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The Latest Breaking News from FDA

Citius Pharma To Spinoff Late-Stage Oncology Asset Into New Publicly Traded Firm

Citius Pharmaceuticals Inc (NASDAQ:CTXR) plans to form a new company (NewCo) focused on developing and commercializing I/ONTAK. A Phase 3 trial was completed in December 2021, and a biologics license application (BLA) is being planned for submission in the second half of 2022. The Company's other pipeline assets, including Mino-Lok, would remain at…

Benzinga

Elevation Oncology Shares Gain On FDA Fast Track Designation For Seribantumab In Tumor-Agnostic Settings

Elevation Oncology, Inc. (NASDAQ: ELEV) received Fast Track designation from the Food and Drug Administration (FDA) for Seribantumab in tumor-agnostic settings for the treatment of advanced solid tumors that harbor NRG1 gene fusions.

Benzinga

Millions of imported baby formula cans are heading to the US, FDA says

Millions more cans of baby formula will be available in the U.S. in the coming months, the nation’s Food and Drug Administration said, detailing steps it’s taken to alleviate a shortage that has left families scrambling to figure out how to feed their babies.

Tribune News Service

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The Daily Biotech Pulse: Third FDA Rejection For Verrica's Skin Disease Drug, Assembly Bio Terminates Hepatitis B Virus Pact, Consistency Data For Valneva's Chikungunya Vaccine

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

Benzinga

Why Verrica Pharma Shares Are Plunging Today

The FDA has issued a Complete Response Letter (CRL) regarding Verrica Pharmaceuticals Inc's (NASDAQ:VRCA) marketing application for VP-102 for molluscum contagiosum. The only deficiency listed in the CRL was related to the deficiencies identified at a general reinspection of Sterling Pharmaceuticals Services LLC, the contract manufacturing organization that manufactures Verrica's bulk solution drug product. …

Benzinga

UK baby milk maker to fly formula to US to help ease shortages

Lake District-based Kendamil steps in after largest producer in US had nationwide recall

The Guardian - UK

71 Biggest Movers From Yesterday

Gainers CynergisTek, Inc. (NYSE: CTEK) shares surged 100% to close at $1.18 on Tuesday after the company entered into a definitive agreement to be acquired by Clearwater Compliance for roughly $17.7 million.

Benzinga

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Baby milk brand used to wean Prince Louis in 'advanced discussions' to help formula shortage in USA

Kendal Nutricare said it expects to ship 100 trucks to the USA over the next six months

Birmingham Post

FDA chief to detail delays inspecting baby formula plant

The head of the Food and Drug Administration is preparing to tell lawmakers about events that led to a months-long gap before inspecting the plant at the center of a nationwide baby formula shortage

The Independent UK

SVB Sees Strategic Value In This Stock As M&A Target In Autoimmune Space

SVB Securities initiated coverage on Argenx SE (NASDAQ:ARGX) with an Outperform rating and a $404 price target. Argenx's Vyvgart (efgartigimod) is a neonatal Fc-Receptor (FcRn) antagonist that selectively reduces IgG levels and has the potential to address numerous IgG-mediated autoimmune diseases. According to the analyst, Argenx has demonstrated strong early launch execution for Vyvgart…

Benzinga

Alnylam's Lumasiran Shows Clinical Benefit In Rare Kidney Disease

Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) announced new results from the six-month primary analysis of the ILLUMINATE-C Phase 3 open-label study of lumasiran for primary hyperoxaluria type 1 (PH1). PH1 is a rare disorder that mainly affects the kidneys. It results from the buildup of a substance called oxalate, typically filtered through the kidneys and…

Benzinga

50 Stocks Moving In Tuesday's Mid-Day Session

Gainers CynergisTek, Inc. (NYSE: CTEK) jumped 100% to $1.18 after the company entered into a definitive agreement to be acquired by Clearwater Compliance for roughly $17.7 million.

Benzinga

Cannabis Strain Labels Are Misleading, Research Suggests: Authors Call For Labeling Similar To FDA For Food

Do you know what kind of weed you're smoking? Have you ever wondered how useful labels on cannabis products are, or not?

Benzinga

US safety, savings rules set stage for baby formula shortage

A massive recall is getting most of the blame for the U.S. baby formula shortage, but experts say the products have long been vulnerable to this type of crisis

The Independent UK

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Benzinga

RVPH: First Quarter Results

By John Vandermosten, CFA NASDAQ:RVPH READ THE FULL RVPH RESEARCH REPORT

Benzinga

Ocugen Diversifies Its Pipeline With New Cell Therapy Platform

Ocugen Inc (NASDAQ:OCGN) says it is diversifying its pipeline by introducing a Phase 3 cell therapy platform technology called NeoCart (autologous chondrocyte-derived neocartilage). Recently, the FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to NeoCart to repair full-thickness lesions of the knee cartilage in adults. NeoCart is a three-dimensional tissue-engineered disc of…

Benzinga

FDA Lifts Partial Hold On Alpine Immune's Davoceticept Combo Trial In Advanced Cancer

The FDA has removed the partial clinical hold placed on Alpine Immune Sciences Inc's (NASDAQ:ALPN) NEON-2 trial of davoceticept (ALPN-202) in advanced malignancies. Davoceticept is a first-in-class conditional CD28 costimulator and a dual checkpoint inhibitor. The partial clinical hold was prompted by Alpine's report of patient death in the NEON-2 trial. The trial is evaluating davoceticept…

Benzinga

Why SpringWorks Shares Are Soaring Today Premarket

SpringWorks Therapeutics Inc (NASDAQ: SWTX) has announced positive topline results from the DeFi Phase 3 trial evaluating nirogacestat in adult patients with progressing desmoid tumors.

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Benzinga

The Daily Biotech Pulse: INmune Bio's Planned Alzheimer's Trial On FDA Hold, Caladrius Stops Enrollment In Heart Disease Study, BiomX Restructures

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

Benzinga

58 Biggest Movers From Yesterday

Gainers Catalyst Biosciences, Inc. (NASDAQ: CBIO) gained 234.2% to close at $1.27 after the company announced it sold its complement portfolio for $60 million.

Chicago Tribune

With Roe v. Wade at risk, Planned Parenthood of Illinois makes abortion pills available by mail for state residents

CHICAGO — With the U.S. Supreme Court poised to overturn Roe v. Wade, Planned Parenthood of Illinois said Monday it has begun offering abortion pills by mail for state residents who qualify.

Benzinga

Jif Peanut Butter Recall In US And Canada Due To Salmonella: What You Need To Know

The U.S.

Salon

Jif peanut butter is being recalled

The recall includes nearly 50 products

Benzinga

The Analyst Says 'Impressive Phase 3 Data Highlight Best-In-Class Opportunity' For Concert Pharma

Concert Pharmaceuticals Inc (NASDAQ:CNCE) has released highly positive Phase 3 data for their alopecia areata drug CTP-543 from the THRIVE-AA1 trial. Mizuho says that the efficacy supports its view that CTP-543 potentially has best-in-class efficacy amongst the three main oral JAK inhibitors in late-stage development for alopecia areata (CTP-543, Eli Lilly And Co's (NYSE: LLY)…

Benzinga

Read Why Did HC Wainwright Cut Price Target On Atara Biotherapeutics

Late last week, Atara Biotherapeutics Inc (NASDAQ:ATRA) announced that Bayer AG (OTC:BAYRY) intends to terminate the exclusive worldwide licensing agreement for Atara's mesothelin-targeted allogeneic and autologous CAR-T assets, ATA3271 and ATA2271. The enrollment was paused in the Phase 1 trial of ATA2271 for mesothelioma after a patient death. The move followed a strategic review and asset-level prioritization.…

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