MedImmune, Inc. v. Genentech, Inc.

EQS-News: Formycon Ranibizumab Biosimilar FYB201/CIMERLI®1 achieved 25% market share2 in the United States

Retrieved on: 
Tuesday, October 17, 2023
Genentech, Food, Ranibizumab, European Medicines Agency, EMA, FDA, Biosimilar, MedImmune, Inc. v. Genentech, Inc., Retina, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Security (finance), Generic drug

Press Release // October 10, 2023

Key Points: 
  • Press Release // October 10, 2023
    Munich – Formycons commercialization partner Coherus BioSciences, Inc. announced that sales of CIMERLI® (ranibizumab-eqrn) to retinal specialists in the United States of America (“U.S.”) have exceeded 100,000 doses since commercial launch on October 3, 2022.
  • CIMERLI® is the first and only FDA-approved biosimilar interchangeable with Lucentis®3 for both strengths.
  • In August 2023, CIMERLI® achieved 25% market share of the ranibizumab market, making it the number one ranibizumab biosimilar in the U.S.
    “This is a great achievement and underlines again that biosimilars are an important treatment option for severe retinal diseases.
  • With FYB201, we have developed an excellent product, which has now become number one ranibizumab biosimilar in the U.S. market.

Pathways to Progress: How Orphan Drug Designation Sparks Biotech Transformation

Retrieved on: 
Wednesday, September 20, 2023
Atezolizumab, Diabetes, Neoplasm, Doctor of Philosophy, ODA, National library, Patient, GC, Disease, Prostate cancer, Carcinoma, CD47, Hope, Research, ACHL, Lung cancer, NLM, Orphan drug, Death, Drug development, Diagnosis, Growth, Rare, FDA, Legislation, Civil service commission, ODD, Roche, Orphan Drug Act of 1983, PharmaMar, Cancer, NSCLC, Treatment of lung cancer, ES, Therapy, Stomach, ORR, European Commission, File, United States National Library of Medicine, MedImmune, Inc. v. Genentech, Inc., Clinical trial, Woman, Lung, Fast track (FDA), SCLC, American Cancer Society, Achilles, Melanoma, OTCQX, Orphan, EC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FTD, RET, Food, Breast cancer, Pharmaceutical industry, Medical imaging, Genentech, Pembrolizumab

NEW YORK, Sept. 20, 2023 /PRNewswire/ -- More than 30 million people in the United States suffer with a rare disease; most of them are receiving no current treatment. Supporting the development and evaluation of new treatments, particularly for rare diseases, is a key priority for the U.S. Food & Drug Administration. As part of that process, the agency can grant Orphan Drug Designation (ODD) to a drug or biological product being developed to prevent, diagnose or treat a rare disease or condition. This designation is intended to spark innovation among biotech companies that are developing treatments for these patient populations, which by definition affect fewer than 200,000 people in the U.S., by providing incentives such as tax credits, user-fee exemptions and up to seven years of market exclusivity after FDA approval. Last month, Genprex Inc. (NASDAQ: GNPX) (Profile) was granted FDA orphan drug designation for its REQORSA(R) immunogene therapy in development for the treatment of small cell lung cancer (SCLC). The Phase 1/2 clinical trial, expected to dose the first patient in the fourth quarter of 2023, uses a combination of REQORSA and Genentech Inc.'s Tecentriq(R) as maintenance therapy in patients with extensive stage small cell lung cancer ("ES-SCLC") who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Genprex joins other companies — including Roche Holding AG ADR (OTCQX: RHHBY), Jazz Pharmaceuticals PLC (NASDAQ: JAZZ), ALX Oncology Holdings Inc. (NASDAQ: ALXO) and Achilles Therapeutics PLC (NASDAQ: ACHL) — that have been granted ODD status or may seek ODD status as they work to develop treatments for rare diseases.

Key Points: 
  • Four decades after the Orphan Drug Act was passed, hundreds of 'orphan' drugs have been approved for use.
  • Genprex's REQORSA Immunogene Therapy has gained both Orphan Drug Designation and Fast Track Designation.
  • Specifically, the report noted that 6,340 orphan drug designations were granted, representing drug development for 1,079 rare diseases.
  • For companies looking to help those in the underserved rare-disease space, an Orphan Drug Designation is the ideal pathway to progress.

Pathways to Progress: How Orphan Drug Designation Sparks Biotech Transformation

Retrieved on: 
Wednesday, September 20, 2023
Atezolizumab, Diabetes, Neoplasm, Doctor of Philosophy, ODA, National library, Patient, GC, Disease, Prostate cancer, Carcinoma, CD47, Hope, Research, ACHL, Lung cancer, NLM, Orphan drug, Death, Drug development, Diagnosis, Growth, Rare, FDA, Legislation, Civil service commission, ODD, Roche, Orphan Drug Act of 1983, PharmaMar, Cancer, NSCLC, Treatment of lung cancer, ES, Therapy, Stomach, ORR, European Commission, File, United States National Library of Medicine, MedImmune, Inc. v. Genentech, Inc., Clinical trial, Woman, Lung, Fast track (FDA), SCLC, American Cancer Society, Achilles, Melanoma, OTCQX, Orphan, EC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FTD, RET, Food, Breast cancer, Pharmaceutical industry, Medical imaging, Genentech, Pembrolizumab

NEW YORK, Sept. 20, 2023 /PRNewswire/ -- More than 30 million people in the United States suffer with a rare disease; most of them are receiving no current treatment. Supporting the development and evaluation of new treatments, particularly for rare diseases, is a key priority for the U.S. Food & Drug Administration. As part of that process, the agency can grant Orphan Drug Designation (ODD) to a drug or biological product being developed to prevent, diagnose or treat a rare disease or condition. This designation is intended to spark innovation among biotech companies that are developing treatments for these patient populations, which by definition affect fewer than 200,000 people in the U.S., by providing incentives such as tax credits, user-fee exemptions and up to seven years of market exclusivity after FDA approval. Last month, Genprex Inc. (NASDAQ: GNPX) (Profile) was granted FDA orphan drug designation for its REQORSA(R) immunogene therapy in development for the treatment of small cell lung cancer (SCLC). The Phase 1/2 clinical trial, expected to dose the first patient in the fourth quarter of 2023, uses a combination of REQORSA and Genentech Inc.'s Tecentriq(R) as maintenance therapy in patients with extensive stage small cell lung cancer ("ES-SCLC") who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Genprex joins other companies — including Roche Holding AG ADR (OTCQX: RHHBY), Jazz Pharmaceuticals PLC (NASDAQ: JAZZ), ALX Oncology Holdings Inc. (NASDAQ: ALXO) and Achilles Therapeutics PLC (NASDAQ: ACHL) — that have been granted ODD status or may seek ODD status as they work to develop treatments for rare diseases.

Key Points: 
  • Four decades after the Orphan Drug Act was passed, hundreds of 'orphan' drugs have been approved for use.
  • Genprex's REQORSA Immunogene Therapy has gained both Orphan Drug Designation and Fast Track Designation.
  • Specifically, the report noted that 6,340 orphan drug designations were granted, representing drug development for 1,079 rare diseases.
  • For companies looking to help those in the underserved rare-disease space, an Orphan Drug Designation is the ideal pathway to progress.

Genprex Granted FDA Orphan Drug Designation (ODD) for REQORSA® Immunogene Therapy for the Treatment of Small Cell Lung Cancer

Retrieved on: 
Thursday, August 10, 2023
MedImmune, Inc. v. Genentech, Inc., Carcinoma, Maintenance, Diabetes, ODD, Clinical trial, Cancer, TUSC2, NSCLC, Lung cancer, PFS, Lung, Fast track (FDA), SCLC, Non-small-cell lung cancer, Patient, Mouse, Orphan, FDA, FTD, Pharmaceutical industry, Pembrolizumab

AUSTIN, Texas, Aug. 10, 2023 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to the Company's lead drug candidate, REQORSA® Immunogene Therapy (quratusugene ozeplasmid), for the treatment of small cell lung cancer (SCLC). 

Key Points: 
  • AUSTIN, Texas, Aug. 10, 2023 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to the Company's lead drug candidate, REQORSA® Immunogene Therapy (quratusugene ozeplasmid), for the treatment of small cell lung cancer (SCLC).
  • With ES-SCLC, the cancer has spread from one lung to the other, or to other parts of the body.
  • "We are excited to receive Orphan Drug Designation from the FDA for REQORSA for patients with SCLC," said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex.
  • "This FDA Orphan Drug Designation in combination with our recently received FDA Fast Track designation underscores the great need for better treatment options for patients with SCLC,ES-SCLC and NSCLC.

EQS-News: Formycon reports results for the first quarter 2023

Retrieved on: 
Thursday, June 1, 2023
Partnership, International, KG, MedImmune, Inc. v. Genentech, Inc., FYB, EBIT, Esselte Leitz GmbH & Co KG, Gesellschaft mit beschränkter Haftung, EBITDA, Euro, Physician, ISIN, CFO, Munich, Security (finance), Tourism

Formycon Group’s revenues increased to a total of Euro 21.5. million in the first quarter of 2023 (Q1/2022: Euro 8.1 million).

Key Points: 
  • Formycon Group’s revenues increased to a total of Euro 21.5. million in the first quarter of 2023 (Q1/2022: Euro 8.1 million).
  • A significant part of revenues resulted from a first milestone payment as part of the commercialization partnership from project FYB202 signed in Q1/2023.
  • „In terms of key figures, the first quarter of 2023 was characterized by various positive special effects.
  • We continue to confirm our guidance for 2023", commented Enno Spillner, CFO of Formycon AG.

Marker Therapeutics Appoints Monic Stuart, M.D., as Chief Medical Officer

Retrieved on: 
Monday, May 8, 2023
Lymphoma, Marker, University, ARTEMIS, Internal medicine, Stanford University, MedImmune, Inc. v. Genentech, Inc., Biotechnology, Non-Hodgkin lymphoma, Clinical trial, Cancer, Drug, Chapel Hill, CMO, University of North Carolina School of Law, Trial of the century, Acute myeloid leukemia, AML, M.D, Public health, Monic, Harvard T.H. Chan School of Public Health, Geron Corporation, Johns Hopkins University, Patient, Division, School, Hematology, Haematopoietic system, Therapy, Bone marrow, Pharmaceutical industry, Medical imaging, Blood, Genentech, Biology

HOUSTON, May 08, 2023 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced the appointment of Monic Stuart, M.D., as its new Chief Medical Officer.

Key Points: 
  • HOUSTON, May 08, 2023 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced the appointment of Monic Stuart, M.D., as its new Chief Medical Officer.
  • “As we undergo a strategic review of our clinical programs, we are thrilled to add Monic to the leadership team at Marker Therapeutics and look forward to benefitting from her deep scientific, industry, and medical knowledge to drive our multiTAA-specific T cell product pipeline across multiple high-need cancer indications,” said Juan F. Vera, M.D., Chief Executive Officer of Marker Therapeutics.
  • Before her role at Geron Corp., she worked at Genentech Inc. as a Senior Medical Director in the Oncology Division.
  • She completed her medical residency in internal medicine and fellowships in hematology and bone marrow transplantation at Stanford University.

EQS-News: Formycon publishes results for financial year 2022

Retrieved on: 
Friday, April 28, 2023
GMP, Trademark, Partnership, International, Half-life, KG, MedImmune, Inc. v. Genentech, Inc., FYB, European Medicines Agency, COVID-19, Tax, EBIT, Genentech, Esselte Leitz GmbH & Co KG, Gesellschaft mit beschränkter Haftung, EMA, EBITDA, Acquisition, Regeneron Pharmaceuticals, Investment, Patient, Ophthalmology, ISIN, United Kingdom, Depreciation, Biosimilar, Development, HGB, FDA, Pembrolizumab, Annual report, Ustekinumab, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Commercial code, Security (finance), Chemical, Cryptocurrency, Generic drug, Fine chemical, Pharmaceutical industry, Euro

The annual report at Group level is published for the first time in accordance with IFRS (International Financial Reporting Standards).

Key Points: 
  • The annual report at Group level is published for the first time in accordance with IFRS (International Financial Reporting Standards).
  • Furthermore, a toxicity study has been initiated, which results are a prerequisite for entering the clinical development phase.
  • On December 31, 2022, the Formycon Group's financial figures had developed as follows: Group revenues, which in addition to Formycon AG also include the fully consolidated subsidiaries Formycon Project 201 GmbH, FYB202 Project GmbH, Formycon Project 203 GmbH, Bioeq GmbH and the 50% stake in Bioeq AG increased to a total of Euro 42.5 million (2021 IFRS: Euro 36.6 million) in the fiscal year 2022.
  • Formycon AG achieved revenues (HGB) of Euro 28.3 million in the financial year 2022 (2021 HGB: Euro 26.5 million).

ISG Study Finds Customer Experience a Top Enterprise Priority, Off-Limits From Cost Optimization

Retrieved on: 
Monday, April 24, 2023
Technology, Mobile, Wireless, Social Media, Search Engine Optimization, Search Engine Marketing, Consulting, Professional Services, Marketing, Software, Networks, Communications, Internet, Data Management, Security, ISG, Lead, IBM, Engineering, MedImmune, Inc. v. Genentech, Inc., TBM, Logistics, CX, Trust, Research, Transport, HTC, IHG Hotels & Resorts, Human voice, San Francisco Giants, A Whole New Ballgame, Acquisition, Curse of Coogan's Bluff, Alaska Airlines, Architecture, DEI, CIO, ESG, Wipro, Zappos, Growth, Travel, Unilever, Environment, San Francisco Public Utilities Commission, Technology Business Management Council, Retail, Management, Online shopping, American Express, Aflac

A new study by Information Services Group ( ISG ) (Nasdaq: III ), a leading global technology research and advisory firm, finds the majority of executives worldwide consider customer experience a top, strategic priority that is off limits to cost optimization efforts.

Key Points: 
  • A new study by Information Services Group ( ISG ) (Nasdaq: III ), a leading global technology research and advisory firm, finds the majority of executives worldwide consider customer experience a top, strategic priority that is off limits to cost optimization efforts.
  • The global ISG Buyer Behavior Study, which surveyed more than 250 senior executives in February 2023, found 48 percent of respondents cite customer experience as extremely important to their organization’s strategic direction, and 53 percent say they intend to “completely protect” customer experience from cost optimization programs.
  • “Enterprises have successfully created friction-free experiences that are consistent across physical and digital platforms.
  • Now they’re challenged by their customers to not only maintain but exceed that experience,” said Sush Apshankar, practice lead, ISG Data Analytics and AI/ML, and co-host of the ISG Xperience Summit.

Matinas BioPharma Reports 2022 Financial Results and Provides a Business Update

Retrieved on: 
Wednesday, March 15, 2023
Transfer, Research, Biomedical Advanced Research and Development Authority, Messenger, Bangladesh Technical Education Board, NYSE, LNC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, MedImmune, Inc. v. Genentech, Inc., BARDA, Partnership, NIH, Dicarboxylic acid, National Resilience Institute, Patient, BioNTech, Oligonucleotide, FDA, Development, Cryptococcosis, ASO, Evaluation, Safety, Clinical trial, RNA, Conference call, Enactment, Food, Small RNA, Pharmaceutical industry, Vaccine, Cryptocurrency, Conference

BEDMINSTER, N.J., March 15, 2023 (GLOBE NEWSWIRE) -- Matinas BioPharma (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, reports 2022 financial results and provides a business update.

Key Points: 
  • Conference call and webcast begin at 4:30 p.m. Eastern time today
    BEDMINSTER, N.J., March 15, 2023 (GLOBE NEWSWIRE) -- Matinas BioPharma (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, reports 2022 financial results and provides a business update.
  • “Phase 2 MAT2203 clinical trial results demonstrated the ability of our platform to efficaciously deliver a safe, well-tolerated oral form of amphotericin B with dramatic survival results.
  • Results from in vitro testing under a Material Transfer and Evaluation Agreement with National Resilience, which was announced in January 2023.
  • Matinas will host a conference call and webcast today beginning at 4:30 p.m. Eastern time.

Antiglaucoma Drugs Global Market Report 2023

Retrieved on: 
Monday, February 20, 2023
Brimonidine/timolol, Bayer, 2020 Vision, Organization, Patent, Paratriathlon, Alcon, Government, Glaucoma, Korea Disease Control and Prevention Agency, Adrenaline, Bimatoprost, Johnson & Johnson, Merck & Co., Incidence, Patient, Geography, Travoprost, Pfizer, Novartis, Optic nerve, Risk, CDC, Dorzolamide/timolol, IOP, US, MedImmune, Inc. v. Genentech, Inc., USFDA, COVID-19, Overalls, Intraocular pressure, Carbonic anhydrase inhibitor, Pharmaceutical industry, Allergan, Brinzolamide

The global antiglaucoma drugs market will grow from $14.02 billion in 2022 to $15.04 billion in 2023 at a compound annual growth rate (CAGR) of 7.3%.

Key Points: 
  • The global antiglaucoma drugs market will grow from $14.02 billion in 2022 to $15.04 billion in 2023 at a compound annual growth rate (CAGR) of 7.3%.
  • The regions covered in the antiglaucoma drugs market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
  • The countries covered in the antiglaucoma drugs market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.
  • The antiglaucoma drug market research report is one of a series of new reports that provides antiglaucoma drug market statistics, including antiglaucoma drug industry global market size, regional shares, competitors with an antiglaucoma drug market share, detailed antiglaucoma drug market segments, market trends and opportunities, and any further data you may need to thrive in the antiglaucoma drug industry.