Biologics license application

SHAREHOLDER ALERT: The Gross Law Firm Notifies Shareholders of Brainstorm Cell Therapeutics Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of January 2, 2024 – (NASDAQ: BCLI)

Retrieved on: 
Monday, December 11, 2023
NEXT, Fraud, Food, Biologics license application, Security (finance)

Appointment as lead plaintiff is not required to partake in any recovery.

Key Points: 
  • Appointment as lead plaintiff is not required to partake in any recovery.
  • DEADLINE: January 2, 2024 Shareholders should not delay in registering for this class action.
  • The deadline to seek to be a lead plaintiff is January 2, 2024.
  • The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship.

Autolus Therapeutics Presents Clinical Data Updates at the American Society of Hematology (ASH) Annual Meeting 2023

Retrieved on: 
Sunday, December 10, 2023
Associate, Food, Bone marrow, MRD, FDA, Royal College of Pathologists, CRi, Cancer Institute, Multiple myeloma, BCMA, EMD, Doctor of Philosophy, Society, Biologics license application, Therapy, ASH, EFS, University College London, Toxicity, CRS, Webcast, Patient, CD19, Safety, ALL, B-ALL, UCL, BLA, Pharmaceutical industry

Finally, in an oral presentation pre-clinical and Phase I clinical data from AUTO8, a BCMA/CD19 co-targeting CAR T cell candidate, evaluated in patients with refractory multiple myeloma.

Key Points: 
  • Finally, in an oral presentation pre-clinical and Phase I clinical data from AUTO8, a BCMA/CD19 co-targeting CAR T cell candidate, evaluated in patients with refractory multiple myeloma.
  • “The FELIX study, with 127 patients, is one of the largest CAR T cell studies in adults with r/r B-ALL.
  • A high proportion of patients responded, with many responses sustained, particularly in patients with low or intermediate disease-burden at lymphodepletion.
  • Cellular kinetic data shows high expansion and long-term persistence of CAR T cells in most responders.

Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15

Retrieved on: 
Monday, December 4, 2023
DSMB, Food, Șaeș, Euronext Paris, BLA, Data monitoring committee, Marketing, PFE, FDA, EMA, MAA, Lyme disease, Disease, Research, Biologics license application, European Medicines Agency, VLA, Safety, Development, Senior, Vaccine

Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15

Key Points: 
  • Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15
    9,437* participants enrolled at sites across the U.S., Europe and Canada in areas where Lyme disease is endemic
    Pfizer aims to submit regulatory filings in the U.S. and Europe in 2026
    New York, NY, and Saint-Herblain (France), December 4, 2023 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that they have completed recruitment for the Phase 3 trial Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) for Lyme disease vaccine candidate VLA15.
  • The trial builds on previous positive Phase 1 and 2 trial results and includes both adult and pediatric participants, with the aim to confirm the efficacy, safety, lot consistency, and immunogenicity of VLA15.
  • “We are pleased that the Phase 3 trial recruitment is complete.
  • Pfizer and Valneva entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.3,4

SHAREHOLDER ALERT: The Gross Law Firm Notifies Shareholders of Brainstorm Cell Therapeutics Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of January 2, 2024 – (NASDAQ: BCLI)

Retrieved on: 
Thursday, November 30, 2023
NEXT, Fraud, Food, Biologics license application, Security (finance)

Appointment as lead plaintiff is not required to partake in any recovery.

Key Points: 
  • Appointment as lead plaintiff is not required to partake in any recovery.
  • DEADLINE: January 2, 2024 Shareholders should not delay in registering for this class action.
  • The deadline to seek to be a lead plaintiff is January 2, 2024.
  • The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship.

Samsung Bioepis Secures US License Date for SB17, a Proposed Biosimilar to Stelara®

Retrieved on: 
Thursday, November 30, 2023
Samsung, Food, Johnson & Johnson, Biologics license application, Ulcerative colitis, Ustekinumab, Patient, Psoriasis, Medicine, BLA, Pharmaceutical industry

In the US, the license period will begin on February 22, 2025.

Key Points: 
  • In the US, the license period will begin on February 22, 2025.
  • Stelara® is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis and active psoriatic arthritis.1 SB17, developed by Samsung Bioepis, is a proposed biosimilar to reference medicine Stelara®.
  • The Biologics License Application (BLA) for SB17 is under review by the U.S. Food and Drug Administration.
  • Samsung Bioepis and Sandoz have entered into a development and commercialization agreement for SB17 in September 2023 for the US, Canada, European Economic Area (EEA), Switzerland and United Kingdom (UK).

SHAREHOLDER ALERT: Levi & Korsinsky Notifies Brainstorm Cell Therapeutics Inc. (BCLI) Investors of a Class Action Lawsuit and Upcoming Deadline

Retrieved on: 
Wednesday, November 29, 2023
Telephone, NEXT, Food, LLP, Court, CLASS, Biologics license application, COST, Cryptocurrency

NEW YORK, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Brainstorm Cell Therapeutics Inc. ("Brainstorm Cell" or the "Company") (NASDAQ: BCLI) of a class action securities lawsuit.

Key Points: 
  • NEW YORK, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Brainstorm Cell Therapeutics Inc. ("Brainstorm Cell" or the "Company") (NASDAQ: BCLI) of a class action securities lawsuit.
  • CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Brainstorm Cell investors who were adversely affected by alleged securities fraud between August 15, 2022 and September 27, 2023.
  • Follow the link below to get more information and be contacted by a member of our team:
    BCLI investors may also contact Joseph E. Levi, Esq.
  • For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services’ Top 50 Report as one of the top securities litigation firms in the United States.

Autolus Therapeutics Submits Biologics License Application to U.S. Food and Drug Administration for obecabtagene autoleucel (obe-cel) for Patients with Relapsed/refractory (r/r) Adult B-Cell Acute Lymphoblastic Leukemia (ALL)

Retrieved on: 
Monday, November 27, 2023
Food, Trust, ASCO, Caregiver, Physician, Priority, Acute leukemia, FDA, EMA, Orphan, Biologics license application, Pivotal, Society, Therapy, Annual general meeting, European Medicines Agency, Patient, ALL, BLA, Pharmaceutical industry

LONDON, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for obecabtagene autoleucel (obe-cel).

Key Points: 
  • LONDON, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for obecabtagene autoleucel (obe-cel).
  • Obe-cel is Autolus’ lead investigational chimeric antigen receptor (CAR) T cell therapy, for the treatment of patients with relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL).
  • The BLA submission is based on data from the Pivotal Phase 2 FELIX study of obe-cel in adult r/r B-ALL.
  • “We are looking forward to continuing working with the FDA through the regulatory approval process,” commented Dr. Christian Itin, Chief Executive Officer of Autolus.

Outlook Therapeutics® Announces Receipt of Type A Meeting Minutes and Reiterates Regulatory Path Forward for ONS-5010

Retrieved on: 
Monday, November 27, 2023
SPA, Ranibizumab, Food, Division, Outlook, Symantec Endpoint Protection, FDA, Retina, Type, CMC, AMD, Biologics license application, Therapy, Clinical trial, Bevacizumab, Calendar, CRL, Patient, BLA, Pharmaceutical industry

As previously reported, the FDA requires an additional adequate and well-controlled study to support the ONS-5010 BLA.

Key Points: 
  • As previously reported, the FDA requires an additional adequate and well-controlled study to support the ONS-5010 BLA.
  • As recommended by the FDA at the Type A meeting, Outlook Therapeutics has been working with the Division of Ophthalmology to design an appropriate study to satisfy the FDA’s requirements.
  • The FDA and Outlook Therapeutics have also identified the approaches needed to resolve the CMC comments in the CRL.
  • Based on the October Type A meeting and ongoing informal discussions with the FDA, Outlook Therapeutics has submitted a protocol for review at an upcoming Type A meeting with the FDA in December 2023.

Abeona Therapeutics Announces FDA Accepts and Grants Priority Review for Pz-cel Biologics License Application (BLA)

Retrieved on: 
Monday, November 27, 2023
Quality of life, Priority review, Food, Concha bullosa, ISID, BLA, FDA, PDUFA, Biologics license application, Advisory Committee, Patient, Safety, Wound healing, COL7A1, Pharmaceutical industry

CLEVELAND, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Biologics License Application (BLA) for pz-cel (prademagene zamikeracel), Abeona’s investigational autologous, COL7A1 gene-corrected epidermal sheets for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 25, 2024. The FDA also advised that it does not currently plan to convene an Advisory Committee meeting to discuss the pz-cel application.

Key Points: 
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 25, 2024.
  • The FDA also advised that it does not currently plan to convene an Advisory Committee meeting to discuss the pz-cel application.
  • Both studies revealed that a one-time application of pz-cel on large and chronic wounds delivered sustained wound healing and pain reduction.
  • The grant of the Priority Review status is an important prerequisite for Abeona’s eligibility for a Priority Review Voucher.

SHAREHOLDER ALERT: The Gross Law Firm Notifies Shareholders of Brainstorm Cell Therapeutics Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of January 2, 2024 – (NASDAQ: BCLI)

Retrieved on: 
Monday, November 27, 2023
NEXT, Fraud, Food, Biologics license application, Security (finance)

Appointment as lead plaintiff is not required to partake in any recovery.

Key Points: 
  • Appointment as lead plaintiff is not required to partake in any recovery.
  • DEADLINE: January 2, 2024 Shareholders should not delay in registering for this class action.
  • The deadline to seek to be a lead plaintiff is January 2, 2024.
  • The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship.