Clinical Research, Clinical Trials and Contract Manufacturing

India’s contract manufacturing gains momentum due to high quality & cost effectiveness: Expert

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 2, 2023

India is strengthening its scope in contract manufacturing as the global customers commend the strengths and dependability of its pharma and biotech sectors.

Contract Manufacturing

Contract Manufacturing Manufacturing Pharmacy Clinical Trials

Bespoke Gene Therapy Consortium Selects 8 Rare Diseases for Clinical Trial Portfolio

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.

Gene Therapy

Gene Therapy Clinical Trials Clinical Trials Gene

Leading clinical packaging companies in contract marketing

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

Packaging Packaging Marketing Clinical Trials

(Lopinavir + ritonavir) by Douglas Pharmaceuticals for Genital Warts (Condylomata Acuminata): Likelihood of Approval

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. Douglas collaborates with scientific researchers and external medical experts to advance clinical research.

Contract Manufacturing

Contract Manufacturing Dermatology Hormones Production

(Lopinavir + ritonavir) by Douglas Pharmaceuticals for Cervical Intraepithelial Neoplasia (CIN): Likelihood of Approval

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. Douglas collaborates with scientific researchers and external medical experts to advance clinical research.

Contract Manufacturing

Contract Manufacturing Dermatology Hormones Production

FDA approves first T cell therapy in solid tumours

Drug Discovery World

FEBRUARY 19, 2024

“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research (CBER). Amtagvi is the first FDA-approved tumour-derived T cell immunotherapy.

FDA Approval

FDA Approval Contract Manufacturing Manufacturing Trials

Decline of novel drug approvals means less business for cutting-edge CMOs

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

Drugs Manufacturing Contract Manufacturing FDA Approval

Lumos Pharma’s Patient-Centric Strategy for Rare Disease Drug Development

XTalks

JANUARY 23, 2024

This venture also led me to identify a gap in the market for contract manufacturing of recombinant proteins. To fill this gap, I established a facility for this purpose in Research Triangle Park in North Carolina, which was eventually acquired by AkzoNobel and is now part of FUJIFILM Diosynth Biotechnologies.

Development

Development Hormones Drugs Trials

Eyeing emergency use of COVID-19 drug, Humanigen partners with Lonza to make it

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

Drugs Antibody Contract Manufacturing Manufacturing

FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

FDA Law Blog

JANUARY 1, 2024

Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators. Finally, FDA said in a Warning Letter that a Clinical Investigator, Anish S. If FDA wanted to create that impression, it likely succeeded.

Manufacturing

Manufacturing Production Drugs FDA Compliance

Accelerate Development of KRAS and TRAILR2 Compounds in Lung Cancer

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

Development Contract Manufacturing Research Medicine

Scaling up: The need for human cells to give better access to cell therapies

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. She has a track record of shepherding complex drug candidates from discovery to pivotal trials.

Manufacturing

Manufacturing In-Vivo Development Production

Johnson & Johnson Announces Landmark Agreement to Enable its COVID-19 Vaccine to be Manufactured and Made Available by an African Company for People Living in Africa

The Pharma Data

MARCH 8, 2022

We initiated clinical trials in all regions of the world to generate evidence across multiple geographies and diverse, at-risk populations and forged a strategic partnership with Aspen in Africa and others to manufacture our vaccine globally. Head of Global Public Health, Johnson & Johnson, Cilag GmbH International. “We

Manufacturing

Manufacturing Vaccination Vaccine Contract Manufacturing

Clinical Research Informer

India’s contract manufacturing gains momentum due to high quality & cost effectiveness: Expert

Bespoke Gene Therapy Consortium Selects 8 Rare Diseases for Clinical Trial Portfolio

Trending Sources

Leading clinical packaging companies in contract marketing

(Lopinavir + ritonavir) by Douglas Pharmaceuticals for Genital Warts (Condylomata Acuminata): Likelihood of Approval

(Lopinavir + ritonavir) by Douglas Pharmaceuticals for Cervical Intraepithelial Neoplasia (CIN): Likelihood of Approval

FDA approves first T cell therapy in solid tumours

Decline of novel drug approvals means less business for cutting-edge CMOs

Lumos Pharma’s Patient-Centric Strategy for Rare Disease Drug Development

Eyeing emergency use of COVID-19 drug, Humanigen partners with Lonza to make it

FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

Accelerate Development of KRAS and TRAILR2 Compounds in Lung Cancer

Scaling up: The need for human cells to give better access to cell therapies

Johnson & Johnson Announces Landmark Agreement to Enable its COVID-19 Vaccine to be Manufactured and Made Available by an African Company for People Living in Africa

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