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. •

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Clinical Trials Clinical Trials Trials Regulation 52

XTalks

JULY 6, 2022

The adoption of decentralized clinical trial models has gained significant momentum in the past several years, even before the COVID-19 pandemic that triggered the need for more remote options to mitigate trial disruptions. Rachel Colite, VP Decentralized Clinical Trials, Cogstate.

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Clinical Trials Clinical Trials Trials Licensing 98

pharmaphorum

AUGUST 19, 2021

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. The Good Clinical Trials Collaborative (GCTC) has published a draft guidance document, and is asking for the life sciences sector to make its views known.

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Trials Clinical Trials Clinical Trials Life Science 104

The Pharma Data

SEPTEMBER 29, 2020

To do so, we will work to expand clinical trials to account for diverse representation including lower-income settings and endeavor to address the specific product characteristics needed for use in lower-income settings even after new innovations are brought forward. . Enable affordability for lower income countries.

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Life Science Production Vaccination Vaccine 52

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

Drug Discovery World

JANUARY 25, 2024

The UK’s life sciences and biotech sector showed resilience in 2023, securing £1.8 ($2.2) This follows another BIA report in January 2024, which showed that the UK is a global leader in cell and gene therapy (CGT), with significant investment and the highest number of clinical trials in Europe.

Life Science 52

Life Science Licensing Licensing Gene Therapy 52

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. (Nasdaq: AUTL), a clinical-stage biopharma and a portfolio company of Syncona Ltd.,

Trials 87

Trials Clinical Trials Clinical Trials Gene Therapy 87

pharmaphorum

MAY 27, 2022

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.

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Clinical Trials Clinical Trials Trials Packaging 78

XTalks

MAY 2, 2022

The Phase IIb clinical trial focused on the long-term clinical outcomes and safety for patients with MCI and amyloid pathology (early AD). A disease simulation model was created based on the results of the clinical trial and published literature to understand the long-term benefits of lecanemab use.

Clinical Trials 98

Clinical Trials Clinical Trials Antibody Trials 98

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

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. A second liver biopsy will be performed after 18 months.

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Licensing Licensing Protein Antibody 52

Drug Discovery World

MAY 6, 2024

Thanks to a prestigious academic legacy, Europe has long been a dominant region for life sciences. Europe is traditionally a life sciences powerhouse, with a strong tradition in pharmaceutical discovery. The oldest, still active pharmaceutical company worldwide, Merck, started life in 1668 in Darmstadt, Germany.

Drugs 59

Drugs Life Science Gene Editing Gene 59

The Pharma Data

DECEMBER 20, 2020

Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties.

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Licensing Licensing Life Science Manufacturing 40

XTalks

AUGUST 13, 2020

and BioNTech’s lead vaccine candidate in a Phase III trial being conducted at sites in California and Oregon. The company announced that it commenced the Phase III clinical trial to evaluate the investigational COVID-19 vaccine this week. Related: Pfizer and BioNTech’s COVID-19 Vaccine Shows Positive Early Trial Results.

Vaccination 89

Vaccination Vaccine Trials Clinical Trials 89

XTalks

APRIL 3, 2024

Voydeya’s FDA approval was based on positive results from the pivotal ALPHA Phase III trial. Results of the trial showed that at Week 12, danicopan plus ravulizumab or eculizumab led to a significant increase in hemoglobin levels from baseline compared to placebo plus ravulizumab or eculizumab.

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FDA Approval Sales Trials Development 102

pharmaphorum

OCTOBER 3, 2022

At present many of the new disruptor PD-1/PD-L1 drugs only have trials conducted in China, which could raise concerns with local regulators that may wish to see more diverse, or locally representative, patient inclusion criteria. It suggested that Lilly and Innovent conduct multiregional clinical trials before reapplication.

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Life Science Marketing Manufacturing Drugs 90

pharmaphorum

NOVEMBER 24, 2021

The pandemic has propelled issues for the pharmaceutical industry to the top of the political and public agenda, from clinical trial recruitment to the journey required for medicines or vaccines to reach patients. The new Life Sciences Vision details priority areas for enhancing regulation. Why is this important for the UK?

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Life Science Regulation Medicine Vaccination 88

XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Surrogate endpoints were used as the basis for approval of 45 percent of new drugs reviewed by the FDA between 2010 and 2012. What Is a Surrogate Endpoint?

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Trials Gene Hormones Clinical Trials 98

XTalks

APRIL 2, 2021

Pfizer released new COVID-19 vaccine trial results this week from its ongoing clinical studies, which include data showing that its COVID-19 mRNA vaccine is 100 percent effective in children between the ages of 12 and 15 and has a 91 percent efficacy against variants with protection lasting at least six months.

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Vaccination Vaccine Trials Clinical Trials 59

Drug Discovery World

SEPTEMBER 27, 2023

“Approximately two-thirds of newly-diagnosed myeloma patients are not eligible for a transplant, and now, at long last, they’ll be able to benefit from a potentially life-extending treatment that could give them precious time with their loved ones,” said Shelagh McKinlay, Director of Research and Advocacy at blood cancer charity Myeloma UK.

Regulation 52

Regulation Life Science Licensing Licensing 52

XTalks

JULY 17, 2023

Phase III Clinical Trials Underpinning the Applications The applications are grounded on two Phase III clinical trials, SPOTLIGHT and GLOW. In both trials, approximately 38 percent of the screened patients had CLDN18.2-positive In both trials, approximately 38 percent of the screened patients had CLDN18.2-positive

Clinical Trials 95

Clinical Trials Clinical Trials Trials Antibody 95

XTalks

DECEMBER 1, 2020

As the research and medical community learns more about population variances in disease outcomes, whether as a result of regional genetic profiles, socioeconomic factors, or environmental inputs, it’s become necessary to ensure that clinical research trials include broad swaths of global participants. billion in 2019.

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Clinical Trials Clinical Trials Trials Clinical Research 96

XTalks

FEBRUARY 29, 2024

Less than a month later after its accelerated approval, the FDA restricted its recommendation of the drug for mild forms of the disease citing a lack of data supporting its use in early stages, which was not studied in trials. Some clinicians are as wary of the drug as they were of Aduhelm.

Drugs 59

Drugs FDA Approval Antibody Life Science 59

XTalks

MAY 20, 2022

Depending on the type of field or company, you can pursue clinical scientist jobs with a major in biology, medicine, medical technology, chemistry, immunology and other related life science and pre-medical degrees. In addition, some clinical scientist jobs require you to be licensed or certified.

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Scientist Life Science Clinical Research Doctors 105

pharmaphorum

OCTOBER 16, 2020

In the age of artificial intelligence, no trial data should be going to waste. These might be licensed drugs that could hold potential for a patent extension, or drugs which failed efficacy trials for an intended indication. The repurposing of drugs is becoming more common, especially in the field of rare diseases.

Clinical Trials 90

Clinical Trials Clinical Trials Trials Life Science 90

pharmaphorum

DECEMBER 2, 2020

Swiss biotech Noema has raised 54 million Swiss francs ($59m) to develop four neurological disorder drugs licensed in from Roche. Lead product is NOE-101, an mGluR5 inhibitor that is ready for phase 2b trials in two indications – for persistent seizures in Tuberous Sclerosis Complex and severe pain in Trigeminal Neuralgia.

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Development Drugs Licensing Licensing 62

pharmaphorum

MARCH 24, 2021

It applies to marketing applications for all new active substances or new indications and could be extended to include new clinical trial applications after an initial “exploratory” phase, according to the regulator. The MHRA initiative has been welcomed by the Health Research Authority, which oversees NHS research in England.

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Drugs Clinical Trials Clinical Trials Trials 67

Drug Discovery World

FEBRUARY 28, 2024

Using IgE to treat cancer In the UK, a Cancer Research UK-funded clinical trial has shown, for the first time, that a new class of antibody could benefit cancer patients whose existing treatments have stopped working. She has over 25 years’ experience in B2B journalism, ten of those being in life sciences.

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Development Research Drugs Antibody 64

pharmaphorum

JUNE 30, 2021

The designation means that LentiGlobin will be reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new innovative licensing and access pathway (ILAP) introduced last December. ILAP is also a key component part of the UK’s plan to attract life sciences investment following the departure from the EU.

Gene Therapy 98

Gene Therapy Gene Medicine Life Science 98

pharmaphorum

NOVEMBER 22, 2022

Merck is one of the oldest companies in the pharma industry, with its roots in the 17th century, but medicines remain a minority part of its business alongside life sciences equipment and services and electronics like liquid crystal display screens and semiconductor chemicals.

Production 52

Production Licensing Licensing Antibody 52

XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease. Malaria Vaccine Phase II Trial.

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

XTalks

SEPTEMBER 9, 2022

Magnus Medical received exclusive licensing rights to commercialize the SAINT (Stanford Accelerated Intelligent Neuromodulation Therapy) technology from Stanford University. Related: Xtalks Voices: Magnus Medical CEO Dr. Brett Wingeier Talks About Neurostimulation for Depression – Xtalks Life Science Podcast Ep.

Radiology 98

Radiology Life Science Licensing Licensing 98

pharmaphorum

AUGUST 12, 2021

The DTx was first developed by researchers from King’s College London under the name Regul8, and was put through its paces in a 558-patient clinical trial in primary and secondary care in the NHS in England, with results showing that helped reduce symptoms when added to current therapies for IBS.

Life Science 92

Life Science Clinical Trials Clinical Trials Licensing 92

pharmaphorum

JULY 18, 2022

Convidencia’s injectable version was granted World Health Organization (WHO) Emergency Use Listing (EUL), and its inhalant counterpart, currently in phase three clinical trials, has shown enormous promise. CanSinoBIO’s inhalant has finished phase three trials in China and is presently undergoing trials in several countries.

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Vaccination Vaccine Development Immune Response 126

XTalks

FEBRUARY 20, 2024

The results of the Phase II trial in patients with IgA nephropathy have been encouraging, and we look forward to completion of the Phase III trial and submission of the Biological Licensing Application (BLA) to the US FDA and other global regulatory authorities,” said Brian J. How Does Sibeprenlimab Work?

Clinical Trials 59

Clinical Trials Clinical Trials FDA Approval Trials 59

XTalks

MARCH 22, 2023

In October 2022, Xtalks celebrated two decades of bringing diverse stakeholders in the life science industry together through first holding physical events, then soon after, hosting exclusively online events. ICON acquired PRA Health Sciences in 2021, the same year that Inotiv acquired Envigo.

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Life Science Drugs FDA Approval Vaccination 97

The Pharma Data

DECEMBER 29, 2020

Proceeds will be used to fund LyGenesis’s Phase 2a clinical trial with a first patient in targeted for early 2021, as well as to push forward on their other cell therapies using lymph nodes as bioreactors to regrow functioning organs, including pancreas, kidney, and thymus regeneration. and Longevity Vision Fund.

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Trials Life Science Clinical Trials Clinical Trials 52