Outsourcing Pharma

JUNE 10, 2024

Clinical trials play a crucial role in driving medical progress, and the accurate capture of patient data is fundamental to their success.

Clinical Trials 60

Clinical Trials Clinical Trials Trials Contract Manufacturing 60

Outsourcing Pharma

JUNE 10, 2024

Clinical trials play a crucial role in driving medical progress, and the accurate capture of patient data is fundamental to their success.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Contract Manufacturing 59

Pharmaceutical Technology

JULY 29, 2022

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 contract manufacturing organisations (CMOs).

RNA 245

RNA Gene Expression Gene Gene Therapy 245

Pharmaceutical Technology

SEPTEMBER 20, 2022

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.

Packaging 100

Packaging Packaging Marketing Clinical Trials 100

Outsourcing Pharma

OCTOBER 12, 2023

Munther Baara has worked in the life sciences arena for more than 30 years. He has always been completely committed.

Clinical Trials 92

Clinical Trials Clinical Trials Life Science Trials 92

Outsourcing Pharma

MARCH 14, 2023

The company releases two SaaS-based applications, GrantPay and GrantPact, to provide clinical trial contract negotiation and payment services.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Contract Manufacturing 52

Pharmaceutical Technology

SEPTEMBER 14, 2022

Pharmaceutical drug research and development (R&D) activities are capital-intensive, which makes the outsourcing of clinical dose manufacturing and marketing popular.

Marketing 100

Marketing Contract Manufacturing Sales Clinical Trials 100

Outsourcing Pharma

DECEMBER 7, 2023

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.

Clinical Trials 101

Clinical Trials Clinical Trials Trials Research 101

Outsourcing Pharma

JULY 26, 2021

A clinical trial logistics expert discusses specialized concerns involved in transporting cell and gene products and other personalized medicine items.

Medicine 98

Medicine Clinical Trials Clinical Trials Gene 98

Outsourcing Pharma

JULY 26, 2021

A clinical trial logistics expert discusses specialized concerns involved in transporting cell and gene products and other personalized medicine items.

Medicine 97

Medicine Clinical Trials Clinical Trials Gene 97

Pharmaceutical Technology

DECEMBER 12, 2022

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.

Manufacturing 147

Manufacturing Drugs Packaging Packaging 147

Outsourcing Pharma

DECEMBER 7, 2023

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.

Life Science 93

Life Science Clinical Trials Clinical Trials Marketing 93

Roots Analysis

FEBRUARY 28, 2024

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.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Manufacturing 40

Outsourcing Pharma

OCTOBER 20, 2023

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 clinical trials.

Clinical Trials 87

Clinical Trials Clinical Trials Trials Contract Manufacturing 87

Pharmaceutical Technology

JANUARY 30, 2023

This is mixed news for contract manufacturing 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.

Drugs 130

Drugs Manufacturing Contract Manufacturing FDA Approval 130

pharmaphorum

NOVEMBER 5, 2020

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.

Gene Therapy 98

Gene Therapy Gene Drugs Contract Manufacturing 98

Pharmaceutical Technology

FEBRUARY 24, 2023

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 contract manufacturing and laboratory services.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

Pharmaceutical Technology

FEBRUARY 24, 2023

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 contract manufacturing and laboratory services.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

Pharmaceutical Technology

AUGUST 30, 2022

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.

Manufacturing 195

Manufacturing Marketing Pharma Companies Vaccine 195

Outsourcing Pharma

SEPTEMBER 16, 2020

A session at the upcoming CPhI Festival of Pharma will examine supply chain, clinical trials, digitalization, and other factors impacting the field.

Clinical Trials 80

Clinical Trials Clinical Trials Trials Contract Manufacturing 80

pharmaphorum

JULY 7, 2021

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 contract manufacturer AGC Biologics, and the drug that teplizumab’s original developer Eli Lilly used in clinical trials.

Drugs 98

Drugs Insulin Contract Manufacturing Antibody 98

Outsourcing Pharma

MARCH 7, 2023

A clinical trial travel solution that can remove administrative burdens for research sites and eliminate logistical and financial barriers for participants has significantly expanded.

Trials 52

Trials Clinical Trials Clinical Trials Research 52

pharmaphorum

SEPTEMBER 15, 2020

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 contract manufacturer Lonza to make sure it can meet demand. Roche meanwhile is continuing to trial its drug in combination with remdesivir.

Drugs 97

Drugs Antibody Contract Manufacturing Immune Response 97

Outsourcing Pharma

SEPTEMBER 22, 2021

SmartSignals Supplies is designed to help trial teams get a handle on clinical trial supply chain management to avoid delays, waste, and cost overruns.

Clinical Supply Chain 69

Clinical Supply Chain Clinical Supply Clinical Trials Clinical Trials 69

Pharmaceutical Technology

JUNE 6, 2023

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 contract manufacturing services.

Contract Manufacturing 100

Contract Manufacturing Manufacturing Production Pharmacy 100

pharmaphorum

FEBRUARY 8, 2022

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 contract manufacturer 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.

Drugs 105

Drugs Contract Manufacturing Clinical Trials Clinical Trials 105

Outsourcing Pharma

JANUARY 24, 2023

The CDMO will manufacture the API for the biotechâs lead drug candidate, ahead of plans to begin clinical trials.

Manufacturing 59

Manufacturing Clinical Trials Clinical Trials Trials 59

Drug Patent Watch

DECEMBER 10, 2024

The typical cost of developing a biosimilar ranges from $100 million to $300 million, with clinical trials 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.

Manufacturing 97

Manufacturing Drugs Production Contract Manufacturing 97

Outsourcing Pharma

JANUARY 9, 2024

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 clinical trial cancellations, minimise protocol amendments, and accelerate patient recruitment. Gen Li is president and founder of Phesi.

Clinical Development 59

Clinical Development Development Clinical Trials Clinical Trials 59

XTalks

JANUARY 23, 2024

This venture also led me to identify a gap in the market for contract manufacturing 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.

Development 72

Development Hormones Drugs Trials 72

BioPharma Reporter

SEPTEMBER 22, 2021

Biocair has expanded its pharmaceutical and clinical trial logistics operations with new location in California, near Los Angeles International Airport.

Life Science 52

Life Science Clinical Trials Clinical Trials Trials 52

Outsourcing Pharma

DECEMBER 5, 2022

Experic raises $14m in series B led by Harro Hofilger Packaging Systems and East Seattle Partners as CDMO sees growth in DPI product and clinical trial supply needs.

Packaging 52

Packaging Packaging Clinical Trials Clinical Trials 52

Outsourcing Pharma

MARCH 30, 2023

In its bid to what it says will make participation in clinical trials easier and more sustainable, Greenphire has revealed a patient-powered registry and expanded a deal with Merck.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Contract Manufacturing 52

pharmaphorum

MARCH 21, 2022

Provention has modified its 14-day treatment course with teplizumab to match the exposure to the drug that was seen with the clinical trial material, and has also submitted responses to FDA questions about manufacturing and product quality.

Drugs 52

Drugs Insulin Contract Manufacturing Clinical Trials 52

pharmaphorum

NOVEMBER 18, 2022

In a clinical trial, 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.

Drugs 52

Drugs FDA Approval Insulin Clinical Trials 52

The Pharma Data

JANUARY 27, 2021

Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

The Pharma Data

JANUARY 6, 2021

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.

Manufacturing 52

Manufacturing Contract Manufacturing FDA Approval Development 52