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Regs & Legs

Guide: Understanding an API and all its forms with XRPD

11 November 2022 | By Malvern Panalytical

This Malvern Panalytical guide explores the use of Xray powder diffraction (XRPD) as a powerful tool to develop and improve pharmaceutical formulation.

news

Altasciences receives accreditation from College of American Pathologists

3 November 2022 | By Altasciences

The College of American Pathologists has given accreditation to Altasciences’ clinical site in Los Angeles, California.

Many type of medical drugs pills capsules and medicine poring from the bottle with isolation background in vintage retro color. Used for manufacturing health industry concept.

news

Simcere receives clearance to investigate a bi-functional fusion protein drug

28 October 2022 | By Ria Kakkad (Drug Target Review)

The FDA has cleared the Simcere's investigational new drug application for SIM0237, an anti-PD-L1/IL-15 bi-functional fusion protein, for the treatment of adult patients with advanced solid tumours.

news

Automated liquid handlers market set to record $242.84m growth

27 October 2022 | By Izzy Wood (Drug Target Review)

A report has found that increased investment in drug discovery will help the demand for personalised medicine, encouraging the growth of the liquid handling market.

news

Incannex completes positive pre-IND meeting for traumatic brain injury candidate

24 October 2022 | By Victoria Rees (Drug Target Review)

Incannex Healthcare has completed a pre-IND meeting with the FDA for IHL-216A, a drug product for treatment of traumatic brain injury.

news

FDA clears Cellenkos IND application for potential ALS treatment

20 October 2022 | By Victoria Rees (Drug Target Review)

Following FDA clearance, Cellenkos will initiate Phase I and Phase Ib trials of CK0803, allogeneic regulatory T cells, in patients with ALS.

Human tuberculosis blood signal replicated in mice

news

NIH awards $3.5 million grant for tuberculosis vaccine research

19 October 2022 | By Victoria Rees (Drug Target Review)

Texas Biomed and The Access to Advanced Health Institute have been granted $3.5 million to initiate tuberculosis vaccine research, which includes using genetically diverse animal models.

news

China approves IND application for Everest Medicines novel BTK inhibitor

18 October 2022 | By Victoria Rees (Drug Target Review)

The Chinese National Medical Products Administration has approved a Phase Ib study of Everest Medicines' EVER001, for potential treatment of glomerular diseases.

news

Decibel Therapeutics submits IND application for hearing loss gene therapy candidate

14 October 2022 | By Victoria Rees (Drug Target Review)

Decibel Therapeutics has submitted an IND application for a Phase I/II trial of DB-OTO, a gene therapy candidate to restore hearing.

news

Silo Pharma initiates pre-IND package for ketamine to treat fibromyalgia

13 October 2022 | By Victoria Rees (Drug Target Review)

Silo Pharma says it is preparing a pre-IND package and meeting with the FDA for a topical formulation of ketamine to treat fibromyalgia.

news

CEPI awards $5.2m funding for Nipah virus vaccine research

13 October 2022 | By Victoria Rees (Drug Target Review)

A Boston University researcher has been granted funding for the development pre-clinical models to test potential Nipah virus vaccines.

news

FDA accepts IND application for Clarametyx antibody therapy CMTX-101

12 October 2022 | By Victoria Rees (Drug Target Review)

Clarametyx says the FDA has accepted an IND application for first-in-human trials of CMTX-101, an antibody to treat bacterial pneumonia.

news

Cellistic and Celyad Oncology announce GMP cell therapy manufacturing operations transaction

21 September 2022 | By Cellistic

Cellistic has agreed to acquire Celyad Oncology’s Manufacturing Business Unit in Mont-Saint-Guibert, Belgium, for €6 million.

news

Monkeypox an international health emergency, WHO declares

23 July 2022 | By Victoria Rees (Drug Target Review)

The World Health Organization has declared monkeypox a Public Health Emergency of International Concern, the highest level of alert.

podcasts

Episode 9 – rDNA detection with Dr Jorge Haller, Prevail Therapeutics & Dr Mark White, Bio-Rad

17 June 2022 | By Drug Target Review

This podcast features an exploration of detecting host cell residual DNA in AAV vector production for gene therapy.

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