Pharmaceutical industry

TAGRISSO® (osimertinib) with the addition of chemotherapy approved in the US for patients with EGFR-mutated advanced lung cancer

Retrieved on: 
Saturday, February 17, 2024

This approval reinforces TAGRISSO as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy.

Key Points: 
  • This approval reinforces TAGRISSO as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy.
  • The safety profile of TAGRISSO with the addition of chemotherapy was generally manageable and consistent with the established profiles of the individual medicines.
  • Adverse event (AE) rates were higher in the TAGRISSO plus chemotherapy arm, driven by well-characterized chemotherapy-related AEs.
  • AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

BRIGHT GREEN CORPORATION ANNOUNCES CHANGES TO BOARD OF DIRECTORS

Retrieved on: 
Saturday, February 17, 2024

Grants, New Mexico, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Bright Green Corporation (NASDAQ: BGXX) – Bright Green Corporation, a Delaware corporation (the “Company”), announced Friday that CEO Groovy Singh is the newest member of the company’s Board of Directors (the “Board”). Current board member and Co-Founder Lynn Stockwell was also announced as the new Chair of the Board. Singh and Stockwell’s appointments follow the resignation of the Executive Chairman, Terry Rafih.

Key Points: 
  • Grants, New Mexico, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Bright Green Corporation (NASDAQ: BGXX) – Bright Green Corporation, a Delaware corporation (the “Company”), announced Friday that CEO Groovy Singh is the newest member of the company’s Board of Directors (the “Board”).
  • Current board member and Co-Founder Lynn Stockwell was also announced as the new Chair of the Board.
  • Speaking on behalf of the company, the Board thanks Mr. Rafih for his contributions to Bright Green, and wish him well on his future endeavors.
  • In addition to continuing his role as Bright Green CEO, Singh will now play a crucial role on company’s Board alongside Stockwell as the new board Chair.

IGC Pharma Reports Third Quarter Fiscal 2024 Results

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Saturday, February 17, 2024

IGC Pharma, Inc. (“IGC” or the “Company”) (NYSE American: IGC) today announced its financial results for the third fiscal quarter of 2024 ended December 31, 2023 (Q3 FY 2024).

Key Points: 
  • IGC Pharma, Inc. (“IGC” or the “Company”) (NYSE American: IGC) today announced its financial results for the third fiscal quarter of 2024 ended December 31, 2023 (Q3 FY 2024).
  • IGC is optimistic that the success in Mexico can pave the way for additional patent approvals in the U.S. and Europe.
  • We are working hard to obtain interim results in 2024.
  • With modest pricing and conservative market penetration IGC-AD1 can potentially be a block buster drug,” said Ram Mukunda, CEO of IGC Pharma.

INSPIRE MEDICAL 96 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 Lawsuit Against Inspire Medical Systems, Inc. - INSP

Retrieved on: 
Saturday, February 17, 2024

This action is pending in the United States District Court for the District of Minnesota.

Key Points: 
  • This action is pending in the United States District Court for the District of Minnesota.
  • Inspire Medical and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws.
  • The case is City of Hollywood Firefighters’ Pension Fund v. Inspire Medical Systems, Inc., No.
  • About Kahn Swick & Foti, LLC
    KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is one of the nation’s premier boutique securities litigation law firms.

Melanoma Research Alliance Applauds FDA Approval of First Cellular Therapy in Melanoma

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Friday, February 16, 2024

WASHINGTON, Feb. 16, 2024 /PRNewswire/ -- The Melanoma Research Alliance (MRA), the largest non-profit funder of melanoma research worldwide, welcomes the U.S. Food and Drug Administration (FDA) decision to approve Iovance Biotherapeutics' AMTAGVI™ (lifileucel) for the treatment of patients with advanced melanoma in the second line treatment setting.

Key Points: 
  • WASHINGTON, Feb. 16, 2024 /PRNewswire/ -- The Melanoma Research Alliance (MRA), the largest non-profit funder of melanoma research worldwide, welcomes the U.S. Food and Drug Administration (FDA) decision to approve Iovance Biotherapeutics' AMTAGVI™ (lifileucel) for the treatment of patients with advanced melanoma in the second line treatment setting.
  • AMTAGVI is the first individualized Tumor Infiltrating Lymphocyte (TIL) therapy to earn FDA approval for any cancer.
  • After the TIL infusion, patients are treated with a therapy that stimulates the immune system to grow and divide.
  • "This groundbreaking T-cell immunotherapy represents a significant advancement in our ability to combat melanoma," says MRA Chief Executive Officer Marc Hurlbert, PhD.

Esperion Announces Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

Retrieved on: 
Friday, February 16, 2024

ANN ARBOR, Mich., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that, on February 13, 2024, the Company granted 66 new employees 204,900 restricted stock units (RSUs) under Esperion’s 2017 Inducement Equity Incentive Plan.

Key Points: 
  • ANN ARBOR, Mich., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that, on February 13, 2024, the Company granted 66 new employees 204,900 restricted stock units (RSUs) under Esperion’s 2017 Inducement Equity Incentive Plan.
  • The 2017 Inducement Equity Incentive Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Esperion (or following a bona fide period of non-employment), as an inducement material to such individual's entering into employment with Esperion, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules.
  • The RSUs are subject to the terms and conditions of Esperion’s 2017 Inducement Equity Incentive Plan, and the terms and conditions of the RSU agreement covering the grant.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.

Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma

Retrieved on: 
Friday, February 16, 2024

SAN CARLOS, Calif., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved AMTAGVI™ (lifileucel) suspension for intravenous infusion. AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response. Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit.

Key Points: 
  • This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response.
  • AMTAGVI is the first and the only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer.
  • “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.
  • Iovance will host a conference call and live audio webcast today to discuss the FDA approval of AMTAGVI.

FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma

Retrieved on: 
Friday, February 16, 2024

"Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research (CBER).

Key Points: 
  • "Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research (CBER).
  • Melanoma can spread to other parts of the body if not detected and treated early, resulting in metastatic disease.
  • Treatment for unresectable or metastatic melanoma may include immunotherapy using PD-1 inhibitors, which are antibodies targeting certain proteins in the body to help the immune system fight off cancer cells.
  • Those patients whose melanoma has progressed with these therapies have a high unmet medical need.

BioVie (BIVI) Faces Securities Fraud Class Action After Uncovering Potential Scientific Misconduct In Failed Phase 3 Clinical Trial – Hagens Berman

Retrieved on: 
Friday, February 16, 2024

SAN FRANCISCO, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Hagens Berman urges BioVie Inc. (NASDAQ: BIVI) investors who suffered substantial losses to submit your losses now .

Key Points: 
  • SAN FRANCISCO, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Hagens Berman urges BioVie Inc. (NASDAQ: BIVI) investors who suffered substantial losses to submit your losses now .
  • The litigation focuses on the propriety of BioVie’s disclosures concerning its adherence to Good Clinical Practice (“GCP”) and protocols related to its Phase 3 clinical trial of NE3107, a potential Alzheimer’s disease drug.
  • ]” This news drove the price of BioVie shares down $1.25, or almost 30% lower, on Nov. 9, 2023.
  • “We’re focused on investors’ losses and are investigating whether BioVie may have intentionally concealed GCP and protocol violations,” said Reed Kathrein, the Hagens Berman partner leading the investigation.

INVESTOR ALERT: Law Offices of Howard G. Smith Announces the Filing of a Securities Class Action on Behalf of Amylyx Pharmaceuticals, Inc. (AMLX) Investors

Retrieved on: 
Friday, February 16, 2024

Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Amylyx Pharmaceuticals, Inc. (“Amylyx” or the “Company”) (NASDAQ: AMLX ) securities between November 11, 2022 and November 8, 2023, inclusive (the “Class Period”).

Key Points: 
  • Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Amylyx Pharmaceuticals, Inc. (“Amylyx” or the “Company”) (NASDAQ: AMLX ) securities between November 11, 2022 and November 8, 2023, inclusive (the “Class Period”).
  • Amylyx investors have until April 9, 2024 to file a lead plaintiff motion.
  • Investors suffering losses on their Amylyx investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to [email protected] .
  • On November 9, 2023, Amylyx released its third quarter 2023 financial results, missing GAAP earnings per share consensus estimates by approximately 29%.