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

pharmaphorum

APRIL 22, 2021

Biosensor firm physIQ has licensed its technology to Johnson & Johnson’s Janssen pharma unit in a multi-year deal, to investigate use of wearable sensors in virtual clinical trials. physIQ has a portfolio of FDA-cleared digital biomarkers and a medical-grade platform that can transform raw sensor data into clinical insight.

Licensing 72

Licensing Licensing Trials Clinical Trials 72

Pharmaceutical Technology

OCTOBER 25, 2022

Additionally, Astellas will obtain an exclusive option for licencing two clinical-stage programmes of Taysha, namely TSHA-102 and TSHA-120, for Rett syndrome and GAN, respectively. Astellas will also receive specific rights linked to any possible change of Taysha’s control.

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

Pharmaceutical Technology

AUGUST 11, 2022

The proceeds from the business combination will be utilised to advance the pipeline of Disc to clinical trials and offer funding into 2025. Disc focuses on discovering and developing new therapies for patients with serious haematologic ailments. Last year, Disc in-licensed bitopertin from Roche.

Medicine 147

Medicine Clinical Trials Clinical Trials Licensing 147

Worldwide Clinical Trials

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. The post Why Proactive AME Studies are Critical to Accelerating Your Approval Journey appeared first on Worldwide Clinical Trials.

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Clinical Trials Clinical Trials Pharmacy Trials 200

Cloudbyz

NOVEMBER 22, 2024

This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinical research teams. Our mission is to enable faster, more efficient trials, ultimately supporting the delivery of life-saving therapies.”

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

Pharmaceutical Technology

MARCH 23, 2023

The drug is currently licensed in combination with chemotherapy for patients with classical Hodgkin lymphoma, both as frontline therapy and for those at risk of progressing or having progressed following stem cell transplantation. Tivdak, a tissue-factor targeting ADC that was developed in collaboration with Genmab, was approved in 2021.

Licensing 147

Licensing Licensing Sales Trials 147

Pharmaceutical Technology

OCTOBER 18, 2022

Under the deal, the companies will leverage MacroGenics’ DART platform to develop MGD024 as well as two further bispecific research programmes. Gilead holds an option for licensing MGD024 as a possible therapy to treat specific blood cancers, including myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML).

Antibody 130

Antibody Development Sales Clinical Trials 130

The Pharma Data

AUGUST 5, 2020

AstraZeneca has signed a licensing deal with UK-based biotech company Redx Pharma for its fibrotic disease candidate RXC006. Redx is also eligible to receive up to $360m in additional payments, dependent on development, regulatory and commercial milestones, as well as tiered royalties on any future sales.

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

Pharmaceutical Technology

AUGUST 4, 2022

P-BCMA-ALLO1 is currently being analysed in a Phase I clinical trial while an investigational new drug (IND) application for P-CD19CD20-ALLO1 is anticipated next year. Furthermore, Roche will oversee the late-stage clinical development and worldwide marketing of all products under the alliance.

Development 147

Development Clinical Trials Clinical Trials Gene Therapy 147

pharmaphorum

JANUARY 29, 2021

US drugmaker Eli Lilly – still waiting for an FDA decision on one non-opioid pain drug – has just added another to its pipeline via a licensing agreement with Japan’s Asahi Kasei worth up to $410 million. Other candidates include a PACAP38 antibody, SSTR4 agonist and TRPA1 antagonist, all in phase 1 development.

Licensing 52

Licensing Licensing Bioavailability Antibody 52

Pharmaceutical Technology

MAY 31, 2023

Setanaxib is under clinical development by Calliditas Therapeutics and currently in Phase III for Primary Biliary Cholangitis (Primary Biliary Cirrhosis). 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.

Clinical Trials 100

Clinical Trials Clinical Trials Production Drugs 100

pharmaphorum

MAY 4, 2022

In testing new treatments, what is promising in animal models may not transfer particularly well to humans, which helps to explain why there is a 90% failure rate during clinical development. Once selected, Quris can in-license them, progress them through to phase 1 trials and, those that succeed, can be licensed to pharma companies.

Drugs 143

Drugs Licensing Licensing Pharma Companies 143

pharmaphorum

JANUARY 13, 2022

Sanofi has joined a growing list of drugmakers going after alpha-synuclein targeting drugs for Parkinson’s disease, licensing a bispecific antibody from South Korea’s ABL Bio in a deal that could be worth more than $1 billion. An AbbVie antibody called ABBV-0805 successfully cleared a phase 1 trial but seems to have been shelved.

Antibody 98

Antibody Drugs Protein Licensing 98

pharmaphorum

AUGUST 4, 2020

Shares in Redx Pharma were soaring this morning after it licensed its preclinical fibrotic disease drug RXC006 to AstraZeneca. AstraZeneca has bought an exclusive global licence to develop and market RXC006, a porcupine inhibitor for fibrotic diseases including idiopathic pulmonary fibrosis (IPF).

Drugs 109

Drugs Clinical Trials Clinical Trials Pharma Companies 109

Pharmaceutical Technology

JUNE 10, 2023

PB-357 is under clinical development by Puma Biotechnology and currently in Phase I for Breast Cancer. 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.

Drugs 100

Drugs Clinical Trials Clinical Trials Licensing 100

Pharmaceutical Technology

JUNE 10, 2023

PB-357 is under clinical development by Puma Biotechnology and currently in Phase I for Breast Cancer. 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.

Drugs 100

Drugs Clinical Trials Clinical Trials Licensing 100

Pharmaceutical Technology

NOVEMBER 21, 2022

Specifically, Instil Bio’s tumour-infiltrating lymphocyte (TIL) therapy, ITIL-168, had its DELTA-1 pivotal trial pause enrollment due to a decrease in the rate of successful manufacturing of ITIL-168.

Manufacturing 147

Manufacturing Development Production Antibody 147

pharmaphorum

DECEMBER 22, 2021

The Swiss pharma group has agreed to pay $800 million upfront for London, UK-based Gyroscope, with another $700 million to be paid if GT005 meets its objectives in terms of clinical development, regulatory approvals and reimbursement. The Gyroscope deal also includes several earlier-stage projects in inherited retinal diseases.

Gene Therapy 105

Gene Therapy Gene Licensing Licensing 105

pharmaphorum

AUGUST 11, 2020

At the beginning of this year, KaNDy completed a phase 2b trial of its first-in-class drug NT-814, showing activity against symptoms of the menopause such as hot flashes and night sweats. A phase 3 trial is expected to begin in 2021 and the company says that the compound could generate peak sales of more than a billion euros globally.

Drugs 98

Drugs Hormones Marketing Trials 98

Pharmaceutical Technology

MARCH 1, 2023

MP-0310 is under clinical development by Molecular Partners and currently in Phase I for Cervical Cancer. 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.

Protein 100

Protein Clinical Trials Clinical Trials Development 100

Pharmaceutical Technology

MARCH 1, 2023

MP-0310 is under clinical development by Molecular Partners and currently in Phase I for Colorectal Cancer. 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.

Protein 100

Protein Clinical Trials Clinical Trials Development 100

Pharmaceutical Technology

MARCH 1, 2023

Orvacabtagene autoleucel is under clinical development by Bristol-Myers Squibb and currently in Phase II for Relapsed Multiple Myeloma. 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

FEBRUARY 24, 2023

ACD-440 is under clinical development by AlzeCure Pharma and currently in Phase I for Neuropathic Pain (Neuralgia). 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.

Development 100

Development Drugs Clinical Trials Clinical Trials 100

XTalks

MARCH 1, 2021

NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) have announced that they are beginning a trial to evaluate the safety and efficacy of a third booster dose for their COVID-19 vaccine (BNT162b2), as well as new vaccine variants. The study will be a part of current Phase I, II and III trials. Pfizer Inc.

Vaccination 111

Vaccination Vaccine Development In-Vitro 111

pharmaphorum

APRIL 22, 2022

Astellas also revealed today that it is terminating the development of ASP2390, a DNA vaccine for house dust mite-induced allergic rhinitis, and GITR agonist antibody ASP1951 for cancer – both in early-stage clinical development – along with DMD gene therapies AT702, AT751 and AT753.

Gene Therapy 105

Gene Therapy Gene DNA Development 105

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

XTalks

NOVEMBER 4, 2022

Pfizer announced positive top-line data from a Phase III trial evaluating its respiratory syncytial virus (RSV) prefusion vaccine candidate, RSVpreF (or PF-06928316) for pregnant individuals to help protect their infants from RSV disease after birth. percent efficacy against medically attended RSV-associated lower respiratory tract infection.

Vaccination 97

Vaccination Vaccine Clinical Trials Clinical Trials 97

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

The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. ” About Ascentage Pharma.

Clinical Development 40

Clinical Development Development Licensing Licensing 40

pharmaphorum

DECEMBER 28, 2022

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. InnoCare says it will also introduce the restrictions on studies ongoing outside the US.

Drugs 75

Drugs Licensing Licensing Trials 75

XTalks

SEPTEMBER 13, 2021

With RNA therapies being the next hot thing in genetic medicine, Eli Lilly is joining the RNA editing race by partnering with Netherlands-based ProQR Therapeutics NV (Nasdaq: PRQR), a biotech company developing RNA-based therapies for rare genetic diseases with a focus on blinding disorders of the retina.

RNA 105

RNA Genetics Genetic Disease Medicine 105

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

pharmaphorum

MAY 30, 2022

Shares in Swedish biotech RhoVac were down 94% in mid-morning trading today after the company revealed a phase 2b trial of its prostate cancer vaccine RV001 showed it was no more effective than placebo.

Vaccination 72

Vaccination Vaccine Trials Licensing 72

Delveinsight

AUGUST 13, 2020

Researchers call out Gilead over the diversity of remdesivir trials. Researchers have challenged the sponsors of COVID-19 clinical trials to run more diverse studies. Roche offloads clinical-phase cancer drug to Celleron. Even so, the decision marked the end of the interest of Roche in developing the asset.

Trials 52

Trials Research Drugs Protein 52

pharmaphorum

FEBRUARY 19, 2021

NVX-CoV2373 is being studied in two ongoing pivotal phase 3 clinical trials: in the United States and Mexico, as well as in the UK for the prevention of COVID-19. Interim results from the UK trial reported last month showed an efficacy of around 89%, although it was less effective against the South African variant.

Vaccination 80

Vaccination Vaccine Manufacturing RNA 80

XTalks

SEPTEMBER 5, 2023

Xtalks spoke with Maria Reyes Boceta-Muñoz, Clinical Operations Head of Development R&D at GlaxoSmithKline in Spain, Portugal & Israel, to understand the current vaccine development climate and where the sector is headed.

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Vaccination Vaccine Development Clinical Trials 96