Pharmaceutical Technology

JUNE 30, 2022

In the wake of Russia’s invasion of Ukraine, sponsors are increasingly evaluating other European countries to conduct their clinical trials. Among them, the Eastern European nation of Georgia has emerged as a key rescue country for multinational clinical trials that were put on hold due to the war. Room to grow.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Licensing 130

Pharmaceutical Technology

OCTOBER 4, 2022

It will allow MPP to enable further manufacturing and supply of ensitrelvir following authorisation or approval from respective regulatory agencies. Under the deal, MPP granted sublicences to eligible generic manufacturers to produce and deliver ensitrelvir to 117 countries.

Licensing 147

Licensing Licensing Manufacturing Medicine 147

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 16, 2023

At least seven more pharma companies and a federation of pharma manufacturers have approached the Delhi High Court against the Central Government’s order in the beginning of June prohibiting manufacturing, distribution and sale of 14 fixed dose combinations (FDCs) licensed prior to the year 1988.

Pharma Companies 188

Pharma Companies Licensing Licensing Manufacturing 188

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 22, 2023

The point of contention, they pinpoint, is that if any retailer and manufacturer fails to display the license in a prominent place and is not conspicuous to the public, it amounts to violation of the […]

Drugs 188

Drugs Licensing Licensing Manufacturing 188

Pharmaceutical Technology

JUNE 19, 2023

Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. Bio-Thera will handle BAT2206’s global development and commercial supply out of its manufacturing plants in Guangzhou, China.

Licensing 130

Licensing Licensing Clinical Trials Clinical Trials 130

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 11, 2023

The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June. […]

Pharma Companies 186

Pharma Companies Licensing Licensing Sales 186

Pharmaceutical Technology

DECEMBER 19, 2022

Initially, the companies signed a research collaboration and licensing agreement in 2016 to develop and assess up to two bispecific NK cell engagers. These two molecules are presently being analysed by the research and development (R&D) team of Sanofi, with one currently being evaluated in clinical trials.

Development 264

Development Engineer Clinical Trials Clinical Trials 264

Cloudbyz

MAY 11, 2023

Clinical trials play a vital role in bringing new therapies and treatments to patients, but they can be expensive and resource-intensive endeavors. Understanding the factors driving clinical trial costs is essential for researchers, sponsors, and other stakeholders involved in the drug development process.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Compliance 98

Pharmaceutical Technology

OCTOBER 25, 2022

There are options in the future to possibly apply the worldwide research and development (R&D), manufacturing and marketing expertise of Astellas in gene therapy to AAV gene therapy development programmes of Taysha for genetic ailments of the central nervous system (CNS).

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

Clinical Trial Podcast

JULY 18, 2020

Have you been tasked to develop a clinical trial budget? Well, you’re in luck because I’m going to share everything you need to know about clinical trial costs. Clinical trial budgets are often put together in haste. Developing a clinical trial budget can be a confusing exercise for sponsors and CROs.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

Pharmaceutical Technology

DECEMBER 2, 2022

Under the Mission COVID Suraksha Program, DBT, the Indian Government and BIRAC provided funding for the development and clinical trials of the vaccine. Phase III trials of BBV154 were conducted to evaluate its safety and immunogenicity in approximately 3100 participants in 14 trial sites across the country.

Vaccination 217

Vaccination Vaccine Clinical Trials Clinical Trials 217

XTalks

AUGUST 25, 2020

Business as usual is anything but in the COVID-19 era, but as the pharmaceutical and clinical trials industries adjust, the US Food and Drug Administration (FDA) has received an influx of questions regarding site inspections and manufacturing-related queries. Impact of COVID-19 on FDA Inspections. Pharmaceutical Safety Concerns.

Manufacturing 89

Manufacturing Clinical Trials Clinical Trials Production 89

XTalks

JANUARY 22, 2025

IXCHIQ is the only licensed chikungunya vaccine in the US for adults aged 18 and older at increased risk of exposure to the virus. Importantly, the vaccine was well tolerated, with no safety concerns identified during the trial. Following the announcement, Valnevas stock rose by 1.4%. The findings reveal a remarkable 98.3%

Immune Response 59

Immune Response Vaccination Vaccine Trials 59

The Pharma Data

OCTOBER 19, 2020

manufacturer, Pharmaceutics International, Inc. (“Pii”), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable.

Clinical Trials 52

Clinical Trials Clinical Trials Manufacturing Trials 52

Pharmaceutical Technology

JUNE 2, 2023

It also noted that the combination of the company’s development and manufacturing capabilities and the Synaffix ADC technology platform will offer a comprehensive service for customers and licensees to quickly discover, develop, scale up and commercialise new ADCs.

Licensing 130

Licensing Licensing Gene Therapy Clinical Trials 130

Pharmaceutical Technology

JANUARY 19, 2023

The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial. It has been developed using the company’s recombinant nanoparticle technology.

Vaccination 147

Vaccination Vaccine Immune Response Protein 147

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

Pharma Business Blog

MARCH 15, 2023

Dears Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact: 1. The CTIS database is publicly available and leads to increased transparency for indirect tax & pharma regulatory licensing. •

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Cloudbyz

MAY 1, 2023

Clinical trial budget management is a complex yet crucial aspect of conducting a successful clinical trial. One of the most challenging tasks for project managers and sponsors is to identify and account for all possible costs, including hidden ones, to ensure that the trial runs smoothly and within budget.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Packaging 52

CTTI (Clinical Trials Transformation Initiative)

DECEMBER 3, 2024

Through this project, CTTI will clarify the needs and expectations of clinical trial partner groups and facilitate unified, action-focused engagement to support the development and execution of trials that recruit, retain, and enroll a diverse, representative patient population.

Clinical Trials 53

Clinical Trials Clinical Trials Trials Development 53

Pharmaceutical Technology

AUGUST 23, 2022

The submission comes after the regulatory agency provided guidance to incorporate clinical findings of the bivalent Omicron BA.1-adapted The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 1-adapted vaccine. On obtaining the FDA EUA, the Omicron BA.4/BA.5-adapted

Vaccination 130

Vaccination Vaccine Gene Therapy Protein 130

The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About BioInvent.

Antibody 52

Antibody Manufacturing Clinical Trials Clinical Trials 52

pharmaphorum

OCTOBER 12, 2021

Usually used to treat rheumatoid arthritis, Actemra was granted emergency approval in June for hospitalised patients 2 years of age and older who are receiving systemic corticosteroids and need respiratory support after it was shown to reduce mortality in a clinical trial.

Licensing 105

Licensing Licensing Manufacturing Clinical Trials 105

pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

Antibody 98

Antibody Trials Licensing Licensing 98

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. Th e first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of inf lu enza vaccines. JUNE 22 , 2021.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

The Pharma Data

JANUARY 6, 2021

a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. Under the terms of the agreement, ImaginAb will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinical trials. LOS ANGELES , Jan.

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

Pharmaceutical Technology

JUNE 10, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Puma in-licenses its drug candidates and advances its development through clinical testing and for commercial use. The drug candidate is administered through oral route.

Drugs 100

Drugs Clinical Trials Clinical Trials Licensing 100

Pharmaceutical Technology

JUNE 10, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Puma in-licenses its drug candidates and advances its development through clinical testing and for commercial use. The drug candidate is administered through oral route.

Drugs 100

Drugs Clinical Trials Clinical Trials Licensing 100

The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. Specifically, the FDA requested that Gamida Cell demonstrate analytical and clinical comparability from the company’s planned commercial manufacturing sites.

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

pharmaphorum

NOVEMBER 2, 2020

Allogeneic, or ‘off the shelf’, cell therapies are derived from banks of cells, and potentially offer the therapeutic benefits seen with autologous cell therapies derived from a patient’s own bodies but without the complex, costly and lengthy manufacturing process.

Life Science 98

Life Science Manufacturing Clinical Trials Clinical Trials 98

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. A 351(K) application must include information explaining that the biosimilarity is completely based on the data related to animal studies, clinical studies, and analytical studies.

Development 161

Development Production Immune Response Licensing 161

Pharmaceutical Technology

MARCH 1, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Pharmacy 100

Pharmacy Production Development Clinical Trials 100

Pharmaceutical Technology

APRIL 6, 2023

AAV is used in hundreds of active clinical trials, and is described as the preferred viral vector for gene therapy. These capsids are available both for licensing and broader partnership. Ginkgo will also receive StrideBio’s existing library of capsids.

Engineer 130

Engineer Gene Therapy Gene Manufacturing 130

The Pharma Data

MAY 7, 2021

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

Licensing 52

Licensing Licensing Vaccination Vaccine 52

The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.

Licensing 52

Licensing Licensing Vaccination Vaccine 52

Pharmaceutical Technology

JANUARY 2, 2023

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. It is developed based on MyoKardia's drug discovery platform. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects.

Drugs 100

Drugs Development Production Pharmacy 100