pharmaphorum

OCTOBER 27, 2020

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.”.

Drug Trials 97

Drug Trials Trials Drugs Contract Manufacturing 97

XTalks

JANUARY 29, 2021

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.

Clinical Trials 104

Clinical Trials Clinical Trials Production Trials 104

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. Clinical trial packaging and labelling solutions.

Packaging 100

Packaging Packaging Marketing Clinical Trials 100

Camargo

FEBRUARY 4, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Previously Approved Oncology Drug Cleared for Rare Pediatric Indication. Contact us to find out how we can support your program.

Development 131

Development Production Drugs Manufacturing 131

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. Find the leading clinical dose companies in contract marketing.

Marketing 100

Marketing Contract Manufacturing Sales Clinical Trials 100

Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Genital Warts (Condylomata Acuminata). 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.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Cervical Intraepithelial Neoplasia (CIN). 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.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

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

Drug Discovery World

FEBRUARY 22, 2023

In 2019 I forecast the arrival of AI in the drug discovery process, in 2023 we are seeing that this approach is now commonplace in molecule design, preclinical selection and the running of clinical trials. Looking to the future we will see more drug discoveries that are tailored to the individual rather than being mass produced.

Development 52

Development Drugs Manufacturing Contract Manufacturing 52

The Pharma Data

AUGUST 3, 2021

A recent trial showed a significantly lower risk with empagliflozin of hospitalization for heart failure or cardiovascular death in adult patients with HFpEF. Progress in mental health pipeline Boehringer Ingelheim also made progress in the area of neuropsychiatric disorders, including two ongoing phase II trials. billion EUR, up 5.8

Development 52

Development Research Contract Manufacturing Sales 52

Drug Discovery World

MARCH 6, 2024

Proceeds from the financing will enable the company to submit an IND for RNDP-001 and complete Phase I clinical trials, which will initiate within the year. Beyond RNDP-001, Kenai is developing a pipeline of off-the-shelf dopamine neuron replacement cell therapeutics for neurological disorders.

Contract Manufacturing 52

Contract Manufacturing Life Science Manufacturing Clinical Trials 52

Roots Analysis

FEBRUARY 27, 2024

On November 1, 2019, Avacta Group and ADC Therapeutics have announced a collaboration agreement for the development of novel drug candidates. The firm also has the right to obtain exclusive licenses to the Affimer proteins for clinical development and commercialization.

Antibody 52

Antibody Licensing Licensing Contract Manufacturing 52

Pharmaceutical Technology

JUNE 6, 2023

According to Globaldata, it is involved in 2 clinical trials, of which 1 was completed, and 1 is ongoing. The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress. The drug candidate is administered through intravenous or subcutaneous route.

Contract Manufacturing 100

Contract Manufacturing Manufacturing Production Pharmacy 100

Pharmaceutical Technology

FEBRUARY 27, 2023

Enzalutamide is under clinical development by Pfizer and currently in Phase I for Relapsed Multiple Myeloma. 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. EU and Asia. EU and Asia.

Hormones 113

Hormones Contract Manufacturing Manufacturing Development 113

The Pharma Data

MARCH 29, 2022

With Veeva Development Cloud, Boehringer Ingelheim aims to establish a connected technology landscape for agile collaboration that can accelerate the development of novel medicines Transformation focuses on reducing complexity and developing an innovative, digital culture to better understand and address unmet medical needs.

Development 52

Development Contract Manufacturing Medicine Clinical Development 52

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

Drug Discovery World

MARCH 8, 2024

For International Women’s Day (IWD), Diana Spencer highlights DDW interviews with eight inspirational women leaders in drug discovery and development. Stefanie Dedeurwaerdere, UCB Stefanie Dedeurwaerdere is Global Strategy Lead for Pipeline Development in Global Epilepsy & Rare Syndromes at UCB. Read the interview.

Drugs 69

Drugs Gene Editing Contract Manufacturing Antibody 69

Pharmaceutical Technology

FEBRUARY 27, 2023

Enzalutamide is under clinical development by Pfizer and currently in Phase I for Myelofibrosis. 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. EU and Asia. EU and Asia.

Hormones 100

Hormones Contract Manufacturing Manufacturing Development 100

Pharmaceutical Technology

FEBRUARY 27, 2023

Enzalutamide is under clinical development by Pfizer and currently in Phase I for Relapsed Chronic Lymphocytic Leukemia (CLL). 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. EU and Asia. EU and Asia.

Hormones 100

Hormones Contract Manufacturing Manufacturing Development 100

Drug Discovery World

MARCH 7, 2023

The two sister companies have developed an anti-cancer and anti-inflammatory drug that was contract-manufactured by Aldevron at the time Dr Ballantyne served there as chief scientific officer. Dr John Ballantyne, co-founder of Aldevron, has invested $3 million in CureLab Oncology and CureLab Veterinary.

Contract Manufacturing 52

Contract Manufacturing DNA Clinical Trials Clinical Trials 52

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

Roots Analysis

FEBRUARY 27, 2024

Ambrx and NovoCodex Biopharmaceuticals announced that they have formed a second collaboration to develop and commercialize Ambrx’s internally developed site-specific antibody drug conjugates. NovoCodex will fund global development activities to the end of Phase 1 clinical trials.

Antibody 40

Antibody Marketing Drugs Contract Manufacturing 40

The Pharma Data

APRIL 17, 2021

The collaboration, launched in 2019, has successfully combined MD Anderson’s innovative clinical research infrastructure and the patient-driven drug development capabilities of the Therapeutics Discovery division with Boehringer Ingelheim’s pipeline of innovative cancer medicines and expertise in advancing breakthrough therapies.

Development 52

Development Contract Manufacturing Research Medicine 52

pharmaphorum

NOVEMBER 5, 2020

An experimental gene therapy developed by Texas biotech Genprex will be paired with AstraZeneca’s Tagrisso and Merck & Co’s Keytruda – both leading their respective drug classes in the treatment of non-small cell lung cancer (NSCLC). Tagrisso is the top-selling EGFR inhibitor, with sales of almost $3.2

Gene Therapy 98

Gene Therapy Gene Drugs Contract Manufacturing 98

pharmaphorum

NOVEMBER 5, 2021

An oral antiviral drug developed by Pfizer has been shown to dramatically cut the risk of hospitalisation or death from COVID-19 when given in the early stages of infection. When the drug was given within three days of symptom onset, 0.8%

Contract Manufacturing 108

Contract Manufacturing DNA HR Manufacturing 108

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 106

Manufacturing Contract Manufacturing Protein Allergies 106

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

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

JANUARY 7, 2021

Shortly after launching large-scale trials of its COVID-19 vaccine candidate, CureVac has the partner it will need to roll the shot out at scale if it works as hoped. It gave CureVac €75 million in funding to develop CVnCoV last July, adding to around €100 million provided by the German government in 2020.

Vaccination 96

Vaccination Vaccine Contract Manufacturing Development 96

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

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 83

Drugs Antibody Contract Manufacturing Manufacturing 83

Pharmaceutical Technology

AUGUST 30, 2022

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.

Manufacturing 195

Manufacturing Marketing Pharma Companies Vaccination 195

The Pharma Data

JANUARY 6, 2021

Viral immunotherapies company Oncorus announced earlier this week that it will begin building a GMP facility this year to manufacture its pipeline as its candidates move into IND-enabling and clinical studies. At least one other company is developing next-generation oncolytic virus-based immunotherapies.

Manufacturing 52

Manufacturing Contract Manufacturing FDA Approval Clinical Trials 52

XTalks

APRIL 11, 2024

Abecma’s approval was based on results from the Phase III KarMMa-3 trial, which demonstrated that the therapy reduced the risk of disease progression by 51 percent compared to standard combinations. This could be seen as a positive for companies developing CAR T-cell therapies for autoimmune diseases and solid tumors.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

pharmaphorum

DECEMBER 18, 2020

GSK estimates that around 60% of the 300,000-plus severe SLE patients in the US suffer from lupus nephritis each year, and a quarter of those develop end-stage renal disease. Another potential lupus nephritis rival is Aurinia Pharma’s voclosporin, which hit the mark last year in the phase 3 AURORA trial.

FDA Approval 75

FDA Approval Contract Manufacturing Sales Trials 75

Camargo

JANUARY 19, 2021

When developing a novel therapy, sponsors can modify certain aspects of their CMC execution as clinical testing progresses. They also have multiple clients, and thus by definition have many demands on their time and resources, particularly their manufacturing equipment and analytical capabilities. Proposed Labeling.

Production 135

Production Branding Contract Manufacturing Manufacturing 135

Pharmaceutical Technology

NOVEMBER 30, 2022

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. Manufacturing for Wegovy was also hit when a contract manufacturer in charge of syringe filling halted deliveries due to issues with good manufacturing practices.

Drugs 264

Drugs Manufacturing Hormones Contract Manufacturing 264