Pharmaceutical Technology

JUNE 12, 2023

Six cannabinoids have recently completed or are undergoing Phase II trials. In 2022, Pfizer acquired the drug, with the promise of accelerating clinical development via new, differentiated, and best-in-class approaches, enhancing optimism for further drug development.

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Drugs Development Clinical Development Sales 358

Pharmaceutical Technology

OCTOBER 25, 2022

Understanding both the significant competitive advantages that FDC products can offer, and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Developing and manufacturing FDCs factors to consider.

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pharmaphorum

SEPTEMBER 4, 2020

Sanofi and GlaxoSmithKline have begun clinical trials of their coronavirus vaccine, as AstraZeneca expanded studies of its rival into Japan. They said the trials would involve 440 adults at 11 sites across the US. They are also scaling up manufacturing of the antigen and adjuvant, aiming to produce up to a billion doses in 2021.

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Clinical Trials Clinical Trials Vaccine Vaccination 106

Pharmaceutical Technology

NOVEMBER 25, 2022

PDF scale and reformulation challenge manufacturers. But the challenges for drug producers developing PDFs are numerous and varied. First and foremost, CDMOs must have expertise in formulation sciences and proven formulation success in clinical development and commercial approvals.

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Manufacturing Production Pharma Companies Development 130

Pharmaceutical Technology

OCTOBER 25, 2022

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

XTalks

FEBRUARY 24, 2025

Carlsbad, California-based Ionis Pharmaceuticals announced it will be sharing promising new trial data for its RNA-targeted prophylactic treatment donidalorsen for hereditary angioedema (HAE) at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in San Diego, California.

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Trials RNA Allergies Drugs 59

Pharmaceutical Technology

APRIL 13, 2023

FPI-2068 is a bispecific targeted alpha therapy (TAT) being jointly developed by Fusion and AstraZeneca under a multi-asset collaboration agreement. The therapy will be assessed in a Phase I trial. It will conduct the Phase I trial, while AstraZeneca will handle the subsequent clinical development of FPI-2068.

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Clinical Development Antibody Development Trials 147

pharmaphorum

APRIL 19, 2021

The UK’s unique offering as a life sciences research hub helped convince US biotech Novavax to develop its COVID-19 jab there, according to the head of the country’s Vaccines Taskforce. . If you look at the development, we signed 15,000 people in six weeks in a trial set up by the NHS.

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Vaccine Vaccination Manufacturing Clinical Development 141

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.

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Antibody Trials Licensing Licensing 98

Pharmaceutical Technology

MAY 26, 2023

At the moment, there are roughly 241 immuno-oncology agents that are studied across solid tumours, noted Chalk, adding that this is largely due to a large number of Phase I trials that are not cancer specific. There are about 149 cell therapies in Phase I trials now , with additional 146 in Phase II studies, noted Chalk.

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Marketing Vaccination Vaccine Development 264

pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.

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Vaccine Vaccination Trials Protein 104

Clinical Trial Podcast

SEPTEMBER 26, 2022

To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinical trials. Cohen has more than 30 years of healthcare experience which includes his work on clinical development. Cohen to the Clinical Trial Podcast.

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Clinical Trials Clinical Trials Trials Clinical Research 98

BioPharma Reporter

AUGUST 2, 2021

Arcturus Therapeutics and its Vietnam partner Vinbiocare will take ARCT-154, a next-generation Arcturus vaccine targeting SARS-CoV-2 variants of concern, into a Phase 1/2/3 trial. The companies will also establish a vaccine manufacturing centre in Vietnam.

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Vaccine Vaccination Trials Manufacturing 105

pharmaphorum

OCTOBER 20, 2020

The UK government has signed a contract to develop a controversial COVID-19 human challenge trial, where participants will be deliberately infected in a controlled environment with coronavirus to test whether a vaccine is effective. hVIVO will also be expanding its clinical operations in London to conduct the trial.

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Trials Vaccine Vaccination Clinical Development 98

Pharmaceutical Technology

MAY 2, 2023

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. Our services allow us to deliver solutions that benefit our partners and ultimately patients.”

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Production Drugs Clinical Trials Clinical Trials 130

Pharmaceutical Technology

JULY 7, 2022

But there are many challenges it will face along the way, such as how to manufacture these drugs in a reproducible, scalable, cost-effective, and safe way for patients. It is certainly a pivotal moment for the cell and gene industry, with the next decade of R&D and clinical trials expected to transform the future of medicine.

Gene Therapy 245

Gene Therapy Gene Medicine Genetics 245

Outsourcing Pharma

JANUARY 9, 2024

Equally, OSP was delighted to speak to him to discuss the evolution of data management in clinical development and how intelligent data use can reduce clinical trial cancellations, minimise protocol amendments, and accelerate patient recruitment. Gen Li is president and founder of Phesi.

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Clinical Development Development Clinical Trials Clinical Trials 59

XTalks

JANUARY 7, 2025

Medtronics Acquisition of Covidien Deal value : $43 billion Announced : June 2014 Closed : January 2015 In January 2015, Medtronic, a leading medtech company, acquired Covidien , an Ireland-based medical device manufacturer, in a deal worth approximately $43 billion, one of the largest to date. billion in 2021. billion.

Life Science 105

Life Science Manufacturing Production Clinical Development 105

Pharmaceutical Technology

FEBRUARY 28, 2023

KFA-115 is under clinical development by Novartis and currently in Phase I for Melanoma. 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.

Generic Pharmaceutical 172

Generic Pharmaceutical Dermatology Clinical Trials Clinical Trials 172

Pharmaceutical Technology

FEBRUARY 24, 2023

(LAI-287 + semaglutide) is under clinical development by Novo Nordisk and currently in Phase III for Type 2 Diabetes. 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.

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Insulin Hormones Drugs Clinical Trials 182

Pharmaceutical Technology

APRIL 5, 2023

The therapy is currently under development for the treatment of patients with relapsed or refractory multiple myeloma (r/r MM). Caribou is presently conducting its Phase l CaMMouflage trial to assess CB-011 in r/r MM patients. The trial includes patients at dose level one.

Gene Therapy 147

Gene Therapy Gene Manufacturing Development 147

XTalks

MARCH 17, 2025

The partnership also outlines development milestones of $1.2 billion, primarily linked to initiating Phase III trials for petrelintide as a stand-alone therapy, with sales-based milestones that could push the total value to $5.3 Under the deal, Zealand Pharma will receive an upfront cash payment of $1.65 billion $1.4

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Hormones Drugs Sales Insulin 59

Pharmaceutical Technology

JUNE 13, 2023

Neobiosis chief scientific officer and CEO Dr Ian White stated: “This is an important milestone for Neobiosis and we are excited to be advancing ViXome, a refined product extracted from thoroughly screened and sterile amniotic fluid obtained at the time of C-section [Caesarean delivery] of full-term pregnancies, into clinical development. “We

FDA Approval 147

FDA Approval Production Clinical Development Manufacturing 147

Camargo

DECEMBER 20, 2021

Enhanced product quality reviews conducted under PDUFA VII will focus on innovative manufacturing technologies like those used to produce cell and gene therapies, particularly products with accelerated clinical development timelines. This is targeted for FY 2023.

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Gene Therapy Gene Development Production 184

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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Compliance Clinical Development Development Clinical Trials 52

pharmaphorum

AUGUST 21, 2020

Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. Pfizer and BioNTech are running a parallel trial in Germany and plan to announce further results from that in the “near future”.

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Vaccine Vaccination Antibody Regulation 122

The Pharma Data

DECEMBER 14, 2020

The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021. AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. More information at www.algotx.com. View source version on businesswire.com: [link].

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Clinical Development Development Clinical Supply Packaging 52

XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.

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Gene Therapy Gene Trials Clinical Trials 95

Pharmaceutical Technology

AUGUST 17, 2022

VLA15 is the only vaccine for Lyme disease in clinical development, according to GlobalData, the parent company of Pharmaceutical Technology. The Phase III trial announcement comes at a notable time, as the number of Lyme disease cases is growing over the long term in several countries, including the UK and the US. “In

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Delveinsight

JULY 27, 2021

Remarkable drop was observed in altered filamin A plasma levels after treatment with simufilam in Phase 2b trials. a biotechnology (clinical stage immuno-oncology) company from California publicized the design of its new XPro therapy in Phase 2 clinical trials. P-tau 181 plasma levels were also reduced in a good amount.

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Vaccine Vaccination Trials Manufacturing 96

Roots Analysis

FEBRUARY 27, 2024

Over the last few decades, various viral vector manufacturing have been developed, optimized and standardized for introduction of therapeutic DNA / gene of interest into a patient’s body / cells.

Manufacturing 52

Manufacturing Gene Therapy Gene DNA 52

XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials.

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Clinical Trials Clinical Trials Vaccine Vaccination 75

The Pharma Data

NOVEMBER 30, 2020

We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide.”. pivotal Phase 3 trial update. South Africa Phase 2b trial update. United Kingdom (U.K.)

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Clinical Development Vaccine Vaccination Development 52

pharmaphorum

DECEMBER 4, 2020

Results from Pfizer’s clinical trial also took longer than expected to materialise and caused further delays, the spokesperson added. The company said it is still on course to manufacture between 500 million and up to a billion doses of the vaccine globally in 2021.

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Vaccine Vaccination Production Regulation 125

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). NEW YORK , Jan.

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Manufacturing Gene Therapy Trials Gene 52

pharmaphorum

NOVEMBER 12, 2020

The vaccine supply for the EU will be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium and based on current projections, the companies expect to produce globally up to 1.3 There is an option for a further 100 million doses. billion doses in 2021.

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Vaccine Vaccination Manufacturing Regulation 105

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-1570 is under clinical development by Astellas Pharma and currently in Phase II for Metastatic Melanoma. 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. It is administered through oral route.

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