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The Latest Breaking News from FDA

U.S. FDA Extends Review By Three Months For Provention Bio's Type 1 Diabetes Candidate

The U.S. Food and Drug Administration (FDA) has extended its review period by three months for Provention Bio’s (NASDAQ: PRVB) Biologics License Application (BLA) for teplizumab in patients with type 1 diabetes. The regulatory agency has set a new target action goal date of November 17, 2022.

Benzinga

FDA says COVID boosters for the fall must target newer omicron types

With immunity waning and the super-contagious omicron family of variants getting better at dodging protection, the Food and Drug Administration decided boosters intended for fall needed an update.

WEKU

SCOTUS delivers a dagger to the planet

"We don't have another option for large-scale reductions in greenhouse gasses"

Salon

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Feeling anxious? Try doing something nice for someone else.

Science says random acts of kindness can help.

Mic

The FDA's War on Juul Will Kill People

Bureaucrats say they want to save lives. But they're moving to block a tool that is proven to help smokers quit entirely.

Reason

Why Did Needham Lift Price Target For Trevi?

Yesterday Trevi Therapeutics Inc's (NASDAQ:TRVI) Phase 2b/3 trial (PRISM) evaluating Haduvio (nalbuphine ER) for prurigo nodularis (PN) successfully met the key primary and secondary endpoints. Needham writes that Haduvio had a quick onset of action, reaching stat sig at 6 weeks with efficacy that had yet to plateau at the wk-14 readout. Trevi…

Benzinga

Pfizer Seeks Complete Approval For Paxlovid For High Risk COVID-19 Patients

Pfizer Inc (NYSE:PFE) has submitted a new drug application to the FDA for the approval of Paxlovid for patients at high risk for progression to severe illness from COVID-19. Paxlovid is currently authorized for emergency use to treat mild-to-moderate COVID-19 in adults and pediatric patients at high risk for progression to severe COVID-19,…

Benzinga

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FDA: Updated COVID boosters will roll out in the fall

The updated shots will provide more protection against subvariants that now make up more than 50% of U.S. cases.

Axios

Tweaked COVID boosters in US must target newer omicron types

U.S. regulators are telling COVID-19 vaccine makers to tweak any booster doses intended for fall so they protect against the newest omicron relatives

The Independent UK

Wall Street Predicts These 2 Sub-$5 Stocks Have More Than 200% Upside

Concerns over the Federal Reserve’s aggressive interest rate hikes to fight elevated inflation and the possibility of the economy tipping into a recession have fostered significant volatility in the market of late. Despite the market uncertainties, Wall Street analysts expect fundamentally sound sub-$5 stocks Provention Bio (PRVB) and Trevi (TRVI)…

StockNews.com

Aura Biosciences' Stock Gains As FDA Grants Fast Track Status To Bladder Cancer Drug

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Aura Biosciences’ (NASDAQ: AURA) belzupacap sarotalocan (AU-011) for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).

Benzinga

The Daily Biotech Pulse: Pfizer/BioNTech Ink New COVID-19 Vaccine Supply Pact, Sanofi Hit By FDA Clinical Hold, Angion Biomedica Halts Second Kidney Disease Trial

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

Avadel Cuts Workforce, Optimizes Cost Structure To Support This

Avadel Pharmaceuticals plc (NASDAQ: AVDL) announced its steps to explore every available pathway to accelerate the FDA approval of its lead drug candidate, FT218, before June 2023.

Benzinga

AstraZeneca Says Imfinzi/Chemo Combo Shows Promising Action In Late-Stage Lung Cancer Study

AstraZeneca Plc (NASDAQ:AZN) announced high-level results from a planned interim analysis of the AEGEAN Phase 3 trial of Imfinzi (durvalumab) combined with neoadjuvant chemotherapy in patients with resectable non-small cell lung cancer (NSCLC). The data showed that Imfinzi plus neoadjuvant chemo before surgery demonstrated a statistically significant and meaningful improvement in pathologic complete…

Benzinga

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Benzinga

Why Sanofi Shares Are Falling Today

The FDA has placed Sanofi SA's (NASDAQ:SNY) Phase 3 studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold. New enrollment in the U.S. is paused, and participants in the U.S. who have been in the trial for fewer than 60 days shall suspend the study drug. The participants who…

Benzinga

US Government Calls For Additional Doses Of Pfizer/BioNTech COVID-19 Vaccine

Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have announced a new vaccine supply agreement with the U.S. government. Under the agreement, the U.S. government will receive 105 million doses (30 µg, 10 µg and 3 µg). This may include adult omicron-adapted COVID-19 vaccines, subject to the FDA authorization. The doses are planned to be delivered…

Chicago Sun-Times

COVID vaccination reboot coming this fall to add tweaks for new coronavirus variants

The FDA will have to decide the exact recipe. But expect a combination shot that adds protection against omicron or some of its newer relatives to the original vaccine.

Benzinga

This Healthcare Stock Surges Around 115%, Here's 74 Biggest Movers From Yesterday

Gainers Allena Pharmaceuticals, Inc. (NASDAQ: ALNA) shares surged 114.3% to close at $0.2550 on Wednesday after the company announced it has terminated its previously announced at-the-market offering.

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Tribune News Service

What you need to know about monkeypox

The World Health Organization said June 25 that monkeypox wasn’t yet a public health emergency of international concern. More than 4,500 cases have been reported worldwide, with more than 300 in the U.S.

Los Angeles Times

Editorial: Drastically reducing nicotine levels will save a lot of lives

Nicotine kills. Oh, not directly, for the most part. It’s just so addictive that cigarette smokers find it nearly impossible to quit a product that subtracts years off their lives, causes cancer, chronic obstructive pulmonary disease, strokes and heart disease, along with worsening Type 2 diabetes. In 2018, more than…

The Independent UK

Baby neck floats can cause ‘death or serious injury’, FDA warns

Agency says they are sometimes marketed as water-therapy products

Tribune News Service

Texas Sen. Ted Cruz blasts Sesame Street – again – after Elmo gets the coronavirus vaccine

WASHINGTON — With a little green bandaid on his furry red arm, Elmo, the beloved 3 1/2-half-year-old Muppet on the long-running children’s PBS program Sesame Street, said “there was a little pinch, but it was okay” when he received his coronavirus vaccine this week.

Benzinga

Analysts Still Believe Verrica's Ycanth Is Approvable Despite FDA Response Letter

Verrica Pharmaceuticals Inc (NASDAQ:VRCA) held a Type A meeting with the FDA regarding the path forward for the resubmission and potential approval of Ycanth (VP-102) for molluscum contagiosum. HC Wainwright says VP-102 was approvable, and at the time of the Complete Response Letter (CRL), Verrica had already engaged a potential alternate solution supplier. It reiterates…

StockNews.com

5 "Strong Buy" Pharmaceutical Stocks to Own for the Long Haul

The inelastic demand and rising investments in research and development should drive the pharmaceutical industry’s growth in the long run. Therefore, pharmaceutical stocks AbbVie (ABBV), Amgen (AMGN), Catalyst (CPRX), Novo Nordisk (NVO), and Vertex (VRTX), which possess sound fundamentals, could be solid long-term investments. These stocks are rated Strong Buy…

Benzinga

FDA Green Lights Ceruvia's Phase 2 Psilocybin Trial Program For Obsessive-Compulsive Disorder Treatment

Clinical-stage biopharma company Ceruvia Lifesciences recently received FDA approval for its Investigational New Drug (IND) application for a Phase 2 clinical trial to determine the efficacy and safety of proprietary synthetic psilocybin (SYNP-101) in treating obsessive-compulsive disorder (OCD).&nbs

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