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India is strengthening its scope in contractmanufacturing as the global customers commend the strengths and dependability of its pharma and biotech sectors.
Regenxbio says it is to delay dosing of patients in its DMD gene therapy clinical trial following a quality issue at an unnamed third-party contractmanufacturer.
Pharma ContractManufacturing: From the pharmaceutical sector there is a group of businesses that have tasked themselves to assist other businesses to provide better solutions to customers. When a contractmanufacturing company wakes up with a customer in the business, the customer cannot control the jobs the CMO is in control of.
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. This means that sponsors are having to fork out for these blockbuster products in order to run their trials more often.
US biotech BioSig Technologies has abandoned a phase 2 trial of its antiviral drug merimepodib with Gilead’s Veklury in severe COVID-19 patients, after concluding the safety of the combination was in doubt. However the Grade 3 group had “markedly different outcomes… making it unlikely that the trial would meet its primary safety endpoints.”.
CAMP4’s CSO David Bumcrot PhD tells Pharmaceutical Technology that the company plans to see clinical trials go forward for their urea cycle disorder programs late next year. In preparation for this, drug manufacturing will begin later this year and will be outsourced to external contractmanufacturing organisations (CMOs).
The Foundation for the National Institutes of Health (FNIH) announced this week that the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (AMP BGTC) has selected eight rare diseases for its clinical trial portfolio. As such, rare disease patients and their families often face little hope for effective treatments.
Under the terms of the agreement Pfizer will become one of several external partners who manufacture the investigational treatment for the disease. Pfizer will provide contractmanufacturing services at its facility in McPherson, Kansas, to supply the drug to Gilead. This is the third iteration of the ACTT trial.
Walgreens and Boehringer Ingelheim have joined forces in a move to enhance diversity and accessibility in clinical trials, aiming to make participation more inclusive and equitable.
Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research. Finding the best clinical trial packaging services providers. Clinical trial packaging and labelling solutions.
This is mixed news for contractmanufacturing organisations (CMOs), as large CMOs such as Thermo Fisher Scientific (Waltham, MA, US) and Catalent Inc (Somerset, NJ, US) are typically involved in the manufacture of the most innovative products. However, non-NME and biosimilar approvals increased in 2022.
Pharmaceutical drug research and development (R&D) activities are capital-intensive, which makes the outsourcing of clinical dose manufacturing and marketing popular.
The phase 3 trial found that Paxlovid – which combines new protease inhibitor PF-07321332 with already-approved HIV drug ritonavir – reduced the risk of hospitalisation or death by 89% when given to newly-diagnosed adults who were at risk of developing severe COVID-19 in the EPIC-HR trial.
The two phase 1/2 trials are zeroing in on NSCLC patients with specific molecular biomarkers, to see if adding Genprex’ Reqorsa (quaratusugene ozeplasmid) – which delivers a gene that suppresses tumour growth – can enhance the activity of the AZ and Merck drugs. Both studies are due to start in the first half of next year.
A leader from the specialty logistics firm discusses how the clinical researching industry is shifting, thanks in large part to the pandemic, and how to prepare for the future.
In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Regulatory decisions and clinical trial news.
A logistics leader from the CRO offers advice on navigating borders, cultures, regulatory issues and other important considerations on worldwide studies.
Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company also offers contractmanufacturing and laboratory services.
Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company also offers contractmanufacturing and laboratory services.
As the DIA conference in San Diego approaches, Outsourcing Pharma secured an exclusive preview with FranÃois Torche, chief product & technology officer and co-founder of CluePoints
Three months ago, the FDA said it was unconvinced by a bridging study designed to show equivalence between Provention’s product intended for commercial sale, made by contractmanufacturer AGC Biologics, and the drug that teplizumab’s original developer Eli Lilly used in clinical trials.
There are ongoing phase 3 trials testing its safety and efficacy in patients infected by the SARS-CoV-2 coronavirus that causes COVID-19, including combination trials with other drugs. Under the terms of the agreement Pfizer will become one of several external partners who manufacture the investigational treatment for the disease.
Oswaldo Cruz Foundation will package the drug in its facility in Rio de Janeiro before supplying it to the Brazilian public health system; the company is also involved in clinical trials for the drug’s possible use as Covid-19 prophylaxis. French and Italian manufacturers have two companies in Brazil.
A leader from the global clinical research logistics company shares how to weigh the complex aspects of a decentralized trial and craft intelligent strategy.
The FDA approval comes on the back of the BLISS-LN trial results, which showed that 43% of patients on Benlysta hit the target of a significant improvement in kidney function, compared with 32% of those in the control arm. GSK’s drug also improved secondary outcome measures including time to death or a kidney-related complication.
Humanigen is hoping for emergency use authorisation in the US for an antibody to treat severe COVID-19 before the end of 2020, and has teamed up with Swiss contractmanufacturer Lonza to make sure it can meet demand. Roche meanwhile is continuing to trial its drug in combination with remdesivir.
According to Globaldata, it is involved in 2 clinical trials, of which 1 was completed, and 1 is ongoing. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contractmanufacturing services.
A clinical trial travel solution that can remove administrative burdens for research sites and eliminate logistical and financial barriers for participants has significantly expanded.
In the US, Health and Human Services Secretary Alex Azar suggested this week that the country will have enough doses of vaccine available for every America citizen by March or April next year, with production underway for six shots backed by the US government across more than 23 manufacturing facilities.
Virtual research organization, ObvioHealth, has just announced the launch of its application programming interface (API) which it says is tailored specifically for digital therapeutics (DTx) clinical trials.
A clinical trial logistics expert discusses specialized concerns involved in transporting cell and gene products and other personalized medicine items.
Nevertheless, the decision by NICE to back routine NHS use of Wegovy is a win for Novo Nordisk, which has been hit by supply constraints linked to a contractmanufacturer for the drug that have affect its rollout in the US, where it was approved last June. billion to the NHS and £27 billion to wider society.
A clinical trial logistics expert discusses specialized concerns involved in transporting cell and gene products and other personalized medicine items.
UK-based Lindus Health and US-based Thirty Madison today (December 14) announced they have completed the enrolment of a trial to assess their personalized dermatology telemedicine platform, Facet.
A new patient-first service that will support sponsors and sites accelerate the development of their therapies has been launched by Innovative Trials yesterday (October 9).
Today, world-leading generative artificial intelligence (AI) company for life sciences, Yseop, is celebrating its involvement in more than 150 clinical trials with pharma giants around the world.
Cell Therapy pipeline update, Talaris Therapeutics , a late-clinical stage biotechnology company based in Boston, MA and Louisville, KY , announced the initiation of FREEDOM-1 ( NCT03995901 ), the company’s Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients.
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