XTalks

JANUARY 23, 2024

Among these, rare pediatric diseases present unique challenges and opportunities for rare disease drug development. Pediatric growth hormone deficiency (PGHD) is one such condition, affecting a child’s growth and development. This venture also led me to identify a gap in the market for contract manufacturing of recombinant proteins.

Development 72

Development Hormones Drugs Trials 72

Roots Analysis

FEBRUARY 14, 2023

Presently, outsourcing of liposomes development and manufacturing related services has become a popular practice. Drug developers are actively outsourcing their operations to specialized repurposed-based service providers, which are known to have the required capabilities and expertise.

Development 52

Development Manufacturing Drug Delivery Systems 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

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

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

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

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

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

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. The team and the strength of their recent clinical data is what made me want to invest,” said Dr Ballantyne.

Contract Manufacturing 52

Contract Manufacturing DNA Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 3, 2021

Boehringer Ingelheim also announced the planned initiation of the innovative CONNEX Phase III clinical trial program assessing the safety and efficacy of BI 425809, a novel glycine transporter-1 (GlyT1) inhibitor, for improving cognition in adults with schizophrenia. In the first six months, the company generated net sales of 9.8

Development 52

Development Research Contract Manufacturing Sales 52

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

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

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

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

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

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 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

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

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

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

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). The post Genprex cancer gene therapy paired with AZ, Merck lung cancer drugs appeared first on.

Gene Therapy 98

Gene Therapy Gene Drugs Contract Manufacturing 98

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

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

The Pharma Data

JANUARY 27, 2021

The two-hour event will cover various topics, including an overview of the Company’s board and executive leadership, its commitment to environment, social and governance (ESG) matters, and progress updates on the Company’s critical care programs, manufacturing and distribution approach, and commercial readiness plans. 28, 2021 11:00 UTC.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

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

XTalks

APRIL 11, 2024

Concerns of Early Deaths The expanded approvals come after the FDA had flagged reports of early deaths in clinical trials evaluating the therapies in earlier treatment line settings. 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

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 246

Drugs Manufacturing Hormones Contract Manufacturing 246

The Pharma Data

FEBRUARY 24, 2022

The accelerated development of BI 1015550 is part of Boehringer Ingelheim’s next wave of potential innovative treatments for interstitial lung diseases aimed at preserving lung function and improving the lives of patients,” said Thomas Seck, M.D., The FDA Breakthrough Therapy designation is supported by data collected to date.

Contract Manufacturing 52

Contract Manufacturing Medicine Clinical Trials Clinical Trials 52

Pharmaceutical Technology

MARCH 21, 2023

In such turbulent times, ensuring the most efficient and cost-effective manufacturing frameworks becomes even more important. Most pharmaceutical and biotech companies outsource certain production tasks to contract manufacturing organizations (CMOs). BioCentriq is contracted to manufacture the biologic API.

Manufacturing 147

Manufacturing Drugs Packaging Packaging 147

pharmaphorum

AUGUST 11, 2021

AXS-05 – a fixed-dose combination of established drugs dextromethorphan and bupropion – is under a priority review by the FDA for major depressive disorder (MDD), based on the results of two clinical trials which revealed statistically significant improvements in symptoms compared to placebo or bupropion alone.

Drugs 52

Drugs Contract Manufacturing Marketing Clinical Trials 52

pharmaphorum

JANUARY 19, 2021

They will announce further updates about European vaccine supplies and the companies said they are planning to add more vaccine suppliers and contract manufacturers to boost worldwide capacity. Vaccines have been developed by companies based in China, India, Russia, the UK and the US, often with help from government funding.

Vaccination 64

Vaccination Vaccine Contract Manufacturing Manufacturing 64

The Pharma Data

NOVEMBER 19, 2021

Pfizer has also begun and will continue to invest up to roughly$ 1 billion of its own finances to support the manufacturing and distribution of this investigational treatment seeker, including exploring implicit contract manufacturing options.

HR 52

HR Contract Manufacturing Manufacturing Clinical Trials 52

Drug Discovery World

FEBRUARY 26, 2024

These therapies, which utilise human cells to replace diseased or damaged cells or use engineered cells to act as therapies for a specific disease, have become more common in recent years, with approvals and clinical trials increasing. The company’s lead programme was chosen based on “minimal clinical risk”, according to Golden. “It’s

Manufacturing 52

Manufacturing In-Vivo Development Production 52

XTalks

FEBRUARY 27, 2024

XTALKS WEBINAR: Development of CAR-T Cells for T-ALL Targeting CCR9 Live and On-Demand: Wednesday, March 6, 2024, at 11am EST (4pm GMT/UK) Register for this free webinar to explore the developments in cancer immunotherapy targeting CC chemokine receptor 9 (CCR9), a potential breakthrough for T-cell acute lymphoblastic leukemia (T-ALL).

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

Drug Discovery World

DECEMBER 14, 2023

With leading academic institutions and significant recent investment, Glasgow is shaping up to be an important centre for drug discovery and development in the UK. Paul Smith, CEO at BioAscent, agrees: “Collaboration is central to the continued development of Glasgow as a globally important drug discovery hub.

Drugs 75

Drugs Life Science Research Scientist 75