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The Latest Breaking News on Pharma

EU regulator clears tweaked versions of COVID vaccines

The European Medicines Agency has recommended the authorization of two coronavirus vaccines made by Pfizer-BioNTech and Moderna Inc., tweaked to include protection against an early version of the omicron variant

The Independent UK

Brisbane biotech firm Ellume puts Australian arm into administration

Ellume rose to prominence last year when it announced a $300 million deal to provide COVID-19 home test kits to the US Department of Defense.

ABC News

Michael Hiltzik: In blow to public health, judge tosses FDA lawsuit targeting a clinic offering unproven stem cell treatments

A federal judge in Riverside, California, declared a stem cell treatment firm operating in the state to be exempt from Food and Drug Administration regulations, opening the door to the further proliferation of clinics offering therapies the FDA says are scientifically unproven and potentially dangerous.

Los Angeles Times

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Nasdaq-listed Bright Minds Closes $4 Million Offering And Begins Dosing In Clinical Trial For Epilepsy

Biopharma company developing next-generation mental health treatments Bright Minds Biosciences Inc. (NASDAQ: DRUG) has closed its overnight offering for gross proceeds of approximately $4 million.

Benzinga

FDA Approves Updated COVID-19 Booster Shots

But does everyone really need to get boosted?

Reason

Bluebird bio Seeks Back-to-Back Nods, 'Go' or 'No-Go' For Revance's Botox Rival, Amylyx' Twin Hurdles And More: September's Key PDUFA Catalysts Biotech Investors Must Know

After August’s mixed tally for Food and Drug Administration approvals, investors turn to a new month, which has a fairly loaded calendar.

Benzinga

FDA clears way for boosters targeted at latest COVID variants

COVID-19 boosters from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE that are tailored to the latest COVID-19 omicron variants got U.S. regulatory clearance, a move toward additional protection as concern grows about potential new waves in the fall and winter.

Tribune News Service

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US clears updated Covid boosters targeting the newest Omicron strain

Omicron booster shots could become available within days

The Independent UK

FDA authorizes Omicron boosters

The updated shots are expected to become available after Labor Day.

Axios

US clears updated COVID boosters targeting newest variants

U.S. regulators have authorized updated COVID-19 boosters, the first to directly target today's most common omicron strain

The Independent UK

Editorial: Extend, fund free COVID tests

The COVID-19 virus's course and evolution remain unpredictable. But this far into the pandemic, there are some safe assumptions.

Tribune News Service

Cybin Announces First Dosing In Human Trial With Proprietary Psychedelic Drug For Depression

Cybin Inc.

Benzinga

FDA to approve new omicron COVID-19 boosters

The Food and Drug Administration is set to approve new boosters that specifically target the omicron mutation of COVID-19.

Tribune News Service

2 Stocks That Are More Than COVID-19 Plays

While the COVID-19 pandemic benefitted Johnson & Johnson (JNJ) and Pfizer (PFE) significantly as their vaccines helped the world recover from the crisis, these stocks are more than just COVID-19 plays because of their strong product portfolio and pipeline. They are well-positioned to capitalize on the rising chronic diseases, an…

StockNews.com

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StockNews.com

2 Biotech Stocks to Buy and Hold for the Long Term

Intensive innovation, breakthrough developments, and growing investments should help the biotech industry witness solid growth over the next decade. And given the sector’s reputation as a safe haven amid economic turmoil, it could be wise for investors to buy and hold fundamentally solid biotech stocks Amgen (AMGN) and AstraZeneca (AZN)…

The Independent UK

FDA chief says long-awaited opioid review still in the works

The head of the Food and Drug Administration says a government review of prescription opioid medications, including their risks and contribution to the U.S. overdose epidemic, is still underway

Birmingham Post

Pharmaceuticals giant acquires California counterpart for £221.5m

Med-Pharmex employs around 130 people

Benzinga

Khiron Q2 Revenue Grows 60% YoY, Despite Decline In Medical Cannabis Sales In Germany

Khiron Life Sciences Corp. (TSXV:KHRN) (OTCQX: KHRNF) (Frankfurt:A2JMZC) Q2 2022 total revenue was CA$4.5 million ($3.45 million), up 60% year-over-year, driven by growth in the medical cannabis segment in Colombia and the United Kingdom.

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Inverse

Should you get a Covid-19 booster now, or wait until the fall?

As we gear up for another wave of Covid-19 this fall, experts say you should definitely be prepared to get a booster shot. Here's when you should get it.

Axios

Moderna's COVID vaccine lawsuit looks ahead to future markets

Moderna's COVID vaccine lawsuit looks beyond the pandemic to future markets

The Hindu

J&J continues to sell talc-based baby powder in India, despite discontinuing in U.S. and Canada

Company says India is part of global transition to cornstarch-based powder

Tribune News Service

Q&A: The new COVID vaccine booster is coming. Should you get it?

The COVID-19 vaccine is getting an upgrade.

Reuters

Bayer initiates asundexian Phase III study program

Germany's Bayer said on Sunday it was starting a Phase III study program to investigate the efficacy and safety of asundexian, an oral Factor XIa (FXIa) inhibitor.

Wales Online

AstraZeneca boss uncertain if yearly Covid-19 boosters for healthy are good use of resources

The chief executive officer believes most of the vaccinated population now has a "foundation immunity against severe disease"

Tribune News Service

Virginia health officials projecting first decrease in overdose deaths since before the pandemic

NORFOLK, Va. — New data on fatal drug overdoses in Virginia suggests this year could be the first time there’s been a decrease in deaths since 2018.

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