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The Latest Breaking News from FDA

Michael Hiltzik: This life-saving drug will cost a record $2.8 million. Who will pay the price?

For the estimated 1,500 Americans suffering from a blood disorder known as beta thalassemia, the Food and Drug Administration's approval Aug. 17 of the drug Zynteglo was almost unalloyed good news.

Los Angeles Times

Anebulo Pharma Posts FY 2022 Earnings, Positive Results From Clinical Trial For Treatment Of Acute Cannabinoid Intoxication

Anebulo Pharmaceuticals, Inc. (NASDAQ: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse, released its financial results for the three months and twelve months ended June 30, 2022.

Benzinga

NOT REAL NEWS: A look at what didn't happen this week

Social media users shared a range of false claims this week

The Independent UK

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read the most diverse news in one place.

Top Financial Stories Friday, September 09: Elon Musk Hints At Potential Apple-SpaceX Partnership, GM's EV For Cost Conscious Buyers, Google Under DOJ Scanner For Search-Engine Dominance And More...

Bloomberg When The Bank Error Is Not In Your Favor: Pay Back $500 Million

Benzinga

Superbugs are a "second punch" after pandemic

There was a 15% rise in drug-resistant infections in hospitalized patients from 2019 to 2020.

Axios

Why ShiftPixy Surged Around 177%; Here Are 71 Biggest Movers From Yesterday

Gainers ShiftPixy, Inc. (NASDAQ: PIXY) shares surged 176.5% to close at $31.00 on Thursday after the company announced plans to spin-off ShiftPixy Labs and dividend its digital securities to shareholders.

Benzinga

Breast implants may be linked to more cancers than previously thought, FDA warns

‘This is an emerging issue and our understanding is evolving,’ FDA says

The Independent UK

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Trump Ally Dr. Oz Hyped Unapproved 'Covid Cures' From Companies He Owns Shares Of

Republican Pennsylvania Senate candidate Dr. Mehmet Oz owns shares of two companies he publicly supported, touting their drugs as potential Covid-19 treatments — even though the drugs weren't approved by the U.S. Food and Drug Administration (FDA).

Benzinga

Why IMARA Jumped Around 75%; Here Are 54 Biggest Movers From Yesterday

Gainers

Benzinga

Controversial ALS drug from Amylyx gets rare second FDA meeting

Amylyx Pharmaceuticals Inc.’s controversial treatment for amyotrophic lateral sclerosis won the support of a panel of U.S. regulatory advisers, putting the product on track for likely clearance.

Tribune News Service

Important Biotech Catalysts For September 7, 2022 - End Of The Day Summary

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Pfizer’s (NYSE:PFE) lead drug GBS6 or PF-06760805 for the prevention of invasive GBS disease due to the vaccine serotypes in newborns and young infants by active immunization of their mothers during pregnancy. Pfizer shares traded in a…

Benzinga

Potential to mix up omicron booster with conventional vaccine raises concerns

Experts are voicing concerns about the potential for vaccine providers to mix up the omicron booster vial with those used for conventional vaccines.

Los Angeles Times

ALS drug gets rare second review at high-stakes FDA meeting

The Food and Drug Administration is holding an unusual second meeting to review a closely watched drug for the illness known as Lou Gehrig’s disease

The Independent UK

Why Korn Ferry Is Trading Lower By Over 8%, Here Are 40 Stocks Moving In Wednesday's Mid-Day Session

Gainers Allena Pharmaceuticals, Inc. (NASDAQ: ALNA) jumped 64% to $0.1199. Allena Pharmaceuticals shares dipped over 30% on Tuesday after the company announced it has filed for bankruptcy.

Benzinga

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Benzinga

E-Cigarette Maker To Pay Over $430M To Settle Multi-State Vaping Inquiry, Cannabis Investors Need To Pay Attention

E-cigarette producer Juul Labs agreed to pay $438.5 million to 34 states and territories to sort out a two-year bipartisan investigation into its marketing and sales practices.

Benzinga

ACOGF: Bioequivalence Complete

By John Vandermosten, CFA OTC:ACOGF READ THE FULL ACOGF RESEARCH REPORT

Tribune News Service

Stopgap funding bill set to dominate September agenda

Lawmakers return to Washington this month to wrestle with a White House request for $47.1 billion in emergency supplemental funds and the need to pass a stopgap spending bill to avoid a partial government shutdown starting Oct. 1.

Tribune News Service

Juul reaches $439 million settlement over marketing to children

Juul Labs Inc. reached an agreement in principle to pay $438.5 million to 33 states to resolve a two-year bipartisan probe into the e-cigarette manufacturer’s marketing and sales practices, particularly claims that it marketed addictive nicotine products to children.

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WEKU

Juul will pay nearly $440 million to settle states' investigation into teen vaping

The electronic cigarette maker has agreed to settle a two-year investigation by 33 states and Puerto Rico into the marketing of its vaping products, which have been blamed for a surge in teen vaping.

The Independent UK

Juul to pay nearly $440M to settle states' teen vaping probe

Electronic cigarette maker Juul Labs will pay nearly $440 million to settle a multi-state investigation into its vaping products, which have long been blamed for sparking a national surge in teen vaping

Roll Call

Stopgap funding bill set to dominate September agenda - Roll Call

Lawmakers will wrestle with a White House request for $47.1 billion in emergency funds and the need to avert a partial government shutdown.

The Independent UK

Unions call on Truss to crack down on sexual harassment in Westminster

Prospect and FDA say new leadership brings a fresh opportunity to restore confidence that Parliament is a safe place to work.

StockNews.com

NERV Stock Is on the Move, but Is It a Buy?

Biopharmaceutical company Minerva Neurosciences (NERV) delivered considerable losses in its last quarter. Investors are increasingly concerned about the company’s massive debt burden and increased cash burn. Despite its limited earnings growth prospects, the stock has gained more than 260% over the past month because the company submitted an NDA for…

Wales Online

The man who breeds tens of thousands of leeches for the NHS from a tiny Welsh farm

Carl Peters-Bond, from Biopharm Leeches in Hendy, is one of just two FDA registered leech farmers in the world

Salon

Food expiration dates are confusing

A food safety researcher explains another way to know what’s too old to eat

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