GMP

Branded Legacy, Inc. Significantly Expands Asset Portfolio and Production Capacity Through Successful Acquisition of Sycamore BioPharma, Inc.

Retrieved on: 
Tuesday, March 12, 2024
Sycamore, Editor-in-chief, Growth, PHD, Biotechnology, Drug discovery, Patient, Research, Environmental technology, Acquisition, Cancer, Mentorship, DSM-IV codes, University, GMP, Clinical trial, Infection, Medical school, Adjunct, PharmaMar, Biomedical sciences, Family, Marketing, FDA, Biochimica et Biophysica Acta, Pharmaceutical industry

MELBOURNE, Fla., March 12, 2024 /PRNewswire/ -- Branded Legacy (OTC.PK: BLEG), Inc., a trailblazing BioTech holdings company, proudly announces the strategic acquisition of Sycamore BioPharma, Inc, a distinguished developer of plant-based pharmaceuticals. This strategic milestone not only fortifies Branded Legacy's standing as a prominent player in the biotech sector but also secures assets exceeding $2 million, along with key personnel crucial for advancing clinical trials following this successful union.

Key Points: 
  • The acquisition brings forth over $500,000 in high-quality, ready-to-sell inventory and aligns seamlessly with Branded Legacy's dedication to quality, authenticity, and a commitment to natural ingredients.
  • David Oswald, CEO at Branded Legacy, Inc., expresses enthusiasm about the acquisition, stating, "Branded Legacy is thrilled to embrace Sycamore BioPharma into our family of companies.
  • Tyler Stone, President of Sycamore Biopharma, Inc., is also enthusiastic about the acquisition stating, "Branded Legacy brings significant strengths in areas where Sycamore BioPharma was seeing significant challenges.
  • The collaboration between Branded Legacy and Sycamore BioPharma is poised to unlock synergies across various business facets.

Alcami Partners with Tanvex CDMO to Offer a Complete Solution for Biologics Developers

Retrieved on: 
Tuesday, March 12, 2024
Partnership, Therapy, Patient, GMP, CDMO, Organization, Pharmaceutical industry

DURHAM, N.C., March 12, 2024 /PRNewswire/ -- Alcami Corporation ("Alcami"), a leading contract development and manufacturing organization (CDMO), today announced a new strategic partnership with Tanvex CDMO , a biologics developer offering pre-clinical to commercial biologic CDMO services.

Key Points: 
  • DURHAM, N.C., March 12, 2024 /PRNewswire/ -- Alcami Corporation ("Alcami"), a leading contract development and manufacturing organization (CDMO), today announced a new strategic partnership with Tanvex CDMO , a biologics developer offering pre-clinical to commercial biologic CDMO services.
  • Through the collaboration, Alcami and Tanvex can now offer clients a complete solution from bulk drug substance production through to finished drug product, pairing Alcami's expertise in liquid and lyophilization sterile filling, packaging, and labeling with Tanvex's high-throughput bulk drug substance development and manufacturing services.
  • "Tanvex is excited to announce our partnership with the team at Alcami.
  • "By combining our deep biologics development and manufacturing expertise, we expect the relationship will expedite the biologics drug development and manufacturing timeline for our clients."

Antibody-Drug Conjugates: Next-Generation Linker Technology for IND Submissions, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Tuesday, March 12, 2024
IND, Science, GMP, SVP, ADC, Drug design, Safety

TORONTO, March 12, 2024 /PRNewswire-PRWeb/ -- Progressing new bioconjugates or antibody-drug conjugates (ADC) forward from discovery to the investigational new drug (IND) submission stage can be a challenging and cumbersome process. The complexity of drug design as well as the extensive technical, safety, stability and scalability challenges — especially when it comes to the linker — makes it incredibly difficult for developers to navigate the development pathway with speed and ease while still ensuring an effective, high-quality product.

Key Points: 
  • In this free webinar, gain insights into designing and developing a bioconjugate or antibody-drug conjugates (ADC).
  • Attendees will learn about the impactful role of linker technologies in accelerating and de-risking the development process.
  • The featured speakers will discuss how to maximize payload potential via site-specific conjugation.
  • Register for this webinar today to gain insights into designing and developing a bioconjugate or ADC and the impactful role of linker technologies in accelerating and de-risking the development process.

TechInvention Lifecare announces the ground breaking of its state-of-the-art Global Collaborative Centre for Medical Countermeasures

Retrieved on: 
Wednesday, February 28, 2024
CEPI, GMP, Global health, One Health, GCMC, Environmental health, Organization, IP, WHO, Research, Vaccine

MUMBAI, INDIA, Feb 28, 2024 - (ACN Newswire) - In a significant stride towards enhancing global health security and pandemic preparedness, TechInvention Lifecare Pvt.

Key Points: 
  • MUMBAI, INDIA, Feb 28, 2024 - (ACN Newswire) - In a significant stride towards enhancing global health security and pandemic preparedness, TechInvention Lifecare Pvt.
  • Ltd. is proud to announce the ground breaking of its Global Collaborative Centre for Medical Countermeasures (GCMC) with an investment of approx.
  • The centre is strategically located close to the upcoming international airport in Navi Mumbai, India.
  • GCMC has been acknowledged for its global significance at the 2nd World Local Production Forum in The Hague on 6-8 November 2023, organized by the WHO.

PharmAla Announces Voting Results of Annual General and Special Meeting of Shareholders and Provides Corporate Update

Retrieved on: 
Friday, March 8, 2024
MDXX, Circular, RSU, Meeting, Red light, OTC, GMP, Chairperson, MDMA, Consultant, Indian stock exchange, Chartered Professional Accountant, RLH, Continuance, Research

The Company is pleased to announce the voting results from its annual general and special meeting of the shareholders of the Company (“Shareholders”) held on Tuesday, February 27, 2024 (the “Meeting”).

Key Points: 
  • The Company is pleased to announce the voting results from its annual general and special meeting of the shareholders of the Company (“Shareholders”) held on Tuesday, February 27, 2024 (the “Meeting”).
  • Shareholders voted in favour of each resolution put forth at the Meeting.
  • “PharmAla continues to make the important choices necessary for the future of both our business, and the Psychedelic Pharmaceuticals sector more broadly,” said Jodi Butts, Board Chair, PharmAla Biotech.
  • “We are grateful that PharmAla’s shareholders have agreed with management’s recommendations on a variety of timely corporate governance matters.

Plus Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

Retrieved on: 
Tuesday, March 5, 2024
Glioblastoma, Breast cancer, PSTV, Rhenium, Decompression (diving), FDA, Food, GMP, PD-1, Ependymoma, Conference, Safety, Plus Therapeutics, Respect, Therapy, Food and Drug Administration, Webcast, Patient, CSF, LM, PD-L1, Pharmaceutical industry

AUSTIN, Texas, March 05, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided an overview of recent and upcoming business highlights.

Key Points: 
  • ET
    AUSTIN, Texas, March 05, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV ) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided an overview of recent and upcoming business highlights.
  • Complete ReSPECT-LM Phase 1 dose escalation trial enrollment, determine the maximum tolerated dose, and recommended Phase 2 dose.
  • Implement Plus’ CNSide cerebral spinal fluid (CSF)-based tumor cell quantification assay as an exploratory clinical endpoint in all ReSPECT-LM trial patients in Q1 2024.
  • The Company will hold a conference call and live audio webcast at 5:00 pm Eastern Time today to discuss its financial results and provide a general business update.

Gritstone bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Tuesday, March 5, 2024
Human services, Research, Gritstone bio, NCI, Messenger, Immunotherapy, FDA, Food, SLATE, GMP, National Cancer Institute, Vaccine, Administration, Autumn, COVID-19, Collaboration, Patient, Clinical trial, Infection, IND, Development, Workforce, HIV, Pharmaceutical industry

EMERYVILLE, Calif., March 05, 2024 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided recent corporate and clinical updates.

Key Points: 
  • Positive signal in this metastatic context would likely unlock enormous opportunity in both adjuvant and metastatic solid tumors.
  • Gritstone met its enrollment target of 100 patients randomized in August 2023.
  • Cash, cash equivalents, marketable securities and restricted cash were $86.9 million as of December 31, 2023, compared to $185.2 million as of December 31, 2022.
  • Research and development expenses were $127.2 million for the year ended December 31, 2023 compared to $111.4 million for the year ended December 31, 2022.

BellaSeno’s 3D-printed Resorbable Scaffold Successfully Used in Critical-Size Large Segmental Radius Bone Defect at Hannover Medical School

Retrieved on: 
Tuesday, March 5, 2024
Paper, ISO, CMO, Infection, RIA, BlackBerry Priv, GMP, PCL, Hannover Medical School, Patient, Anatomy, Medtech, Fracture, Dentistry

-- Recently published as a case report in the Journal of Personalized Medicine

Key Points: 
  • Philipp Mommsen, successfully used a customized, resorbable bone replacement scaffold produced by BellaSeno to reconstruct a 14 cm segmental bone defect of the radial shaft after third degree open infected fracture due to traumatic gunshot injury.
  • Following six further operations and systemic antibiotic treatment to achieve bacterial eradication of the surgical field, bone reconstructive surgery was performed at Hannover Medical School using BellaSeno’s resorbable scaffold in conjunction with an autologous bone graft from the medullary cavity of the femoral bone.
  • Philipp Mommsen, Managing Senior Physician, Clinic for Trauma Surgery at Hannover Medical School and lead author of the paper.
  • “Using one of our scaffolds, the outstanding team at Hannover Medical School was able to perform the reconstruction of such an extensive radial shaft bone while ensuring immediate vascularization.

CytoMed Therapeutics Limited Announces Research Collaboration with Singapore Sengkang General Hospital to Advance Injectable Umbilical Cord-Derived Mesenchymal Stem Cells for Cartilage Diseases and Repair

Retrieved on: 
Monday, March 4, 2024
IIT, Regenerative medicine, Research, Microsoft Exchange Server, News, Ageing, Cancer, GMP, Cartilage, Cell, National University Hospital, SingHealth, SKH, B cell, Safety, UC, Transplant, Knee, Patient, Clinical trial, Osteoarthritis, MSC, Umbilical cord, RCA, Pharmaceutical industry

Osteoarthritis of the knee is a debilitating disease affecting Singapore’s aging population and the clinical trial will pioneer stem cell use for regenerative medicine in Singapore.

Key Points: 
  • Osteoarthritis of the knee is a debilitating disease affecting Singapore’s aging population and the clinical trial will pioneer stem cell use for regenerative medicine in Singapore.
  • UC-MSCs are a type of adult stem cells that can be isolated from the umbilical cord tissue after childbirth.
  • UC-MSCs are considered multipotent and are able to differentiate into different cell types, including bone, cartilage, fat, and muscle cells.
  • "Our collaboration with CytoMed marks a significant step in advancing research on allogeneic in-vivo UC-MSC for cartilage repair, including osteoarthritis of the knee.

HYTN Clears PIC/S GMP Audit, Primed for Global Expansion

Retrieved on: 
Monday, March 4, 2024
TGA, Growth, PIC/S, GMP, Psilocybin, Therapeutic Goods Administration, Certification, THC, Cannabis, Drink, Partnership

The positive outcome of the audit has set the stage for the subsequent issuance of formal GMP certification allowing the company to access international medical markets.

Key Points: 
  • The positive outcome of the audit has set the stage for the subsequent issuance of formal GMP certification allowing the company to access international medical markets.
  • The GMP audit conducted by the TGA was performed in accordance with the standards of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme ("PIC/S").
  • Once issued, GMP certification under the PIC/S framework allows HYTN to engage with international medical markets that recognize the PIC/S standard, through established reciprocal agreements.
  • This step also allows us to elevate our existing systems, bringing our current and future product offerings into compliance with GMP standards.”