Biologics license application

Atara Biotherapeutics to Present Recent Progress and Key Upcoming Milestones at the 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 8, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, EST, Conference, IND, Biologics license application, Cancer, ATRA, EBV, Lupus nephritis, PST, Patient, Lymphoma, Epstein–Barr virus, BLA, Pharmaceutical industry

Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced Pascal Touchon, President and Chief Executive Officer of Atara, will present the Company’s 2023 accomplishments across strategic priorities and key upcoming milestones at the 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11 at 9:45 a.m. PST / 12:45 p.m. EST.

Key Points: 
  • Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced Pascal Touchon, President and Chief Executive Officer of Atara, will present the Company’s 2023 accomplishments across strategic priorities and key upcoming milestones at the 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11 at 9:45 a.m. PST / 12:45 p.m. EST.
  • “Our off-the-shelf, allogeneic CAR EBV T cell pipeline now spans both oncology and autoimmune indications and is designed to overcome current limitations of autologous CAR T and other allogeneic cell therapy approaches.
  • An archived replay of the webcast will be available on the Company's website for 30 days following the live presentation.
  • A new corporate presentation will be available on Monday, January 8 at 8:00 a.m. EST / 5:00 a.m. PST.

Abeona Therapeutics Announces $50 Million Credit Facility

Retrieved on: 
Monday, January 8, 2024
Marketing, Food, Concha bullosa, Priority review, FDA, PDUFA, PZ, RDEB, Biologics license application, Patient, COL7A1

CLEVELAND, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has entered into a $50 million credit facility with the Avenue Venture Opportunities Fund, L.P.

Key Points: 
  • CLEVELAND, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has entered into a $50 million credit facility with the Avenue Venture Opportunities Fund, L.P.
  • The credit agreement, which has a term of three and a half years, includes a first tranche of $20 million at closing, a second tranche of $10 million of committed capital, and an additional accordion option to upsize the credit facility by an additional $20 million upon satisfaction of certain terms and conditions.
  • The FDA has accepted and granted Priority Review with a PDUFA target action date of May 25, 2024 for the Biologics License Application for pz-cel.
  • “We are excited to enter into this relationship with Avenue Venture Fund and secure additional financial resources to further support our launch and commercialization efforts for pz-cel,” said Joe Vazzano, Chief Financial Officer of Abeona.

Axogen Announces Plan for Leadership Transition with CEO Karen Zaderej to Retire from Company by January 2025

Retrieved on: 
Thursday, January 4, 2024
Marketing, Quality of life, Nerve, Biologics license application, Growth, BLA, Management

While the transition is planned to be no later than Jan. 5, 2025, it could occur sooner depending on the timing of a new CEO appointment.

Key Points: 
  • While the transition is planned to be no later than Jan. 5, 2025, it could occur sooner depending on the timing of a new CEO appointment.
  • Ms. Zaderej has led the transformation of Axogen from a small start-up company to a category leader in the growing market of nerve repair.
  • Under her leadership, Axogen has built awareness of the patient quality of life impact related to nerve damage and has created the market for nerve repair.
  • I am proud of the accomplishments of our team and know that Axogen is positioned well for continued growth.

Vaxcyte Provides Clinical and Regulatory Progress Update on Potential Best-in-Class Pneumococcal Conjugate Vaccine (PCV) Franchise

Retrieved on: 
Thursday, January 4, 2024
Licensure, Food, PCV, End, Breakthrough therapy, FDA, CMC, Ageing, Phase 10, SAN, Pivotal, Biologics license application, Advisory Committee, PCV20, Breakthrough, Data monitoring committee, Immunization, Initiation, IPD, PCV15, Infant, Safety, Tolerability, Genetically modified bacteria, BLA, Vaccine

-- Enrollment in Ongoing VAX-24 Infant Phase 2 Study Continues to Progress; Topline Data from Primary Immunization Series Expected by End of First Quarter of 2025, Followed by Topline Data from Booster Dose by End of 2025 --

Key Points: 
  • Vaxcyte’s carrier-sparing PCV franchise candidates, including VAX-24, a 24-valent PCV proceeding to Phase 3, and VAX-31, the Company’s next-generation 31-valent PCV, are being studied for the prevention of invasive pneumococcal disease (IPD).
  • The VAX-24 Phase 2 infant study continues to enroll participants in the second and final stage of the study.
  • This is a randomized, observer-blind, dose-finding two-stage clinical study evaluating the safety, tolerability and immunogenicity of VAX-24 in healthy infants.
  • Topline safety, tolerability and immunogenicity data from the ongoing adult Phase 1/2 study in the third quarter of 2024.

Medytox, Inc. Announces the Formation of Luvantas Subsidiary and Appointment of Key Executives

Retrieved on: 
Wednesday, January 3, 2024
Yee, Citadel, Accounting, Warner–Lambert, Invention, Mercer University, Sale, CFO, Acquisition, Marketing, Stephanie, Nobel Biocare, University, Parke Davis, Allergan, Inphi Corporation, Syneron Medical, GSK plc, Biologics license application, Patient, Pharmaceutical industry

IRVINE, Calif., Jan. 3, 2024 /PRNewswire/ -- Medytox, Inc. is pleased to announce the formation of Luvantas, Inc. ( www.luvantas.com ) as its wholly-owned North American subsidiary.

Key Points: 
  • IRVINE, Calif., Jan. 3, 2024 /PRNewswire/ -- Medytox, Inc. is pleased to announce the formation of Luvantas, Inc. ( www.luvantas.com ) as its wholly-owned North American subsidiary.
  • More information on this state-of-the-art formulation of Botulinum toxin will be provided once regulatory approvals are obtained.
  • In connection with the formation of Luvantas, Thomas A. Albright has been appointed its President and CEO and Stephanie A. Yee has been appointed its CFO.
  • As CEO, Tom brings 40 years of healthcare experience to Luvantas with medical aesthetic leadership roles since 2000.

INOVIO Plans to Submit a BLA for INO-3107 as a Potential Treatment for RRP in Second Half of 2024 Under Accelerated Approval Program

Retrieved on: 
Wednesday, January 3, 2024
European Commission, Food, Priority review, Breakthrough therapy, FDA, Type, Health, DNA, Cancer, RRP, Recurrence, Biologics license application, Patient, Infection, Food and Drug Administration, BLA, Pharmaceutical industry

This announcement follows an Initial Comprehensive Multidisciplinary Breakthrough Therapy (Type B) Meeting with the FDA on critical aspects of the data package required to submit a BLA under the agency's accelerated approval program.

Key Points: 
  • This announcement follows an Initial Comprehensive Multidisciplinary Breakthrough Therapy (Type B) Meeting with the FDA on critical aspects of the data package required to submit a BLA under the agency's accelerated approval program.
  • "Based on productive discussions with the FDA, we believe we now have established a path to submitting a BLA for INO-3107 under the accelerated approval program," said Dr. Jacqueline Shea, INOVIO's President & Chief Executive Officer.
  • "Our plan is to complete the submission of our BLA in the second half of 2024 and request a Priority Review.
  • Concurrently, we will continue advancing our commercial plans, with the goal of being ready to launch INO-3107 in 2025."

ImmunityBio Announces $320 Million Investment by Oberland Capital, with $210 Million Funded at Closing, Bringing Total Financing in 2023 to $850 Million

Retrieved on: 
Tuesday, January 2, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Immunotherapy, Food, Immune system, Jefferies Group, CIS, Bladder cancer, RIPA, FDA, PDUFA, Note, Biologics license application, BCG, Patient, Capital, VWAP, Patrick Soon-Shiong, Food and Drug Administration, Carcinoma in situ, NMIBC, BLA

ImmunityBio, Inc. ( NASDAQ: IBRX ), a clinical-stage immunotherapy company (“ImmunityBio” or the “Company”), today announced an up to $320 million royalty financing and equity investment in the Company by Oberland Capital, with $210 million of gross proceeds received at closing on December 29, 2023.

Key Points: 
  • ImmunityBio, Inc. ( NASDAQ: IBRX ), a clinical-stage immunotherapy company (“ImmunityBio” or the “Company”), today announced an up to $320 million royalty financing and equity investment in the Company by Oberland Capital, with $210 million of gross proceeds received at closing on December 29, 2023.
  • The proceeds will also be used to fund ongoing business operations and clinical trials expanding N-803 (Anktiva®) indications into multiple solid tumors.
  • Oberland Capital has also an option to purchase an additional $10 million of common stock at a future date.
  • Jefferies LLC acted as exclusive financial advisor to the Company on the transaction.

EQS-News: Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration

Retrieved on: 
Saturday, December 30, 2023
Fresenius (company), Food, EMA, FDA, Biologics license application, Ulcerative colitis, Press release, Ustekinumab, Patient, Psoriasis, Biosimilar, BLA, Generic drug

Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration

Key Points: 
  • Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration
    The issuer is solely responsible for the content of this announcement.
  • Press Release // November 30, 2023
    Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration
    Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its commercialization partner Fresenius Kabi today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the Biologics License Application (“BLA”) for FYB202, a proposed biosimilar candidate to Stelara®1.
  • FYB202 is a human monoclonal antibody that targets interleukin 12 and interleukin 23 for the treatment of immune-mediated disorders.
  • “The FDA file acceptance for our Stelara® biosimilar candidate FYB202 underlines the great expertise and capabilities of #TeamFormycon.

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, December 28, 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 Announces Changes to its Board of Directors

Retrieved on: 
Friday, December 22, 2023
Senior, Fortress Biotech, Food, DSM-IV codes, AstraZeneca, FDA, Hearing loss, Neuroscience, M.B.A, Inflammation, Complexa, Senior management, Biologics license application, Therapy, University, University of Pennsylvania, Patient, Corporate development, ALL, Bluebird bio, Corporation, BLA, Pharmaceutical industry

LONDON, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced the appointment of Elisabeth Leiderman, M.D. to the Board of Directors. Additionally, the Company announced that Kapil Dhingra M.D., who has served on Autolus’ Board of Directors since May 2015, has advised the Board of his intent to step down from his role as a member of the Board and chair of the Nominating and Corporate Governance Committee of the Board, effective December 31, 2023.

Key Points: 
  • LONDON, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced the appointment of Elisabeth Leiderman, M.D.
  • Additionally, the Company announced that Kapil Dhingra M.D., who has served on Autolus’ Board of Directors since May 2015, has advised the Board of his intent to step down from his role as a member of the Board and chair of the Nominating and Corporate Governance Committee of the Board, effective December 31, 2023.
  • “The Autolus Board and Management Team would like to welcome Lis Leiderman to the Board of Directors.
  • Dr. Leiderman is a member of the board of directors of bluebird bio, Inc. She holds an M.D.