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• Juno Pharmaceuticals receives approval to import Eptifibatide as Canadian hospitals continue to grapple with shortages of critical medicines

  3/29/2023

  Juno Pharmaceuticals Canada (“Juno”), a Canadian specialty pharmaceutical company, announced that it has received approval from Health Canada to import Eptifibatide solution for infusion and injection (“Eptifibatide”) pursuant to Health Canada’s exceptional importation and sale guidelines.

• Coya Therapeutics, Inc. Provides Business Update and Reports FY 2022 Unaudited Financial Results

  3/29/2023

  Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics and cell therapies intended to enhance function of Regulatory T Cells (Tregs) function, today announced its financial results for fiscal year ended December 31, 2022, and provided a clinical and business update.

• PharmaForce International: Key US Immunology-Focused Organizations Expanded into the Respiratory Space in 2022

  3/28/2023

  PharmaForce International recently published a report in December that benchmarked the leading Immunology sales and marketing organizations in the United States.

• BioCina Awarded Grant to Develop Enabling Technologies for Manufacturing Precision mRNA Vaccines

  3/28/2023

  BioCina, a leading contract development and manufacturing organization (CDMO), has been awarded a $5 million AUD grant under the Federal Government's Medical Research Future Fund (MRFF) Grants scheme to fund work with its industry partners to develop enabling technologies for manufacturing precision mRNA vaccines.

• Innovent Announces 2022 Annual Results and Business Updates

  3/28/2023

  Innovent Biologics, Inc. (Innovent) (HKEX: 01801) announces its 2022 annual results and major company business updates.

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  AbbVie Clinches Back-to-Back Clinical Wins in Ulcerative Colitis, Lupus

  3/24/2023

  In a double data drop Thursday, AbbVie touted two clinical trial wins, for Skyrizi in ulcerative colitis and Rinvoq in systemic lupus erythematosus.

• Kymanox Acquires Agilis Consulting Group, A Trusted Human Factors Provider

  3/24/2023

  Kymanox Corporation, a professional services company exclusively serving the life science industry, announced the acquisition of Agilis Consulting Group.

• FDA Roundup: March 24, 2023

  3/24/2023

  The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

• EMA Validates Marketing Authorization Application for Henlius' HANSIZHUANG (Serplulimab)

  3/23/2023

  Shanghai Henlius Biotech, Inc. (2696.HK) announced that the European Medicines Agency (EMA) has validated the application for its self-developed anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab), in combination with chemotherapy (carboplatin and etoposide), for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

• Rani Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results; Provides Corporate Update

  3/22/2023

  Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today reported financial results for the quarter and full year ended December 31, 2022 and provided a corporate update.

• Coya Therapeutics, Inc. Announces an Agreement with Dr. Reddy’s Laboratories, Ltd. to License its proposed biosimilar Abatacept for the Development and Commercialization of COYA 302 for the Treatment of Neurodegenerative Diseases

  3/20/2023

  Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing multiple therapeutic platforms intended to enhance Treg function, including biologics and cell therapies, today announced a worldwide agreement with Dr. Reddy’s Laboratories Limited.

• Vizient to Share Insights on Biosimilars at Festival of Biologics

  3/20/2023

  Vizient, Inc. announced today that Steven Lucio, PharmD, BCPS, senior principal, pharmacy solutions for Vizient, will share insights on biosimilars in the panel discussion, “Building the Sustainable Future of Biosimilars,” at the Festival of Biologics being held March 20-22 in San Diego.

• Innovent Announces Clinical Data of Multiple Trials Will be Presented at the AACR Annual Meeting 2023

  3/20/2023

  Innovent Biologics, Inc. ("Innovent") (HKEX: 01801) today announced that clinical data from multiple trials in relation to TYVYT® (sintilimab injection), Pemazyre® (pemigatinib) and IBI351 (KRASG12C inhibitor) will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2023 in Orlando, April 14 - 19, 2023.

• California Selects Civica Rx as Its Insulin Manufacturing Partner

  3/18/2023

  Civica Inc. announced it will manufacture insulins for the State of California’s CalRx Biosimilar Insulin Initiative as part of its insulin manufacturing work.

• Bimekizumab Phase 3 Data in Hidradenitis Suppurativa Show Clinically Meaningful, Deep and Maintained Response over 48 Weeks

  3/18/2023

  UCB, a global biopharmaceutical company, announced detailed positive results from two Phase 3 studies evaluating the efficacy and safety of bimekizumab in the treatment of adults with moderate to severe hidradenitis suppurativa.

• Aquavit Files Additional IND for DTX-024, a New Botulinum Toxin With Microchannel Technology™ for Palmar Hyperhidrosis

  3/18/2023

  Aquavit Holdings has submitted to FDA an IND for its DTX-024, for the treatment of palmar hyperhidrosis using its patented microchannel technology™.

• Samsung Bioepis Presents Phase 1 Study Results of SB17 (Ustekinumab), A Proposed Biosimilar to Stelara, at 2023 AAD Annual Meeting

  3/17/2023

  Samsung Bioepis Co., Ltd. today announced that SB17, a proposed biosimilar to Stelara 1  (ustekinumab), demonstrated pharmacokinetic (PK) bioequivalence and comparable safety, tolerability, and immunogenicity to reference ustekinumab in Phase 1 clinical study with healthy volunteers.

• Alvotech to Present Clinical Study Data for AVT04, a Proposed Biosimilar to Stelara®, at 2023 American Academy of Dermatology (AAD) Annual Meeting

  3/17/2023

  Alvotech (NASDAQ: ALVO) today announced the presentation of two posters related to its clinical studies in support of biosimilarity and clinical comparability of Alvotech’s ATV04 (ustekinumab) and the reference product Stelara® at the 2023 American Academy of Dermatology (AAD) Annual Meeting, March 17-21 in New Orleans.

• Phase 3 Study Shows XTANDI® (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer

  3/16/2023

  Pfizer Inc. and Astellas Pharma Inc. announced positive topline results from the Phase 3 EMBARK trial evaluating XTANDI® in men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence.

• Glenmark receives acceptance from U.S. FDA on its IND application for GRC 54276 to proceed with a Phase 1/2, first-in-human clinical study of the molecule for the treatment of patients with advanced solid tumors and lymphomas

  3/16/2023

  Glenmark Specialty SA, the subsidiary of Glenmark Pharmaceuticals Ltd., an innovation-driven, global pharmaceuticals company received acceptance from the U.S. Food and Drug Administration (FDA) on its Investigational New Drug (IND) application for GRC 54276 to proceed with a Phase 1/2, first-in-human, clinical study of GRC 54276 for the treatment of patients with advanced solid tumors and lymphomas.