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Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
Hookipa Pharma and Roche have signed a strategic partnership and licence agreement for developing HB-700 and another undisclosed arenaviral immunotherapy. Under the deal, Hookipa will carry out research and initial clinicaldevelopment through Phase Ib for HB-700 to treat KRAS-mutated cancers.
Indian pharmaceutical company Laurus Labs has signed a memorandum of agreement (MoA) with the Indian Institute of Technology, Kanpur (IIT Kanpur) to bring new gene therapy products to the market. Laurus Labs will be responsible for launching these products in India and emerging markets.
As novel therapeutics become more complex — and costly — to bring to market, drug developers are looking to unified clinicaldevelopment platforms to streamline operations.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinicaldevelopment? A recent draft from the FDA provides valuable insight.
C4X Discovery (C4XD) and AstraZeneca have entered an exclusive global licensing agreement worth up to $402m to develop oral therapy to treat inflammatory and respiratory ailments. The deal has been signed to develop the C4X NRF2 Activator programme for these ailments. This includes an upfront payment of $2m from AstraZeneca.
Chinook Therapeutics and Ionis Pharmaceuticals have entered a partnership to develop an antisense oligonucleotide (ASO) therapy to treat a rare, severe chronic kidney disease. The collaboration aims to discover, develop and commercialise an ASO therapy.
The success of chimeric antigen receptor T-cells (CAR-T) in blood cancers has led to the US Food and Drug Administration's (FDA) approval of six products with a pipeline of cell therapies that numbers in the thousands.
Vectura Group plc, an industry leading inhalation CDMO, today announced it has signed an agreement with Incannex Healthcare Limited, an Australian cannabinoid medicines development company, to provide pre-clinicaldevelopment services for IHL-216A, Incannex’s proprietary inhaled drug product for the treatment of traumatic brain injury (TBI).
Forge Biologics has joined the public-private collaboration, the Bespoke Gene Therapy Consortium (BGTC), to expedite the development and manufacture of new AAV [adeno-associated virus] gene therapies to treat patients with rare diseases. Shilling was appointed to represent the company on the steering committee of the BGTC.
It is also preparing for a swift transition to Phase III development. The therapy showed that it can inhibit the production of cytokine from both CD4+ T cells and ILC2, and completely suppressed skin allergic reactions in a monkey model in pre-clinical trials.
However, the current MS pipeline offers new hope for PPMS patients, with three late-stage agents currently in development. Nonetheless, the increased focus on the development of PPMS treatment is a welcome game-changer for patients.
One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). Many of the advancements included in PDUFA VII are driven in large part by an increase in the development of innovative products such as cell and gene therapies.
Stephanie Manson Brown, VP & Head of ClinicalDevelopment & Scientific Innovation of R&D at Allergan Aesthetics at AbbVie. Allergan Aesthetics is focused on creating products and technologies that drive the advancement of aesthetic medicine.
A new CTTI publication , published in Clinical Pharmacology & Therapeutics , reviews current applications of disease progression modeling (DPM) and opportunities to advance the awareness and value of DPM in clinical trials.
Zerion Pharma has entered a partnership with Insud Pharma for the development and marketing of drug products using Zerion Pharma's solubility-boosting Dispersome technology. . Under the deal, Zerion will handle the development of Dispersome formulations of marketed drugs.
Poseida Therapeutics and Roche have signed a strategic partnership and licence agreement to develop allogeneic CAR-T cell therapies for hematologic malignancies. Roche and Poseida will also partner in a research programme for creating and developing next-generation features and enhancements for allogeneic CAR-T therapies.
Indonesia has granted Emergency Use Authorization (EUA) for the patent-free Covid-19 vaccine, IndoVac, developed by the Texas Children’s Hospital Center for Vaccine Development (CVD) and Baylor College of Medicine, US. Indonesia is pursuing halal certification for IndoVac as its production did not utilise any animal cells or products.
Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. Bioanalysis to support drug development requires meticulous attention to detail across many clinic and laboratory disciplines.
Plus Therapeutics has expanded its partnership with Piramal Pharma Solutions (PPS) to produce additional cGMP liposome intermediate drug products. This will help to meet the rising demand for Plus Therapeutics’ lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, for clinical trials that are underway and planned.
2seventy bio has announced a strategic collaboration with JW Therapeutics to expedite the research and development of T cell-based immunotherapies. This programme is currently being developed under a partnership with Regeneron. It is intended to develop T cell receptor (TCR) therapies for treating MAGE-A4 positive solid tumours.
ImmunoForge has expanded its licence agreement with Duke University in North Carolina, US, to jointly improve research and drug development opportunities. ImmunoForge will expedite the development of new drugs based on the elastin-like polypeptide (ELP) platform technology originally developed by Duke’s Professor Ashutosh Chilkoti.
Rilzabrutinib joins a wave of innovative ITP therapies , including thrombopoietin-receptor agonists like eltrombopag and romiplostim, which boost platelet production. By inhibiting this protein, the drug disrupts pathways that contribute to platelet destruction and insufficient production.
GSK has entered a strategic partnership with Wave Life Sciences to progress the discovery and development of oligonucleotide therapies for new genetic targets. The discovery alliance, with a preliminary research period of four years, will aid GSK in progressing up to eight programmes and Wave to develop up to three programmes.
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.
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma.
While a handful of therapies have launched since then, late-stage pipeline therapies that are currently in development reveal that drug developers are exploring a broad set of mechanisms of action (MOAs), many of which are innovative, to tackle DES. The other late-stage pipeline therapies have shown multiple MOAs to tackle DES.
Lacerta Therapeutics has entered a new licensing and research partnership agreement with Eli Lilly and Company subsidiary, Prevail Therapeutics, to discover and develop adeno-associated virus (AAV) capsids for treating central nervous system (CNS) diseases. . Topic sponsors are not involved in the creation of editorial content.
Pfizer has entered a research partnership and exclusive licence agreement with Clear Creek Bio to progress new SARS-CoV-2 papain-like protease (PLpro) inhibitors’ discovery and development for the oral treatment of Covid-19. On entering the clinic, Pfizer will solely handle the development and marketing works of the candidate.
Regeneron Pharmaceuticals has entered a collaboration and licensing agreement with CytomX Therapeutics for developing conditionally-activated bispecific cancer therapies. This collaboration will use Regeneron’s Veloci-Bi bispecific antibody development platform and CytomX's Probody therapeutic platform.
Evaxion Biotech and ExpreS 2 ion Biotechnologies have entered a vaccine discovery collaboration agreement to co-develop a new cytomegalovirus (CMV) vaccine candidate. Additionally, this project will be part of the development pipeline of Evaxion under EVX-V1. Evaluations will follow this method in preclinical models of Evaxion.
The US Food and Drug Administration (FDA) has granted approval for Ferring Pharmaceuticals’ faecal microbiota product, Rebyota, to prevent Clostridioides difficile infection (CDI) recurrence in people aged 18 years and above. A live biotherapeutic, Rebyota is intended for usage following the completion of antibiotic treatment.
Myeloid Therapeutics has raised $73m to support the continued clinicaldevelopment of its lead cell therapy programme, MT-101, in Phase I/II trials for T cell lymphoma. The financing will help to fast-track the development of other in vivo programming candidates into clinical trials.
Highlights include expansion of biotech operations in Philadelphia, acquisition of a new pharma-device facility near Dublin, Ireland, and a new Center of Excellence for advanced drug delivery and drug-device combination product assembly in Rockford, Illinois.
In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinicaldevelopment.
Influenza vaccine 2 is under clinicaldevelopment by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. 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.
Influenza vaccine 2 is under clinicaldevelopment by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. 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.
UK psychedelic medicine specialist Beckley Psytech has raised an impressive £58 million (around $80 million) in an oversubscribed second-round financing that will help fund clinicaldevelopment of its psilocybin-based therapies. The post Beckley Psytech raises $80m for psychedelic meds development appeared first on.
This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials.
As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. The decentralized procedure applies to all products without a prior marketing authorization in the EU that are not required to use the centralized procedure.
Biotechnology company Enveda Biosciences has raised $51m in equity financing in a Series B1 round to advance several drug candidates to clinicaldevelopment. Enveda Biosciences intends to use the additional financing to advance several candidates derived from its drug discovery platform to clinicaldevelopment in 2023 and 2024.
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