pharmaphorum

MAY 26, 2022

Within pharma and healthcare, where greater representation has been proven to lead to better health outcomes for all patients and the pharmaceutical companies developing medicines, change is also happening. While many pharma companies are actively working on initiatives to improve diversity in clinical trials, we still have a long way to go.

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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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Pharmaceutical Technology

JULY 28, 2022

Rezafungin is a new, once-weekly echinocandin antifungal being developed by Cidara to treat and prevent serious fungal infections such as candidemia and invasive candidiasis in adults. It is also being developed for invasive fungal infection prophylaxis in adults who undergo allogeneic blood and marrow transplantation.

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Pharmaceutical Technology

OCTOBER 4, 2022

Developed under joint research between Shionogi and Hokkaido University, the antiviral averts SARS-CoV-2 replication by hindering 3CL protease. In the Phase III portion of a Phase II/III clinical trial in Asia, ensitrelvir met the primary endpoint. An investigational Covid-19 drug, ensitrelvir is an inhibitor of 3CL protease.

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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.

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Drug Discovery World

JANUARY 31, 2024

Onward Therapeutics has announced the Phase I clinical trial of OT-A201, a first-in-class bispecific antibody targeting two immune checkpoints is in progress.

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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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Pharmaceutical Technology

AUGUST 16, 2022

Q32 Bio has signed a partnership and option agreement with Horizon Therapeutics for developing ADX-914 to treat autoimmune ailments. According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. A fully human anti-IL-7R?

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Pharmaceutical Technology

AUGUST 4, 2022

Poseida Therapeutics and Roche have signed a strategic partnership and licence agreement to develop allogeneic CAR-T cell therapies for hematologic malignancies. 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.

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pharmaphorum

JANUARY 10, 2023

Astellas has licensed rights to a drug developed by Selecta Biosciences that could make more patients eligible for treatment with its gene therapy for inherited neuromuscular disorder Pompe disease. The post Astellas licenses companion drug for Pompe gene therapy appeared first on.

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Pharmaceutical Technology

OCTOBER 18, 2022

Gilead Sciences has entered an exclusive option and partnership agreement with MacroGenics for developing bispecific antibodies. Under the deal, the companies will leverage MacroGenics’ DART platform to develop MGD024 as well as two further bispecific research programmes.

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pharmaphorum

FEBRUARY 24, 2022

Clinical stage pharmaceutical company Cantex Pharmaceuticals has obtained a global licence from Harvard University’s Office of Technology Development to develop the small-molecule drug azeliragon into a treatment for inflammatory lung diseases, including COVID-19. said Cantex CEO Stephen Marcus.

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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. Biosimilars are increasingly becoming the standard of care and both have several licensed biosimilar drugs (e.g.

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Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

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pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The post Lava fires up a $700m cancer licensing deal with Seagen appeared first on.

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Cloudbyz

MAY 1, 2023

Clinical trial budget management is a complex yet crucial aspect of conducting a successful clinical trial. One of the most challenging tasks for project managers and sponsors is to identify and account for all possible costs, including hidden ones, to ensure that the trial runs smoothly and within budget.

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pharmaphorum

JANUARY 9, 2023

Swiss biotech Stalicla has continued to diversify its pipeline from a focus on autism therapies with a deal to license Novartis’ mavoglurant, in clinical trials for cocaine use disorder (CUD) as well as neurodevelopmental disorders (NDD). STP-2 was licensed from Evgen Pharma in October last year.

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Drug Discovery World

OCTOBER 11, 2023

Collaborators Boehringer Ingelheim and CDR-Life have commenced a Phase I evaluation of BI 771716, their antibody fragment-based treatment developed to preserve the vision of people with geographic atrophy (GA).

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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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Pharmaceutical Technology

APRIL 12, 2023

Panbela Therapeutics has regained the global rights for the development and commercialisation of Flynpovi (a combination of CPP-1X [eflornithine] and sulindac) to treat familial adenomatous polyposis (FAP) patients. The trial will also be designed to show the potential efficacy and safety of Flynpovi in the treatment of patients with FAP.

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Cloudbyz

MARCH 17, 2021

Monitoring patient safety during a clinical trial is one of the founding principles to be followed throughout the drug development life cycle. It can be defined as a collaborative relationship between sponsors, sites, researchers, and everyone involved in the clinical trial phases.

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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. This post covers the key cost drivers for medical device clinical trials.

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pharmaphorum

JANUARY 18, 2022

Cancer Research UK’s Centre for Drug Development, working with the Ludwig Institute for Cancer Research and Vaccitech, has begun a phase I/IIa clinical trial of a new lung cancer vaccine. The post Clinical trial begins of lung cancer immunotherapeutic appeared first on.

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Camargo

AUGUST 5, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. In short, the entire regulatory history of tacrolimus until now, spanning 25+ years, has been based on prospective clinical trials.

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Pharmaceutical Technology

JANUARY 13, 2023

The Biomedical Advanced Research and Development Authority (BARDA) has awarded a multi-year contract to the Sabin Vaccine Institute for developing and producing single-dose vaccine candidates for Ebola Sudan and Marburg virus diseases. Currently, there are no licensed vaccines against these viruses.

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Drug Discovery World

FEBRUARY 1, 2023

But more robust studies are needed across the board to help with the discovery and development of cannabis-based pharmaceuticals. Big pharma is helping to shape the focus The good news is that clinical trials are on the increase and market education is upping pace.

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Pharmaceutical Technology

MAY 12, 2023

On 8 May 2023, China-based Bliss Biopharmaceutical (BlissBio) announced a clinical trial collaboration with Eisai to develop BB-1701, an antibody-drug conjugate (ADC) for multiple cancer types. Eisai intends to conduct a Phase II clinical trial for BB-1701 in breast cancer.

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XTalks

SEPTEMBER 5, 2023

Vaccines have been an integral piece of the global public health toolbox for over 200 years, but the COVID-19 pandemic brought about a new era in vaccine development with renewed interest in mRNA technology and unprecedented accelerated regulatory approvals. What are the major challenges you’re facing right now in vaccine development?

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STAT News

OCTOBER 12, 2022

Merck on Wednesday agreed to extend an ongoing collaboration with Moderna to develop a personalized vaccine for the treatment of patients with skin cancer. The two companies are jointly conducting a mid-stage clinical trial that combines the customized, mRNA-based vaccine with Merck’s checkpoint inhibitor Keytruda.

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Camargo

MAY 10, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The members of the ODAC voted to continue the use of four of the six drugs it discussed during the meeting, despite failed clinical trials.

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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.

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Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. for patients with NTRK fusion cancer across all solid tumors.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Regulatory Considerations for Biologics. BLA process (CBER). 510(k) process (CBER). Premarket Approval (PMA) process (CBER).

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Pharmaceutical Technology

DECEMBER 19, 2022

With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate. On choosing the candidate, the company will oversee the complete development, production and marketing.

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Drug Discovery World

JANUARY 3, 2023

A monoclonal antibody to prevent Covid-19 in vulnerable patients, AZD3152, has entered clinical trials less than 12 months after discovery. . The commencement of the trial triggers a $5 million milestone payment to RQ Bio and will enable the company to execute its four scientific programmes focused on viral diseases. .

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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.

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Pharmaceutical Technology

JUNE 2, 2023

Synaffix is focused on the commercialisation of its clinical-stage technology platform to develop ADCs that offer a range of potential targeted treatments for cancer. This is expected to streamline the path for ADCs to clinical trial and commercialisation.

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