Pharmaceutical Technology

OCTOBER 21, 2022

Under the deal, Hookipa will carry out research and initial clinical development through Phase Ib for HB-700 to treat KRAS-mutated cancers. On concluding this trial, Roche will gain the right to develop and market the licenced products across various indications, contingent on approval.

Development 278

Development Production Licensing Licensing 278

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 73

Licensing Licensing Trials Clinical Trials 73

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

FEBRUARY 14, 2023

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). We look forward to working with CSPC to advance clinical development of this asset and realise its full potential.”

Antibody 130

Antibody Drugs Clinical Development Licensing 130

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.

Clinical Trials 200

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

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

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

pharmaphorum

NOVEMBER 10, 2021

Under the terms of the deal, Biohaven would be responsible for further clinical development of Nurtec ODT and the two partners will cooperate on securing approval for the product in ex-US markets. The post Pfizer strikes $1.2bn licensing deal for Biohaven migraine drug appeared first on.

Licensing 52

Licensing Licensing Drugs Sales 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

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

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 106

Gene Therapy Gene Licensing Licensing 106

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

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

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

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. 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. “We are pleased to work with U.S.

Licensing 52

Licensing Licensing Vaccination Vaccine 52

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

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

DECEMBER 21, 2021

Novartis licensed rights to tislelizumab for $650 million upfront and up to $1.55 billion in milestones – shortly after its own PD-1 drug candidate spartalizumab failed a phase 3 trial in melanoma. Pharma companies are looking at whether blocking TIGIT as well as PD-1/PD-L1 can improve the efficacy of cancer immunotherapy.

Drugs 98

Drugs Antibody Pharma Companies Development 98

The Pharma Data

MARCH 8, 2021

We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

Trials 69

Trials In-Vivo Genotoxicity RNA 69

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

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

JANUARY 7, 2021

Shortly after launching large-scale trials of its COVID-19 vaccine candidate, CureVac has the partner it will need to roll the shot out at scale if it works as hoped. The post Bayer joins the COVID-19 vaccine push, backing CureVac shot appeared first on.

Vaccination 106

Vaccination Vaccine Contract Manufacturing Development 106