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The Latest Breaking News from FDA

Acasti Pharma's IV Hemorrhage Drug Candidate At Par With Oral Nimodipine

Acasti Pharma Inc's (NASDAQ:ACST) pharmacokinetic (PK) bridging study with IV GTX-104, its lead drug candidate for Subarachnoid Hemorrhage (SAH), met all its planned study endpoints. The study's primary objective was to evaluate the relative bioavailability of IV GTX-104 compared to oral nimodipine in healthy subjects, while the secondary objective was to assess…

Benzinga

Parents attack Jill Biden’s message on baby formula amid weeks-long shortage: ‘Help us’

Administration ‘working around the clock’ to restore supplies

The Independent UK

The Daily Biotech Pulse: Pfizer/BioNTech's COVID-19 Booster For Kids, Moderna Starts First African Trial Of mRNA HIV Vaccine, Tonix Extends COVID-19 Antiviral Research Pact

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

Benzinga

From analysis to the latest developments in health,
read the most diverse news in one place.

Despite Congress’ efforts, it’ll take time to refill the baby bottles

WASHINGTON — Lawmakers are throwing nearly every tool in their arsenal, including a proposed $28 million in taxpayer dollars, at the baby formula shortage. But it isn’t clear how quickly those solutions will result in cans on grocery store shelves.

Tribune News Service

Victories for Rand Paul, Pot, and Some MAGA Candidates in Primary Elections

Plus: a debate about sex work, Facebook blocks a baby formula recipe, and more...

Reason

University Of Nebraska Medical Center And ANANDA Scientific Get FDA Approval For Clinical Trial Of CBD-Based Drug For PTSD

The University of Nebraska Medical Center (UNMC) and ANANDA Scientific Inc. are collaborating on a new clinical trial investigating treatment for adults with post-traumatic stress disorder (PTSD).

Benzinga

IO Biotech Starts Dosing In Late-Stage IO102-IO103/Keytruda Combo Trial In Melanoma Patients

IO Biotech (NASDAQ: IOBT) dosed first patient in its phase 3 clinical trial of lead drug candidate, IO102-IO103, in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with previously untreated, unresectable or metastatic (advanced) melanoma.

Benzinga

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Morning Brief: Top Financial Stories Dominating on Wednesday, May 18

CNBC Toyota Looks To Develop Hydrogen Mobility In Europe

Benzinga

Why is the FDA seeking to ban menthol cigarettes? 4 questions answered

The FDA has opened the public comment period for the agency’s proposed ban on menthol cigarettes. Epidemiology and global health professor Rafael Meza studies data modeling in disease prevention and cancer risk. David Mendez, who studies smoking cessation and tobacco control policies, is an associate professor of health management and…

The Conversation

Racism is different than colorism – here's how

Ronald Hall is a professor in the School of Social Work at Michigan State University. He has written over 200 books/articles/monographs, etc., on colorism – discrimination on the basis of skin tone, often among the same ethnic or racial group. Below are highlights from an interview with The Conversation. Answers…

The Conversation

How Does Grupo Somar Acquisition Reaffirms Procaps' Strategy To Strengthen Footprint In LatAm

Integrated LatAm healthcare and pharmaceutical company Procaps Group (NASDAQ:PROC) has agreed to acquire Grupo Somar (including Grupo Farmacéutico Somar, Química y Farmacia, Gelcaps, and related entities) from Advent International, private equity. Deal terms were not disclosed. Grupo Somar is focused on developing, manufacturing, and marketing branded generic, private label, and OTC products targeted to…

Benzinga

US Lawmakers Reveal FDA Emergency Funds Bill To Tackle Baby Formula Shortage: Reuters

U.S. House Democrats unveiled a bill to provide $28 million in emergency funds to the FDA to help it respond to a shortage of infant formula and strengthen supervision. A House Appropriations Committee said that the funds would provide the FDA with the resources to prevent fraudulent products from being placed on…

Benzinga

How America feeds its young

The widespread use of baby formula across America has come under the spotlight as a national shortage has sparked an infant nutritional crisis.

Axios

Baby formula shortage puts spotlight on how America feeds its young

The widespread use of baby formula across America has come under the spotlight as a national shortage has sparked an infant nutritional crisis.

Axios

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Roll Call

Despite Congress’ efforts, it’ll take time to refill the baby bottles - Roll Call

Lawmakers are scrambling to end the formula shortage, but experts say it will be months before families will feel an impact.

Tribune News Service

As Red Cross moves to pricey blood treatment method, hospitals call for more choice

Americans generally don’t spend much time thinking about the nation’s blood supply.

Salon

A love letter to the perfect pasta shape

They bounce, they squeak, they whistle, they fling sauce in unpredictable directions — and I love it

Los Angeles Times

With old-school technology, can Novavax win over COVID vaccine skeptics?

Since their debut just 18 months ago, three COVID-19 vaccines have saved an estimated 2.2 million American lives, changed the trajectory of a pandemic and inspired all manner of conspiracy theories.

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Benzinga

FDA Declines Emergency Use Request For An Antidepressant As COVID-19 Treatment

The FDA has decided not to authorize fluvoxamine, an antidepressant, to treat COVID-19. The agency that data has not shown the drug to be an effective therapeutic for fighting the virus. "Based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine…

Benzinga

Sorrento Starts Mid-Stage Study Of Abivertinib In Prostate Cancer

The FDA has signed off Sorrento Therapeutics Inc's (NASDAQ:SRNE) investigational new drug application (IND) for Abivertinib (Fujovee) for Phase 2 MAVERICK study in metastatic castrate-resistant prostate cancer (mCRPC). The MAVERICK study will be conducted in a partnership with the Prostate Cancer Clinical Trials Consortium and will enroll participants with both abiraterone-naïve and abiraterone-progressing…

The Independent UK

Why is there a baby formula shortage in the US?

With children hospitalised and parents paying up to $100 for a can, the president has now invoked a wartime measure to try to ensure there is enough formula to feed America’s babies

Axios

House Democrats release $28 million aid bill to address baby formula shortage

The money is intended to help the FDA prepare for potential future shortages.

WEKU

FDA authorizes first COVID booster for children ages 5 to 11

The Food and Drug Administration expanded authorization of Pfizer-BioNTech's COVID vaccine to enable kids ages 5 to 11 who were vaccinated at least five months ago to get a third shot.

Benzinga

FDA Gives Nod To First Nonprescription COVID-19 Test That Also Detects Flu, RSV

The FDA has authorized the first nonprescription test to detect Covid-19, influenza, and respiratory syncytial virus (RSV). The test, called the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test, was developed by Laboratory Corp of America Holdings (NYSE:LH). It can be sold directly to consumers online or at retail. A person can self-collect a nasal…

Benzinga

FDA May Authorize Pfizer-BioNTech's COVID-19 Booster For 5-11 Year Kids Soon: NYT

The FDA is expected to authorize a booster shot of Pfizer Inc (NYSE:PFE) / BioNTech SE's (NASDAQ:BNTX) COVID-19 vaccine for children aged 5 to 11 probably by today, the New York Times reported, citing people familiar with the matter. The companies submitted an application to the FDA for authorization last month. They have cited data from…

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