BioPharma Reporter

OCTOBER 10, 2024

Evaxionâs proprietary AI-Immunology platform has shown in clinical trials that it can select clinically relevant cancer vaccine targets.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Vaccination 98

XTalks

MAY 17, 2023

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.

Gene Therapy 98

Gene Therapy Clinical Trials Clinical Trials Gene 98

Fierce Pharma

OCTOBER 31, 2023

Even as Catalent dusts itself off from a pandemic sales plunge, the company may be teetering on the edge of another contract manufacturing precipice.

Gene Therapy 59

Gene Therapy Gene Contract Manufacturing Trials 59

pharmaphorum

AUGUST 7, 2020

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 contract manufacturing services at its facility in McPherson, Kansas, to supply the drug to Gilead. This is the third iteration of the ACTT trial.

Manufacturing 119

Manufacturing Contract Manufacturing Protein Allergies 119

Outsourcing Pharma

MAY 7, 2024

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.

Clinical Trials 86

Clinical Trials Clinical Trials Trials Contract Manufacturing 86

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

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

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

pharmaphorum

NOVEMBER 5, 2021

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.

DNA 116

DNA Contract Manufacturing HR Manufacturing 116

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

Outsourcing Pharma

JULY 22, 2020

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.

Trials 101

Trials Clinical Research Research Contract Manufacturing 101

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

SEPTEMBER 22, 2021

A logistics leader from the CRO offers advice on navigating borders, cultures, regulatory issues and other important considerations on worldwide studies.

Trials 98

Trials Contract Manufacturing Manufacturing 98

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

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

BioPharma Reporter

JUNE 5, 2024

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

Research 94

Research Trials Production Contract Manufacturing 94

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

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

pharmaphorum

AUGUST 10, 2020

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.

Drugs 99

Drugs In-Vivo In-Vitro Contract Manufacturing 99

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 22, 2021

A leader from the global clinical research logistics company shares how to weigh the complex aspects of a decentralized trial and craft intelligent strategy.

Trials 60

Trials Clinical Research Research Contract Manufacturing 60

pharmaphorum

DECEMBER 18, 2020

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.

FDA Approval 99

FDA Approval Contract Manufacturing Sales Trials 99

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

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

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

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

OCTOBER 9, 2020

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.

Vaccine 105

Vaccine Vaccination Drugs Contract Manufacturing 105

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

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

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

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

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

BioPharma Reporter

DECEMBER 14, 2023

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.

Dermatology 97

Dermatology Trials Contract Manufacturing Manufacturing 97

Outsourcing Pharma

OCTOBER 9, 2023

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).

Trials 52

Trials Development Contract Manufacturing Manufacturing 52

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