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.

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Licensing Licensing Manufacturing Medicine 147

Pharmaceutical Technology

NOVEMBER 21, 2022

Manufacturing woes have affected both cell and gene-modified cell therapies in oncology recently, disadvantaging patients with multiple myeloma (MM) and melanoma. DELTA-1 is a Phase II single-arm trial in metastatic melanoma, evaluating the efficacy of ITIL-168 in patients who have progressed on previous therapy.

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Manufacturing Development Production Antibody 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

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.

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Licensing Licensing Clinical Trials Clinical Trials 130

Pharmaceutical Technology

APRIL 6, 2023

The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).

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FDA Approval Licensing Licensing Antibody 264

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. The VLA1553-321 trial, conducted in Brazil, was the first to assess the vaccine in an endemic region. Importantly, the vaccine was well tolerated, with no safety concerns identified during the trial.

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Immune Response Vaccination Vaccine Trials 59

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

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 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.

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Vaccination Vaccine Clinical Trials Clinical Trials 217

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. Logistics expertise.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Licensing 130

Fierce Pharma

JANUARY 9, 2024

But the Japanese company will have to clear up manufacturing issues first. The FDA has sent a complete response letter to Astellas, rejecting zolbetuximab because of unresolved deficiencies identified in a pre-license inspection of a third-party manufacturing facility.

Manufacturing 88

Manufacturing Antibody Licensing Licensing 88

pharmaphorum

JANUARY 12, 2021

ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio. The post Oral COVID-19 vaccine beckons, as ImmunityBio licenses iosBio tech appeared first on. Symvivo also has an oral candidate in a phase 1 study which started last November.

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Licensing Licensing Vaccination Vaccine 119

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.

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Development Engineer Clinical Trials Clinical Trials 264

Pharmaceutical Technology

MARCH 2, 2023

Additionally, due to the acquisition of Exelead, a biopharmaceutical contract development and manufacturing company, sales increased by 0.4%. Merck presented strong data in Healthcare from its 2022 pipeline about Phase II trials for xevinapant (head and neck cancer) and evobrutinib (multiple sclerosis). to €3.76bn, reflecting a 9.7%

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Sales Life Science Licensing Licensing 245

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

pharmaphorum

OCTOBER 27, 2021

Merck & Co has signed a licensing deal with the UN-backed Medicines Patent Pool (MPP) that could pave the way for generic companies to manufacture its much-anticipated oral antiviral for COVID-19. ” Under the agreement, MPP will sublicense manufacturing rights to other drugmakers.

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Licensing Licensing Manufacturing Clinical Trials 143

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

XTalks

JANUARY 29, 2021

This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. This means that sponsors are having to fork out for these blockbuster products in order to run their trials more often.

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Clinical Trials Clinical Trials Production Trials 104

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

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.

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pharmaphorum

OCTOBER 27, 2020

US biotech BioSig Technologies has abandoned a phase 2 trial of its antiviral drug merimepodib with Gilead’s Veklury in severe COVID-19 patients, after concluding the safety of the combination was in doubt. However the Grade 3 group had “markedly different outcomes… making it unlikely that the trial would meet its primary safety endpoints.”.

Drug Trials 98

Drug Trials Trials Drugs Contract Manufacturing 98

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

World of DTC Marketing

APRIL 12, 2021

A blood-thinning agent, heparin, had been adulterated due to the product license holder (Baxter) procuring a toxic substance that had been illegally substituted for the genuine registered material. We can’t continue to develop drugs the same way as we have done before. We need a 21st-century approach that puts patient safety first.

Generic Drugs 187

Generic Drugs Manufacturing Drugs Production 187

Pharmaceutical Technology

MAY 16, 2023

Emergent will also hand over San Diego, California-based research facilities (focused on the Chikungunya vaccine candidate), a Swiss-based biologics manufacturing facility, and the EU/US-based commercial operations. Following the completion of the deal, Bavarian Nordic now boasts the only oral vaccine licensed by the U.S.

Vaccination 130

Vaccination Vaccine Licensing Licensing 130

XTalks

MARCH 17, 2025

Roche, a global leader in biotechnology and diagnostics, has entered into an exclusive collaboration and licensing agreement with Zealand Pharma, a specialist in innovative therapeutics, to co-develop and co-commercialize petrelintide as a potential foundational therapy for people with overweight and obesity. billion $1.4 billion $1.4

Hormones 59

Hormones Drugs Sales Insulin 59

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

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. Patient Grant.

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Clinical Trials Clinical Trials Trials Clinical Research 98

pharmaphorum

DECEMBER 9, 2022

has announced that the pivotal phase 2 FELIX clinical trial of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult Acute Lymphoblastic Leukaemia (ALL) patients has met its primary endpoint of overall remission rate (ORR) at interim analysis. Autolus Therapeutic Plc. Syncona has agreed to invest circa $28 million (£22.9

Trials 98

Trials Clinical Trials Clinical Trials Gene Therapy 98

pharmaphorum

FEBRUARY 24, 2022

It is currently the only oral small molecule RAGE inhibitor in human clinical trials. According to Cantex, azeliragon has previously been tested for Alzheimer’s disease and diabetic nephropathy, where the drug demonstrated high levels of safety in phase 3 clinical trials involving more than 2,000 patients.

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Licensing Licensing Development Drugs 64

pharmaphorum

MARCH 19, 2021

DeepVerge has announced trial data showing its COVID-19 Microtox BT breath test can deliver accurate results in under 60 seconds, with a potential roll-out later this year if further tests support it. It has licensed in a patented breathalyser, the analysts noted. A large clinical trial is ongoing in Dubai.

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Contamination Clinical Trials Clinical Trials Protein 145

pharmaphorum

AUGUST 25, 2020

The first patients have been dosed in a trial of two AstraZeneca antibodies, collectively known as AZD7442, that are being developed to both treat and prevent coronavirus infections. The phase 1 trial – funded by the US government – will take place in the UK and will test the safety of AZD7442 and its pharmacokinetic profile.

Antibody 84

Antibody Trials Trial Funding Licensing 84

XTalks

APRIL 24, 2023

Rare disease clinical trials are complex due to the additional scientific, medical, operational and regulatory requirements of newly emerging advanced therapies, such as gene therapy,” says Dr. Terence Eagleton, MB BS, Senior Medical Director at the global clinical research organization (CRO) Medpace. Reference: Chung DC, et al.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

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.

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Licensing Licensing Manufacturing Clinical Trials 105

Pharmaceutical Technology

AUGUST 23, 2022

The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. A clinical trial of the vaccine to assess its safety, tolerability and immunogenicity in people aged 12 years and above is anticipated to commence this month. 1-adapted vaccine. On obtaining the FDA EUA, the Omicron BA.4/BA.5-adapted

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Vaccination Vaccine Gene Therapy Protein 130

Pharmaceutical Technology

MARCH 31, 2023

On March 30, ViiV Healthcare and Medicines Patent Pool (MPP), announced sublicensing agreements with the pharma manufacturers Aurobindo , Cipla and Viatris to produce generic forms of the long-acting cabotegravir used as pre-exposure prophylaxis (PrEP) for HIV. Truvada is a combination of emtricitabine and tenofovir disoproxil fumarate.

Medicine 130

Medicine Manufacturing Pharma Companies Licensing 130

The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Few details of the deal were disclosed in the announcement. Vivity received FDA approval in February 2020.

Licensing 52

Licensing Licensing Protein Antibody 52

The Pharma Data

SEPTEMBER 6, 2021

Takeda today announced that the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) will purchase 150 million doses of Novavax’ vaccine candidate (TAK-019 in Japan) manufactured in Japan by Takeda subject to licensing and approval. The details of the terms and conditions of the agreement are confidential.

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Manufacturing Vaccination Vaccine Clinical Trials 52