Regulation of food and dietary supplements by the U.S. Food and Drug Administration

SESEN BIO 72 HOUR DEADLINE ALERT: Former Louisiana Attorney General and Kahn Swick & Foti, LLC Remind Investors With Losses in Excess of $100,000 of Deadline in Class Action Lawsuits Against Sesen Bio, Inc. - SESN

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Saturday, October 16, 2021 - 3:50am

These actions are pending in the United States District Court for the Southern District of New York.

Key Points: 
  • These actions are pending in the United States District Court for the Southern District of New York.
  • Sesen Bio and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws.
  • On August 13, 2021, the Company disclosed that the BLA for its product candidate, Vicineum, was denied approval by the U.S. Food and Drug Administration (FDA).
  • About Kahn Swick & Foti, LLC
    KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is one of the nations premier boutique securities litigation law firms.

REVANCE ALERT: Bragar Eagel & Squire, P.C. is Investigating Revance Therapeutics, Inc. on Behalf of Revance Stockholders and Encourages Investors to Contact the Firm

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Saturday, October 16, 2021 - 2:00am

Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against Revance Therapeutics, Inc. (Revance or the Company) (NASDAQ: RVNC) on behalf of Revance stockholders.

Key Points: 
  • Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against Revance Therapeutics, Inc. (Revance or the Company) (NASDAQ: RVNC) on behalf of Revance stockholders.
  • Our investigation concerns whether Revance has violated the federal securities laws and/or engaged in other unlawful business practices.
  • Click here to participate in the action.
  • On October 12, 2021, the U.S. Food and Drug Administration (FDA) posted Form 483 to its website citing issues found during the inspection of a Revance facility in July 2021.

SESEN BIO DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds Investors that a Class Action Lawsuit Has Been Filed Against Sesen Bio, Inc. and Encourages Investors to Contact the Firm

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Saturday, October 16, 2021 - 2:00am

Investors have until October 18, 2021, to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until October 18, 2021, to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • On August 13, 2021, Sesen Bio announced that the FDA declined to approve its BLA for Vicineum in its current form.
  • On this news, the Companys share price fell $2.80, or 57%, to close at $2.11 per share on August 13, 2021, on unusually heavy trading volume.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

The Law Offices of Frank R. Cruz Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Sesen Bio, Inc. (SESN)

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Friday, October 15, 2021 - 6:10pm

Sesen Bio is a late-stage clinical company that purports to advance targeted fusion protein (TFP) therapeutics for cancer treatments.

Key Points: 
  • Sesen Bio is a late-stage clinical company that purports to advance targeted fusion protein (TFP) therapeutics for cancer treatments.
  • Sesen Bio reported preliminary efficacy data from its ongoing Phase 3 clinical trial for Vicineum, the VISTA trial, in August 2019.
  • On August 13, 2021, Sesen Bio announced that the FDA declined to approve its BLA for Vicineum in its current form.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Glancy Prongay & Murray LLP Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Sesen Bio, Inc. (SESN)

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Friday, October 15, 2021 - 6:00pm

Sesen Bio is a late-stage clinical company that purports to advance targeted fusion protein (TFP) therapeutics for cancer treatments.

Key Points: 
  • Sesen Bio is a late-stage clinical company that purports to advance targeted fusion protein (TFP) therapeutics for cancer treatments.
  • Its most advanced product candidate is Vicineum (VB4-845), a locally administered TFP developed as a treatment of bacillus Calmette-Gurin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC).
  • Sesen Bio reported preliminary efficacy data from its ongoing Phase 3 clinical trial for Vicineum, the VISTA trial, in August 2019.
  • On August 13, 2021, Sesen Bio announced that the FDA declined to approve its BLA for Vicineum in its current form.

Seqirus Receives FDA Approval of its Cell-Based Quadrivalent Influenza Vaccine, Expanding the Age Indication to Include Children as Young as Six Months

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Friday, October 15, 2021 - 3:56pm

"The FLUCELVAX QUADRIVALENT expanded age indication for children as young as six months of age now allows all eligible people to receive a differentiated influenza vaccine option."

Key Points: 
  • "The FLUCELVAX QUADRIVALENT expanded age indication for children as young as six months of age now allows all eligible people to receive a differentiated influenza vaccine option."
  • As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.
  • Please be aware that information relating to the approval status and labels of approved Seqirus products may vary from country to country.
  • The decision to give FLUCELVAX QUADRIVALENT should be made by your healthcare provider, based on careful consideration of the potential benefits and risks.

LAVA Therapeutics Receives FDA Orphan Drug Designation for LAVA-051 for the Treatment of Chronic Lymphocytic Leukemia

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Friday, October 15, 2021 - 12:00pm

This designation will be helpful in enhancing our communication with the FDA on our development of LAVA-051.

Key Points: 
  • This designation will be helpful in enhancing our communication with the FDA on our development of LAVA-051.
  • We are grateful to the FDA for highlighting the need for new and improved therapies to address the unmet needs in CLL.
  • The term orphan drug refers to pharmaceutical products developed for the prevention, diagnosis and treatment of rare diseases or conditions.
  • Inthe U.S., an orphan disease is defined as a disease or condition with a U.S. prevalence of less than 200,000 people.

Emergent BioSolutions Announces Initiation of Pivotal Phase 3 Study Evaluating the Safety and Immunogenicity of Its Single-Dose Chikungunya Vaccine Candidate, CHIKV VLP

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Friday, October 15, 2021 - 11:30am

GAITHERSBURG, Md., Oct. 15, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced the first participant dosed in its pivotal phase 3 study evaluating the safety and immunogenicity of the companys investigational chikungunya virus (CHIKV) virus-like particle (VLP) vaccine candidate, CHIKV VLP, in a single dose.

Key Points: 
  • GAITHERSBURG, Md., Oct. 15, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced the first participant dosed in its pivotal phase 3 study evaluating the safety and immunogenicity of the companys investigational chikungunya virus (CHIKV) virus-like particle (VLP) vaccine candidate, CHIKV VLP, in a single dose.
  • CHIKV VLP is the only VLP-based vaccine currently in clinical development for active immunization against chikungunya disease.
  • Emergent has achieved a major milestone as we begin our phase 3 study for our single-dose chikungunya vaccine candidate, said Karen L. Smith, M.D., Ph.D., executive vice president and chief medical officer at Emergent BioSolutions.
  • Early this year, the company announced two-year persistence data from its Phase 2 safety and immunogenicity study of CHIKV VLP in 415 healthy adults.

RVNC BREAKING NEWS: ROSEN, A TOP RANKED LAW FIRM, Encourages Revance Therapeutics, Inc. Investors with Losses to Inquire About Class Action Investigation – RVNC

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Thursday, October 14, 2021 - 8:59pm

The Rosen Law firm is preparing a class action seeking recovery of investor losses.

Key Points: 
  • The Rosen Law firm is preparing a class action seeking recovery of investor losses.
  • WHAT TO DO NEXT: To join the prospective class action, go to http://www.rosenlegal.com/cases-register-2179.html or call Phillip Kim, Esq.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.

INVESTOR ALERT: Kirby McInerney LLP Continues Investigation of Shareholder Claims on Behalf of Owlet, Inc. (OWLT) Investors

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Thursday, October 14, 2021 - 8:12pm

The law firm of Kirby McInerney LLP is investigating potential claims against Owlet, Inc. (Owlet or the Company) (NYSE: OWLT ).

Key Points: 
  • The law firm of Kirby McInerney LLP is investigating potential claims against Owlet, Inc. (Owlet or the Company) (NYSE: OWLT ).
  • The investigation concerns whether Owlet has violated the federal securities laws and/or engaged in other unlawful business practices.
  • Kirby McInerney LLP is a New York-based plaintiffs law firm concentrating in securities, antitrust, whistleblower, and consumer litigation.
  • The firms efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars.