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The Latest Breaking News from FDA

Pro-Patient Psychedelic Treatments Are Finally Moving Forward In A 'New Paradigm Shift'

Last week, Benzinga’s Psychedelics Capital Conference brought a premier gathering of the biggest publicly traded psychedelics companies in North America with forward-thinking investors to Miami, where the hottest topic seemed to revolve around LSD and derivative molecules.

Benzinga

Editas Medicine's EDIT-301 receives FDA Rare Pediatric Disease designation for Beta Thalassemia

The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to EDIT-301, an investigational, gene-edited medicine for the treatment of beta thalassemia from leading genome editing company, Editas Medicine, Inc. (NASDAQ: EDIT).

Benzinga

Prothena Receives FDA Fast Track Designation for PRX012 for the Treatment of Alzheimer's Disease

Prothena Corporation plc (NASDAQ: PRTA) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the anti-amyloid beta (Aβ) antibody therapy drug candidate PRX012 for the treatment of Alzheimer's disease.

Benzinga

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Gamida Cell Shares Jump On FDA Nod To Cell Therapy Trial In Blood Cancer Settings

The FDA has signed off and removed the clinical hold for a cryopreserved formulation of Gamida Cell Ltd's (NASDAQ:GMDA) GDA-201, an off-the-shelf cell therapy candidate for follicular and diffuse large B cell lymphomas. Gamida Cell expects to initiate a Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022.…

Benzinga

U.S. FDA Grants Fast Track designation To Ofra-Vec (VB-111) For Platinum-Resistant Ovarian Cancer

VBL Therapeutics (NASDAQ: VBLT) received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its drug candidate Ofra-Vec (VB-111) in combination with Paclitaxel for the treatment of patients with platinum-resistant ovarian cancer.

Benzinga

The Daily Biotech Pulse: Protagonist's Ulcerative Colitis Study Disappoints, Gilead's Remdesivir Approved For Pediatric COVID-19 Patients, FDA Gives Nod To Gamida's Cell Therapy Trial, Fast Track Tag For Vascular Biogenics Ovarian Cancer Gene Therapy

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

Benzinga

Evoke Shares Skyrocket On New FDA Market Exclusivity For Gimoti Nasal Spray

The FDA has granted new drug product exclusivity to Evoke Pharma Inc's (NASDAQ:EVOK) Gimoti (metoclopramide) nasal spray to relieve symptoms associated with acute and recurrent diabetic gastroparesis in adults. Evoke now has exclusive marketing rights over three (3) years from the original date of approval under the Hatch-Waxman Act to protect the product from…

Benzinga

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The dietary supplement you're taking could be tainted with prescription medications and dangerous hidden ingredients, according to a new study

The Research Brief is a short take about interesting academic work.

The Conversation

Rush for weed licences ahead of narcotic delisting in June

Thailand’s Food and Drug Administration (FDA) has received some 4,700 applications for licences from people and organisations to import, possess, grow and produce cannabis and hemp.

Bangkok Post

Gilead's Remdesivir Becomes First Approved Treatment For Pediatric COVID-19 Patients

The FDA has approved Gilead Sciences Inc's (NASDAQ:GILD) supplemental marketing application for Veklury (remdesivir) for pediatric COVID-19 patients older than 28 days. The approval covers patients weighing at least 3 kg and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe infection. This approval…

Benzinga

60 Biggest Movers From Yesterday

Gainers

Benzinga

Magically suspicious: why are thousands claiming sickness after eating Lucky Charms?

Reported symptoms include nausea, vomiting and diarrhea, but experts are raising questions about self-diagnosis

The Guardian - US

1st COVID treatment for kids under 12 gets FDA approval. What to know about Veklury

The Food and Drug Administration approved Veklury — also known as the drug remdesivir — as the first COVID-19 treatment for children younger than 12 on Monday, April 25.

McClatchy Washington Bureau

Psyched: Big Pharma's Sanofi Enters Psychedelics Space, DNA From 80 Psilocybe Mushrooms Published Online, Maine Psychedelics Bill Shelved

Benzinga’s first-ever Psychedelics Capital Conference was a colossal success. Over 600 investors, policymakers, industry executives and thought leaders gathered at the Fontainebleau Hotel in Miami Beach for a full day of networking and education.

Benzinga

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Benzinga

Missed The Benzinga Psychedelics Capital Conference? Check Out Full Recording And Exclusive Coverage

The Times of India

Asthma drug can block crucial SARS-CoV-2 protein, says IISc

BENGALURU: Indian Institute of Science on Monday said a drug used to treat asthma and allergies can bind to and block a crucial protein produced by SARS-CoV-2 — the virus causing Covid-19 — and reduce viral replication in human immune cells.

Benzinga

FDA Gives Green Signal To Human Trial For Sorrento's STI-9167 Against Omicron

The FDA has cleared Sorrento Therapeutics Inc's (NASDAQ:SRNE) investigational new drug application (IND) for intravenous (IV) STI-9167 (COVISHIELD) to study the safety and pharmacokinetics in healthy volunteers. STI-9167 is the IV formulation of the intranasal STI-9199 neutralizing antibody. Also Read: Sorrento To Start Late-Stage Trial Of Abivertinib In Critically-Ill COVID-19 Patients. The Phase 1 study…

The Hindu

Asthma drug can block crucial SARS-CoV-2 protein: IISc study

The study found that montelukast can reduce viral replication in human immune cells

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ABC News

COVID-19 breath tests could be the future of living with the virus, but this pandemic solution has a catch

The US has just approved a new COVID-19 breathalyser test that promises to deliver results within minutes, with no nasal swabs required. Scientists say it could help safeguard big gatherings from becoming superspreader events, but there are still a few kinks to iron out.

Benzinga

Monitoring Board Gives Positive Recommendation On Ocugen's Eye Disease Gene Therapy Trial

The independent Data and Safety Monitoring Board (DSMB) for Ocugen Inc's (NASDAQ:OCGN) Phase 1/2 trial of OCU400 has recommended that the study proceeds with enrolling additional subjects. The recommendation follows the review of safety data based on dosing to date. OCU400 is the Company's flagship modifier gene therapy candidate for Retinitis Pigmentosa (RP)…

Benzinga

34 Stocks Moving In Monday's Mid-Day Session

Gainers Nkarta, Inc. (NASDAQ: NKTX) shares jumped 108.6% to $16.21 after the company announced Phase 1 data from independent dose finding studies of its two lead chimeric antigen receptor natural killer cell therapy candidates, NKX101 and NKX019.

Benzinga

Why Ardelyx Shares Are Rising

Ardelyx Inc (NASDAQ: ARDX) shares are trading higher by 29.32% at $0.97 after the company reported it received an interim response from the OND, CDER and FDA for the company’s second level of appeal of the Complete Response Letter for XPHOZAH.

Benzinga

Axsome Poised To Receive FDA Rejection For Its Migraine Candidate, Shares Fall

The FDA has informed that Axsome Therapeutics Inc (NASDAQ:AXSM) chemistry, manufacturing, and controls issues identified during the review of AXS-07 remain unresolved. The Company is seeking approval for AXS-07 for the acute treatment of migraine. Based on the time remaining in the review cycle, the Company expects to receive a Complete Response Letter…

Benzinga

Mid-Morning Market Update: Markets Open Lower; Dow Tumbles Over 300 Points

U.S. stocks opened lower this morning, with the Dow Jones dropping more than 300 points on Monday.

Benzinga

Why Axsome Therapeutics Stock Is Falling Today

Axsome Therapeutics Inc (NASDAQ: AXSM) shares are trading higher Monday after the company reported it was informed by the U.S.

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