Florida to serve 72 months in prison for selling the prescription drug known as Adderall.

Acting Assistant Attorney General Stuart F. Delery announced today that the Department of Justice, on behalf of the Food and Drug Administration (FDA), has filed suit in the U.S. District Court for the Western District of Louisiana against Sage Pharmaceuticals.

You know as well as anyone that the challenges we face are daunting. You’ve shown us that, as we seek to address the problem of substance abuse, it makes sense to focus on the most dangerous types of drugs. And right now, few substances are more lethal than prescription opioids and heroin.

An Illinois man, who previously pleaded guilty to trafficking in counterfeit goods and introducing counterfeit drugs into interstate commerce in violation of the Food, Drug and Cosmetic Act, was sentenced today to serve 41 months in prison

Though it issued an Emergency Use Authorization (EUA) for anti-malaria drugs to treat or prevent coronavirus (COVID-19), the U.S. Food and Drug Administration (FDA) reiterated its warning about the known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems.

The coronavirus pandemic has infected more than 2.5 million people worldwide, with the United States accounting for nearly 1 million of those cases.

Biological drugs remain unaffordable for many in the US due to strategies used by pharmaceutical companies and negative messaging about biosimilars, explains a recent commentary by Dr Joel Lexchin, School of Health Policy and Management at York University, Canada [1].

Posted by Roger Bate My op-ed with Dinesh Thakur in The Hill today highlights the recent recommendation by Europe's chief drug regulator to suspend 700 generic drugs whose approvals were based on flawed – or forged – clinical studies conducted by GVK Bio, an Indian contract research organization. We urge U.S. Federal regulators to follow Europe’s lead and move to rescind market approval for these drugs while conducting their own investigation. You can read the op-ed here [...]

By Karla L. Palmer —