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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.
This is relevant for clinicaltrials 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.
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 clinicaltrial portfolio. As such, rare disease patients and their families often face little hope for effective treatments.
Walgreens and Boehringer Ingelheim have joined forces in a move to enhance diversity and accessibility in clinicaltrials, aiming to make participation more inclusive and equitable.
Regenxbio says it is to delay dosing of patients in its DMD gene therapy clinicaltrial following a quality issue at an unnamed third-party contractmanufacturer.
CAMP4’s CSO David Bumcrot PhD tells Pharmaceutical Technology that the company plans to see clinicaltrials 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).
Unlike commercial pharmaceutical packaging, the primary consideration in clinicaltrial packaging is protecting the product quality and reliability for research. Finding the best clinicaltrial packaging services providers. Clinicaltrial packaging and labelling solutions.
Pharmaceutical drug research and development (R&D) activities are capital-intensive, which makes the outsourcing of clinical dose manufacturing and marketing popular.
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) clinicaltrials.
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 clinicaltrial news.
Today, world-leading generative artificial intelligence (AI) company for life sciences, Yseop, is celebrating its involvement in more than 150 clinicaltrials 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 clinicaltrial of FCR001 in living donor kidney transplant (LDKT) recipients.
Matteo Lai was part of a panel at DPharm in Boston this year, it was called working together to accelerate the adoption of digital biomarkers in clinicaltrials.
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.
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.
Attributes of the drug, company and its clinicaltrials 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 clinicaltrials play a fundamental role in drug-specific PTSR and likelihood of approval. The company also offers contractmanufacturing and laboratory services.
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 clinicaltrials for the drug’s possible use as Covid-19 prophylaxis. French and Italian manufacturers have two companies in Brazil.
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 clinicaltrials.
A clinicaltrial travel solution that can remove administrative burdens for research sites and eliminate logistical and financial barriers for participants has significantly expanded.
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 clinicaltrials, of which 1 was completed, and 1 is ongoing. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contractmanufacturing services.
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.
The typical cost of developing a biosimilar ranges from $100 million to $300 million, with clinicaltrials accounting for more than half of the budget. This approach can help reduce the complexity and variability associated with biologic manufacturing, leading to more efficient and cost-effective processes.
Equally, OSP was delighted to speak to him to discuss the evolution of data management in clinical development and how intelligent data use can reduce clinicaltrial cancellations, minimise protocol amendments, and accelerate patient recruitment. Gen Li is president and founder of Phesi.
This venture also led me to identify a gap in the market for contractmanufacturing of recombinant proteins. We’ve conducted Phase II studies, which have met all primary and secondary endpoints and are now moving towards a pivotal Phase III trial. Lumos Pharma places a strong emphasis on being patient focused.
Biocair has expanded its pharmaceutical and clinicaltrial logistics operations with new location in California, near Los Angeles International Airport.
Experic raises $14m in series B led by Harro Hofilger Packaging Systems and East Seattle Partners as CDMO sees growth in DPI product and clinicaltrial supply needs.
In its bid to what it says will make participation in clinicaltrials easier and more sustainable, Greenphire has revealed a patient-powered registry and expanded a deal with Merck.
Provention has modified its 14-day treatment course with teplizumab to match the exposure to the drug that was seen with the clinicaltrial material, and has also submitted responses to FDA questions about manufacturing and product quality.
In a clinicaltrial, Tzield given once daily as an intravenous infusion for 14 days to patients with stage 2 T1D showed that after a median follow-up of 51 months, 45% had progressed to stage 3, compared to 72% of patients who received a matched placebo.
Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.
In addition to its lead program, which began Phase I testing in 2020, the company expects to nominate three clinical candidates in 2021. ONCR-177, its lead oncolytic herpes simplex virus (oHSV)-based immunotherapy, is in human trials as a monotherapy and in combination with Merck’s Keytruda (pembrolizumab) for a range of solid tumors.
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