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The Latest Breaking News from FDA

HC Wainwright Finds 'Synergies In Treatment' For This Bipolar-Focused Stock

HC Wainwright initiated coverage on NRx Pharmaceuticals Inc (NASDAQ:NRXP) with a Buying rating and a price target of $2. Earlier today, the FDA declined to issue an Emergency Use Authorization for NRx's Zyesami for a subgroup of patients who also received Gilead Sciences Inc's (NASDAQ:GILD) remdesivir in addition to Zyesami. The analyst is bullish on: Significant potential for NRX-101 for…

Benzinga

US conservatives vow harsh restrictions to curtail abortion pills

Discreet and available by mail, abortion-inducing pills could make conservative abortion bans challenging to enforce.

Al Jazeera

Updating Coronavirus Vaccines Is Good, But a Universal Coronavirus Vaccine Would Be Better

Time for a new Operation Warp Speed?

Reason

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The Daily Biotech Pulse: FDA Wants Omicron-Targeted COVID-19 Boosters, Provention Bio Clears Hits Hurdle For Diabetes Prevention Drug, Oxford Biomedica, AstraZeneca Strike Vaccine Pact

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

Benzinga

FDA Turns Down NRx Pharmaceuticals' Emergency Use Submission For Covid-19 Candidate

The U.S.

Benzinga

FDA Expert Panel Favors COVID-19 Boosters Targeting Omicron BA.4, BA.5 Subvariants

The FDA's independent experts voted to include a SARS-CoV-2 omicron component in COVID-19 vaccines that would be used for boosters in the U.S. beginning in fall 2022. The panel has advised manufacturers to develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a…

Benzinga

Review: How Melatonin-Filled 'Lazy Cakes' Became the Subject of a Moral Panic

Senators asked for an investigation since the "sweet, chocolaty taste may encourage consumers to eat well over a recommended quantity of melatonin."

Reason

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Attention Biotech Investors: Mark Your Calendar For These July PDUFA Dates

The biotech sector is poised to end June on a positive note, despite largely disappointing regulatory decisions scheduled during the month, thanks to a reversal in broader market sentiment.

Benzinga

Ask the Pediatrician: How do I know these unfamiliar brands of infant formula on store shelves are safe?

Q: Why am I seeing brands of baby formula I’ve never heard of, and are they safe?

Tribune News Service

White House touts abortion pill as answer to Roe reversal but FDA rules limit use

The Biden administration says it’s taking steps to increase access to medication abortion in response to the Supreme Court decision to reverse Roe v. Wade, but some of the administration’s own policies stand in the way of people trying to get the drug.

Tribune News Service

The Supreme Court has curtailed EPA's power to regulate carbon pollution – and sent a warning to other regulators

In a highly anticipated but not unexpected 6-3 decision, the Supreme Court ruled on June 30, 2022, that the Obama administration’s Clean Power Plan exceeded the U.S. Environmental Protection Agency’s authority under the Clean Air Act.

The Conversation

New Restrictions On Synthetic Marijuana: Harm To The Cannabis Industry?

Beginning July 1, the Oregon Liquor and Cannabis Commission (OLCC) will be restricting the sale of some artificially derived synthetic cannabinoids in the state, reported the Oregonian.

Benzinga

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

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Salon

SCOTUS delivers a dagger to the planet

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

Mic

Feeling anxious? Try doing something nice for someone else.

Science says random acts of kindness can help.

Reason

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.

Benzinga

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…

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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,…

Axios

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.

The Independent UK

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

StockNews.com

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)…

Benzinga

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.

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