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The Latest Breaking News from FDA

The FDA needs more information on supplements. Consumers’ safety is at risk

The COVID-19 quarantine changed everyday life for Americans, including many aspects of our diet, health and exercise regimens. One change that has not received enough scrutiny is that during the pandemic, millions of Americans turned to dietary supplements. In 2020, sales of dietary supplements were 14.5% higher than the previous…

Chicago Tribune

Q&A: A parents’ guide to COVID booster shots for kids 5-11

SAN JOSE, Calif. -- With COVID-19 cases rising again in the Bay Area, parents have a new consideration for protecting their children this week: The Food and Drug Administration granted emergency use authorization Tuesday for kids ages 5-11 to get a booster shot of Pfizer’s COVID-19 vaccine.

Tribune News Service

Viewpoint 2: Cronyism makes the baby formula shortage worse

Bad policy makes people vulnerable, and the current baby formula shortage is just the latest example. The immediate cause of the shortage was contamination in a Michigan factory, which might not resume production until June. But the underlying cause is a slew of bad policies that make the market less…

Tribune News Service

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Viewpoint 3: To avoid the next infant formula crisis, make food safety a priority

The Food and Drug Administration has reached an agreement with Abbott Laboratories to resume production at the company’s Sturgis, Michigan, facility. The announcement gives hope of relief for the three-fourths of American parents who rely on infant formula, and have struggled to find the product in recent weeks.

Tribune News Service

Biden invokes the Defense Production Act for the baby formula shortage

Biden is also authorizing the Defense Department to use commercial aircraft to fly formula supplies that meet federal standards from overseas to the U.S.

WEKU

Third Largest Player In Baby Formula Jumps In To Ease Shortage In US

Europe's Nestlé SA (OTC: NSRGF) is ramping up hypoallergenic (HA) baby formula production to alleviate the shortage in U.S. supermarkets.

Benzinga

Aldeyra's Dry Eye Candidate Tops Vehicle In Post-Hoc Analysis Using Computer Automated Grading In Ocular Redness

Aldeyra Therapeutics Inc (NASDAQ:ALDX) reported a post-hoc analysis from the completed Phase 3 TRANQUILITY dry eye chamber trial of reproxalap for dry eye disease. Using computer-automated grading of digital photography from the trial demonstrated statistical significance in favor of reproxalap over the vehicle for the primary endpoint of reducing ocular redness. As previously…

Benzinga

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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

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

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

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

Congress pushes Biden on baby formula

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

Axios

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

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

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The Independent UK

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

Administration ‘working around the clock’ to restore supplies

Benzinga

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.

Tribune News Service

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.

Reason

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...

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Benzinga

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

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

CNBC Toyota Looks To Develop Hydrogen Mobility In Europe

The Conversation

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…

Benzinga

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…

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