NDA

Kaplan Fox Continues to Investigate Potential Securities Fraud at Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) - INVESTOR UPDATE

Retrieved on: 
Friday, December 2, 2022
Workforce, NSCLC, Spectrum, HER2, FOX, Pulmonary toxicity, News, Large-cell lung carcinoma, Research, FDA, CRL, ODAC, NDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SPPI, Patient, Endpoint security, Lung cancer, Food, Pharmaceutical industry, Reuters, Spectrum Pharmaceuticals

NEW YORK, Dec. 02, 2022 (GLOBE NEWSWIRE) -- Kaplan Fox & Kilsheimer LLP ( www.kaplanfox.com ) is continuing to investigate claims on behalf of investors in Spectrum Pharmaceuticals, Inc. (Spectrum or the Company) (NASDAQ: SPPI) securities.

Key Points: 
  • NEW YORK, Dec. 02, 2022 (GLOBE NEWSWIRE) -- Kaplan Fox & Kilsheimer LLP ( www.kaplanfox.com ) is continuing to investigate claims on behalf of investors in Spectrum Pharmaceuticals, Inc. (Spectrum or the Company) (NASDAQ: SPPI) securities.
  • If you purchased Spectrum securities and would like to discuss our investigation, please contact us by emailing [email protected] or by calling (212) 329-8571.
  • WHY CONTACT KAPLAN FOX - Kaplan Fox is a leading national law firm focusing on complex litigation with offices in New York, Oakland, Los Angeles, Chicago and New Jersey.
  • With over 50 years of experience in securities litigation, Kaplan Fox offers the professional experience and track record that clients demand.

Allarity Therapeutics Reschedules 2022 Annual Stockholders Meeting and Sets New Record Date

Retrieved on: 
Thursday, December 1, 2022
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Boston, MA U.S.A. (December 1, 2022) Allarity Therapeutics, Inc. (Allarity or the Company), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, today announced that the Companys adjourned 2022 Annual Stockholders Meeting (2022 ASM) set for December 2, 2022 has been cancelled and a new meeting date for the Annual Stockholders Meeting (2023 ASM) will be held, as a virtual meeting, on January 19, 2023.

Key Points: 
  • Boston, MA U.S.A. (December 1, 2022) Allarity Therapeutics, Inc. (Allarity or the Company), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, today announced that the Companys adjourned 2022 Annual Stockholders Meeting (2022 ASM) set for December 2, 2022 has been cancelled and a new meeting date for the Annual Stockholders Meeting (2023 ASM) will be held, as a virtual meeting, on January 19, 2023.
  • The annual meeting was rescheduled to January 19, 2023 in light of the new proposals to be considered at the annual meeting.
  • Stockholders of record as of December 6, 2022, will be entitled to notice of, and to vote at, the 2023 ASM.
  • The Company, however, reserves the right to change the record date prior to the 2023 ASM.

Aldeyra Therapeutics Announces Positive Primary Vitreoretinal Lymphoma Pre-NDA Meeting with the FDA

Retrieved on: 
Thursday, December 1, 2022
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Marketing, Retina, Risk, Therapy, Photophobia, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Priority review, Survey of Ophthalmology, Security (finance), Retinoblastoma, Incidence, AAO, Patient, NDA, Viscosity, Duane syndrome, Allergic conjunctivitis, New Drug Application, FDA, COVID-19, Growth, Result, Financial condition report, Diagnosis, Methotrexate, Food, Analysis, Toxicity, Annual report, Retinitis pigmentosa, Floater, Failure, Data analysis, Type, Clinical trial, Safety, Drug discovery, PH, Conversation, Annals of Oncology, Survival, USP, Pharmaceutical industry, Ophthalmology

ADX-2191, which has received FDA Orphan Drug Designation for the treatment of primary vitreoretinal lymphoma, is a novel, vitreous-compatible formulation of methotrexate.

Key Points: 
  • ADX-2191, which has received FDA Orphan Drug Designation for the treatment of primary vitreoretinal lymphoma, is a novel, vitreous-compatible formulation of methotrexate.
  • ADX-2191 has received FDA Orphan Drug Designation for the prevention of proliferative vitreoretinopathy, and the treatment of primary vitreoretinal lymphoma and retinitis pigmentosa.
  • Primary vitreoretinal lymphoma is a rare, aggressive, and potentially fatal retinal cancer that is diagnosed in approximately 300 to 600 patients in the United States per year.
  • Data on file; Primary Vitreoretinal Lymphoma by D. J. Wilson on AAO EyeWiki; M. Sagoo, Survey of Ophthalmology (2014); Grimm et.

Sapience Therapeutics Announces Appointment of Abi Vainstein-Haras, M.D. as Chief Medical Officer

Retrieved on: 
Thursday, December 1, 2022
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HARRISON, N.Y., Dec. 1, 2022 /PRNewswire/ -- Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, announced today the appointment of Dr. Abi Vainstein-Haras as Chief Medical Officer, effective December 1, 2022. Dr. Alice S. Bexon, who has served as a clinical advisor since 2017 and as Sapience's consulting Chief Medical Officer since 2019, will continue in an advisory role to support the transition to Dr. Vainstein-Haras and beyond. In addition, Dr. Bexon's clinical consulting group, Bexon Clinical, will continue to support the development of Sapience's clinical-stage pipeline and strategy. 

Key Points: 
  • HARRISON, N.Y., Dec. 1, 2022 /PRNewswire/ -- Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, announced today the appointment of Dr. Abi Vainstein-Haras as Chief Medical Officer, effective December 1, 2022.
  • "We are thrilled to welcome Abi to Sapience as Chief Medical Officer," commented Dr. Barry Kappel, CEO and President of Sapience.
  • She joins Sapience from BioLineRx, where she spent the last eight years serving in multiple roles of increasing responsibility, most recently serving as Chief Medical Officer sinceJanuary 2021.
  • "It has been my honor to serve as Chief Medical Officer of Sapience for the past three years," said Dr. Bexon.

Innoviva Announces FDA Acceptance and Priority Review of New Drug Application for Sulbactam-Durlobactam (SUL-DUR)

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Wednesday, November 30, 2022
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The Agency is currently planning to hold an advisory committee meeting to discuss this application.

Key Points: 
  • The Agency is currently planning to hold an advisory committee meeting to discuss this application.
  • SUL-DUR also exhibited a favorable safety profile with statistically significant reduction in nephrotoxicity.
  • Carbapenem-resistant and multidrug-resistant Acinetobacter infections are an urgent and emergent threat due to increasing rates of resistance and few viable treatment options.
  • Our focused and dedicated team looks forward to continuing to work with the FDA throughout the priority review process.

Exro Announces Major Milestone with Linamar e-Axle Phase One Project Completion and Provides Operational Update

Retrieved on: 
Wednesday, November 30, 2022
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The project now transitions to the second and final phase which includes electric axle ("e-axle") integration, testing, and validation by Linamar.

Key Points: 
  • The project now transitions to the second and final phase which includes electric axle ("e-axle") integration, testing, and validation by Linamar.
  • "Phase one completion of our project with Linamar marks a major milestone for the project, and a significant corporate milestone for Exro", said Exro CEO, Sue Ozdemir.
  • We look forward to the next phase of the project and to an exciting future with a great partner."
  • Exro is pleased to report that the Company has completed phase one of the project marking a significant project, and corporate milestone.

Aurion Biotech Expands Its Leadership Team

Retrieved on: 
Wednesday, November 30, 2022
Research, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Optical, Science, Gilead Sciences, Takeda Pharmaceutical Company, Liberty University, Human services, Union, University, Multimedia, Purdue University, Seagen, Abbott Laboratories, BLA, Patient, BS, Regulatory affairs, Endothelial dysfunction, Biotechnology, Petrichor, American University, NDA, AMD, Alcon, Political science, Sherita Ceasar, Clinical trial, Pharmaceutical industry, Psychology, Biology

View the full release here: https://www.businesswire.com/news/home/20221130005132/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20221130005132/en/
    Im delighted to welcome Sherita and Sterling to Aurion Biotech, said Greg Kunst, Aurion Biotech chief executive officer.
  • Before joining Aurion Biotech, Mr. Chung held regulatory leadership roles at Neoleukin Therapeutics, Molecular Templates, Immatics US, Seattle Genetics, Gilead Sciences, Astellas Pharmaceuticals, Takeda Pharmaceuticals, and Abbott Laboratories.
  • With offices in Seattle, Boston and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with its life-changing regenerative therapies.
  • Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech.

CIPLA ANNOUNCES LAUNCH OF LEUPROLIDE ACETATE INJECTION DEPOT (22.5Mg)

Retrieved on: 
Wednesday, November 30, 2022
Urology, Growth, HIV/AIDS, Development, Patient, Movement, FDA, Freeze-drying, CNS, BSE, NDA, Leuprorelin, US FDA, HIV, NSE, Cardiology, Pharmaceutical industry, IQVIA, Cipla

MUMBAI, India and WARREN, N.J., Nov. 29, 2022 /PRNewswire/ --Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) and its wholly owned subsidiary Cipla USA Inc. (hereafter referred to as 'Cipla'), today announced the launch of Leuprolide Acetate Injection Depot 22.5mg.

Key Points: 
  • MUMBAI, India and WARREN, N.J., Nov. 29, 2022 /PRNewswire/ --Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) and its wholly owned subsidiary Cipla USA Inc. (hereafter referred to as 'Cipla'), today announced the launch of Leuprolide Acetate Injection Depot 22.5mg.
  • Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3-month administration given as a single dose injection.
  • Arunesh Verma, CEO Cipla North America, said, "The launch of Leuprolide Acetate Injection Depot reinforces our commitment as an organization to bring high quality and affordable treatments to patients in the US.
  • The active ingredient, route of administration, dosage form and strength are the same as LUPRON DEPOT 22.5 mg strength, from Abbvie.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Spectrum Pharmaceuticals, Inc. - SPPI

Retrieved on: 
Tuesday, November 29, 2022
HER2, CRL, Pulmonary toxicity, SPPI, LLP, Reuters, Spectrum Pharmaceuticals, Food, Pomerantz, Large-cell lung carcinoma, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Endpoint security, News, NDA, Spectrum, FDA, Pharmaceutical industry

NEW YORK, Nov. 29, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Spectrum Pharmaceuticals, Inc. (Spectrum or the Company) (NASDAQ:SPPI).

Key Points: 
  • NEW YORK, Nov. 29, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Spectrum Pharmaceuticals, Inc. (Spectrum or the Company) (NASDAQ:SPPI).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Spectrum and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

KemPharm Announces Appointment of Christopher Posner as New Independent Director

Retrieved on: 
Tuesday, November 29, 2022
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CELEBRATION, Fla., Nov. 29, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a biotechnology company focused on the discovery, development and commercialization of novel treatments for rare central nervous system (CNS) and neurodegenerative diseases, lysosomal storage disorders and related treatment areas, today announced the appointment of Christopher Posner to serve on the Company’s Board of Directors.

Key Points: 
  • Mr. Posner is currently the president and CEO of Cara Therapeutics (Nasdaq: CARA), a commercial-stage biopharmaceutical company.
  • He brings more than 20 years of global pharmaceutical experience to KemPharm, including expertise in preparing and executing commercial product launches.
  • Prior to joining Cara Therapeutics, Mr. Posner was President and Chief Executive Officer of LEO Pharma, Inc., the U.S. subsidiary of LEO Pharma A/S.
  • I welcome the opportunity to join KemPharm at a very exciting period for the company, said Mr. Posner.