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Results For "regulatory"

1222 News Found

I Peace triples GMP cell manufacturing by expanding CDMO facility
Biotech | March 15, 2022

I Peace triples GMP cell manufacturing by expanding CDMO facility

The facility registration, along with DMF registration and GMP certification provides peace of mind to clients looking to use our iPSCs for clinical and commercial use in the United States, Japan, and other global markets


Biogen and Eisai amend collaboration agreements on Alzheimer’s disease treatments
News | March 15, 2022

Biogen and Eisai amend collaboration agreements on Alzheimer’s disease treatments

Aducanumab collaboration to convert from Eisai sharing of global profits and losses to a global royalty arrangement, effective January 1, 2023


Spectrum Chemical launches products for vaccines, therapeutics and biopharmaceuticals
Biotech | March 15, 2022

Spectrum Chemical launches products for vaccines, therapeutics and biopharmaceuticals

A growing portfolio of chemicals is part of a larger quality management system that sets new standards in bioprocessing


AbbVie and Scripps Research plan to develop anti-viral for Covid-19
News | March 15, 2022

AbbVie and Scripps Research plan to develop anti-viral for Covid-19

The initial SARS-CoV-2 research program at Calibr, the drug discovery and development division of Scripps Research, was supported by funding from the Bill & Melinda Gates Foundation


Draft policy on medical devices released
Policy | March 14, 2022

Draft policy on medical devices released

Feedback and remarks of the industry and stakeholders are invited till the 25th of March 2022


USFDA clears Niramai's breast thermography device
News | March 14, 2022

USFDA clears Niramai's breast thermography device

The SMILE-100 System is a breast thermography device that helps healthcare personnel review, measure and analyze thermally significant indications in the breast region


Indian pharma companies must become the global benchmark of quality: Amit Jaju, Sr. MD, India, Ankura Consulting
interviews | March 13, 2022

Indian pharma companies must become the global benchmark of quality: Amit Jaju, Sr. MD, India, Ankura Consulting

Amit Jaju, Senior Managing Director, India in an interview with Thomas C Thottathil outlined the steps Indian pharma companies should follow to be compliant with global regulatory requirements


Govt earmarks Rs 500 crore for pharma clusters and MSMEs
Policy | March 12, 2022

Govt earmarks Rs 500 crore for pharma clusters and MSMEs

Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers releases guidelines for the scheme


AbbVie and Gedeon Richter to collaborate on neuropsychiatric diseases
Biotech | March 11, 2022

AbbVie and Gedeon Richter to collaborate on neuropsychiatric diseases

Agreement builds on 15 years of successful collaboration between AbbVie and Richter, including globally launched cariprazine products


AbbVie’s Phase 3 data of Atogepant indicates positive outcome for migraine treatment
Biotech | March 11, 2022

AbbVie’s Phase 3 data of Atogepant indicates positive outcome for migraine treatment

Data from this study will support a submission to expand the use of atogepant to include preventive treatment of chronic migraine in the United States and additional submissions globally