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The Latest Breaking News from FDA

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.

Benzinga

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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.

Benzinga

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.

Chicago Tribune

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

The U.S.

Benzinga

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Jif peanut butter is being recalled

The recall includes nearly 50 products

Salon

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.…

Benzinga

What's next for COVID-19 vaccines for youngest US children

Parents hoping to get their youngest children vaccinated against COVID-19 have some encouraging news

The Independent UK

What's Going On With ImmunoGen Shares Today?

ImmunoGen, Inc. (NASDAQ: IMGN) shares are trading flat at $3.57 after the company's Biologics License Application to treat ovarian cancer was accepted by the FDA with priority review.

Benzinga

Biohaven's Neurological Disease Candidate Flunks In Late-Stage Study

Biohaven Pharmaceutical Holding Co Ltd (NYSE:BHVN) has announced topline Phase 3 results of troriluzole in patients with spinocerebellar ataxia (SCA). The primary endpoint measured the change in the severity of symptoms among patients from the baseline to week 48 of treatment. It did not reach statistical significance in the overall SCA population as…

Benzinga

Seagen Posts Encouraging Data From Tucatinib Combo Trial In Colorectal Cancer

Seagen Inc (NASDAQ:SGEN) announced topline results from phase 2 MOUNTAINEER trial investigating Tukysa (tucatinib) in combination with trastuzumab in previously treated HER2-positive metastatic colorectal cancer (mCRC) patients. Trastuzumab is sold under the name Herceptin by Genentech, a unit of Roche Holdings AG (OTC:RHHBY). Data from this trial will form the basis of a planned supplemental…

Benzinga

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Benzinga

Innoviva Acquires AstraZeneca-Spin Off At $2.20/Share

Innoviva Inc (NASDAQ:INVA) has agreed to acquire Entasis Therapeutics Holdings Inc (NASDAQ:ETTX) at $2.20 per share in cash. Innoviva currently owns approximately 60% of the outstanding shares of Entasis common stock. The acquisition consideration values Entasis' equity at $113 million on a fully diluted basis. "This acquisition will build upon our overall strategy to acquire differentiated,…

Benzinga

Why Nymox Pharma Shares Sinking to 52-Week Low?

Nymox Pharmaceutical Corporation (NASDAQ:NYMX) has received a Refusal to File (RTF) letter from FDA regarding its marketing application for Fexapotide Triflutate. Nymox's position is that clarifications remain to be resolved at a follow-up meeting and that some significant inconsistencies were involved. In March, the company submitted a Fexapotide Triflutate application for benign prostatic…

Benzinga

FDA Removes Clinical Hold On Ocugen's COVID Vaccine Trial

The FDA has lifted the clinical hold on Ocugen Inc's (NASDAQ:OCGN) Phase 2/3 trial, OCU-002, for Covaxin (BBV152), a whole virus inactivated COVID-19 vaccine candidate. In April, the agency paused the trials of the shot, Covaxin, after an inspection of a Bharat Biotech facility by the World Health Organization (WHO) revealed deficiencies…

Reuters

Pfizer/BioNTech say 3 COVID shots elicit good response in children under 5

Drugmakers Pfizer Inc and BioNTech SE said on Monday that three doses of their COVID-19 vaccine generated a strong immune response in children under age 5 and was safe and well-tolerated in their clinical trial.

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The Independent UK

Pfizer says 3 COVID shots protect children under 5

Pfizer says three small doses of its COVID-19 vaccine protect kids under 5 and that it plans to give the data to U.S. regulators later this week

WEKU

Abbott CEO apologizes for the formula shortage as the first overseas shipment arrives

"We're sorry to every family we've let down," wrote CEO Robert Ford. The shuttered plant at the heart of the shortage will reopen in June, but it may take months before production is back to normal.

The Independent UK

Jif peanut butter products recalled over salmonella outbreak traced to Kentucky plant

Cases have been reported in 14 states

The Independent UK

Abbott CEO says ‘sorry’ over baby formula shortage and vows to ensure ‘this never happens again’

Chairman and CEO of the embattled company Robert Ford insists the company is taking steps ‘to ensure this never happens again’

McClatchy Washington Bureau

The U.S. Food and Drug Administration, along with Centers for Disease Control and Prevention, and others have been investigating a multistate outbreak of salmonella senftenberg infections and they are linked to a product so many of us enjoy daily.

WEKU

Jif peanut butter is being recalled for potential salmonella contamination

The J.M. Smucker Co. announced the recall on Friday. The Food and Drug Administration says current epidemiologic evidence points to a Lexington, Ky., facility as the likely cause of the outbreak.

Salon

Formula scarcity spurs deeper questions

Corporate consolidation of baby formula-makers got us to this point of crisis

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