Quality Systems

Articles

The new mechanism of action targets cholinergic receptors instead of the standard dopamine receptors.

FDA Approves Schizophrenia Treatment that Targets Cholinergic Receptors

The agency is recommending that the market authorization for Oxbryta (voxelotor) be suspended so that emerging data may be reviewed.

EMA Suspends Sickle Cell Disease Medicine

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Bio/pharma companies should be approaching their decarbonization journey as a strategic business move for the future as industry stakeholders are placing greater value on sustainability.

Strategic Decarbonization

Feliza Mirasol is the science editor for 

Phase III trial results showed that Imfinzi (durvalumab in combination with chemotherapy reduced the risk of recurrence, progression, or death by 32% in patients with resectable non-small cell lung cancer before and after surgery.

AstraZeneca’s Imfinzi Gets Expanded Indication in Lung Cancer on FDA Approval

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

PiaSky (crovalimab) has previously been approved in countries such as the United States and Japan for monthly, subcutaneous use that may be self-administered with adequate training.

Roche Treatment for Paroxysmal Nocturnal Hemoglobinuria Approved in EU

Opaganib was given orphan drug designation for the treatment of neuroblastoma in children, which is rare, but the most common infancy malignancy.

FDA Grants Orphan Drug Designation to RedHill’s Treatment for Neuroblastoma

In a 24-week study of patients with PAH, six-minute walking distance improved by an average of 40.8 meters, and risk of death or clinical worsening was reduced by 82%.

European Commission Approves Merck Treatment Combined with Other Therapies for Pulmonary Arterial Hypertension

The combination of Opdivo plus Yervoy is already established as a second-line treatment for patients with advanced hepatocellular carcinoma.

FDA Accepts Bristol Myers Squibb Application for Unresectable Hepatocellular Carcinoma First-Line Treatment

The International Coalition of Medicines Regulatory Authorities’ new Collaborative Hybrid Inspection Pilot program allows a CDMO to gain approval from multiple countries simultaneously, as opposed to separately phased inspections from different corners of the globe.

PCI Pharma Services Successfully Completes International Inspection of New Hampshire Campus

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Videos

This Behind the Headlines news roundup panel discussion covers news items such as the resurgence of mpox in Africa, “medical tourism” in India, Eli Lilly’s new Boston CGT facilities, and contract development and manufacturing organization (CDMO) projected growth rates for the 2023–2029 period, and the reasons behind them. 

Regulatory Authority Actions