Pharmaceutical Technology

JUNE 9, 2023

The therapy showed that it can inhibit the production of cytokine from both CD4+ T cells and ILC2, and completely suppressed skin allergic reactions in a monkey model in pre-clinical trials. A new recombinant fully human immunoglobulin G1 monoclonal antibody, UPB-101, is now being evaluated in a Phase 1b trial to treat asthma.

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Pharma Mirror

MARCH 29, 2022

NIEL, BELGIUM, eTheRNA Manufacturing, a specialist RNA process developer and manufacturing member of the Belgian eTheRNA group, is introducing a new Lipid Nanoparticle (LNP) formulation development and production service to support the discovery and early pre-clinical development of RNA-based therapeutics and vaccines.

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Pharma Mirror

JUNE 23, 2021

Vectura Group plc, an industry leading inhalation CDMO, today announced it has signed an agreement with Incannex Healthcare Limited, an Australian cannabinoid medicines development company, to provide pre-clinical development services for IHL-216A, Incannex’s proprietary inhaled drug product for the treatment of traumatic brain injury (TBI).

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Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

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BioTech 365

AUGUST 31, 2021

Bayer Starts Phase III Clinical Development Program OASIS With Investigational Product, Elinzanetant Bayer Starts Phase III Clinical Development Program OASIS With Investigational Product, Elinzanetant Elinzanetant is a non-hormonal development compound investigated for the treatment of vasomotor symptoms during menopause WHIPPANY, … Continue (..)

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Pharmaceutical Technology

MAY 2, 2023

Plus Therapeutics has expanded its partnership with Piramal Pharma Solutions (PPS) to produce additional cGMP liposome intermediate drug products. This will help to meet the rising demand for Plus Therapeutics’ lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, for clinical trials that are underway and planned.

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Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. It serves various markets including medical clinics and hospitals, pharmaceuticals, health information systems, dental and orthodontic practitioners.

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Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. It serves various markets including medical clinics and hospitals, pharmaceuticals, health information systems, dental and orthodontic practitioners.

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BioTech 365

DECEMBER 3, 2020

Moderna Provides Updates on the Clinical Development and Production of Its COVID-19 Vaccine Candidate Moderna Provides Updates on the Clinical Development and Production of Its COVID-19 Vaccine Candidate Interim durability data from NIH-led Phase 1 study of mRNA-1273 published as … Continue reading →

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BioPharma Reporter

OCTOBER 11, 2021

Samsung Biologics and Enzolytics have entered into a strategic CDMO partnership agreement targeting monoclonal antibody production.

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Outsourcing Pharma

DECEMBER 19, 2023

The US contract development and manufacturing organization (CDMO) Agno Pharma has taken over compatriot firm Lubrizol Particle Sciences to increase its drug product formulation offerings.

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BioPharma Reporter

MARCH 3, 2021

The number of advanced therapy medicinal product (ATMP) clinical trials in the UK continues to increase year on year with 154 ongoing trials observed in 2020, demonstrating the appeal of that market for the clinical development of ATMPs, shows a new report.

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Drug Discovery World

MAY 25, 2023

Several new products for the life sciences sector have been launched over the last month, from miniature semiconductor chip (MSC) technology to a new inhalation testing service. Astera Software: Astera API Management The new product is a no-code, automated, unified platform for complete API lifecycle management and integrations.

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pharmaphorum

DECEMBER 4, 2020

Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses.

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The Pharma Data

DECEMBER 14, 2020

AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. In parallel, AlgoTx firmed-up ATX01’s development pathway via a pre-IND consultation with the FDA and obtained an Orphan Drug Designation from the FDA to explore ATX01’s activity in erythromelalgia. Source link.

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Scienmag

SEPTEMBER 8, 2021

BORDEAUX & NARBONNE, France – The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) apply an aligned and complimentary mindset when advising the clinical development steps for live biotherapeutic products (LBPs), YSOPIA Bioscience and the Pharmabiotic Research Institute have found.

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BioSpace

SEPTEMBER 17, 2020

difficile infection through the final stages of clinical development and regulatory submission. The company plans to use the funds to advance its lead candidate CP101 for recurrent C.

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The Pharma Data

MARCH 23, 2022

Baynes, head of Global Clinical Development (GCD) and Chief Medical Officer, Merck Research Laboratories (MRL), will be retiring from Merck in July. He also led the expansion of Merck’s research and development in China and Japan. “It Eliav Barr, senior vice president, Global Clinical Development.

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Pharmaceutical Technology

APRIL 3, 2023

The agreement allows Ablaze to clinically develop and commercialise the drug in Greater China. It is based on RayzeBio’s specialisation in targeted radiotherapy (TRT) discovery and Ablaze’s know-how in therapeutic product clinical development, as well as on the radiopharmaceutical infrastructure in China.

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pharmaphorum

DECEMBER 7, 2020

China’s Sinovac has raised $515 million to increase its distribution and production capacity as clinical development of its potential coronavirus vaccine nears conclusion. Sinovac has a coronavirus vaccine in late-stage development, which is undergoing large-scale trials in Brazil, Pakistan, Indonesia and Chile.

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Pharmaceutical Technology

APRIL 21, 2023

Biotechnology company Enveda Biosciences has raised $51m in equity financing in a Series B1 round to advance several drug candidates to clinical development. Enveda Biosciences intends to use the additional financing to advance several candidates derived from its drug discovery platform to clinical development in 2023 and 2024.

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The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. You should not place undue reliance on these statements.

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BioTech 365

OCTOBER 15, 2020

GHENT, Belgium–(BUSINESS WIRE)–Confo Therapeutics today announced the selection of its first preclinical drug candidate, CFTX-1554, a compound designed to address peripheral neuropathic pain with the potential to address additional pain indications.

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Pharmaceutical Technology

MAY 9, 2023

The new deal, which does not include any initial consideration, will see FibroGen conducting and financing new research, development and production of FOR46 and PET46. FOR46 is a natural fit with our research and development capabilities and expertise.

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BioPharma Reporter

MARCH 17, 2021

Autolus Therapeutics is seeking a partner for clinical development of an ACE2 fusion soluble receptor decoy designed to work against SARS-CoV-2 and its variants.

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Pharmaceutical Technology

JUNE 13, 2023

ViXome is an acellular product derived from amniotic fluid. In pre-clinical testing, the therapy showed potent immunomodulatory and pro-reparative effects. We are eager to confirm our preclinical data in the clinic and expect to begin enrolling patients in Phase I during the second quarter of 2024.”

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Pharmaceutical Technology

AUGUST 30, 2022

Zerion Pharma has entered a partnership with Insud Pharma for the development and marketing of drug products using Zerion Pharma's solubility-boosting Dispersome technology. . Under the deal, Zerion will handle the development of Dispersome formulations of marketed drugs.

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The Pharma Data

NOVEMBER 30, 2020

Therefore, the Company has been working closely with the FDA to complete trial-initiation gating activities related to its commercial-scale production at FUJIFILM Diosynth Biotechnologies in Research Triangle Park, North Carolina. Novavax will use vaccine material produced at commercial scale for this trial. Novavax was awarded $1.6

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Pharmaceutical Technology

JUNE 28, 2022

Sutro will oversee the research and preclinical research to detect candidate compounds and subsequently Astellas will carry out the clinical development. As per the deal, Sutro is eligible to get $90m in upfront cash payment for developing iADCs for three biological targets.

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BioTech 365

AUGUST 20, 2020

New collection campaign to support future clinical development of microbiome biotherapeutic product portfolio and to supply the French compassionate use program in acute Graft-vs-Host-Disease (aGvHD) Planned initiation follows ANSM (French National Agency for the Safety of Medicines and Health Products) … Continue reading →

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Pharmaceutical Technology

MAY 17, 2023

They will also have the potential to treat diseases that are caused by too little protein by increasing production, thus restoring the protein to normal levels. The company will also be entitled to receive potential development and regulatory milestone payments, along with royalty payments.

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BioPharma Reporter

JUNE 25, 2021

Augmenta Bioworks and TFF Pharmaceuticals Inc have selected their first lead monoclonal antibody (mAb) for clinical development against COVID-19 as part of their collaborative alliance.

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The Pharma Data

SEPTEMBER 29, 2021

Healthy kidneys act as the body’s filter, removing waste products from the blood. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. In the U.S., 1 in 3 adults is at risk for the disease.

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BioPharma Reporter

APRIL 10, 2024

Elisa Cascade is the chief product officer at Advarra and is responsible for driving the clinical research company's technology product vision and management. We had a fascinating and inspiring conversation with her - touching on imposter syndrome, how to avoid suffering in silence and her 'just do it' mantra.

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The Pharma Data

NOVEMBER 29, 2020

Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. . ” About Ascletis.

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Pharmaceutical Technology

MAY 22, 2023

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma.

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Pharmaceutical Technology

JUNE 2, 2023

China’s National Medical Products Administration (NMPA) has granted regulatory approval to Amarin’s commercial partner EddingPharm (EDDING) for Vascepa (icosapent ethyl). The agreement obligates Amarin to provide developmental support and supply the finished bulk product.

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