Biopharma LLC

GC Biopharma Announces US FDA Approval for ALYGLO™ (Immune Globulin Intravenous, Human-stwk) 10% Liquid for Adults with Primary Humoral Immunodeficiency (PI)

Retrieved on: 
Monday, December 18, 2023
Frontiers in Cardiovascular Medicine, GC, Safety, Food, PI, Ageing, Infection, US Foods, Xia, Immunodeficiency, Clinical trial, CEX, Patient, Liquid, Indian stock exchange, Biopharma LLC, FDA, Palm Beach International Airport, Trial of the century, Diagnosis, Frontiers, Hospital, Cardiology, ASBIS, Pharmaceutical industry, Medical device, Immunology

The ALYGLO pivotal phase 3 clinical study followed FDA guidance for the treatment of patients with PI.

Key Points: 
  • The ALYGLO pivotal phase 3 clinical study followed FDA guidance for the treatment of patients with PI.
  • ­­The results of the phase 3 trial by GC Biopharma are published in Frontiers in Immunology (2021).
  • Dr. Eun-chul Huh, President and CEO of GC Biopharma, said, "The approval of ALYGLO by the US FDA is a significant milestone for GC Biopharma and patients with primary immunodeficiency disease.
  • For any medical or scientific questions regarding ALYGLO, call the GC Biopharma USA medical department at 1-833-426-6426, or email [email protected] .

GC Biopharma USA Announces Publication Describing Proprietary Cation Exchange Chromatography (CEX) Removing FXIa from a 10% Intravenous Immunoglobulin (GC5107) Preparation

Retrieved on: 
Tuesday, December 5, 2023
Frontiers in Cardiovascular Medicine, GC, Safety, Plasma, Kidney disease, Immobilization, CEX, Hemorheology, Patient, Biopharma LLC, IVIG, Manuscript, Cardiology, Pharmaceutical industry

TEANECK, N.J., Dec. 5, 2023 /PRNewswire/ -- GC Biopharma USA announced that a manuscript describing its landmark CEX technology, which removes FXIa from its 10% intravenous immunoglobulin (IVIG) preparation (GC5107), was published in Frontiers in Cardiovascular Medicine.

Key Points: 
  • TEANECK, N.J., Dec. 5, 2023 /PRNewswire/ -- GC Biopharma USA announced that a manuscript describing its landmark CEX technology, which removes FXIa from its 10% intravenous immunoglobulin (IVIG) preparation (GC5107), was published in Frontiers in Cardiovascular Medicine.
  • Numerous licensed IG products formulated for intravenous (IV) or subcutaneous administration are available.
  • GC Biopharma USA's rigorous studies have confirmed that a novel 10% IVIG manufacturing process, including CEX chromatography, is a reliable means of removing FXIa from the final preparation.
  • It is hoped that this novel proprietary manufacturing process will further support the product's safety—especially for high-risk patients who require IVIG.

Stratevi Launches Novel Software Platform - StrateFlow™ - specifically designed for HEOR, Medical and Access Departments within the BioPharma Industry.

Retrieved on: 
Friday, November 10, 2023
Biopharma LLC, Medicine, Mathematical optimization, HTA, Communication, CCO, Access, Risk management

SANTA MONICA, Calif., Nov. 9, 2023 /PRNewswire-PRWeb/ -- Stratevi LLC, an integrated, health economics, outcomes research, pricing and market access consulting firm is excited to announce the launch of StrateFlow, a custom-built software solution that helps HEOR, Medical and Access teams juggle priorities and enables project management and stakeholder alignment.

Key Points: 
  • With the addition of StrateFlow, Stratevi is able to further support clients as they navigate their evidence and access needs.
  • We believe StrateFlow specifically addresses key unmet evidence and access needs for HEOR, Medical and Access teams in BioPharma and will make our clients' work lives easier and more impactful.
  • "Having worked with many biopharma manufacturers of various sizes since starting Stratevi 8 years ago, we have come to understand some of their pain points.
  • Consistent among these have been the challenges of navigating and managing evidence generation and communication needs.

ADMA Biologics Announces Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, November 8, 2023
Adjustment, FDA, Growth, Immunodeficiency, Plasma, FY, Abu Dhabi Medical Congress, Food, PIN, RVI, Urinary tract infection, Mortality, EBITDA, Conference, Biopharma LLC, GAAP, Doctor of Philosophy, Net income, Licensure, Borescope, Marketing, Master of Science, Total revenue, Infection, ADMA, Collection, Patient, Food and Drug Administration, Increase, San Jose BioCenter, Bookkeeping, Fine chemical, Pharmaceutical industry, Beauty salon, Video game, MD

ET

Key Points: 
  • ET
    RAMSEY, N.J. and BOCA RATON, Fla., Nov. 08, 2023 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty plasma-derived biologics, today announced its third quarter 2023 financial results and provided a business update.
  • Third Quarter 2023 Milestones & Objectives:
    Increased Revenue Guidance for Full Years (FY) 2023, 2024, and 2025.
  • 2023 & Long-Term Financial Guidance:
    Updated 2023 Financial Guidance: ADMA now anticipates FY 2023 total revenues to exceed $250 million, increased from $240 million previously.
  • As a result, ADMA achieved a gross margin of 36.6% in the third quarter of 2023 as compared to 23.5% in the third quarter of 2022.

IDEOlogy Health Appoints Sandra Park as General Counsel and Chief Compliance Officer

Retrieved on: 
Monday, November 6, 2023
FDA, Assistant, Physician, Publication, Ideology, Biopharma LLC, University of North Carolina, Chapel Hill, George Mason University, Pharmacy, University, Genentech, General counsel, Pharmaceutical industry

AUSTIN, Texas, Nov. 6, 2023 /PRNewswire/ -- IDEOlogy Health, a leading medical education company, announced that Sandra Park will join the company as General Counsel and Chief Compliance Officer effective today.

Key Points: 
  • AUSTIN, Texas, Nov. 6, 2023 /PRNewswire/ -- IDEOlogy Health, a leading medical education company, announced that Sandra Park will join the company as General Counsel and Chief Compliance Officer effective today.
  • Sandra will lead the legal and compliance functions for IDEOlogy Health, providing internal stakeholders with strategic and solutions-oriented advice and legal direction.
  • "I am thrilled to join IDEOlogy's mission in providing unbiased medical information to their network of physicians," said Sandra Park.
  • Prior to Kite, Sandra served as Assistant General Counsel at Genentech, Regulatory Counsel at the FDA, and outside counsel for a wide variety of healthcare clients.

Avantor Inaugurates Expanded Singapore Hub

Retrieved on: 
Tuesday, July 11, 2023
CGMP, EVP, NYSE, AVTR, SVP, Senior, EDB, Drug discovery, Head, Infrastructure Investment Facilitation Company, The Singapore Economic Review, Airline, Avantor, Biopharma LLC

Avantor today officially inaugurated its expanded Singapore Manufacturing & Distribution Hub.

Key Points: 
  • Avantor today officially inaugurated its expanded Singapore Manufacturing & Distribution Hub.
  • Standing from left to right: Christophe Couturier (EVP, Asia Middle East Africa, Avantor), Elaine Teo (SVP & Head, Investment Facilitation, Singapore EDB) and Narayana Rao Rapolu (VP, Biopharma, Asia Middle East Africa, Avantor).
  • Avantor's expanded Singapore Hub to bolster Asia Pacifics Biopharma ecosystem with enhanced manufacturing and distribution.
  • "Avantor's latest expansion of its Singapore hub enhances the supply of key materials and services required by biopharma manufacturers in Singapore and the region.

Press Release: Sanofi Enters Next Chapter of Play to Win Strategy

Retrieved on: 
Friday, October 27, 2023
Science, Q&A, Policy, McNeil Consumer Healthcare, Vaccine, TNF inhibitor, General Medicine Faculty of RostGMU (Rostov State Medical University), B Corporation (certification), Development, CHC, Information technology, Biopharma LLC, Growth, EPS, Medicine, Business, Research and development, Reward, Investment, Patient, Fine chemical, Pharmaceutical industry, Renewable energy, Research, Sanofi

Sanofi today provided a comprehensive update regarding its Play to Win strategy.

Key Points: 
  • Sanofi today provided a comprehensive update regarding its Play to Win strategy.
  • To that end, Sanofi announced plans to increase its R&D investments to fully realize its pipeline potential, drive long-term growth and enhance shareholder value.
  • Sanofi reiterates its financial guidance for 2023 and provides a preliminary outlook for 2024 and 2025 that reflects this new chapter of its strategy.
  • In this new chapter of our strategy, we are deepening our investment in R&D, taking steps toward becoming a pure play biopharma company, and further optimizing our cost structure.

Genexine and KGbio received the first market approval for novel long-acting Erythropoietin, Efepoetin alfa, from The Indonesian Food and Drug Authority (BPOM)

Retrieved on: 
Monday, October 23, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Biopharma LLC, EPO, Ministry, Chronic kidney disease, Dialysis, PT, Anemia, Roche, CKD, Safety, Patient, Pharmaceutical industry, Medical device, Food, Korean

This milestone marks the first market approval for a drug originating from Genexine's research and development with KGbio.

Key Points: 
  • This milestone marks the first market approval for a drug originating from Genexine's research and development with KGbio.
  • Genexine, in collaboration with KGbio, has been co-developing Efepoetin alfa for CKD patients in both non-dialysis and dialysis settings.
  • Furthermore, a multinational Phase 3 clinical trial targeting dialysis patients is set to commence in the Q4 of 2023, spearheaded by Genexine and KGbio.
  • In 2020, Genexine and KGbio initiated phase 3 clinical trials for non-dialysis patients in a multinational setting, spanning seven countries across Asia and Oceania.

Horizon Therapeutics plc Ranks Number One on the Fortune Best Workplaces in Biopharma 2023 List

Retrieved on: 
Tuesday, September 19, 2023
Biotechnology, Pharmaceutical, Health, Patient, Great Places, 100 Best Workplaces in Europe, Workplace, Management, Biopharma LLC

1 on the Fortune Best Workplaces in Biopharma 2023 list in the large company category.

Key Points: 
  • 1 on the Fortune Best Workplaces in Biopharma 2023 list in the large company category.
  • This is the seventh consecutive year Horizon has been named to the list and the company’s fourth time ranking No.
  • 1 Best Workplace in Biopharma for the third consecutive year,” said Tim Walbert, chairman, president and chief executive officer, Horizon.
  • Great Place to Work, the global authority on workplace culture, selected the list using rigorous analytics and confidential employee feedback.

Deloitte Digital and Salesforce Join Forces to Accelerate Innovation for the BioPharma Industry

Retrieved on: 
Wednesday, September 13, 2023
Cloud, Culture, Salesforce, Research, Multimedia, Biopharma LLC, Marketing, Creativity, Organization, Pioneer, Trust, GM, Patient, CRM, Digital, AI, Health, SVP, Pharmaceutical industry, Accounting

NEW YORK, Sept. 13, 2023 /PRNewswire/ -- Today, Deloitte Digital and Salesforce announced plans to accelerate CRM innovation for the BioPharma industry. As this sector rapidly evolves, legacy platforms struggle to keep pace, hampering progress and innovation. Informed by Deloitte Digital's deep life sciences and health care experience serving clients around the world and Salesforce's CRM technology, the two organizations intend to develop new solutions to advance BioPharma innovation.

Key Points: 
  • With Deloitte Digital's BioPharma industry knowledge and Salesforce technology, both companies will work together on new innovations to help pharmaceutical companies bring innovative therapies to patients faster
    NEW YORK, Sept. 13, 2023 /PRNewswire/ -- Today, Deloitte Digital and Salesforce announced plans to accelerate CRM innovation for the BioPharma industry.
  • Brett Davis, Deloitte's chief innovation officer, highlights the urgency of modernization, "BioPharma is experiencing groundbreaking advancements in treatments and personalized medicine.
  • Deloitte and Salesforce's collaboration will empower BioPharma firms to bring innovative therapies to patients faster.
  • "Our deep understanding of BioPharma positions us as valuable contributors to this collaboration," said David Rosner, Deloitte Digital life sciences leader.