FDA

INVESTIGATION NOTICE: The Schall Law Firm Encourages Investors in Nuvation Bio Inc. with Losses of $100,000 to Contact the Firm

Retrieved on: 
Thursday, June 30, 2022 - 2:06am

The Schall Law Firm , a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Nuvation Bio Inc. (Nuvation or the Company) (NYSE: NUVB ) for violations of the securities laws.

Key Points: 
  • The Schall Law Firm , a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Nuvation Bio Inc. (Nuvation or the Company) (NYSE: NUVB ) for violations of the securities laws.
  • The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.
  • We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge.
  • The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against First High-School, Upstart, Oscar, and Axsome and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, June 30, 2022 - 2:00am

First High-School Education Group Co., Ltd. (NYSE: FHS)

Key Points: 
  • First High-School Education Group Co., Ltd. (NYSE: FHS)
    First High-School Education provides tutoring services and operates private high schools in Western China.
  • Then, on May 14, 2021, Chinas state council announced rules that it would further tighten regulations on compulsory education and training institutions.
  • For more information on the Axsome class action go to: https://bespc.com/cases/AXSM
    About Bragar Eagel & Squire, P.C.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Verrica, Apyx, Waste Management, and Tupperware and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, June 30, 2022 - 2:00am

In November 2021, Verrica resubmitted the NDA for VP-102, claiming [t]he resubmission addresses the successful resolution of inspection deficiencies at the manufacturing facility.

Key Points: 
  • In November 2021, Verrica resubmitted the NDA for VP-102, claiming [t]he resubmission addresses the successful resolution of inspection deficiencies at the manufacturing facility.
  • For more information on the Waste Management class action go to: https://bespc.com/cases/WM
    On May 4, 2022, Tupperware announced its financial results for the first quarter of 2022.
  • For more information on the Tupperware class action go to: https://bespc.com/cases/TUP
    About Bragar Eagel & Squire, P.C.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against CareDx, Spero, LMP, and Dentsply Sirona and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, June 30, 2022 - 2:00am

Throughout the Class Period, CareDx reported growing revenue and strong demand in the Companys testing services segment.

Key Points: 
  • Throughout the Class Period, CareDx reported growing revenue and strong demand in the Companys testing services segment.
  • In order to facilitate this scheme, Dentsply and its executives made numerous false and misleading statements to investors during the Class Period.
  • For more information on the Dentsply Sirona class action go to: https://bespc.com/cases/XRAY
    About Bragar Eagel & Squire, P.C.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

Bragar Eagel & Squire, P.C. Is Investigating Inotiv, TG Therapeutics, Allianz, and Outset Medical and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, June 30, 2022 - 2:00am

Our investigations concern whether these companies have violated the federal securities laws and/or engaged in other unlawful business practices.

Key Points: 
  • Our investigations concern whether these companies have violated the federal securities laws and/or engaged in other unlawful business practices.
  • The complaint is a civil action by DOJ alleging violations of the Animal Welfare Act at the Cumberland, Virginia facility.
  • For more information on the Outset Medical investigation go to: https://bespc.com/cases/OM
    About Bragar Eagel & Squire, P.C.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

MediciNova Announces Extension of BARDA Contract to Develop MN-166 (ibudilast) as a Medical Countermeasure Against Chlorine Gas-induced Lung Injury

Retrieved on: 
Thursday, June 30, 2022 - 12:00am

Department of Health and Human Services, to repurpose MN-166 (ibudilast) as a potential medical countermeasure (MCM) against chlorine gas-induced lung damage such as acute respiratory distress syndrome (ARDS) and acute lung injury (ALI).

Key Points: 
  • Department of Health and Human Services, to repurpose MN-166 (ibudilast) as a potential medical countermeasure (MCM) against chlorine gas-induced lung damage such as acute respiratory distress syndrome (ARDS) and acute lung injury (ALI).
  • MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF).
  • Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof.
  • MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

ClearPoint Neuro Congratulates Neurona Therapeutics on Dosing of Initial Subject in First Clinical Trial of Regenerative Human Cell Therapy in Adults with Drug-Resistant Focal Epilepsy

Retrieved on: 
Wednesday, June 29, 2022 - 9:05pm

An estimated three million Americans have epilepsy, and 25 to 35 percent live with ongoing seizures despite dozens of approved drugs on the market.

Key Points: 
  • An estimated three million Americans have epilepsy, and 25 to 35 percent live with ongoing seizures despite dozens of approved drugs on the market.
  • The first stage of the trial is an open-label dose-escalation study in up to 10 patients with MTLE.
  • Our team is proud to partner with Neurona to support their Phase 1/2 clinical trial of what could potentially be a breakthrough regenerative cell therapy for MTLE.
  • ClearPoint Neuro is partnered with approximately 45 biologics/pharmaceutical companies and academic centers, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide.

Avadel Pharmaceuticals Provides Corporate Update

Retrieved on: 
Wednesday, June 29, 2022 - 9:05pm

DUBLIN, Ireland, June 29, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced the steps it is taking to explore every available pathway to accelerate the decision by the U.S. Food and Drug Administration (FDA) to grant final approval of its lead drug candidate, FT218, prior to June 2023. Concurrent with this strategy, Avadel has received and agreed upon what is expected to be a final label and is completing the last edits of the Risk Evaluation and Mitigation Strategy (“REMS”) with FDA and expects to receive tentative approval of FT218.

Key Points: 
  • In March 2020, Avadel completed the REST-ON trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial, to assess the efficacy and safety of FT218 in adults with narcolepsy.
  • Avadel is currently evaluating the long-term safety and tolerability of FT218 in the open-label RESTORE clinical study.
  • Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives.
  • We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

Hyperfine Announces CEO Transition

Retrieved on: 
Wednesday, June 29, 2022 - 9:05pm

GUILFORD, Conn., June 29, 2022 (GLOBE NEWSWIRE) -- Hyperfine, Inc. (Nasdaq: HYPR), (“Hyperfine” or “the Company”), the groundbreaking medical device company that created Swoop®, the world's first FDA-cleared portable MRI system™, today announced that Dave Scott will step down from his role as President, Chief Executive Officer (CEO), and Board Member for personal reasons, effective July 29, 2022. Scott Huennekens, who currently serves as Executive Chairperson of the Board, will succeed Mr. Scott as interim President and CEO, also effective July 29, 2022. The Company is engaging in a search for a long-term CEO as it continues to execute its business strategy focused on commercial expansion of the Swoop system. The Company will host a conference call to discuss the CEO transition today, June 29, 2022, at 4:30 PM Eastern Time.

Key Points: 
  • The Company will host a conference call to discuss the CEO transition today, June 29, 2022, at 4:30 PM Eastern Time.
  • As interim President and CEO, Mr. Huennekens will oversee the ongoing expansion of Hyperfine to become a leading medical imaging provider.
  • We wish him well as he addresses the personal reasons limiting his ability to continue as President and CEO of Hyperfine.
  • I am disappointed to have to step back from my role as President and CEO of Hyperfine.

Life Edit Therapeutics Appoints Joy A. Cavagnaro to Its Scientific Advisory Board

Retrieved on: 
Wednesday, June 29, 2022 - 9:30pm

Life Edit Therapeutics Inc., an ElevateBio company focused on next-generation genome editing technologies and therapeutics, today announced the appointment of Joy A. Cavagnaro, Ph.D., DABT, Fellow ATS, RAC, FRAPS, to its Scientific Advisory Board (SAB).

Key Points: 
  • Life Edit Therapeutics Inc., an ElevateBio company focused on next-generation genome editing technologies and therapeutics, today announced the appointment of Joy A. Cavagnaro, Ph.D., DABT, Fellow ATS, RAC, FRAPS, to its Scientific Advisory Board (SAB).
  • We are thrilled to welcome Joy to our Scientific Advisory Board as we rapidly advance our gene editing platform to harness the vast potential of our novel nucleases and base editors as therapeutics, said Mitchell Finer, Ph.D., Chief Executive Officer, Life Edit Therapeutics and President, R&D, ElevateBio.
  • Joys expertise in drug discovery and development will complement our esteemed Scientific Advisory Board slate, and collectively our advisors will continue to help Life Edit and our partners further therapeutic programs to address the tremendous unmet needs of genetically-defined diseases.
  • About Life Edit Therapeutics Inc.
    Life Edit Therapeutics, an ElevateBio company, is a next-generation genome editing company that has built a highly innovative platform with one of the worlds largest and most diverse collections of novel RNA-guided nucleases (RGNs) and base editors.