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The Latest Breaking News from FDA

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

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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

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

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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…

Benzinga

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.

Reuters

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

The Independent UK

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.

WEKU

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’

The Independent UK

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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

The Independent UK

Is Trump to blame for the baby formula shortage?

Reexamining a trade deal with bipartisan support

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Tribune News Service

Amanda Little: US should follow the EU model for baby formula

Startup Bobbie introduced its infant formula product in January 2021, the first new brand to be approved for sale in nearly a decade. It was a small operator representing a tiny fraction of the $4 billion U.S. formula market, but when shortages began roiling the industry in recent months, Bobbie…

Los Angeles Times

Editorial: The shame of America’s baby-formula shortage

When the sudden COVID-19 shutdown caused people to hoard toilet paper, the nation was half amused by the inability to find a roll on any retail shelf.

Benzinga

6 Stocks To Watch Amid Monkeypox Outbreak

A Monkeypox outbreak has been reported in several European countries, two cases in Canada and one confirmed case in a man from Massachusetts.

Benzinga

FDA Approves Regeneron and Sanofi's Dupixent (dupilumab) For Eosinophilic Esophagitis (EoE) Ahead of Schedule

The U.S. Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals, Inc.

Benzinga

New FDA 510(k) Clearance Expands Anika's Sports Medicine Soft Tissue Portfolio

Anika Therapeutics Inc (NASDAQ:ANIK) has received FDA 510(k) clearance for the X-Twist Knotless Fixation System, a platform of suture anchors designed to be mechanically robust, easy to use, and support healing for critical repairs such as rotator cuff repair. According to SmartTRAK, nearly 670,000 rotator cuff procedures were performed in 2021, mainly in…

Benzinga

AbbVie Submits FDA Application For Continuous, 24-Hour Infusion Therapy For Parkinson's

AbbVie Inc (NYSE:ABBV) submitted its FDA marketing application for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy. AbbVie’s theory here revolves around using a continuous, 24-hour infusion of its therapy. The levodopa and carbidopa prodrugs are delivered in small doses…

Benzinga

CHMP Backs Approval of Lilly/Incyte's Olumiant For Patchy Hair Loss

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Eli Lilly And Co (NYSE:LLY) and Incyte Corporation's (NASDAQ:INCY) Olumiant (baricitinib) for severe alopecia areata (AA). If approved, Olumiant would be the first centrally-authorized oral treatment and first JAK inhibitor for severe AA in the European Union. …

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