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The Latest Breaking News from FDA

Medical Psychedelics Series In Davos Will Showcase Clinical Efficacy Of Psychedelics To World Economic Forum Attendees

This year, at Davos some of the world’s most prominent psychedelic industry leaders and researchers will attend a satellite event that will run parallel to the World Economic Forum.

Benzinga · May 18, 2022

EXCLUSIVE: Bexson Biomedical's CSO Says Subcutaneous Ketamine Could Treat Wide Range Of Health Issues

Bexson Biomedical recently signed a deal with the Stevanato Group to develop a subcutaneous delivery system of ketamine.

Benzinga · May 18, 2022

Applied Molecular Cuts Its Workforce By 40%, Pauses Early-Stage Research Programs

Applied Molecular Transport Inc (NASDAQ:AMTI) will prioritize the advancement of AMT-101 into late-stage clinical development. It is preparing for the end of Phase 2 meetings with the FDA to advance AMT-101 to Phase 3 in chronic pouchitis. Applied Molecular is evaluating the next steps for AMT-126, which recently demonstrated safety and tolerability in…

Benzinga · May 18, 2022

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Why is there a baby formula shortage in the US, and what can parents do?

Many parents are struggling to feed their babies, and the crisis is hitting poorer families disproportionately hard

The Guardian - US · May 18, 2022

Congress pushes Biden on baby formula

A bipartisan resolution urges the president to invoke the Defense Production Act.

Axios · May 18, 2022

Charlotte's Web Reports Second Cohort Of CBD Safety Study Finds Zero Liver Toxicity And No Drowsiness

Charlotte's Web Holdings, Inc. (OTCQX: CWBHF) (TSX:CWEB) shared the conclusions of the combined first and second cohort of the industry-sponsored liver safety study. Cohort two added another 222 adults who daily consumed hemp CBD tinctures orally for 60 days.

Benzinga · May 18, 2022

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 · May 18, 2022

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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 · May 18, 2022

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 · May 18, 2022

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 · May 18, 2022

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 · May 18, 2022

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 · May 18, 2022

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 · May 18, 2022

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

CNBC Toyota Looks To Develop Hydrogen Mobility In Europe

Benzinga · May 18, 2022

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The Conversation · May 18, 2022

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 · May 18, 2022

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…

Benzinga · May 18, 2022

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 · May 18, 2022

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…

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Axios · May 18, 2022

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 · May 18, 2022

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.

Roll Call · May 18, 2022

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 · May 18, 2022

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 · May 17, 2022

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 · May 17, 2022

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.

Benzinga · May 17, 2022

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…

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