Scott Gottlieb

A scrappy upstart in the pain pill business takes on mighty Purdue Pharma

CANTON, Mass. — Collegium Pharmaceutical, the scrappy upstart taking on the mighty opioid maker Purdue Pharma, is having a moment.The company …

Pharma

FDA issues guidance on development of generic abuse-deterrent opioids

In a statement, FDA Commissioner Scott Gottlieb, M.D. says the agency will take steps to help drug makers develop approvable generic opioid …

Business

Report: Herpes Researcher Secretly Experimented On People In Hotels

The researcher behind an offshore herpes vaccine trial widely viewed as unethical first secretly experimented on patients in US hotel rooms, …

Technology (Australia)

FDA pushes for generic painkillers intended to deter abuse

The Food and Drug Administration is making moves to spur development of generic and cheaper opioids that are difficult to abuse.<p>The agency released …

Pharma

FDA Raids Florida Stores That Consumers Use To Buy Drugs From Canada

The Food and Drug Administration last month sent criminal investigation agents with search warrants into nine storefronts across Central Florida that …

Health Policy

The rate of parents opting out of vaccines for their kids has plateaued in America

This is good news — but the longer-term trends suggest vaccine refusals are on the rise.<p>Health researchers have been convinced the anti-vaccine movement is gaining traction in America. Earlier this year, Minnesota battled its largest measles outbreak in nearly 30 years — an outbreak sparked …

Public Health

Medicare Part D rule change would be another win for pharma’s lobbyists, analyst says

Pharma stands to win again in Washington, D.C., if a new Part D rule proposal from the Centers for Medicare & Medicaid Services comes to fruition. …

Pharma

Is the $35 Billion Rehab Industry Ready For A Disruption?

In today’s recovery industry, what many people think of as “rehab” is about as far from the prestigious environment of the Betty Ford Center as you …

Health Care

FDA finally rules on kratom: It’s a potential killer

The herbal supplement known as kratom poses “deadly risks” and can be addictive, according to a long-awaited Food and Drug Administration health …

Lifestyle

Big Pharma is taking advantage of patent law to keep OxyContin from ever dying

The US opioid epidemic seems to many to have come out of nowhere, and there’s been much finger-pointing in recent years about how this state of affairs came to be. Some have argued that inadequate mental healthcare is to blame. Others have postulated that doctors were naively over prescribing them …

Pharma

FDA clears electronic earpiece to block opioid withdrawal symptoms

A wearable device claiming to block the pain of opioid withdrawal has been cleared by the Food and Drug Administration under an expedited review …

Medicine

The FDA wants to expedite approval of regenerative organ therapies

Organ Ordinance<p>Scientists are making great strides toward more realistically using stem cells to grow replacement organs. Now, the US Food and Drug …

Medicine

FDA asks that Baxter saline plants in Puerto Rico get power restored ahead of others

The FDA has been helping dozens of U.S. drugmakers in Puerto Rico get power and supplies to their plants in the wake of the infrastructure disaster …

Pharma

Senate committee passes GOP tax plan, but mandate repeal might not be a devastating blow

<b>SENATE FINANCE MOVES ACA MANDATE REPEAL FORWARD —</b> The committee on Thursday night advanced Senate Republicans' tax plan in a party-line vote, hours after the House approved its own competing tax plan, POLITICO's Brian Faler reports.<p>The Senate's measure includes a repeal of the Affordable Care Act's …

Health Care

The FDA closes a huge loophole used by bogus stem cell clinics, but postpones serious enforcement

There was good news and bad news in the regulatory initiative the Food and Drug Administration rolled out on Thursday, aimed partially at clinics marketing unproven stem-cell therapies directly to consumers.<p>The good news is that the FDA firmly closed a loophole exploited by many of these …

Medicine

Food and Drug Administration Closes a Loophole in Stem Cell Clinic Regulations

The Food and Drug Administration plans to more strictly regulate some stem-cell treatments offered by private clinics, the agency announced …

Medicine

Trump vs. the Deep Regulatory State

Federal regulation has been growing mightily since the early 1970s, powered by statutes that delegate Congress’s lawmaking authority to mission-driven executive agencies. Beginning in 2008, the executive state achieved autonomy. The Bush administration during the financial crisis, and the Obama …

Opinion

Alkermes: Bearish Technicals But Several Value Drivers In 2018

Stock price performance has disappointed over the past year and three years. Bearish technicals suggest a move even lower is possible in the near …

Business

FDA Warns Against Using Kratom as Alternative to Opioid Painkillers

"We’ve learned a tragic lesson from the opioid crisis."<p>By on<p>Filed Under Health, Medicine & Public Health<p>The future, straight to your inbox.<p>The drug …

Pain

What is kratom? FDA warns against drug which users claim can help treat opiate addiction

The use of the drug derived from a plant has risen in recent years<p>To some kratom is a harmless, khaki green legal high and a lifeline for those …

Scientific Research

F.D.A. Speeds Review of Gene Therapies, Vowing to Target Rogue Clinics

The Food and Drug Administration on Thursday issued new guidelines to speed the introduction of treatments involving human cells and tissues, including gene therapy. But the agency also said it would crack down on rogue clinics offering dangerous or unproven versions of those treatments.<p>The …

Medicine

The FDA Wants To Bring Gene Therapies to Market Much Faster

The first gene therapy took place so long ago that, at the time, Milli Vanilli lip syncing was a headline-grabbing scandal. But with the advent of …

Science

Trump Rails Against Drug Industry, but Turns to its Ranks to Fill Administration

WASHINGTON—President Trump has vilified the pharmaceutical industry and made bold promises to lower prescription drug prices. But when it comes to …

Pharma

Some stem cell therapies would skip usual FDA rules under new guidelines

In a move aimed at encouraging the emerging field of regenerative medicine while also protecting patients from dangerous products, the U.S. Food and …

Medicine

FDA grants marketing authorization of the first device for use in helping to reduce the symptoms of opioid withdrawal

Today, the U.S. Food and Drug Administration granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of …

Pain

STAT Plus: Is the FDA approving drugs faster than ever? No, as the data show

With each breathless announcement and triumphant press release, it seems clear that the Food and Drug Administration is approving new drugs at a …

Health

FDA’s Opioid Crackdown: What Is Kratom And Why Authorities Fear It Could ‘Fuel’ Addiction

The Food and Drug Administration issued a strong warning on Tuesday against the use of an herbal opioid treatment called kratom, saying regulators …

Pain

US health agency to crack down on risky stem cell offerings

U.S. health authorities say they will crack down on doctors pushing stem cell therapies that pose the gravest risks to patients amid an effort to …

Medicine

Hurricane Damage To Manufacturers In Puerto Rico Affects Mainland Hospitals, Too

At MedStar Washington Hospital Center, doctors and nurses are moving as many patients as they can from intravenous medications to the same drugs in pill form.<p>If the patients are getting common antibiotics like ampicillin, and they can swallow, they're likely to be switched to pills, says Bonnie …

News (U.S.)

Some Marijuana Companies Say Their Products Can Cure Cancer. The U.S. Government Isn't Impressed

The U.S. Food and Drug Administration is now paying close attention to the marijuana industry after four businesses claimed that their cannabis products or treat, or even cure, cancer.<p>Marijuana businesses are well used to run-ins with federal regulators. Now some are encountering a whole new area …

Cannabis