Pharmaceutical Technology

JANUARY 12, 2023

The National Medical Products Administration (NMPA) of China has approved Takeda ’s Exkivity (mobocertinib) to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients. The regulatory approval is based on the data obtained from the Phase I/II trial of the therapy.

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Drug Discovery World

AUGUST 8, 2023

Astex Pharmaceuticals and MSD (Merck & Co) have announced an exclusive worldwide research collaboration to identify small molecule candidates with activity towards a tumour suppressor protein for the treatment of cancer.

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XTalks

DECEMBER 20, 2022

While clinical trials are becoming more complex, oncology trials have generally had a greater level of complexity than trials in many other disease spaces. Despite this, the number of oncology trials worldwide has increased dramatically over the past two decades. Regulatory Considerations. Study Design Considerations.

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Camargo

OCTOBER 15, 2020

If a single-arm trial was conducted as the pivotal trial for regulatory approval of those existing products, the sponsor will certainly want to do the same. While the FDA considers single-arm trials for regulatory approval, there are conditions that sponsors must meet. What is the FDA’s current thinking on the use of single-arm trials?

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XTalks

DECEMBER 4, 2023

Most oncology products approved in the past few decades are known for being highly toxic, non-specific and fraught with severe side effects for cancer patients. But today, with a rise in molecularly targeted therapies, oncology development has shifted to identifying an optimal biologic dose that balances toxicity with efficacy.

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Drug Discovery World

OCTOBER 17, 2023

The DDW Turning Science into Business Summit, ‘ Cancer research opportunities and advances ’ will feature experts and thought leaders in cancer research, precision medicine and immunotherapy. The post DDW Cancer Research Summit: Strategies to get to market faster appeared first on Drug Discovery World (DDW).

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Drug Discovery World

NOVEMBER 10, 2023

With the first DDW Turning Science into Business Summit taking place next week on the theme of Cancer Research, this dynamic area of drug discovery is my round-up focus again. News round-up for 6-10 November by DDW Digital Content Editor Diana Spencer.

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Pharmaceutical Technology

MAY 3, 2023

CBMG will receive $245m in an upfront payment and will also be entitled to potential development, regulatory filing, commercialisation and sales milestones along with tiered royalty payments on net trade sales. The transaction is anticipated to be completed in the second quarter of 2023.

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XTalks

FEBRUARY 14, 2024

Advancements in Pediatric Oncology In recent years, pediatric oncology has witnessed remarkable progress and the treatment options to combat childhood cancer have offered new hope to the affected families. In fact, for healthcare providers and medical device companies, these advancements are both a challenge and an opportunity.

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Camargo

OCTOBER 8, 2020

Regulatory pathway, FDA center, Key Opinion Leaders (KOLs), Target Product Profile (TPP) inclusions, Data to rely on, Studies to conduct, Indication and patient population, Commercial strategy, and much more. Those key areas were in regulatory and commercial. Regulatory. They must decide on the correct…. The Solutions.

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Pharmaceutical Technology

MARCH 1, 2023

The Covid-19 pandemic led to massive developments and scientific advances within the field of messenger ribonucleic acid (mRNA) vaccines. The urgency of the pandemic resulted in rapid development, numerous regulatory approvals, and widespread use of mRNA vaccines across the globe.

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XTalks

MAY 9, 2024

As we explore Genmab’s strategic vision, technological advancements and the next frontier in antibody research, we gain insights into the future of medicine — a future where Genmab’s cutting-edge therapies are poised to transform patient care and meet the complex challenges of the next generation of healthcare.

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Roots Analysis

JANUARY 22, 2024

This resulted in the discovery of an individualized concept of treatment known as oncology precision medicine which primarily utilizes the patient’s genomic information to provide gene-targeted diagnostics and therapeutics. What is Oncology Precision Medicine?

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Drug Discovery World

JANUARY 5, 2024

AbbVie and Umoja Biopharma have entered into two exclusive option and license agreements to develop multiple in-situ generated CAR-T cell therapy candidates in oncology. Additionally, for the two agreements combined, Umoja may be eligible to receive up to $1.44B in aggregate for option exercise fees, development and regulatory milestones.

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Worldwide Clinical Trials

JUNE 15, 2022

At the end of May, we hosted a webinar titled “ Changing Times, Changing Therapies: Keeping Up with Advancements in Cell and Gene Therapies ” to provide a quick update on the latest advancements and ongoing in development of these advanced therapeutics. We’re noticing that around half of clinical holds are for oncology programs.

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Advarra

JUNE 20, 2023

According to a 10-year oncology research study conducted by the Biotechnology Innovation Organization (BIO), only 5.1% Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54

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XTalks

OCTOBER 11, 2023

The company was recently granted clinical trial authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its investigational biologic CAR T-Cell engager ALETA-001. Tune into the episode to hear more about Dr. Rennert’s work in advancing CAR T cell therapies in oncology.

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XTalks

JANUARY 16, 2024

Dr. Barnum discusses the challenges posed by infrequent measurements, the need for new approaches due to low therapy approval rates and specific hurdles in researching neurodegenerative and neuropsychiatric disorders. Drawing parallels with the field of oncology, Dr. Barnum suggests a more segmented approach to CNS therapy trials.

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Drug Discovery World

SEPTEMBER 4, 2023

Cross-over arms in oncology clinical trials: An important consideration for patients’ was published by the Cholangiocarcinoma Foundation (CCF) with the aim of opening new doors for patients with limited treatment options. It also encourages sponsors, investigators and regulators to advance patient-centric trial designs.

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pharmaphorum

MARCH 22, 2021

AstraZeneca is mourning the loss of one of its top scientists after eminent cancer researcher José Baselga passed away at the age of just 61. . News reports suggest that Baselga succumbed to Creutzfeldt-Jakob disease (CJD), a rare and progressive neurodegenerative disorder that tends to appear late in life and advances quickly.

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Camargo

JUNE 4, 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 product was approved for use in adults, and the Pediatric Research Equity Act (PREA)-required pediatric studies were deferred.

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Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Background: The Advancement of Cell and Gene Therapies. The Purpose of INTERACT Meetings.

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Camargo

JANUARY 12, 2022

As we noted in a separate blog post , the forthcoming reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA VII) includes several provisions that are expected to help advance cell and gene therapy products, as well as therapies designed to treat rare diseases. regulatory environment. VP, Regulatory Affairs, CMC.

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Drug Discovery World

FEBRUARY 16, 2024

DDW recently hosted an online event, sponsored by Taconic Biosciences, which outlined areas of advancement and opportunity in the cancer research market. New drug discovery and development concepts The event started with a panel discussion on new drug discovery and development concepts and tools in cancer research.

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Delveinsight

SEPTEMBER 15, 2021

Oncology is the study of cancer and encompasses the diagnosis and treatment of cancer. Oncology is one of the most competitive healthcare domains as several key players at the global level are involved in R&D activities to provide an effective therapeutic option for the people affected with different cancer.

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Drug Discovery World

SEPTEMBER 14, 2023

Immatics will also receive research funding and is eligible to receive development, regulatory, and commercial milestone payments that could exceed $1.7 Immatics has an option to enter into a global profit and loss share arrangement for the most advanced TCER.

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pharmaphorum

JULY 6, 2022

A new cross-sectional study has found that the FDA green lit 95% of the 89 new oncology therapies approved between 2010 and 2019 before the EMA, with the Europeans trailing the Americans by a median of 241 days. The past decade has seen huge advances in cancer therapy, with a swathe of first-in-class or breakthrough therapies being developed.

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Worldwide Clinical Trials

OCTOBER 17, 2022

Phase 3 oncology studies have approximately a 35% likelihood of leading to regulatory approval. There are particular challenges for oncology studies, in view of the fact that the overall likelihood of non-oncology Phase 3 studies leading to approval averages 65%.

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Drug Discovery World

SEPTEMBER 14, 2023

Total revenue from oncology medicines increased 22%, CVRM 20%, R&I8 10%, and rare disease 12%. joined Pfizer’s Executive Leadership Team as Chief Oncology Research and Development Officer and Executive Vice President reporting to Chairman and Chief Executive Officer, Albert Bourla. Chris Boshoff, M.D., Chris Boshoff, M.D.,

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XTalks

OCTOBER 4, 2023

Health economics and outcomes research (HEOR) and market access strategies play a critical role in ensuring that newly approved therapies are made available to patients. In my current role, I have country-level responsibility for AstraZeneca’s entire portfolio, including cardiovascular, respiratory, vaccines and oncology.

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Drug Discovery World

FEBRUARY 9, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to AstraZeneca for Imfinzi (durvalumab) in combination with gemcitabine and cisplatin in Great Britain for use as a first-line treatment of adults with locally advanced, unresectable or metastatic biliary tract cancer (BTC).

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The Pharma Data

MARCH 17, 2022

Merck (NYSE: MRK), known as MSD outside the United States and Canada, the European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP) today announced results from the pivotal Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS. Median DFS was 53.6

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Cloudbyz

MARCH 6, 2024

However, in recent years, there has been a significant shift towards a new class of therapeutics known as biologics, marking a revolutionary advancement in medical treatment. Pharmaceutical companies are increasingly investing in biotechnology research and development to capitalize on the growing demand for biologic therapies.

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pharmaphorum

JANUARY 21, 2022

First-line standard of care is currently a chemotherapy regimen of gemcitabine and the powerful intravenous drug cisplatin However, there are no globally accepted standards of care for locally advanced or metastatic biliary tract cancer (BTC) if first-line chemotherapy fails. This type of cancer is known as epithelial adenocarcinoma.

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pharmaphorum

NOVEMBER 6, 2020

Accelerate the Bench to Bedside Development of Novel CAR Immunotherapies for Safe, Effective & Affordable Advanced Therapies. Provide a mechanistic rationale for combination therapies with Agenus & Ziopharm Oncology. Discuss ‘gold standards’ and innovations in assay development GlaxoSmithKline & bluebird bio.

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Pfizer

AUGUST 3, 2022

“This development confirms the complexity of advancing new treatments for rare cardiovascular diseases and the need to further increase knowledge in this space. We thank the patients, families, investigators and members of the advocacy community who contributed to this research,” said Chris Boshoff, M.D., About REALM-DCM.

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The Pharma Data

SEPTEMBER 10, 2020

(NYSE:PFE) announced today that more than 50 abstracts representing data from nine approved and investigational Pfizer medicines, including several biomarker-driven and immuno-therapies, will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 being held from September 19-21, 2020. Solomon B. . .

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