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Ayush Ministry to amend D&C Rules mandating cGMP for homoeopathic drug manufacturing license

AuroBlog - Aurous Healthcare Clinical Trials blog

The Union Ministry of Ayush will soon amend the Drugs and Cosmetic Rules, 1945 to mandate good manufacturing practices for Homoeopathy drug manufacturing, stipulating procedures for loan licensing in the system of Homoeopathy and specifying timelines for issuance of license, among others.

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Licensing regime posing challenge to micro and small medical devices industry: SMTA

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central government’s actions to mandate licensing of all medical devices is posing a challenge to the industry, especially the micro and small enterprises in the sector, says the Surgical Manufacturers and Traders Association (SMTA), the pan India organisation of manufacturers and traders of surgical equipment for healthcare services providers (..)

Licensing 171
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6 Operational Considerations You Need To Know for Psychedelic Trials

Worldwide Clinical Trials

Bringing a psychedelic into a clinical trial setting is complex and requires a thorough operational approach to ensure the study’s success. Psychedelic trials need to be done with scientific rigor. Our team published recently in The Journal of Psychedelic Psychiatry exploring how we can bring more rigor to these trials.

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OncoVerity eyes cusatuzumab development in AML after licensing rights

Pharmaceutical Technology

On March 27, OncoVerity announced the acquisition of worldwide licensing rights of the anti-CD70 monoclonal antibody cusatuzumab from the biotech argenx. Alongside this, the company closed a $30 million Series A, which came from both argenx and the venture of UCHealth and the University License Equity Holdings.

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Biogen licenses Denali’s amyloid beta programme for Alzheimer’s

Pharmaceutical Technology

Biogen has exercised an option to license Denali Therapeutics ’ (Denali) programme to develop immunotherapies for the treatment of Alzheimer’s disease. We are pleased with Biogen’s decision to license ATV: Aβ and we are hopeful this will foster the development of next-generation anti-Aβ therapeutics.”

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Bio-Thera and Biomm enter licensing deal for ustekinumab biosimilar

Pharmaceutical Technology

Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. The therapy, which completed a Phase I trial, is now being assessed in an international Phase III clinical trial that includes participants from China and Eastern European countries.

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Renaissance Pharma licenses Hu14.18 for neuroblastoma

Drug Discovery World

Renaissance Pharma has announced its first development programme focused on Hu14.18, a humanised anti-GD2 monoclonal antibody (mAb), licensed from St Jude Children’s Research Hospital for the treatment of newly diagnosed high-risk neuroblastoma. A novel Phase II trial incorporating Hu14.18 and three-year event-free (EFS) of 73.7%.